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The Law on Medicines
Law, OG 76 / 2013-1522 More 
CROATIAN PARLIAMENT
1522
Pursuant to Article 89 of the Constitution of the Republic of Croatia, I hereby
DECISION
ON THE DECLARATION OF THE MEDICINAL LAW
I hereby declare the Law on Medicines, adopted by the Croatian Parliament at its session of 14 June 2013.
Class: 011-01 / 13-01 / 136
Reg. No: 71-05-03 / 1-13-2
Zagreb, 18 June 2013
The President
Of the Republic of Croatia
Ivo Josipović, Ph.D. r.
THE MEDICINAL LAW
I. GENERAL PROVISIONS
Article 1
(1) For the purpose of ensuring effective, quality and safe medicines as products of special importance for human health, this Law establishes
testing and marketing process, production, labeling, classification, marketing, pharmacovigilance, quality control, advertising, supply
of the Croatian market for medicines and supervision of medicines, tested medicines, active substances and excipients.
(2) Terms used in this Law and regulations adopted thereunder that have a gender meaning, whether or not used in
masculine or feminine gender, encompassing male and female gender alike.
Article 2
(1) The following Directives are transposed into the legal order of the Republic of Croatia by this Law:
1. Council Directive 89/105 / EEC of 21 December 1988 on transparent standards determining the prices of medicines for human use
and their inclusion in national health insurance systems (OJ L 40, 11.2.1989),
2. Directive 2001/20 / EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States
relating to the application of good clinical practice in conducting clinical trials of medicinal products for human use (OJ L 121, 1.5.2001),
3. Commission Directive 2005/28 / EC of 8 April 2005 laying down the principles and detailed guidelines of good clinical practice for medicinal products for use in
people in the testing phase and the requirements for approval of the manufacture and import of these drugs (OJ L 91/13, 9.4.2005),
4. Directive 2001/83 / EC of the European Parliament and of the Council of 6 November 2001 on a Community code relating to medicinal products for human use
(OJ L 311, 28.11.2001),
5. Directive 2002/98 / EC of the European Parliament and of the Council of 27 January 2003 supplementing Directive 2001/83 of the European Parliament and of the Council of 6 January 2003.
November 2001 on the Community code relating to medicinal products for human use (OJ L 33/30, 8.2.2003),
6. Commission Directive 2003/63 / EC of 25 June 2003 supplementing Directive 2001/83 of the European Parliament and of the Council of 6 November 2001
The Community Code relating to Medicinal Products for Human Use (OJ L 159, 27.6.2003),
7. Commission Directive 2003/94 / EC of 16 October 2003 on the principles and guidelines of good manufacturing practice for medicinal products for human use and
tested medicines for human use (OJ L 262/22, 14.10.2003),
8. Directive 2004/24 / EC of the European Parliament and of the Council of 31 March 2004 on traditional herbal medicinal products (OJ L 136, 30.4.2004),
9. Directive 2004/27 / EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83 / EC on the Code
Community relating to medicinal products for human use (OJ L 136, 30.4.2004),
10. Directive 2008/29 / EC of the European Parliament and of the Council of 11 March 2008, supplementing Directive 2001/83 of the European Parliament and of the Council of 6 March 2008.
November 2001 on the Community code relating to medicinal products for human use (OJ L 81, 20.3.2008),
11. Directive 2009/53 / EC of the European Parliament and of the Council of 18 June 2009 supplementing Directive 2001/83 of the European Parliament and of the Council of 6 June 2009.
November 2001 on the Community code relating to medicinal products for human use (OJ L 168, 30.3.2009),
12. Commission Directive 2009/120 / EC of 14 October 2009 supplementing Directive 2001/83 of the European Parliament and of the Council of 6 November 2001
The Community Code relating to Medicinal Products for Human Use (OJ L 242, 15.9.2009),
13. Directive 2010/84 / EU of the European Parliament and of the Council of 15 December 2010 supplementing Directive 2001/83 of the European Parliament and of the Council of 6 December 2010.
November 2001 on the Community code relating to medicinal products for human use (OJ L 276, 21.10.2011),
14. Directive 2011/62 / EU of the European Parliament and of the Council of 8 June 2011 supplementing Directive 2001/83 of the European Parliament and of the Council of 6 June 2011.
November 2001 on the Community code relating to medicinal products for human use (OJ L 174, 1. 7. 2011),
15. Directive 2012/26 / EU of the European Parliament and of the Council of 25 October 2012 supplementing Directive 2001/83 / EC on pharmacovigilance
(OJ L 299, 27.10.2012).
(2) This Law regulates the implementation of the following regulations:
1. Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on medicines for rare and serious diseases (OJ L 18, 22.1.2000),
2. Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down criteria for the designation of a medicinal product as a cure for rare and serious diseases and diseases
the terms "similar drug" and "clinical superiority" (OJ L 103, 28.4.2000),
3. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community authorization and control procedures
of medicinal products for human and animal use, establishing the European Medicines Agency (OJ L 136, 30.4.2004),
4. Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 20 December 2006 on medicinal products for pediatric use (OJ L 378, 27.12.2006),
5. Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 on medicinal products for children and supplementing Regulation (EC) No 1901/2006
medicines for pediatric use (OJ L 378, 27.12.2006),
6. Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 supplementing Directive 2001/83 of the European Parliament and
Council Regulation of 6 November 2001 on the Community code relating to medicinal products for human use and Regulation (EC) No 726/2004 (OJ L 324, 10. 12.
2007),
7. Commission Regulation (EC) No 658/2007 of 14 June 2007 on the penalties for breach of the obligations relating to authorizations issued under EC Regulation
No 726/2004 of the European Parliament and of the Council (OJ L 155, 15.6.2007),
8. Commission Regulation (EC) No 1234/2008 of 24 November 2008 examining changes to the conditions of a marketing authorization for medicinal products for use in
humans and animals (OJ L 334/7, 12.12.2008),
9. Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 712/2012 Amending Regulation (EC) No 1234/2008 examining the modification of the conditions of approval of
the placing on the market of medicinal products for human and animal use (OJ L 209, 4.8.2012),
10. Regulation (EU) No 1095/2010 1027/2012 of the European Parliament and of the Council of 25 October 2012 supplementing Regulation (EC) No 726/2004 on pharmacovigilance
(OJ L 316, 14.11.2012).
Article 3
Some terms within the meaning of this Act have the following meaning:
1. The cure is:
- any substance or combination of substances presented with the properties of treating or preventing disease in humans, or
- any substance or combination of a substance that can be used or applied to humans for the purpose of restoring, correcting or adjusting biological functions
by pharmacological, immunological or metabolic action or for medical diagnosis,
2. The substance referred to in item 1 of this Article may be:
- of human origin, e.g. human blood and human blood products,
- of animal origin, e.g. microorganisms, animals, organ parts, animal secretions, toxins, extracts, blood products,
- of plant origin, e.g. microorganisms, plants, plant parts, plant secretions, plant extracts,
- of chemical origin, e.g. chemical elements, chemical substances of natural origin and chemical products obtained by synthesis,
3. Active substance is a substance or mixture of substances intended to produce a drug that becomes the active ingredient of the drug with a pharmacological, immunological or
metabolic activity for the purpose of restoring, correcting or adjusting physiological functions or making a medical diagnosis,
4. Excipient is an ingredient of a drug that is not an active substance or a container material,
5. Intermediate is a product for which a partial treatment has been carried out and is used as a raw material in the further process of drug production,
6. Master preparation is a drug made in a pharmacy laboratory for a particular patient according to a doctor's prescription, according to a standard prescription from a specialist
pharmaceutical manuals or pharmacopoeia,
7. Galenic preparation is a drug made in a pharmacy laboratory or galenic laboratory according to a manufacturing method in a valid pharmacopoeia or according to
standard recipes from expert pharmaceutical manuals and standards of good practice for galenic laboratories,
8. The name of a medicinal product is the name given to a medicinal product, which may be either a newly invented or a common or scientific name. With the common name, that is, the scientific name
the trademark or name of the authorization holder is added. The newly invented name must be different from the common name and should not be confused,
9. The common name is an international non-proprietary name (INN) recommended by, or in the absence of, the World Health Organization, other
common name,
10. Strength of the drug is the content of the active substance expressed quantitatively per unit dose, per unit volume or mass according to the pharmaceutical form,
11. Immunologicals are vaccines, toxins, serums and allergen products.
a) Vaccine, toxin and serum include in particular:
- agents used to create active immunity;
- agents used to create passive immunity;
- agents used to diagnose the immune state;
b) An allergen product is a drug that is intended to detect or stimulate a specific acquired change in the immune response to an allergenic agent.
12. A human blood or human plasma drug is an industrially produced drug based on blood components such as: albumin, clotting factors and
immunoglobulins of human origin, having regard to the principle of self-sufficiency in the supply of these drugs,
13. A radiopharmaceutical is a medicinal product that is prepared for use containing one or more radionuclides (radioactive isotopes) intended for medical use,
14. A radionuclide generator is a system with a parent (source) radionuclide to obtain a particular radionuclide needed for fresh preparation
radiopharmaceuticals,
15. A closed-source radionuclide is a radioactive substance tightly enclosed in a container that irradiates a patient from outside for treatment,
1 6. A radionuclide kit is a preparation that will be established or mixed with a radionuclide, usually just before use, in the finished state.
radiopharmaceutical,
17. A radionuclide precursor is a radionuclide produced to radiolabel other substances before administration,
18. Homeopathic remedy is a remedy made from substances used as homeopathic sources, according to the homeopathic manufacturing process described in
To the European Pharmacopoeia or to any other applicable pharmacopoeia of the Member States of the European Union, if not described by the European Pharmacopoeia; homeopathic remedy
may contain multiple principles,
19. An herbal remedy is a medicinal product containing, as active substances, only one or more herbal substances or one or more herbal preparations, or one or more herbal substances in
in combination with one or more herbal preparations,
20. Traditional herbal medicine is a herbal medicine whose safety of use and effectiveness can be recognized by its traditional use and which
meets the conditions set out in this Law,
21. Herbal substances are whole or sliced ​​plants, parts of plants, algae, lichens, fungi, in dried or fresh form, and untreated plant secretions; herbal
substances are indicated by the part of the plant used and the botanical name of the plant according to the binomial system (genus, species, subspecies and author),
22. Herbal preparations are preparations obtained by various processes from plant substances (grinding, extraction, fermentation, distillation, purification,
concentrating, weighing) and include ground or powdered herbal substances, tinctures, extracts, essential oils, squeezed juices and processed secretions
plants,
23. The risk associated with the administration of the drug is:
- any risk to the health of the patient or the population, related to the quality, safety of administration or efficacy of the medicinal product,
- any risk of adverse effects on the environment,
24. The risk-benefit balance is an assessment of the positive therapeutic effects of the medicinal product with respect to the risks referred to in point 23 of this Article,
25. Clinical trial is any human trial designed to detect or confirm clinical, pharmacological and / or other pharmacodynamic
the effects of one or more test drugs and / or the detection of side effects of one or more test drugs, and / or the absorption, distribution,
metabolism and excretion of one or more investigated drugs for the purpose of determining the safety of administration and / or efficacy. This includes
clinical trials conducted in one or more study sites, in one or more Member States of the European Union,
26. Multicenter clinical trial is a clinical trial that is conducted in accordance with a single trial plan, but on more than one trial
more than one examiner. Test sites may be located in one Member State of the European Union, in several Member States and / or in
Member States of the European Union and third countries,
27. Non-profit clinical trial is a clinical trial conducted by an examiner without the involvement of the pharmaceutical industry,
28. Non-interventional study of a medicinal product is any study in which the medicinal product is prescribed in accordance with the marketing authorization. Patient involvement
to a particular therapeutic procedure is not predetermined by the test plan but is carried out in accordance with normal practice, and prescribing is a cure
regardless of the decision to enroll the patient in the trial. Additional diagnostic and patient follow-up procedures are not performed but are performed
use epidemiological methods to analyze the data collected,
29. The investigational drug is a pharmaceutical formulation with an active substance or a placebo that is being tested or used as a comparison in a clinical trial and includes
medicinal products authorized on the market but used in a different way from that approved or different in formulation or packaging, or
are used in unauthorized indications or used to obtain additional information on a marketing authorization form,
30. The client of the clinical / non-intervention trial is a legal or legal person responsible for initiating a clinical / non-intervention trial,
the management of the clinical / non-intervention trial and / or the cost of the clinical / non-intervention trial,
31. The representative of the clinical / non-intervention trial client is a legal or registered person established in the European Union.
a clinical / non-intervention trial based outside the European Union,
32. The examiner is a doctor of medicine or a person with appropriate professional qualifications for clinical trials due to his / her expertise and
required experience in treating patients. The examiner is responsible for conducting the clinical trial at the test site. If a clinical trial
is conducted by a group of individuals at one test site, the examiner is responsible and is called the lead examiner,
33. The test site is the health care institution where the clinical trial is conducted,
34. The respondent is an individual who participates in a clinical trial and receives the study drug or is part of a control group,
35. The Examiner Instruction is a document that presents clinical and non-clinical information on a study drug that is relevant to a particular clinical
examination,
36. A clinical trial plan is a document that describes the objectives, design, methodology, statistical considerations, and organization of the clinical trial
which includes the test plan itself, all subsequent versions of the test plan, and any amendments thereto,
37. Informed consent is consent to participate in a clinical trial given voluntarily on the basis of received and properly documented
notices of the nature and importance, consequences and risks of the examination, in writing, signed by the respondents and dated. If a person
incapable of giving such consent or is a minor, the consent is signed by a legal representative or guardian. If the respondent is illiterate or cannot
to write, give oral consent in the presence of at least one witness who is not a member of the examination team,
38. Good laboratory practice is a quality system that relates to the organizational processes and conditions in which non-clinical trials are safe for health and
the environment (hereinafter referred to as "non-clinical trial") plan, conduct, monitor, record, store and submit reports,
39. Good clinical practice is a set of internationally recognized ethical and scientific requirements that are followed in the planning, implementation, recording and
clinical trial reporting,
40. The Central Ethics Committee is an independent body composed of health professionals and other members of the non-medical profession, whose task is to protect rights,
the safety and well-being of the subjects involved in the clinical trials and to provide assurance as to that protection, inter alia by expressing an opinion on the plan
the examinations, the eligibility of the examiner, the legal entity in which the test is conducted, the equipment and the methods and documents to be used for
informing the respondents and obtaining their consent based on informed consent. The Central Ethics Committee is appointed by the minister in charge
for Health (hereinafter: the Minister),
41. Inspection of clinical trials is the supervision of the competent authority over the conduct of the clinical trial, review of documentation, premises, records,
quality assurance systems and other resources related to the conduct of the clinical trial, which may be conducted at the test site, in the premises
of the clinical trial client and / or the contracting authority or in other legal entities where the competent authority deems it necessary to carry out supervision.
42. The inner medicine package is a container or other form of packaging in direct contact with the medicine,
43. The outer packaging of a medicinal product is a packaging containing the medicinal product fitted in an inner packaging,
44. The summary of product characteristics is a summary of the expert information on a medicinal product approved in the authorization process, intended for healthcare professionals,
45. Medication labeling is information on the outer or inner packaging,
46. ​​The Package Leaflet is a package leaflet of the medicine for the users that comes with the medicine
47. A biological drug is a drug whose active substance is a biological substance; biological substance is a substance that is produced or extracted from a biological source and for which it is characterized
and determining the quality of the required chemical, chemical and biological tests, together with information on the manufacturing process and its control. Biological
medicines are considered to be immunological medicines, medicines from human blood or human plasma, medicines obtained by biotechnological processes and medicines for
advanced therapy,
48. Advanced therapy is a medicine for humans based on gene therapy, somatic cell therapy or tissue engineering as prescribed
Regulation (EC) No 1394/2007,
49. A counterfeit drug is a drug that is misrepresented with intent to deceive, given that:
a) identity, including the packaging and labeling of the medicinal product, the name or composition of the medicinal product with respect to any constituent of the medicinal product, including excipients and strength
drug;
b) the origin, including the manufacturer, the country of manufacture and the country of origin of the medicinal product or the marketing authorization holder;
c) traceability, including records and documents relating to the marketing of the medicinal product.
The definition does not refer to a drug with unintentional quality defects and does not cover issues of infringement of intellectual property rights,
50. A natural person is a person who independently carries out an activity permanently in accordance with a special regulation, that is, a person established in the European Union who
acting independently in accordance with the regulations of a Member State of the European Union,
51. The marketing authorization holder is a legal or legal person established in the European Union who is approved by the Medicines Agency and
medicinal products or the European Commission for placing a medicine on the market and is responsible for the placing on the market,
52. The representative of the marketing authorization holder is a legal or legal person authorized by the marketing authorization holder to represent it in the Republic.
Croatia,
53. A production permit is a decision by a competent authority certifying that a manufacturer is manufacturing or manufacturing plants
of the medicinal product and / or the investigated medicinal product meets the requirements for premises, equipment and staff and applies the principles and guidelines of good manufacturing
practices,
54. The manufacturer of the medicinal product is a natural or legal person holding a manufacturing authorization to manufacture the medicinal product and / or the investigational medicinal product issued by the competent authority,
55. Good manufacturing practice is part of a quality assurance system that ensures that medicines are consistently and permanently manufactured and checked against
appropriate quality standards in accordance with their purpose,
56. The person responsible for placing a batch of a medicinal product on the market is a person who fulfills the conditions laid down in Article 49 of Directive 2001/83 / EC,
57. Pharmacovigilance is a set of activities related to the detection, evaluation, understanding, prevention and treatment of medicines side effects as well as
new knowledge about the harmfulness of drug administration,
58. The responsible person of the marketing authorization holder for a pharmacovigilance in the Republic of Croatia is a doctor of medicine, a specialist clinical
Pharmacology or Doctor of Medicine, Doctor of Dental Medicine, Master of Pharmacy, Master of Medical Biochemistry, or Doctor of Veterinary Medicine
medicine with two years of pharmacovigilance experience or two years of professional experience with appropriately documented
pharmacovigilance education,
59. A side effect is any adverse and adverse reaction to a drug,
60. A side effect in clinical trials is any adverse and adverse reaction to a drug, regardless of the dose used,
61. An unexpected side effect is any side effect whose nature, severity or outcome is not in accordance with the approved summary of product characteristics,
that is, in the instructions for the examiner for medicines that are in clinical trials,
62. Adverse event is any adverse and unwanted sign, symptom or disease (including deviations in laboratory findings) associated with
administration of a drug that may not be causally related to the administration of the drug,
63. A serious adverse event / serious adverse event is any adverse event / adverse event that includes the following: death of a person, life-threatening condition, need for
hospital treatment or extension of pre-existing hospital treatment, permanent or severe disability or incapacity, congenital anomaly / defect from
birth and other medically significant conditions,
64. The Periodic Safety Update Report (hereinafter referred to as PSUR) is a medicinal product safety report containing a comprehensive and
critical analysis of the risk / benefit ratio of the medicinal product, taking into account all available information, and submitted by the marketing authorization holder in certain
the time intervals after obtaining marketing authorization,
65. Misuse of a drug is a permanent or occasional willful overuse of a drug that is accompanied by a detrimental physical or psychological effect,
66. A risk management system is a set of pharmacovigilance activities and interventions aimed at identifying, characterizing, preventing or
minimizing drug-related risk, including evaluating the effectiveness of these activities and interventions,
67. The Risk Management Plan (hereinafter: RMP) is a detailed description of the risk management system,
68. The pharmacovigilance system is a system used by marketing authorization holders and the Agency for Medicinal Products and Medical Devices
fulfilling the tasks and responsibilities prescribed by the provisions of this Pharmacovigilance Act and aimed at monitoring the safety of medicinal products that
have approval to place on the market and detect changes in risk-benefit ratio,
69. The Pharmacovigilance System Master Master File (hereinafter referred to as PSMF) is a detailed description of the pharmacovigilance system
the system used by the marketing authorization holder in respect of one or more medicinal products that have been granted marketing authorization,
70. Post-authorization study (PAS) drug testing is any trial carried out under the conditions of
a summary of the product characteristics, or other conditions that have been imposed when the product is authorized or marketed
the usual way of using the drug. It may be a clinical trial, a non-interventional test, or a post-dose safety study
its placing on the market,
71. Post-authorization safety study study (hereinafter referred to as "PASS")
testing carried out to identify, characterize and determine the safety risk of drug administration, confirmation of the safety of the medicinal product
or measuring the effectiveness of risk management measures,
72. Compassionate administration of a medicine is a process by which a non-marketable medicinal product is made available to patients suffering from
chronic, serious or life-threatening illnesses that cannot be appropriately treated with an approved drug and cannot participate in
clinical trial,
73. Spontaneous report is any adverse reaction report received through the applicant's irreproachable communication with the competent authority, the marketing authorization holder.
placing on the market or other organization describing a side effect in a patient who receives one or more drugs and which does not arise from
testing or any other form of organized data collection,
74. The Pharmacovigilance Risk Assessment Committee (hereinafter referred to as the "Pharmacovigilance Risk Assessment Committee") is the committee
composed of representatives of EU Member States and other designated experts in charge of making binding decisions, recommendations and
advice on all aspects of risk management of medicines in accordance with Regulation (EU) No 1235/2010 and Directive 2010/84 / EC,
75. EudraVigilance is the central base of medicines side effects in the European Union,
76. The European Union reference dates list (hereinafter referred to as the "EURD list") is a list containing a list of active substances and
combination of active substances with denoted dates and frequency of PSUR submission in accordance with decisions of the CHMP
and the MRP and DCP Coordination Group (CMD (h)), based on the advice of the PRAC,
77. Wholesale trade in a medicinal product includes the procurement, receipt, storage, sale, delivery other than dispensing to the end-user, entry and removal and / or
import and export of medicine,
78. Wholesale is a natural or legal person established in the European Union who is licensed to carry out the wholesale business of medicinal products,
79. The importer is a legal or registered person established in the European Union who carries out the activity of importing a medicinal product and holds a manufacturing license for parts
the production it performs,
80. Retail trade of medicinal products includes the ordering, storage, dispensing of prescription and non-prescription medicines, as well as the production and dispensing of main and galen
preparations,
81. Medication is the sale of a medicinal product to the end user in retail of medicinal products,
82. Prescription drug prescription is the prescription drug prescription by an authorized person,
83. Mediation is an activity related to the purchase and sale of medicinal products, other than wholesale of medicinal products, consisting of an independent
negotiating and negotiating on behalf of another legal or natural person, not involving the physical handling of medicines,
84. A mediator is a natural or legal person established in the European Union who is authorized to carry out the business of mediation,
85. Public service obligation is the obligation of the wholesale and marketing authorization holder to ensure timely, durable and appropriate
drug supply in a specific geographical area,
86. Good practice in the wholesale of a medicinal product is a quality system relating to the storage and transport of the medicinal product and ensuring the organization, implementation and control
over storage in accordance with the prescribed conditions, ie transport of the drug to wholesale users,
87. The person responsible for the wholesale marketing of a medicinal product is a master of pharmacy or a person who fulfills the conditions laid down in Article 49 of Directive 2001/83 / EC,
at least two years of work experience in relevant jobs,
88. Introduction of a medicinal product is a wholesale circulation of a medicinal product from a Member State of the European Union to the Republic of Croatia,
89. Removal of a medicinal product is a wholesale circulation of a medicinal product from the Republic of Croatia to the Member States of the European Union,
90. Third countries are countries that are not members of the European Union or of the European Economic Area,
91. Import of a medicinal product is a wholesale trade of a medicinal product imported from third countries into the Republic of Croatia,
92. Export of a medicinal product is the wholesale trade of a medicinal product exported from the Republic of Croatia to third countries,
93. Parallel imports are the introduction of a medicinal product into the Republic of Croatia authorized in the exporting country, which is essentially similar to the medicinal product
which has been granted marketing authorization in the Republic of Croatia by national, mutual recognition or
a decentralized authorization procedure and introduced from one EU Member State to another on the basis of a parallel authorization
import of a medicinal product issued by the competent drug authority, if the parallel import was carried out by a wholesale company not affiliated with the holder
of the marketing authorization,
94. Parallel wholesale of a medicinal product is the introduction of a medicinal product for which a marketing authorization has been granted by a centralized authorization procedure, from
from one Member State of the European Union to another if it has been carried out from a wholesaler who is not commercially affiliated with the marketing authorization holder
traffic,
95. A specialized retail store is a store that sells over-the-counter medicines in accordance with this
The Law and the Regulations adopted pursuant to this Law,
96. The Croatian Pharmacopoeia is a set of professional texts and procedures that determine the quality, design requirements and procedures for checking the quality of medicines and
medicinal products and is properly linked and aligned with the European Pharmacopoeia,
97. The Agency for Medicinal Products and Medical Devices is a legal person with public authority established by the Law on Medicines and Medical Devices
(Official Gazette 121/03) - hereinafter referred to as "the Agency", the scope of which in the field of medicines and medicinal products is determined by this
By law,
98. The Centralized Procedure (hereinafter: CP) is a marketing authorization procedure.
the placing on the market of a medicinal product in the European Union in accordance with the provisions of Regulation (EC) No 726/2004,
99. The Decentralized Procedure, hereinafter referred to as "DCP", is the administration procedure.
approval, which starts at the same time in the reference and in other Member States of the European Union participating in the same procedure. He is obliged to
medicines not administered CP in accordance with Regulation (EC) No 726/2004 or MRP, which have not yet been authorized in the European Union and
which will be marketed in more than one Member State of the European Union in accordance with the provisions of Directive 2001/83 / EC,
100. The Mutual Recognition Procedure (hereinafter: MRP) is a procedure of mutual recognition for the granting of a marketing authorization.
of authorization, which, after obtaining authorization in the reference Member State, begins in the reference Member State and other Member States
Of the European Union to participants in the same procedure and who is obliged for non-CP medicines in accordance with Regulation (EC) No 726/2004 or DCP and who will
be marketed in more than one Member State of the European Union in accordance with the provisions of Directive 2001/83 / EC,
101. The reference country is the country which, in the process of MRP or DCP, produces a report on the medicinal product dossier on the basis of which the participating countries
decide on the acceptability of the risk-benefit ratio, ie on the evaluation of the quality, safety of use and efficacy of the medicinal product in accordance with the provisions of the Directive
2001/83 / EC,
102. A State party to the Mutual Recognition and Decentralized Procedure shall be the State which, in the MRP or DCP proceedings, decides on the
the acceptability of the risk-benefit ratio, that is, the quality, safety, and efficacy evaluation of the medicinal product based on the
a medicinal product made by a reference Member State of the European Union in accordance with the provisions of Directive 2001/83 / EC,
103. Coordination Group for Mutual Recognition and Decentralized Procedure, Human Medicinal Products, hereinafter
CMD (h)) is a group that acts on behalf of the authorities responsible for medicines in the Member States of the European Union and is established within the European Agency for the
medicines. Addresses issues related to the granting of a marketing authorization in two or more EU Member States participating in the
MRP procedure or DCP,
104. The Committee for Medicinal Products for Human Use, hereinafter referred to as "the CHMP", has established a committee.
from representatives of EU Member States and designated experts in charge of preparing the opinion of the European Medicines Agency on all
questions concerning medicinal products for human use in accordance with Regulation (EC) No 726/2004,
105. The national authorization procedure for marketing a medicinal product in the Republic of Croatia is the authorization procedure for marketing a medicinal product.
medicinal products authorized in the Republic of Croatia only and not subject to CP,
106. The European Medicines Agency (EMA) is the agency established by Regulation (EC) No 726/2004,
107. Medicinal product quality control is a procedure for determining the conformity of a medicinal product with the quality requirements, based on laboratory testing, verification
furnishing and labeling and checking documents relating to the sample of the medicinal product,
108. The OCABR Certificate (hereinafter: OCABR) is a certificate certifying that the series is immune
a drug or drug from human blood or human plasma tested by an official laboratory in accordance with the guidelines for the OCABR procedure,
109. Repeat use procedure (hereinafter: RUP) is an authorization procedure that is carried out for the same authorization for which it was completed.
the first mutual recognition procedure or decentralized marketing authorization procedure which the marketing authorization holder may
to be used subsequently for recognition by EU Member States which were not involved in the first procedure or who withdrew from the first procedure
approval given during the first procedure,
110. The simplified repeat procedure is the procedure referred to in item 109 of this Article for medicinal products authorized in the Republic of Croatia.
simplified procedure based on the nCadreac agreement.
II. MEDICINES
Article 4
(1) The provisions of this Act refer to medicinal products for human use intended for placing on the market that are manufactured industrially or
a manufacturing process involving an industrial process.
(2) If a product according to its definition and characteristics can at the same time be considered a medicinal product and another product to which it may be applied
the provisions of other regulations and there is doubt, the provisions of this Act shall apply.
Article 5
The provisions of this Act shall not apply to:
- trunk preparations,
- galenic preparations, except the provisions on quality control,
- medicines intended for research and development, with the exception of medicines tested in clinical trials,
- intermediate products intended for further processing by an authorized manufacturer,
- whole blood, plasma or blood cells of human origin, other than blood plasma prepared by the industrial manufacturing process,
- closed-source radionuclides,
- advanced therapy medicinal products exclusively prepared according to special requirements, for use in a hospital, under the professional supervision of a physician at
based on a doctor's prescription for an individual patient in the Republic of Croatia.
Article 6
(1) Interchangeable medicinal products are those medicinal products which the Agency determines to be interchangeable and include them in the list of interchangeable medicinal products.
of medicinal products, which is published on the Agency's website.
(2) When listing the medicinal products referred to in paragraph 1 of this Article in the list of interchangeable medicinal products, the Agency shall take into account the likelihood of the occurrence
clinically significant differences in the efficacy and safety of drug administration are negligible or acceptably small.
(3) The decision on the interchangeability of medicinal products shall be based on:
- determining the same or comparable characteristics of a medicinal product or group of medicinal products in accordance with this Act and the regulations adopted pursuant to this Act
The law,
- the approved properties of the medicinal product in the process of granting marketing authorization,
- the latest knowledge and discoveries in the field of biomedical sciences and profession,
- pharmacovigilance data.
(4) The criteria for determining the interchangeability of medicinal products shall be prescribed by an ordinance by the Minister.
Article 7
(1) The activity of testing, production, marketing, brokering and quality control of a medicinal product may be performed by qualified and legal persons who fulfill the conditions.
to perform these activities.
(2) The Minister shall prescribe the conditions for performing the activities referred to in paragraph 1 of this Article.
1. TESTING MEDICINES
Article 8
(1) For the purpose of placing a medicinal product on the market, each medicinal product must be tested for its quality, safety and efficacy.
(2) Drug testing is a pharmaceutical, non-clinical and clinical trial.
(3) The examinations referred to in paragraph 2 of this Article shall be conducted in accordance with the regulations issued by the Minister.
Article 9
(1) The examination of a medicinal product shall be carried out in a legal person who fulfills the conditions prescribed by the ordinance referred to in Article 7 of this Act.
(2) The clinical examination of a medicinal product may be carried out by a natural or legal person who has been approved by the Minister for such examination.
(3) The study of the medicinal product shall be carried out in the legal person referred to in paragraph 1 of this Article, at the cost and at the request of the legal or legal person requesting the examination of the medicinal product and on
request by the Minister or the Agency.
2. CLINICAL TESTING OF MEDICINES
Article 10
A clinical trial of a drug may only be conducted where the foreseeable risks and disadvantages are estimated to be less than the anticipated benefit to the
individual respondent and other present and future patients, assessed by the Central Ethics Committee and the ministry responsible for health (in
(hereinafter: the Ministry).
Article 11
(1) The request for conducting a clinical trial shall be submitted by the client of the clinical trial referred to in Article 3, item 30 of this Act or by the representative of the client from
Article 3, item 31 of this Act (hereinafter: the applicant for the clinical trial).
(2) If the clinical trial client is not established in the European Union, he must have an authorized representative established in a Member State of the European Union.
Union.
(3) The client of the clinical trial may delegate all or part of his / her responsibilities to another legal or legal entity by contract, but does not release him / her
responsibilities for clinical trial of the drug.
(4) The request for conducting a non-intervention test shall be submitted by the marketing authorization holder in the Republic of Croatia, the holder
of the marketing authorization granted by a centralized procedure, ie the representative of the marketing authorization holder.
Article 12
(1) The Central Ethics Committee is responsible for giving opinions in the process of approving clinical, non-interventional and unproven trials in
Republic of Croatia.
(2) Authorization to conduct clinical trials, including non-profit clinical trials of medicinal products, shall be granted by the Ministry.
(3) The approval for conducting non-interventional testing shall be granted by the Agency, except for non-interventional testing referred to in Article 163, paragraph 1 of this Act.
Article 13
Method of giving opinion to the Central Ethics Committee and authorizing the conduct of clinical, non-interventional and inaccurate testing
The Minister shall prescribe the ordinance for the medicinal product and the necessary documentation.
Article 14
(1) The Central Ethics Committee is obliged to issue a written opinion on the acceptability of the proposed clinical, non-interventional and unproven
examinations within 30 days of receipt of a valid request and submit it to the applicant for clinical, non-interventional and unproven
examination, to the Ministry and the Agency.
(2) The Central Ethics Committee is obliged to give a written opinion on the acceptability of a proposed clinical trial of a medicinal product intended for gene
therapy, treatment of somatic cells, including medicines containing genetically modified organisms, within 90 days of receipt
orderly request.
(3) The time limit referred to in paragraph 2 of this Article may be extended by an additional 90 days in the case of consultation with experts or committees.
(4) For xenogenic drugs there is no time limit for giving opinions on the acceptability of conducting a clinical trial.
Article 15
(1) Applicant for a clinical trial, including an incorrect clinical trial based on a positive opinion of the Central Ethics
Committees submit an application to the Ministry for approval to conduct a clinical trial in the Republic of Croatia.
(2) The Ministry is obliged to approve or withhold approval for conducting a clinical trial within 30 days of receipt of a duly requested request.
(3) The time limit referred to in paragraph 2 of this Article may be extended by 30 days in the case of a clinical trial of a gene therapy medicinal product,
treatment of somatic cells, including medicines containing genetically modified organisms and xenogenic drugs.
(4) If, within the time limit referred to in paragraphs 2 and 3 of this Article, the Ministry does not or does not withhold the approval, the approval shall be deemed to have been granted, except when it was previously
initiation of a clinical trial must obtain the written approval of the Ministry of Clinical Trials of the medicinal product intended for gene therapy,
somatic cell therapy, including medicines containing genetically modified organisms and xenogenic drug trials.
(5) The Ministry shall withhold approval to conduct a clinical trial for gene therapy if there is a risk of genome alteration
the reproductive cells of the subjects.
(6) The Ministry shall grant, or deny, a decision to conduct a clinical trial, including an incorrect clinical trial, by a decision against
who is not allowed to appeal but can initiate an administrative dispute.
(7) By way of derogation from paragraph (1) of this Article, an applicant for a clinical trial may request to conduct a clinical trial
at the same time to the Central Ethics Committee and the Ministry.
(8) The applicant for non-intervention testing shall submit a request to the Agency.
(9) The Agency shall, within 30 days from the receipt of a duly requested request, approve or withhold authorization to conduct a non-intervention
testing.
(10) Approval for conducting non-interventional testing shall be given by the Agency, ie withheld by a decision against which no appeal is allowed, but may be
initiate an administrative dispute.
Article 16
(1) The client of the clinical trial is obliged to inform the Central Ethics Committee and the Ministry of any significant changes and additions
clinical trial.
(2) The deadline for issuing the opinion of the Central Ethics Committee and the Ministry for Significant Changes to the Clinical Trial is 35 days from the date
receiving an orderly request.
(3) The client may introduce significant changes and additions after receiving the positive opinion of the Central Ethics Committee and
if the Ministry has not informed the applicant of the reasons for the refusal of approval within the time limit referred to in paragraph 2 of this Article.
Article 17
(1) A clinical trial of a medicinal product may only be conducted with the informed consent of the person undergoing the trial.
(2) In exceptional cases, for an unconscious person with a severe mental disability, for a legally incompetent person or a minor,
informed consent is given by the legal representative or guardian of the person after being aware of the risks and objectives of the examination.
(3) The persons referred to in paragraphs 1 and 2 of this Article may at any time withdraw informed consent to participate in a clinical trial.
(4) A clinical trial may not be conducted if the potential risk of administration of the drug is greater than the health justification for the study of the drug.
(5) Clinical trials should not be conducted on inmates and on persons for whom coercion could interfere with consent to participate in
clinical trial.
Article 18
(1) The clinical trial of a medicinal product shall be conducted in compliance with the principles of medical ethics and mandatory protection of the privacy and data of the subjects in accordance with
the ordinance on clinical trials of medicine and the ordinance on good clinical practice issued by the minister.
(2) A clinical trial of a medicinal product may be carried out only in the legal person referred to in Article 9 of this Act with which the contracting entity or its authorized representative
has concluded a clinical trial agreement with the EU in the European Union.
(3) The contract referred to in paragraph 2 of this Article shall specify the total costs of conducting the clinical trial of the medicinal product and the costs to be borne by the applicant.
clinical trial requirements, including the costs of medical and other services of a legal entity referred to in Article 9 of this Act, and fees for examiners; and
to the respondents.
(4) The fees for examiners and subjects referred to in paragraph 3 of this Article shall be paid by the applicant for the clinical trial of the medicinal product to the legal person with whom it is
concluded a contract for clinical trial of the drug.
(5) The clinical trial sponsor or his authorized representative established in the European Union is obliged before the clinical trial begins.
to be insured from liability in the event of injury, death, or treatment of subjects related to the clinical trial.
Article 19
(1) The Ministry is obliged to enter in the European clinical trial database data on:
- the application for authorization to conduct a clinical trial,
- amendments to the requirements referred to in subparagraph 1 of this paragraph,
- amendments to the test plan,
- the positive opinion of the Central Ethics Committee,
- completion of the clinical trial and
- surveillance performed on compliance with the requirements of good clinical practice.
(2) In addition to the information referred to in paragraph 1 of this Article, the Ministry shall be obliged upon a reasoned request by a Member State of the European Union, EMA or the European Commission.
provide other clinical trial data.
Article 20
(1) The Ministry may suspend a clinical trial or revoke an authorization to conduct a clinical trial if, based on established
the fact establishes that the conditions on which authorization to conduct a clinical trial are no longer existed, if there is doubt about the safety
the subjects or the scientific validity of the clinical trial, of which they will inform the clinical trial client or his representative,
Central Ethics Committee, EMA or European Commission.
(2) Prior to the decision referred to in paragraph 1 of this Article, the Ministry shall request a written statement from the client of the clinical trial, ie
representatives and / or examiners.
(3) The deadline for submitting the statement referred to in paragraph 2 of this Article is seven days from the date of receipt of the request of the Ministry, except in the case of immediate and significant
risk.
Article 21
During the development and production of the investigational medicinal product, the preparation of clinical trial documentation and the conduct of the clinical trial
the client of the clinical trial and the examiners shall, in addition to the provisions of this Act and the regulations made thereunder, observe the principles and
standards prescribed by the relevant guidelines of the European Commission or EMA.
3. PLACING THE MEDICINAL PRODUCT
Article 22
(1) The marketing authorization in the Republic of Croatia is granted by the Agency or the European Commission.
(2) For the purpose of placing a medicinal product on the market, each medicinal product must be determined by its quality, safety and efficacy.
(3) Authorization for placing the medicinal product on the market by national, mutual recognition and decentralized administration procedures
of the marketing authorization is given by the Agency with a decision on the granting of the authorization, which completes the process of granting the marketing authorization in accordance with this
The law and the ordinances adopted pursuant to this Act.
(4) In the process of mutual recognition and decentralized procedure, the Republic of Croatia may be a reference country or a participating country.
(5) The marketing authorization is granted by the European Commission in accordance with the provisions of Regulation (EC) No 726/2004.
(6) Marketing authorization shall also be granted for radionuclide generators, radionuclide kits, radiopharmaceuticals, radionuclide precursors and
industrially prepared radiopharmaceuticals.
(7) After the medicine is first granted marketing authorization in the European Union, any additional strength, pharmaceutical form, route of administration, type and
the size of the package as well as any changes to the marketing authorization and extension of the marketing authorization must be authorized or made available
included in the first approval.
(8) All authorizations referred to in paragraph 7 of this Article shall be considered as part of the same global authorization.
Article 23
Marketing authorization is not granted for radiopharmaceuticals that are being prepared for use from approved radionuclide generators,
of a radionuclide kit or precursor of a radionuclide by an authorized person or institution according to the manufacturer's instructions, and are used exclusively in
authorized health facility in accordance with special regulations.
Article 24
(1) The Agency may use the professional services of institutions that perform certain tasks in the process of granting marketing authorization.
carry out scientific activities and services of certain experts in the field of medicines.
(2) The persons referred to in paragraph 1 of this Article shall be obliged to keep confidential any information they find out in the performance of entrusted tasks.
(3) Agency employees and experts referred to in paragraph 1 of this Article who, in the process of granting a marketing authorization, evaluate
the pharmacist inspector and the Agency inspector are obliged to act in accordance with the provisions of this Act in performing surveillance
impartial and should not be in conflict of interest.
(4) The persons referred to in paragraph 3 of this Article shall be deemed to be in conflict of interest when:
- the private interest of the person affects his or her impartiality in the performance of the marketing authorization procedure, or
- it may reasonably be considered that a person's private interest affects his or her impartiality in the conduct of the authorization procedure
drug into the market or
- a person's private interest may affect his or her impartiality in the performance of the marketing authorization procedure.
(5) The persons referred to in paragraph 3 of this Article shall be obliged to annually announce to the Commission for determining the existence of a conflict of interest
conflicts of interest.
(6) The Commission referred to in paragraph 5 of this Article shall be composed of the President and four members of the Commission for the Conflict of Interest Decision, appointed by the Minister.
for a period of four years.
(7) The Commission referred to in paragraph 5 of this Article shall adopt its rules of procedure.
Article 25
(1) Prior to initiating the marketing authorization procedure, and at the request of the applicant, the Agency may advise on the preparation
requirements and documentation for the drug and expert advice on the quality, safety of administration and efficacy of the drug.
(2) The costs of giving the advice referred to in paragraph 1 of this Article shall be determined with the consent of the Minister of the Agency and shall be borne by the applicant.
Article 26
(1) An application for marketing authorization may be submitted by a legal or legal person established in the European Union (hereinafter:
the applicant).
(2) For the purpose of obtaining a marketing authorization in the Republic of Croatia, the applicant shall submit an application to the Agency.
(3) In addition to the request referred to in paragraph 2 of this Article, the applicant shall submit documentation on the medicinal product in accordance with the ordinance referred to in paragraph 7 of this Article.
article, which contains the following information and documents:
a) the name and permanent address of the applicant and, where applicable, the manufacturer,
b) the name of the medicine,
c) the qualitative and quantitative composition of all constituents of the medicinal product, including the internationally unprotected name, if any, or other common name
name,
d) an assessment of the risks to the environment of the drug; the environmental impact of the medicinal product is assessed on a case by case basis and specific procedures are foreseen for
its limitation,
e) a description of the production process,
f) therapeutic indications, contraindications and side effects,
g) dosage, pharmaceutical form, route and route of administration and expected expiry date,
h) the reasons for which special precautions should be taken when storing the medicinal product, its administration to the patient and the waste management measures with
an indication of all possible hazards the drug poses to the environment,
i) a description of the test methods used by the manufacturer,
j) if applicable, a written confirmation that the manufacturer of the medicinal product has verified, on the basis of the controls carried out, that the manufacturer of the active substance complies with the
principles and guidelines of good manufacturing practice. The written confirmation must include the date of the surveillance carried out and a statement confirming the result of the surveillance
that production complies with the principles and guidelines of good manufacturing practice,
k) results:
- pharmaceutical (physico-chemical, biological and / or microbiological) tests,
- non-clinical (toxicological and pharmacological) studies,
- clinical trials,
l) a summary of the applicant's pharmacovigilance system, which must include the following parts:
- evidence that the applicant has at his disposal a qualified person responsible for pharmacovigilance in the European Union,
- information on the Member State of the European Union in which the person responsible for pharmacovigilance in the European Union resides and performs his duties,
- the contact details of the responsible person for pharmacovigilance in the European Union,
- statement by the applicant that he has the necessary means to fulfill his duties and responsibilities under the provisions of this Law which
related to pharmacovigilance,
- PSMF storage location,
m) an RMP describing the risk management system that the applicant will introduce for the drug together with a summary of the plan,
n) a statement confirming that clinical trials conducted outside the EU Member States meet the ethical requirements laid down
Directive 2001/20 / EC,
o) summary of the product characteristics, mock-up of the outer and inner packaging of the medicinal product and a package leaflet,
p) a document proving that the manufacturer has been granted a manufacturing authorization in the country of manufacture (manufacturing license),
r) copies of:
- approvals obtained in other Member States of the European Union or third countries, summary information on the safety of use of the medicinal product, including
information contained in periodic safety reports, if available, and suspected adverse reaction reports, together with a list of those
Member States of the European Union where the approval process is ongoing;
- a summary of the product characteristics of the medicinal product proposed in the pending approval process in the Member States of the European Union or last approved by
the competent authorities of other Member States of the European Union; the instructions for the medicine proposed in the pending approval process in the Member States
The European Union or drafts last approved by the competent authorities of other Member States of the European Union,
- decisions / refusals of authorization, explaining the reasons for refusing marketing authorization in any Member State of the European Union
union or third country,
s) a copy of the document for the status of the medicine for rare and serious diseases and a copy of the opinion of the EMA.
(4) Documents and information relating to the results of the pharmaceutical, non-clinical and clinical trials referred to in paragraph 3, point k) of this Article shall be enclosed
detailed expert summaries of the said portions of the product documentation.
(5) In addition to the information and documents referred to in paragraph 3 of this Article, the applicant shall submit to the Agency evidence that the applicant has
dispose of a qualified person responsible for pharmacovigilance residing in the Republic of Croatia and his contact information.
(6) The request referred to in paragraph 2 of this Article and the documentation received at the Agency shall be classified according to the secrecy of the data in accordance with the regulations on
information secrecy and the corresponding general act of the Agency.
(7) The Minister shall prescribe the manner of granting the marketing authorization and the contents of the documentation referred to in paragraphs 3, 4 and 5 of this Article.
Article 27
At the request of the Agency, the applicant shall be obliged to supply the samples of the medicinal product and the prescribed reference standards necessary for verifying the quality of the medicinal product.
Article 28
Application for authorization to place a radionuclide generator on the market, together with the particulars and documents and documentation prescribed in Articles 26 and 29
of this Law, should also contain the following information:
- a description of the overall system and a detailed description of the system components which may affect the composition or the preparation quality of the nuclide daughter,
- data on the quality and quantity of the eluate or sublimate.
Article 29
(1) The applicant for the authorization referred to in Article 26, paragraph 1 of this Act, without prejudice to the regulations on industrial and
intellectual property, shall not be obliged to submit the results of the non-clinical and clinical trials referred to in Article 26 (3) (k) of this Act if it can
prove that the medicinal product is a generic medicine of a reference product which has been or has been authorized for marketing in a Member State of the European Union, or
based on a centralized approval process at least eight years ago.
(2) The marketing authorization holder may not place on the market the generic medicine referred to in paragraph 1 of this Article for 10 years from the date of the first marketing authorization.
of the reference medicine into circulation.
(3) The period of 10 years referred to in paragraph 2 of this Article may be extended to a maximum of 11 years if in the first eight years of the 10-year period
of the holder of the authorization of the reference medicinal product has been granted one or more new therapeutic indications and has been scientifically assessed to achieve these
significant clinical benefit compared to existing drug administration.
(4) The reference medicine referred to in paragraph 1 of this Article is a medicinal product which has been authorized or has been authorized in a Member State of the European Union in accordance with the Directive.
2001/83 / EC or in accordance with the provisions of Regulation (EC) No 726/2004, on the basis of complete documentation of the quality, efficacy and safety of use
drug.
(5) The generic medicine referred to in paragraph 1 of this Article is a medicinal product having the same qualitative and quantitative composition of the active substances and the same pharmaceutical form as the reference
a medicinal product whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability testing.
(6) Different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of active substances are considered to be the same active substance, unless they exist
significant differences in their properties in terms of application safety and / or efficacy. In case there are significant differences the applicant
additional information demonstrating the safety of administration and / or efficacy of different salts, esters or derivatives of the approved active substance should be provided.
(7) Different immediate-release oral forms are considered to be the same pharmaceutical form.
(8) An applicant shall not be obliged to submit the results of a bioavailability test if he can prove that the generic medicinal product meets the conditions laid down in
guidance from the European Commission and the EMA on bioequivalence testing.
(9) Calculation of the protection period referred to in paragraphs 1, 2 and 3 of this Article for the purpose of applying for the authorization and placing on the market of a generic
drug, begins on the date of the first approval from the global approval referred to in Article 22, paragraphs 7 and 8 of this Law.
(10) The protection period referred to in paragraphs 1, 2 and 3 of this Article shall apply mutatis mutandis to the reference medicinal products used for the purpose of filing
requests in accordance with Articles 32, 33, 34 and 35 of this Act.
Article 30
(1) When an application for authorization of a new indication for a known active substance is submitted, the applicant may be granted a one-year period
data protection only relating to this new indication, if significant non-clinical or clinical trials have been conducted to demonstrate
the efficacy of that active substance in that indication.
(2) The applicant may submit the request referred to in paragraph 1 of this Article in the procedure of granting the authorization referred to in Article 26 of this Act or in the procedure
change approvals.
Article 31
(1) If the reference medicine referred to in Article 29, paragraph 4 of this Act does not have a marketing authorization in the Republic of Croatia, the applicant shall
authorizing the placing on the market of a generic medicine is obliged to indicate in the request the Member State of the European Union in which that reference medicine is available
or had a marketing authorization and date of first approval.
(2) If the reference medicine is approved or has been authorized in the Republic of Croatia, the Agency shall, at the request of the competent authority of a Member State of the European Union,
submit within one month a confirmation that the reference medicine has been or has been approved in the Republic of Croatia, with information on the complete composition
the reference product and, if necessary, other information in the product documentation.
Article 32
The applicant for the authorization referred to in Article 26, paragraph 1 of this Act shall be obliged to submit with the application the results of the relevant non-clinical or
clinical trials in accordance with Article 26, paragraph 3, point k) of this Law if the drug does not fully correspond to the definition of the generic medicinal product in accordance with
Article 29, paragraphs 5, 6, 7 and 8 of this Law or when the bioequivalence of a medicinal product cannot be proven by bioavailability testing or in the case of
changes in the active substance or active substances, therapeutic indications, strength, pharmaceutical form or route of administration relative to the reference drug.
Article 33
(1) The applicant for the authorization referred to in Article 26, paragraph 1 of this Act shall be obliged to submit with the application the results of the relevant non-clinical
or clinical trials if a biological drug similar to a reference biological drug does not fit the generic drug definition due to differences with respect to
the raw material or the difference in the manufacturing process of the biological drug and the reference biological drug.
(2) The content of additional information and the scope of testing referred to in paragraph 1 of this Article shall be prescribed by the ordinance referred to in Article 26, paragraph 7 of this Act, and
European Commission and EMA guidelines for a biological medicine similar to the reference medicine.
(3) The applicant referred to in paragraph 1 of this Article shall not be obliged to submit the results of the other tests in the reference medicinal product documentation.
Article 34
(1) The applicant for the authorization referred to in Article 26, paragraph 1 of this Act, without prejudice to the regulations on industrial and
intellectual property, is not obliged to submit the results of non-clinical or clinical trials in accordance with Article 26, paragraph 3, item k) of this Law, if
can demonstrate that the active substance (s) of the medicinal product have a proven medical use in the European Union for at least ten years, known efficacy and
acceptable security of application in accordance with the conditions specified in the ordinance referred to in Article 26, paragraph 7 of this Act.
(2) In the case referred to in paragraph 1 of this Article, the applicant shall be obliged to replace the results of the clinical and non-clinical trials referred to in Article 26, paragraph 3, in place of the results
k) to provide this Law with adequate comprehensive scientific information from the literature.
Article 35
For a medicine containing a new combination of active substances not previously used for therapeutic purposes in the combination, which have been individually authorized in
the applicant for the authorization referred to in Article 26, paragraph 1 of this Act is obliged to submit the composition of the medicinal products authorized in the European Union
the results of new non-clinical or clinical trials relating to that combination in accordance with Article 26 (3) (k) of this Act, and
the conditions specified in the ordinance referred to in Article 26, paragraph 7 of this Act, and is not obliged to submit scientific data or results of non-clinical or clinical
tests for each individual active substance.
Article 36
The marketing authorization holder may authorize another applicant to use pharmaceutical, non-clinical and clinical records of the medicinal product on the basis of which
he was granted marketing authorization for the purpose of submitting new applications for marketing authorization for other medicinal products of the same qualitative and
the quantitative composition of the active substances and the same pharmaceutical form.
Article 37
(1) The Agency shall be obliged to give or deny the marketing authorization within 210 days from the date of determining the regularity of the request.
(2) The regularity of the request referred to in paragraph 1 of this Article shall be determined by the Agency within a period not exceeding 30 days from the date of receipt of the request, which shall be notified.
of the applicant. A valid request implies that the Agency has determined that the request is orderly and that all information and documents have been submitted as well
documentation in accordance with this Act and the ordinances issued pursuant to this Act.
(3) When the Agency determines that the request is not orderly, it shall, by a conclusion, request the applicant to rectify the request within the time limit set by the Agency.
supplements.
(4) During the approval procedure, the Agency may, by a conclusion, request the applicant to submit additional information and / or a document and / or
documentation, or adequate justification, for which he is given a deadline for delivery.
(5) If the Agency requests from the applicant during the procedure of approval by the conclusion referred to in paragraphs 3 or 4 of this Article the submission of additional
information and / or document and / or documentation, or adequate justification, the deadline referred to in paragraph 1 of this Article shall not run from the date of receipt
the conclusion by the applicant until the date of submission of the corrected or amended request to the Agency. Agency during the approval process
may ask the applicant to provide reasons.
(6) Approval shall be granted or denied by a decision against which an appeal is not allowed, but an administrative dispute may be instituted against that decision.
(7) The provisions of paragraphs (2), (3), (4), (5) and (6) of this Article shall apply mutatis mutandis to procedures for the approval of an amendment, the renewal of an authorization, the revocation and
transfer of the marketing authorization.
(8) The expenses in the procedure of granting, denying, renewing, modifying, transferring and revoking the authorization shall be determined with the consent of the Minister of the Agency, and shall be borne by them.
the applicant.
(9) If the applicant withdraws the application in the procedure of granting, renewal and modification of the authorization, he is obliged to cover the costs of the procedure, which in addition to
the Minister's consent shall be determined by the Agency.
Article 38
(1) In the process of granting a marketing authorization, the Agency shall assign a marketing authorization number to which it authorizes.
(2) The authorization number referred to in paragraph 1 of this Article shall remain the same and shall not be changed during the authorization, modification, renewal and transfer procedures of a medicinal product authorization.
Article 39
In the authorization process, the Agency may examine the medicinal product and its raw materials, as appropriate, intermediates or other ingredients of the medicinal product, either on its own or in the
the purpose of the approved laboratory, to determine that the quality test methods used by the manufacturer are described in the documentation accompanying
in accordance with Article 26, paragraph 3, item i) of this Law is satisfactory.
Article 40
(1) In the process of granting a marketing authorization, the Agency must establish that manufacturers and importers of medicinal products from third countries comply with
conditions for the manufacture of the medicinal product in accordance with the information referred to in Article 26 (3) (e) of this Act and / or carry out quality checks according to methods
tests described in the information referred to in Article 26, paragraph 3, item i) of this Act
(2) If the manufacturers or importers referred to in paragraph 1 of this Article have an agreement to carry out certain parts of the production and / or quality control of the medicinal product,
to another legal entity or entity, the Agency must determine that the other entity or entity meets the conditions for manufacturing the medicinal product in accordance with
the information referred to in Article 26 (3) (e) of this Act and / or carry out quality checks according to the test methods described in the information referred to in Article 26.
paragraph 3 item i) of this Act.
(3) When, on the basis of the submitted documentation, the Agency is not in a position to establish, on the basis of the submitted documentation in the process of granting marketing authorization, that
manufacturers and importers of medicinal products satisfy the conditions referred to in paragraphs 1 and 2 of this Article, and shall notify the Agency's inspection thereof to carry out surveillance.
(4) The costs of surveillance referred to in paragraph 3 of this Article shall be borne by the manufacturer or the applicant for authorization.
Article 41
(1) During the marketing authorization procedure, the Agency shall approve a summary of product characteristics, package leaflet and labeling
drug and delivered to the marketing authorization holder.
(2) The Agency shall be responsible for the compliance of the information in the approved summary of product characteristics with the information accepted in the authorization procedure.
or subsequently approved data.
(3) The Agency is obliged to regularly publish on its web site information on valid decisions on marketing authorization.
of the market, summaries of the characteristics of the medicinal product, package leaflet and any conditions under which approval has been granted with the deadlines for fulfilling these conditions established in accordance with
Articles 46, 47 and 48 of this Law.
Article 42
(1) In the authorization process, the Agency shall prepare a report on the evaluation of the dossier on the medicinal product, with an opinion and opinion on the results of the pharmaceutical,
non-clinical and clinical drug trials, risk management plan and pharmacovigilance system.
(2) The Agency shall supplement the report on the evaluation of the dossier on the medicinal product in accordance with the latest available information relevant for quality, safety of use.
and / or efficacy of the drug.
(3) The Agency shall make public the report on the evaluation of the dossier on the medicinal product, together with the reasoning of the opinion delivered separately for each indication, without
information of a confidential nature.
(4) The public report on the evaluation of the medicinal product dossier should include a summary written in a manner that is understandable to the public, and which will contain the conditions of use
drug.
Article 43
(1) Authorization for the placing on the market of the same medicinal product in two or more Member States of the European Union shall be by mutual recognition procedure.
or a decentralized approval process.
(2) If the Agency, in the authorization procedure, determines that the authorization procedure for the same medicinal product is carried out in another Member State of the European Union,
the decision shall suspend the procedure and direct the applicant to initiate a mutual recognition or decentralized procedure
of marketing authorization.
(3) If, on the basis of the information referred to in Article 26 (3) (r) of this Act, the Agency finds that another Member State of the European Union has granted authorization for
the placing on the market of a medicinal product for which an application for authorization has been submitted in the Republic of Croatia shall, by decision, suspend the procedure, unless
is a request made under a mutual recognition procedure.
(4) The applicant is obliged in all Member States of the European Union participating in the mutual recognition procedure or
submit to the decentralized marketing authorization procedure a request with identical product documentation.
(5) The applicant will request one of the Member States of the European Union participating in the mutual recognition or decentralized procedure
the procedure for granting the reference country the procedure and preparing a report on the evaluation of the dossier and a summary
drug properties, package leaflet, and labeling.
(6) Following the completion of the mutual recognition procedure and the decentralized procedure, the Agency accepts the reference country's assessment report
of the medicinal product documentation, together with a summary of the product characteristics, package leaflet and labeling, except as provided for in Article 44.
of this Act.
(7) The applicant shall be obliged within five days from the completion of the mutual recognition or decentralized procedure to the Agency.
provide the relevant Croatian translations of the summary of product characteristics, package leaflet and labeling.
(8) Within 30 days of the end of the mutual recognition or decentralized approval process, the Agency shall grant
marketing authorization.
(9) The Minister shall prescribe the manner of granting the marketing authorization referred to in this Article and the contents of the documentation.
Article 44
(1) If, because of a possible serious risk to human health, the Agency is in the process of mutual recognition or decentralized giving
of the approval as the competent authority of the participating State does not accept the evaluation report of the product dossier, summary of product characteristics, package leaflet and
marking in accordance with Article 43, paragraph 6 of this Law, shall explain in detail the reasons and inform the reference country, other states
participants and the applicant.
(2) If a State or States participating in a mutual recognition procedure or a decentralized authorization procedure because of a possible serious risk
for human health does not accept the Agency's report as the competent authority of the reference Member State on the evaluation of the dossier, summary of product characteristics
The Agency will refer the remedy to the CMD (h) for resolution of the medicinal product, package leaflet and labeling.
(3) In the case referred to in paragraphs 1 or 2 of this Article, the Agency shall endeavor to reach an agreement on the necessary measures at the CMD (h) meeting.
(4) If the agreement referred to in paragraph 3 of this Article is not reached within 60 days from the date of notification of the CMD (h), the reference country shall immediately inform
EMA, initiating the arbitration proceedings referred to in paragraph 10 of this Article.
(5) If different decisions have been taken by Member States of the European Union concerning the granting, suspension or withdrawal of authorization
placing on the market of a particular medicinal product, the Agency, the competent authorities of another Member State of the European Union, the European Commission or the Marketing Authorization Holder
they may propose that the CHMP initiate the arbitration proceedings referred to in paragraph 10 of this Article.
(6) In order to encourage compliance of the Marketing Authorization in the European Union, the Agency sends CMD (h) a list of medicines for
which need to be prepared in a harmonized summary of the product characteristics.
(7) The European Commission or the Agency, in cooperation with the EMA, may request the CHMP to comply with the list referred to in paragraph 6 of this Article.
paragraph 5 of this article.
(8) Prior to the decision on marketing authorization, on suspension or withdrawal of marketing authorization
the placing on the market of a medicinal product, or the granting of an amendment where it is in the interest of the European Union, the Agency, the competent authorities of other Member States of the European Union
The European Commission, the applicant or the authorization holder may refer the matter to the CHMP for the purpose of conducting the arbitration procedure referred to in paragraph 10.
of this article.
(9) If the arbitration procedure is initiated in connection with the pharmacovigilance of the approved medicinal product, it shall be referred to the PRAC.
(10) The conduct of arbitration proceedings at the CHMP and the issuing of the European Commission's opinion are carried out in accordance with Articles 32, 33 and 34 of the Directive.
2001/83 / EC.
Article 45
(1) The marketing authorization holder shall be responsible for the placing on the market and for the medicinal product in accordance with this Act and the ordinances issued pursuant to this Act.
of this Act.
(2) If the marketing authorization holder is not the manufacturer of the medicinal product, it must have a written agreement with the manufacturer / manufacturers of the medicinal product.
(3) For medicinal products authorized by the Agency, the authorization holder not established in the Republic of Croatia shall be obliged to appoint his representative with
based in the Republic of Croatia.
(4) The appointment of the representative of the authorization holder referred to in paragraph 3 of this Article shall not relieve the authorization holder of his legal responsibility.
Article 46
(1) In the marketing authorization, the Agency may determine the holder of the authorization the following conditions:
- to take certain measures contained in the risk management system to ensure the safe administration of the medicinal product and / or
- to conduct safety testing of the medicinal product after obtaining authorization and / or
- fulfill obligations more stringent than those prescribed by the provisions of this Pharmacovigilance Act relating to record keeping, or
reporting of reported suspected adverse reactions and / or
- to comply with any other conditions or restrictions regarding the safe and effective use of the drug and / or
- to ensure the existence of a suitable pharmacovigilance system and / or
- to conduct post-authorization drug efficacy tests where there are questions about certain aspects of drug efficacy, and
which can only be answered after the drug has been placed on the market.
(2) In the approval referred to in paragraph 1 of this Article, the Agency shall set deadlines for fulfilling the conditions referred to in paragraph 1 of this Article.
(3) If the marketing authorization holder fails to fulfill the conditions / conditions referred to in paragraph 1 of this Article, the Agency shall revoke the marketing authorization
against which no appeal is allowed but an administrative dispute may be instituted against that decision.
Article 47
(1) In exceptional circumstances and on the basis of a written statement from the applicant, the Agency may grant conditional approval for placing the medicinal product in the
traffic obliging the marketing authorization holder to fulfill certain obligations relating to the safety of administration of the medicinal product, to reporting to the Agency on any
what contingency the drug is taking and what measures need to be taken.
(2) The approval referred to in paragraph 1 of this Article may be granted when the applicant is unable to provide complete information on the effectiveness and
the safety of the use of the medicine in daily use for objective and well-reasoned reasons in accordance with the ordinance referred to in Article 26, paragraph 7 of this
Of the law.
(3) The validity of the authorization referred to in paragraph 1 of this Article depends on the annual reassessment of the fulfillment of the conditions specified in the authorization for placing the medicinal product in the
traffic.
(4) If the marketing authorization holder does not fulfill the conditions prescribed by this Article, the Agency shall revoke the marketing authorization by a decision against
which may not be appealed but an administrative dispute may be instituted against that decision.
Article 48
(1) After giving marketing authorization, the Agency may, in justified cases, order the marketing authorization holder in writing
the following obligations:
- conducting safety testing of the medicinal product after obtaining marketing authorization, if there are risk issues
administration of an approved drug,
- conducting post-authorization drug efficacy testing if knowledge of the disease or clinical methodology indicates that previous
drug efficacy ratings could be significantly altered.
(2) If, in the case referred to in paragraph 1, subparagraph 1 of this Article, the same risks exist for more than one drug, the Agency shall, after consulting the PRAC,
Direct the marketing authorization holders to carry out a joint safety review of the medicinal product after the marketing authorization has been granted.
(3) The Agency shall, with a justification, require the authorization holder to fulfill the obligations referred to in paragraph 1, subparagraphs 1 and 2 of this Article in writing, stating
goals and deadlines for applying and conducting the examination.
(4) If within 30 days from the receipt of the notification referred to in paragraph 3 of this Article, the authorization holder requests the possibility of a written explanation of
The Agency shall give the authorization holder the time limit not exceeding 60 days for the submission of a written explanation.
(5) On the basis of a written explanation by the authorization holder, the Agency shall confirm or withdraw the obligation referred to in paragraph 1, subparagraphs 1 and / or 2 of this Article.
(6) If the Agency confirms the obligation referred to in paragraph 1, subparagraphs 1 and / or 2 of this Article, it shall issue a decision on modification of the marketing authorization and
the obligation referred to in paragraph 1, subparagraphs 1 and / or 2 of this Article shall be stated as conditions of authorization, in which case the authorization holder is obliged to modify the system
risk management.
Article 49
(1) The authorization holder shall enter the conditions and obligations referred to in Articles 46, 47 and 48 of this Act into the risk management system.
(2) The Agency shall notify the marketing authorizations granted in accordance with Articles 46, 47 and 48 of this Act to EMA.
Article 50
(1) After granting a marketing authorization, the marketing authorization holder shall be obliged to:
a) keep up to date with the latest scientific and technical developments in the manufacturing and quality control processes of the medicinal product and make the necessary changes to ensure
that the medicinal product is manufactured and its quality checked in accordance with generally accepted scientific methods,
b) without delay, provide the Agency with any new information that may cause the data, documents and documentation on the medicinal product to be modified or supplemented
the procedure for granting approval or from arbitration proceedings in the European Union and / or the ordinance referred to in Article 26, paragraph 7 of this Act,
c) without delay, inform the Agency of any measure of restriction or prohibition imposed by the competent authorities of other countries in which the medicinal product is marketed; or
provide new data that may influence the risk / benefit assessment of the drug. The marketing authorization holder shall submit it to the Agency
positive and negative results of clinical or other trials conducted for all indications or across all study populations, whether or not
the same covered by the authorization, as well as information on the use of the medicinal product not covered by the authorization,
d) ensure that the information on the medicinal product is in accordance with the latest scientific knowledge, including the conclusions of the public evaluation reports of the medicinal product dossier
and EMA recommendations published on the Internet portal.
(2) In the case referred to in paragraph 1 of this Article, the Agency may request the marketing authorization holder to initiate the authorization procedure
modification / s or ex officio modify the marketing authorization.
(3) The Agency may at any time request information from the marketing authorization holder confirming the positive risk-benefit balance of the use of the medicinal product for the sake of
the possibilities of its continuous assessment.
(4) The Agency may, at any time, request a copy of the pharmacovigilance master file from the marketing authorization holder.
shall be obliged to submit no later than seven days from the receipt of the Agency's request.
Article 51
(1) In the cases referred to in Article 50, paragraph 1, points (a) and (b) of this Act, the authorization holder shall submit to the Agency an application for approval of the amendment.
(2) In the cases referred to in Article 50, paragraph 1, points c) and d). of this Act, the authorization holder shall submit to the Agency an application for approval of the amendment,
if the above causes a change in the information in the approved product documentation.
(3) In addition to the request for approval of the change referred to in paragraphs 1 and 2 of this Article, the authorization holder shall submit data and / or documents and / or documentation,
depending on the type of change.
Article 52
(1) An amended authorization in accordance with the provisions of Articles 50 and 51 of this Act shall be granted until the expiry of the validity of the authorization whose amendment was requested.
(2) If the approved amendment requires a change in the information in the authorization decision, the Agency shall, with the approval of the amendment, also issue a decision on the change
of the approval decision, which is not allowed to be appealed, but an administrative dispute can be initiated against that decision.
(3) If the approved modification requires modification of the information in the summary of product characteristics and / or package leaflet and / or labeling of the medicinal product with the approved modification,
The Agency approves a new amended summary of product characteristics and / or package leaflet and / or labeling.
(4) The approval of the amendment and the decision on the amendment of the marketing authorization decision shall be obliged to be given or denied by the Agency, depending on the type
modifications, within not more than 180 days from the date of receipt of the duly requested request.
(5) The Minister shall, by an ordinance, specify in more detail the manner of approving the amendments and the content of the documentation submitted for the purpose of approving the amendment.
Article 53
(1) The Agency shall grant a marketing authorization for a period of five years.
(2) No later than nine months before the expiry of the marketing authorization, the Agency may submit an application for renewal of the authorization
for placing the drug on the market.
(3) The Agency may renew the marketing authorization for the next five years on the basis of a reassessment of the risk-benefit ratio of the use.
drug.
(4) In addition to the request for renewal of the marketing authorization, the marketing authorization holder shall submit to the Agency consolidated documentation on
the quality, safety of administration and efficacy of the medicinal product, including the evaluation of the information contained in the suspected adverse reaction reports and periodic reports
on the harmlessness of the medicinal product in accordance with the provisions on pharmacovigilance of this Act, as well as information on any changes introduced since the date of receipt
of the marketing authorization until the date of application for renewal of the authorization.
(5) Once renewed marketing authorization may be granted for an indefinite period of time, unless for justified reasons which
relating to pharmacovigilance, including the insufficient number of patients exposed to that drug, the Agency does not request a renewal of the authorization
in accordance with paragraphs 3 and 4 of this Article.
(6) The contents of the documentation referred to in paragraph 4 of this Article submitted for the purpose of renewal of the marketing authorization shall be prescribed by an ordinance
the minister.
Article 54
(1) If the medicinal product has not been placed on the market in the Republic of Croatia three years after the granting of the authorization, the Agency shall withdraw the marketing authorization for that medicinal product.
traffic.
(2) An approved medicinal product that was previously placed on the market in the Republic of Croatia and subsequently not on the market in the Republic of Croatia
consecutive years the Agency will revoke the marketing authorization.
(3) By way of derogation from paragraphs 1 and 2 of this Article, the Agency shall not revoke an authorization for the protection of public health, provided that the authorization is valid in the Republic
Croatia's condition for granting and / or renewing the marketing authorization in other countries or in other exceptional circumstances, based on
detailed written justification of the marketing authorization holder.
Article 55
(1) The marketing authorization holder shall notify the Agency in writing of the date of the first placing of the medicinal product on the market without delay, and within 15 days at the latest.
days of marketing for each pharmaceutical form and dose.
(2) When the marketing authorization holder decides to discontinue the marketing of the medicinal product or to withdraw the medicinal product from the market temporarily or permanently before its expiry date
of the marketing authorization, decide to apply for the withdrawal of the marketing authorization or decide not to apply
for renewal of the authorization, is obliged to notify the Agency at least two months before the supply of the drug is interrupted, unless it is an emergency procedure
withdrawal of the drug or other extraordinary circumstances.
(3) In the case referred to in paragraph 2 of this Article, the marketing authorization holder shall inform the Agency of the reasons for the interruption of the market supply of the medicinal product.
(4) The authorization holder shall inform the Agency of the case referred to in paragraph 2 of this Article, which occurred in a third country when based on the reasons given in
Article 58, paragraph 1, subparagraphs 1 to 9 of this Act, or for the reasons referred to in Article 62, paragraph 1, subparagraphs 1 to 6 of this Act.
(5) The authorization holder shall inform the EMA of the case referred to in paragraph 2 of this Article, which occurred in a Member State or in a third country when established.
for the reasons referred to in Article 58, paragraph 1, subparagraphs 1 to 9 of this Act, or for the reasons referred to in Article 62, paragraph 1, subparagraphs 1 to 6 of this Act.
(6) At the request of the Agency, the marketing authorization holder shall submit data on the consumption and prescribing of the medicinal product for reasons related to pharmacovigilance.
Article 56
(1) At the request of the marketing authorization holder, the Agency shall, by decision, revoke the marketing authorization.
(2) No appeal shall be allowed against the decision referred to in paragraph 1 of this Article, but an administrative dispute may be initiated.
(3) The contents of the documentation submitted for the purpose of revoking the marketing authorization shall be prescribed by the Minister in an ordinance.
Article 57
(1) The Agency shall by a decision deny the granting of a marketing authorization if, in the conducted procedure on the basis of documentation, ie
of the enclosed information and documents referred to in Articles 26, 29, 30, 32, 33, 34, 35 and 36 of this Law and the ordinance referred to in Article 26, paragraph 7 of this Law shall determine:
- the risk-benefit ratio is rated as unfavorable, or
- that the therapeutic effect of the drug is not sufficiently demonstrated, or
- that the qualitative and / or quantitative composition of the medicinal product does not correspond to the declared composition, or
- that the labeling or package leaflet does not comply with the provisions of this Act or if the information in the labeling or package leaflet does not comply with the data
listed in the summary of product characteristics, or
- that the data, documents and documentation enclosed with the request do not meet the requirements of Articles 26, 29, 30, 31, 32, 33, 34, 35 and 36 of this Law.
(2) The applicant or the marketing authorization holder shall be responsible for the accuracy of the information and documents and the documentation submitted
the request for marketing authorization.
Article 58
(1) The Agency shall suspend, revoke or amend the approval in one of the following cases if:
- the drug is unacceptably harmful, or
- the drug is insufficiently therapeutically effective, or
- the risk-benefit ratio is unfavorable, or
- the qualitative and / or quantitative composition of the medicinal product does not comply with the declared one, or
- the quality of the medicinal product, the composition of the medicinal product and the intermediate products have not been checked, or
- the information in the approved product documentation is incorrect, or
- the information has not been amended in accordance with Articles 50 and 51 of this Act, or
- the conditions and obligations determined in accordance with Articles 46, 47 and 48 of this Law have not been fulfilled, or
- the medicinal product is not manufactured by a manufacturing process in accordance with Article 26, paragraph 3, item e) of this Act and that the quality check is not carried out by methods
tests in accordance with Article 26, paragraph 3, item i) of this Law, or
- the medicinal product has not been in circulation for three consecutive years in the Republic of Croatia after the marketing authorization has been granted in accordance with the provisions
Article 54 of this Law, or
- the medicinal product has been placed on the market contrary to the provisions of this Act, or
- the authorization holder information is incorrect, or
- the package leaflet and the labeling of the medicinal product do not comply with the provisions of this Act, or
- the production permit does not comply with the provisions of this Act, or
- the holder of the authorization no longer fulfills the conditions and obligations in accordance with the provisions of this Act and the regulations made thereunder.
(2) The therapeutic efficacy of the medicinal product referred to in paragraph 1, subparagraph 2 of this Article shall be considered insufficient when it is determined that the medicinal product cannot be administered
achieve therapeutic effects.
(3) No appeal shall be allowed against the decision on the revocation and suspension of the marketing authorization.
initiate an administrative dispute.
(4) The Agency shall regularly publish on its web site a list of decisions revoking the marketing authorization.
Article 59
Granting a marketing authorization to a manufacturer and / or marketing authorization holder does not absolve him of material or criminal liability.
Article 60
(1) The marketing authorization holder may request the transfer of the marketing authorization to another natural or legal person who fulfills the conditions prescribed
the provisions of this Act.
(2) A medicinal product placed on the market on the basis of a previous authorization may, after the transfer of the authorization, be on the market for a maximum of 18 months, if not previously
expires.
(3) The medicinal product referred to in paragraph 2 of this Article shall be the responsibility of the holder of the authorization after the transfer of the authorization.
(4) The Minister shall, by an ordinance, specify in more detail the manner, deadlines and content of the documentation submitted for the purpose of transferring the marketing authorization
traffic.
Article 61
(1) The Ministry or the Agency may, in justified cases, decide for the protection of human health that the Agency ex officio authorize
placing on the market of a medicinal product authorized in another Member State of the European Union but not authorized or applied for in the Republic of Croatia
giving approval.
(2) In the case referred to in paragraph 1 of this Article, the Agency shall request from the competent authority of the Member State of the European Union in which the medicinal product is authorized a report on the
drug documentation and current approval.
(3) Before granting the marketing authorization referred to in paragraph 1 of this Article, the Agency shall notify the marketing authorization holder from a Member State.
Of the European Union in which the medicinal product has been authorized for ex officio authorization in the Republic of Croatia.
(4) The authorization referred to in paragraph 1 of this Article shall be granted by the Agency to the marketing authorization holder from the Member State of the European Union in which the medicinal product is authorized or to wholesale
launches the medicine in the Republic of Croatia.
(5) The marketing authorization holder referred to in paragraph 4 of this Article shall be responsible for providing a summary of the characteristics of the medicinal product, package leaflet, labeling and advertising of the medicinal product, and
pharmacovigilance shall be in accordance with the provisions of this Act.
(6) At the request of a competent authority of a Member State of the European Union conducting a procedure in accordance with paragraph 1 of this Article for a medicinal product authorized in the Republic
Within 30 days, the Agency will send the Croatian Medicines Agency report and a valid approval.
Article 62
(1) The Agency must suspend the marketing of the medicinal product and request the withdrawal of the medicinal product from the market in one of the following cases:
- the drug is unacceptably harmful, or
- the drug is insufficiently therapeutically effective, or
- the risk-benefit ratio is unfavorable, or
- the qualitative and / or quantitative composition of the medicinal product is not in conformity with the declared one, or
- the quality of the medicinal product, the composition of the medicinal product and the intermediate products have not been checked, or
- the product has not been manufactured in accordance with the manufacturing authorization, or
- that the drug is counterfeit.
(2) The Agency may suspend the placing on the market of the medicinal product and / or request the withdrawal of the medicinal product from the market in the case referred to in Article 58, paragraph 1, subparagraphs 5 to 14.
of this Act.
(3) The Agency may limit the suspension or withdrawal referred to in paragraph 1 of this Article to a specific series of medicinal products.
(4) In exceptional cases, the Agency may, in a transitional period, allow the supply of a medicinal product to
withdrawn from circulation only to patients whose treatment is ongoing.
(5) If the medicinal product withdrawn from the market poses a serious direct threat to human health, the Agency shall promptly notify the Member States of the European Union.
(6) The suspension of marketing or withdrawal of a medicinal product shall be initiated by the marketing authorization holder, the marketing authorization holder.
parallel importation of the medicinal product or the Agency ex officio or at the request of the pharmaceutical inspector. The holder of the authorization is about the suspension procedure
of the medicinal product on the market or withdrawal of the medicinal product from the market is obliged to notify the Agency within 24 hours from the moment of finding out the reason for the
initiating the measures referred to in paragraph 1 of this Article.
(7) For a medicinal product being marketed in the Republic of Croatia on the basis of the consent to enter or import the medicinal product in accordance with Article 129 of this Act,
the procedure referred to in paragraph 6 of this Article shall be initiated by a wholesaler who has placed the medicinal product on the market in the Republic of Croatia.
(8) Suspension of the marketing of the medicinal product, the procedure for withdrawal of the medicinal product from the market and the deadlines and method of notification of the suspension and withdrawal of the medicinal product
the ordinance shall be prescribed in greater detail by the Minister.
4. TRADITIONAL HERBS
Article 63
(1) The authorization procedure for placing a traditional herbal medicinal product on the market is a simplified procedure, ie the registration procedure
a traditional herbal remedy.
(2) The registration procedure for a traditional herbal medicinal product shall be carried out for medicinal products that fulfill the following conditions:
- have indications exclusively appropriate for traditional herbal remedies which, by virtue of their composition and purpose, are administered without the supervision of a physician,
- are intended solely for use in accordance with the specified strength and dosage of the medicinal product,
- intended for external or oral administration or for inhalation,
- the period of traditional use of the medicinal product or its corresponding medicinal product is at least 30 years until the date of application, of which at least 15 years
in the European Union,
- there is sufficient information on the traditional use of the medicinal product, in particular evidence of the safety of the medicinal product under the indicated conditions of use and evidence that
pharmacological effects or efficacy of the drug are likely based on long term use and experience.
(3) The matched medicinal product referred to in paragraph 2, subparagraph 4 of this Article is a medicinal product containing the same active substances, regardless of the composition of the excipients, having the same or
of a similar purpose, is of equivalent strength and dosage and has the same or similar route of administration as the traditional herbal medicinal product for which application is made
registration.
(4) Traditional herbal remedies may also contain vitamins and minerals, of well-known safety of use, whose action promotes action
of the contained herbal active substances with respect to the indication indicated.
(5) If, in the process of registration of a traditional herbal medicinal product, the Agency finds that the medicinal product fulfills the conditions for granting a marketing authorization
the marketing or registration of a homeopathic remedy, the provisions of this Act relating to traditional herbal remedies shall not apply.
(6) The registration, form and content of the documentation submitted for the purpose of obtaining the registration decision, the necessary evidence of traditional use, and
the rules on labeling and advertising for traditional herbal remedies shall be laid down in a regulation by the Minister.
(7) The costs in the procedure of granting, denying, renewing, modifying, transferring and revoking the decision on registration of a traditional herbal medicinal product shall be determined by
the consent of the Minister of the Agencies and borne by the applicant.
Article 64
(1) Registration of a traditional herbal medicinal product shall be refused if the information and documents accompanying the request do not comply with the prescribed one and if it is determined
one of the following reasons:
- the qualitative and / or quantitative composition does not equal the declared, or
- the indications are not in accordance with Article 63, paragraph 2, subparagraph 1 of this Act, or
- a traditional herbal remedy may be harmful under normal conditions of use, or
- data on traditional use are insufficient, especially if pharmacological effects or efficacy are unlikely based on long-term use, and
experiences, or
- Pharmaceutical quality is not satisfactorily demonstrated.
(2) The Agency shall be obliged to inform the European Commission and other competent authorities of the refusal of registration of a traditional herbal medicinal product and of the reasons for such a decision.
the body requesting it.
Article 65
The provisions of this Act relating to the placing on the market of a medicinal product, manufacture, classification, advertising, marketing, import, quality control,
pharmacovigilance, discontinuation and withdrawal, and drug monitoring are appropriately applied to traditional herbal
medicines, unless otherwise prescribed by this Act or a regulation made pursuant to this Act.
5. HOMEOPATHIC MEDICINES
Article 66
(1) A homeopathic medicinal product may be marketed if it has a marketing authorization given by the Agency or a decision of the Agency on registration in accordance with
provisions of this Act and regulations made pursuant to this Act.
(2) For anthroposophic medicinal products described in the applicable pharmacopoeia of the Member States of the European Union and prepared by the homeopathic method,
the provisions of this Act relating to homeopathic remedies.
Article 67
For the purpose of obtaining a marketing authorization for a homeopathic medicine, a request shall be submitted to the Agency and the documentation prescribed in Article 26 shall be attached,
29, 30, 31, 32, 33, 34, 35 and 36 of this Law.
Article 68
(1) A simplified marketing authorization procedure shall be carried out for homeopathic medicinal products placed on the market without therapeutic indications
homeopathic remedy for sale, that is, the procedure for registering a homeopathic remedy.
(2) The registration of a homeopathic remedy shall be carried out if the homeopathic remedies fulfill the following conditions:
- are intended for oral or external use,
- they do not have a therapeutic indication or indication of the indication in the instructions and labeling of the homeopathic medicine,
- have a sufficient degree of dilution to guarantee the safety of drug administration; in particular, the homeopathic remedy must not contain more than one part
of the original tincture per ten thousand parts, or not more than one hundredth of the lowest therapeutic dose of the active substance for which the medicinal product referred to in Article 3 would be given.
points 1 of this Act obligatory to issue on medical prescription.
(3) In the process of registration of a homeopathic medicine, the Agency shall determine the classification with regard to the place of dispensation of the homeopathic medicine.
Article 69
(1) The application for registration of a homeopathic medicine referred to in Article 68 of this Act may include batches of a homeopathic medicine derived from the same
a homeopathic source or more.
(2) In addition to the application for registration of the homeopathic medicinal product, the applicant shall submit the following:
- scientific name or other name given in the pharmacopoeia for a homeopathic source or several, indicating the various routes of administration, pharmaceutical
the form and degree of dilution for which registration is sought,
- documentation describing how the homeopathic source or more are obtained and verified and proving his or her
homeopathic application based on appropriate bibliographic data,
- documentation on the production and quality control of each pharmaceutical form, describing the method of dilution and amplification,
- stability data of the homeopathic remedy,
- production permit,
- copies of the marketing authorization or the marketing authorization in the other Member States of the European Union,
- draft (mock-up) of the outer and inner packaging of the medicinal product for which registration is sought.
(3) The application for registration of a homeopathic medicine need not be accompanied by proof of its therapeutic efficacy.
(4) Registration, the contents of the documentation for the registration of the homeopathic medicine shall be prescribed by an ordinance by the Minister.
(5) Determine the costs in the procedure of granting, denying, renewing, modifying, transferring and revoking the authorization or the decision on the registration of a homeopathic medicine
shall, with the consent of the Minister, be borne by the applicant.
Article 70
In addition to the clear label: "homeopathic remedy", the outer and inner packs and, if necessary, the instructions for homeopathic remedies referred to in Article 68 of this Act
will only contain the following information:
- the scientific name of one or more homeopathic sources and an indication of the degree of dilution using the pharmacopoeia symbol; if the homeopathic remedy contains
two or more homeopathic sources, in addition to the scientific names of the sources on the labeling, the newly invented name of the medicine may be indicated,
- the name and address of the holder of the registration decision for the homeopathic medicinal product and, if necessary, the name and address of the manufacturer,
- pharmaceutical form,
- the designation "homeopathic medicine without approved therapeutic indications",
- the route of administration and, where appropriate, the route of administration,
- the contents of the package, expressed in weight, volume or number of units of the homeopathic remedy,
- special precautionary measures, if necessary,
- the expiry date of the homeopathic medicine (month and year),
- a warning that the patient is referred to a physician in case the symptoms persist while administering the homeopathic remedy,
- special warning, if necessary,
- the manner and place of dispensing of the homeopathic remedy,
- production batch number,
- number of the decision on the registration of the homeopathic medicine.
Article 71
(1) The provisions of this Act relating to the labeling and package leaflet of the medicinal product shall apply mutatis mutandis to homeopathic medicinal products.
(2) The outer and inner packaging of a homeopathic remedy must indicate in a clear and legible manner the homeopathic nature of the remedy.
(3) The provisions of this Act relating to the advertising of a medicinal product shall apply mutatis mutandis to homeopathic remedies.
(4) By way of exception, only the information referred to in Article 70 of this Act may be used in advertising about homeopathic remedies referred to in Article 68 of this Act.
Of the law.
(5) The provisions of this Act relating to the placing on the market, manufacture, marketing, import, quality control, suspension and withdrawal of a medicinal product
unless otherwise provided by this Act, shall be appropriately applied to the marketing and supervision of medicines
prescribed.
(6) The provisions of Article 44 paragraphs 4 to 10 of this Act shall not apply to homeopathic remedies referred to in Article 68 of this Act.
(7) The provisions of this Act relating to pharmacovigilance shall apply mutatis mutandis to approved homeopathic medicinal products.
for marketing.
6. PRODUCTION
Article 72
(1) Natural and legal persons established in the Republic of Croatia may manufacture intermediate products, medicinal products and / or investigational medicinal products only on the basis of and in
in accordance with the production permit.
(2) The production permit is obligatory for:
- the manufacturing plant or plants in which the pharmaceutical forms and / or groups of medicinal products will be manufactured,
- the complete process or individual parts of production,
- production of medicines intended for export and / or removal only.
(3) Importers of medicinal products from third countries are required to hold a manufacturing license.
Article 73
(1) The natural and legal persons referred to in Article 72, paragraph 1 of this Act must fulfill at least the following conditions:
- given the scale and complexity of the manufacture of the medicinal product or group of medicinal products, have an adequate number of experts in the field of pharmacy, chemistry, biology,
biochemistry, biotechnology, chemical technology, medicine, dental medicine, veterinary medicine or other relevant profession,
- have a responsible person in charge of placing the batch of the medicinal product on the market, which must be constantly available,
- have key staff in manufacturing, quality control and drug marketing,
- have adequate facilities, equipment for the production, quality control, storage and delivery of medicines,
- follow the principles and guidelines of good manufacturing practice.
(2) The detailed conditions referred to in paragraph 1 of this Article, which must be fulfilled by the legal and legal persons referred to in Article 72, paragraph 1 of this Act, shall be prescribed by an ordinance
the minister.
Article 74
(1) The holder of a production license shall, subject to the conditions referred to in Article 73 of this Act, also be obliged to:
- enable the person responsible for putting the batch of the product on the market to perform his duties independently and provide for all the necessary means,
- ensure that all manufacturing processes for a particular drug are carried out in accordance with the product documentation approved in the authorization procedure,
that is, for the investigational medicinal product in accordance with the data on the medicinal product authorized in the clinical trial authorization process,
- use only active substances manufactured in accordance with good manufacturing practice in manufacturing for commercially available active substances
good practice in the wholesale of active substances, as well as to ensure the use of excipients of adequate quality for the manufacture of medicinal products,
- in writing, immediately notify the Agency and the Marketing Authorization Holder if he / she learns that the medicinal products concerned are manufacturing
the license is forged or if it is suspected of being forged,
- determine that manufacturers, importers and wholesalers from whom it procures active substances are authorized to carry out the said activity on the date of the competent
bodies of the Member State of the European Union in which they are established,
- determine the authenticity and quality of the active substances and excipients,
- at all times to allow the competent authority's representatives access to the production site.
(2) The Minister shall, by an ordinance, prescribe the requirements of good manufacturing practice for the production of medicines, active substances and auxiliaries and the method of determining these
requests also the entry in the register of manufacturers and importers of active substances.
(3) The requirements of good practice in wholesale trade of active substances and the entry in the register of wholesale of active substances shall be prescribed by an ordinance by the Minister.
Article 75
(1) For the purpose of obtaining a production permit, a natural or legal person established in the Republic of Croatia shall submit an application to the Agency.
(2) In addition to the request referred to in paragraph 1 of this Article, with evidence of compliance with the conditions of good manufacturing practice referred to in Article 73 of this Act, the applicant shall
it is obliged to submit documentation containing the following information and documents:
a) the full name and registered office of the legal or natural person,
b) proof of entry in the court register or the trade register,
c) evidence of the registered activity in the court register or the trade register,
d) evidence of professional competence and employment contract with the person responsible for the marketing of the batch of the medicinal product,
e) evidence of professional competence and a contract of employment with key personnel in accordance with production volume,
f) personal data for the person responsible for the marketing of the batch of medicinal products and for key personnel,
g) data on premises and equipment for production, quality control and storage of medicinal products,
h) a description of the process or part of the manufacturing process of the medicinal product for which the license is sought, or of other parts of the manufacture such as sterilization of the active substance;
excipients,
i) the list of medicines and pharmaceutical forms for which authorization is sought,
j) the master file of the place of production.
Article 76
In the process of granting a production permit, the Agency's inspector gives an opinion on the fulfillment of the conditions of good manufacturing practice.
Article 77
(1) The Agency is obliged to give or deny the manufacturing authorization for a medicinal product within 90 days from the date of receipt of a valid request.
(2) The orderly request referred to in paragraph 1 of this Article implies that the Agency, within a period not exceeding 30 days from the day of receipt of the request, determined that
the request is orderly and all data and documents, ie documentation referred to in Article 75 of this Law, have been submitted.
(3) If the Agency determines that the request is not correct, by a conclusion it will ask the applicant to correct the request within no more than 30 days,
supplement or provide written justification.
(4) During the process of granting a production permit, the Agency may, by a conclusion, request from the applicant additional documentation, ie
information or documents, or an adequate justification, for which he is given a time limit for delivery.
(5) If the Agency requests the applicant to rectify or supplement the request, the deadline referred to in paragraph 1 of this Article shall not run until the date of delivery of the corrected one or
of the amended application nor during the time granted to the applicant to provide written explanation.
(6) The production permit referred to in paragraph 1 of this Article shall be granted or denied by a decision against which no appeal is allowed, but against that decision.
may initiate an administrative dispute.
Article 78
(1) If the applicant meets all the conditions prescribed by the provisions of this Act and the ordinances adopted pursuant to this Act,
The agency gives the production permit indefinitely.
(2) If it is found that the applicant does not meet all the prescribed conditions, the Agency may grant a conditional production permit with a deadline for
elimination of identified deficiencies.
(3) The permit referred to in paragraph 2 of this Article shall cease to be valid at the expiry of the deadline for elimination of identified deficiencies, if the deficiencies have not been eliminated within that period.
(4) The costs of the procedure of granting, denying, modifying and revoking a production permit with the consent of the Minister shall be determined by the Agency and shall be borne by the applicant.
the application or the holder of the production permit.
Article 79
(1) For any change in the documentation, that is, the data and documents on the basis of which the production license was granted to the holder of the production license
it is obliged to submit to the Agency an application for approval of the production permit change.
(2) In addition to the request referred to in paragraph 1 of this Article, the holder of the production license shall be obliged to submit data and documents or documentation, depending on the type
modifications.
(3) If the Agency determines that the request is not correct, by a conclusion it will ask the applicant to correct the request within no more than 15 days,
supplement or provide written justification.
(4) During the process of approval of the production permit change, the Agency may, by a conclusion, request from the applicant additional documentation,
that is, information or documents, or a proper justification for which he is given a deadline for delivery.
(5) If the Agency requests the applicant to rectify or supplement the request, the deadline referred to in paragraph 6 of this Article shall not run until the date of delivery of the corrected or
of the amended application nor during the time granted to the applicant to provide written explanation.
(6) If the amendments relate to the information and documents referred to in Articles 73 and 75 of this Act, the Agency shall be obliged to approve or withhold approval of the amendment,
depending on the type of change, within no more than 30 days from the date of receipt of the duly requested request. Exceptionally, this time limit may be extended to 90 days from the day
receipt of an orderly request.
(7) If the approved modification requires a modification of the production permit, the Agency shall issue a decision against which no appeal is allowed but against that decision
may initiate an administrative dispute.
Article 80
(1) The Agency shall, ex officio, issue a decision on revocation of the production license if it is found that the manufacturer does not meet the conditions laid down
this Act and the regulations made pursuant to this Act.
(2) On the basis of a written request from the license holder, the Agency shall, by decision, terminate the production license if the license holder ceases to operate.
(3) No appeal shall be allowed against the decision revoking the production license, but an administrative dispute may be instituted against that decision.
Article 81
(1) The importation of medicinal products shall be carried out by importers of medicinal products which fulfill the conditions of good manufacturing practice to the extent applicable to them.
(2) A production permit shall be compulsory for the pursuit of the activities referred to in paragraph 1 of this Article.
(3) Importers who import medicinal products from third countries and who do not themselves have the facilities and equipment to check the quality of each batch of imported medicinal product may
these needs to contract with a legal or natural person holding a manufacturing license that covers the business of quality assurance.
(4) The batches of medicinal products subjected to quality checks in another Member State of the European Union are not subject to additional quality checks, but are subject to
they release marketing in the Republic of Croatia on the basis of a certificate of quality control of a batch of a medicinal product in a Member State of the European Union which has signed
responsible for the marketing of the batch.
(5) When importing a medicinal product from a country which has concluded a mutual recognition agreement with the European Union in the field of medicinal products, the medicinal product shall be placed in
turnover in the Republic of Croatia on the basis of a certificate of quality control from the exporting country.
Article 82
(1) The production of an active substance used as a starting material also includes the entire process and parts of production, the import activity and the procedures
such as weighing, packing or equipping an active substance before incorporation into a drug.
(2) The procedures referred to in paragraph 1 of this Article must be carried out in accordance with good manufacturing practice for active substances.
(3) The wholesaler and / or importer who carries out the process of sizing, repackaging and equipping the active substance must meet the conditions of good manufacturing
active substance practices.
Article 83
(1) Natural or legal persons referred to in Articles 72 and 84 of this Act may import active substances under the following conditions:
- the active substance is manufactured in accordance with the requirements of good manufacturing practice which is in conformity with those prescribed by the European Union,
- the delivery of the active substance is accompanied by a written confirmation from the competent authority of the exporting third country certifying that:
a) an active substance manufactured at the place of production to which the requirements of good manufacturing practice in accordance with those prescribed by it apply
European Union,
b) a place of production under regular, rigorous and transparent supervision of good manufacturing practice; and
c) the exporting country is obliged to notify the European Union without delay in the case of non-compliance with the surveillance.
(2) The conditions referred to in paragraph 1, subparagraph 2 of this Article shall not apply if the exporting country is on the list of countries approved by the European Union.
commissions.
(3) By way of derogation from the provision of paragraph 1, subparagraph 2 of this Article, in order to ensure the availability of medicines the imported active substance need not have a written confirmation
during the period of validity of the certificate of good manufacturing practice, if a state-controlled export site of the active substance for export
Member States of the European Union and if the requirements of good manufacturing practice for the active substance prescribed in the European Union are met.
(4) In the event of the use of the exception referred to in paragraph 3 of this Article, the Agency shall be obliged to inform the European Union.
(5) The Minister shall prescribe by an ordinance the conditions for the import of active substances.
Article 84
Natural or legal persons established in the Republic of Croatia who manufacture, import and deliver active substances are obliged to enroll in
register of manufacturers, importers and / or wholesale of active substances.
Article 85
(1) The request for entry in the register referred to in Article 84 of this Act shall be submitted by the legal or legal person to the Agency not later than 60 days before the date of the planned start.
performing that activity.
(2) In addition to the request referred to in paragraph 1 of this Article, the applicant must submit documentation containing the following information and documents:
a) the full name and registered office of the legal or natural person,
b) proof of entry in the court register or the trade register,
c) evidence of the registered activity in the court register or the trade register,
d) information on the active substances that will be manufactured, imported or made wholesale,
e) information on the premises and equipment in accordance with the activities / activities to be performed,
f) information and documents on the person responsible for placing the batch of intermediate products and / or the active substance on the market.
Article 86
(1) In the process of entry into the register of manufacturers, importers and / or wholesale of active substances, the Agency shall decide on the basis of a risk assessment on
supervision, which will be reported in writing to the applicant within 60 days from the date of receipt of a duly registered entry.
(2) If the Agency notifies the applicant in writing of the supervision in accordance with paragraph 1 of this Article, the applicant shall
the conducted supervision must not start performing the activities referred to in Article 84 of this Act.
(3) After the supervision has been carried out or if the risk assessment has not been carried out on the basis of a risk assessment, the Agency shall, within 60 days from the receipt of the
requests, that is, the supervision carried out by a decision to give or deny entry in the register.
(4) No appeal shall be allowed against the decision granting or denying entry in the register, but an administrative dispute may be instituted against that decision.
(5) The orderly request referred to in paragraph 1 of this Article implies that the Agency has determined that the request is orderly and that all information and documents have been submitted,
that is, the documentation referred to in Article 85 of this Act.
(6) If the Agency determines that the request is not correct, by a conclusion it will ask the applicant to correct the request within no more than 15 days,
supplement or provide written justification.
(7) During the procedure of entry into the register, the Agency may, by a conclusion, request from the applicant additional documentation or data, or
documents, or appropriate justification and set a time limit for their delivery.
(8) If the Agency requests the applicant to rectify or supplement the request, the deadline referred to in paragraph 3 of this Article shall not run until the date of delivery of the corrected one or
amended request. The time limit referred to in paragraph 1 of this Article shall not extend beyond the time allowed for the applicant to provide written explanation.
Article 87
In the process of entry in the register referred to in Article 86, paragraph 1 of this Act, the opinion on the fulfillment of the conditions of good manufacturing practice for active substances is given by
inspector of the Agency.
Article 88
(1) The holder of the entry in the register is obliged to annually report to the Agency all changes in the documentation, that is, data and documents on
on the basis of which the decision on the entry in the register was given and applied for the approval of the change / s of entry in the register.
(2) For the change (s) that may affect the quality or safety of the active substance, the holder of the register entry shall submit an application for approval.
changes to the entry in the register.
(3) In addition to the request referred to in paragraphs 1 and 2 of this Article, the holder of the register entry shall be obliged to submit data and documents or documentation, depending on
the type of change / s.
(4) If the Agency determines that the request is not orderly, by a conclusion it shall ask the applicant to correct the request within no more than eight days,
supplement or provide written justification.
(5) The Agency may, during the process of approving the change of entry in the register, request additional documentation from the applicant,
that is, information or documents, or an adequate justification and set a deadline for their submission.
(6) If the Agency requests the applicant to rectify or supplement the request, the deadline referred to in paragraph 7 of this Article shall not run until the date of delivery of the corrected or
amended request. The time limit referred to in paragraph 7 of this Article shall not extend beyond the time allowed for the applicant to provide written reasons.
(7) The Agency shall approve or deny the approval of the change (s) of the entry in the register within 30 days from the date of receipt of the duly filed request.
(8) If the approved amendment requires an amendment of the decision on entry in the register, the Agency shall issue a decision against which no appeal is allowed but against
solutions can be initiated by an administrative dispute.
Article 89
(1) A certificate of good manufacturing practice shall be provided by the Agency's inspection within 90 days after the implementation of the good control
manufacturer's practice and at the request of the manufacturer or importer.
(2) The Minister shall prescribe the ordinance for the manner of issuing the certificate on the implementation of good manufacturing practice.
Article 90
(1) The Agency shall, at the request of the European Commission or an individual Member State of the European Union, provide information on the licenses issued under Article 72 of this Act.
(2) Data on production permits issued, revocation of production licenses and certificates of good manufacturing practice shall be entered in
EMA database (EudraGMP).
Article 91
The provisions of this Act relating to the manufacture of a medicinal product shall apply mutatis mutandis to the manufacture of a test drug, unless
The law does not prescribe otherwise.
7. LABELING, PACKAGE LEAFLET AND SUMMARY OF PRODUCT CHARACTERISTICS
Article 92
(1) Medicinal product on the outer packaging, or, if there is no outer packaging, on the inner packaging must contain the following information in English
language:
a) the name of the medicinal product with the strength and pharmaceutical form and, if applicable, whether the medicinal product is intended for infants, children or adults; when the drug contains up to
the three active substances are referred to as an international non-protected name (INN) or, if none, another common name
b) qualitative and quantitative composition of the active substances, given by their usual names, expressed per unit dose or, depending on the form
applications, by given volume or weight
c) the pharmaceutical form and content by weight, volume or number of doses of the drug
d) a list of excipients which have a known effect or effect and for the medicinal product to be administered parenterally, topically or for the eyes, must be indicated
all excipients
e) the route of administration and, if necessary, the route of administration, space should be left to indicate the prescribed dose
f) special warning that the drug should be kept out of the reach and sight of children
g) Special warnings, if necessary
h) clearly stated expiry date (month and year)
i) special preservation measures for the drug, if necessary
j) special measures for the treatment of waste from unused medicinal product or waste residues originating from the medicinal product, where appropriate, with instructions on appropriate
the collection system in place
k) the name and address of the marketing authorization holder or, where applicable, the name of the authorized representative of the marketing authorization holder
l) drug approval number
m) batch number
n) in the case of over-the-counter medicines, the instructions for use of the medicinal product, including indications, should be provided
o) method of dispensing the drug.
(2) Medicines, other than radiopharmaceuticals, must bear on their packaging a safety label and the types of medicinal products which must include a safety label and method
the labeling of a drug by a safety label shall be prescribed by an ordinance by the Minister.
(3) The excipients referred to in paragraph 1, item d) of this Article shall be listed in accordance with the guidelines of the European Commission.
Article 93
(1) It is not necessary to provide all the information referred to in Article 92 (1) on the inner blister pack and on the small inner packaging
Of the law.
(2) Inner packagings in the form of blisters contained in outer packagings which satisfy the requirements referred to in Article 92, paragraph 1 of this Act
at least include the following information:
- the name of the medicinal product in accordance with Article 92 (1) (a) of this Act
- the name of the marketing authorization holder or the name of the manufacturer
- expiry date
- batch number.
(3) The small inner packaging on which it is not possible to provide all the information referred to in Article 92, paragraph 1 of this Act must at least contain the following
data:
- the name of the medicinal product in accordance with Article 92 (1) (a) of this Act and, if necessary, the route of administration
- method of administration
- expiry date
- batch number
- content by weight, volume or unit of dose.
Article 94
(1) The information given on the outer and inner packaging of the medicinal product must be easily legible, comprehensible and indelible.
(2) The information given on the outer and inner packaging of the medicinal product must be in the Croatian language and in the Latin script.
(3) In addition to providing information in the Croatian language and Latin script, it may be possible to provide additional information in other languages, if the content is
of the information provided on the outer and inner packaging of the medicinal product is identical to the content of the information in the Croatian language.
(4) The name of the medicinal product referred to in Article 92, paragraph 1, item (a) of this Act must also be indicated on the packaging on Braille. At the request of the patient association,
the Marketing Authorization Holder must provide and provide to the patient association a form of medication guidance appropriate for the blind and partially sighted
persons.
(5) The Minister shall prescribe in detail an ordinance for the labeling of medicines.
Article 95
Outer packaging and package leaflet may contain symbols or pictograms approved by the Agency to clarify certain information in the
in accordance with the wording of the summary of product descriptions that are useful to the user but with the exception of all promotional elements.
Article 96
(1) Attachment of the package leaflet to the packaging of the medicinal product is mandatory for all medicinal products.
(2) By way of derogation from paragraph 1 of this Article, the adaptation of the package leaflet to the medicinal product is not obligatory if all the necessary information referred to in Articles 92 and 95 of this Act has been transmitted
to the outer or inner packaging of the medicine.
Article 97
(1) The package leaflet must be written in a clear and comprehensible manner to the user, if necessary in consultation with a healthcare professional and written
in Croatian and Latin script.
(2) In addition to the Croatian language and Latin script, the use of other languages ​​is possible, provided that the content of the information given in the instruction is identical to the content of the information on
Croatian language.
Article 98
(1) The package leaflet must be consistent with the information in the summary of product characteristics and must include in the following order:
a) information for the identification of the medicinal product:
- the name of the medicine with the strength and pharmaceutical form and, if applicable, whether it is intended for infants, children or adults. The common name is a must
state if the medicine contains only one active substance and if the name of the medicine is a registered name.
- the pharmacotherapeutic group (according to ATK classification) or the mode of action of the drug in a user-friendly language,
b) therapeutic indications,
c) information necessary to inform the user or patient before taking the drug:
- contraindications,
- appropriate precautions for use,
- interactions with other drugs and other forms of interaction (eg alcohol, tobacco, food) that may affect the action of the drug,
- special warnings,
d) instructions necessary and usual for the correct use of the drug:
- dosage,
- the route and, if necessary, the route of administration,
- the frequency of administration, with an indication of the appropriate time at which the drug may or must be administered and, if necessary, depending on the nature of the drug,
se:
- duration of treatment, if treatment should be limited,
- overdose procedures (eg symptoms and emergency measures to be taken),
- the measures to be taken in the case of omitting one or more doses of the medicinal product,
- warning, if necessary, of the risk of problems occurring when the medication is stopped,
- a recommendation to the user or patient to consult a doctor or pharmacist in the event of any ambiguity regarding the use of the medicinal product,
e) a description of the side effects that may occur with the usual use of the drug and the measures to be taken in the event of their occurrence and an explicit warning
the user to inform the health care provider or the Agency of any adverse reaction in accordance with the provisions of this Law,
f) a reference to the expiry date indicated on the packaging:
- with the warning that the medicine should not be used after the expiry date,
- with special storage conditions, if necessary,
- with warning of visible signs of discrepancy in the quality of the medicinal product, if necessary,
- with the stated complete qualitative composition of the active substances and excipients and the quantitative composition of the active substances specified in the usual
names,
- with said pharmaceutical form and content in weight, volume or dosage units,
- the name and address of the marketing authorization holder and, where applicable, the name of the authorized representative of the marketing authorization holder,
- with the name and address of the drug manufacturer,
g) for medicinal products authorized by the mutual recognition procedure or by the decentralized authorization procedure authorized under different
the names should indicate the names of the medicinal product in other EU Member States,
h) date of last revision of the instruction.
(2) When citing the information referred to in paragraph 1, subparagraph (c) of this Article, particular warnings should be given regarding the special situations of particular categories
drug users, e.g. children, pregnant or lactating women, the elderly and persons with special pathological conditions, as well as the consequences on their ability to manage
vehicles or machinery, and warnings regarding excipients that may affect the efficacy and safety of drug administration.
(3) Excipients which may affect the efficacy and safety of administration of the medicinal product are listed in accordance with European Commission guidelines.
(4) The intelligibility and simplicity of the medication instruction should be checked in the target patient groups.
(5) The Minister shall, in an ordinance, prescribe in greater detail the content and manner of adapting the medication instruction.
Article 99
(1) In the process of granting the authorization, the applicant shall, in accordance with Article 26 (3) (o) of this Act, submit one or
multiple mock-ups of the outer and inner packaging of the medicine, together with the proposal for a drug instruction.
(2) The applicant shall also submit to the Agency, in the authorization procedure, the results of the assessment of the readability of the package leaflet carried out in
cooperation with target groups of patients.
Article 100
(1) The summary of product characteristics of the medicinal product must contain the following information in the following order:
1. name of the medicine with strength and pharmaceutical form,
2. qualitative and quantitative composition of the medicinal product according to the active substances and excipients which are important for the proper administration of the medicinal product, stated
by a common name or chemical name,
3. pharmaceutical form,
4. clinical data:
4.1. therapeutic indications
4.2. dosage and route of administration for adults and, if necessary, for children
4.3. contraindications
4.4. special warnings and precautions for use, and in the case of immunological drugs, special precautions for patients and persons administering these
they also administer medicines
4.5. interactions with other drugs and other forms of interaction
4.6. use during pregnancy and lactation
4.7. affecting the ability to drive and use machines
4.8. side effects
4.9. overdose (symptoms, emergency procedures, antidotes)
5. Pharmacological properties:
5.1. pharmacodynamic properties
5.2. pharmacokinetic properties
5.3. non-clinical data on safety of administration
6. pharmaceutical information:
6.1. list of excipients
6.2. more important incompatibilities
6.3. shelf life, when necessary and after reconstitution of the medicinal product or after first opening the inner package
6.4. special precautions for storage
6.5. the type and contents of the container
6.6. special measures for the treatment of unused medicinal product waste or residues arising from the medicinal product, if applicable
7. the name and address of the marketing authorization holder
8. the number of the marketing authorization
9. date of first approval or renewal of approval
10. date of revision of the summary text
11. for radiopharmaceuticals, complete data on internal radiation dosimetry
12. for radiopharmaceuticals, additional detailed instructions for the immediate preparation and quality checks of such preparation and where necessary
the prescribed storage time during which a preparation made immediately before administration, such as eluate or ready-to-use form, is appropriate
the prescribed specifications.
(2) For approvals given in accordance with Articles 29, 30, 31, 32, 33, 34, 35 and 36 of this Act, the parts of the summary of the characteristics of the reference medicinal product which
refer to indications or dosage forms still under patent protection at the time the product is placed on the market.
summary of the product characteristics.
(3) It is obligatory to include in the summary of the product characteristics a standard text clearly indicating to healthcare professionals to report any suspicion
a side effect in accordance with the provisions of this Act and the ordinances adopted pursuant to this Act.
(4) The Minister shall prescribe the contents and method of attachment of the summary of the product characteristics.
Article 101
Medicines intended for rare and serious illnesses may be marketed on the basis of a written reasoned request by the applicant
in only one language of one of the Member States of the European Union.
Article 102
(1) For a medicinal product not intended for direct use by users or patients, or if problems arise in the supply of the medicinal product market and in accordance with
by the measures necessary to safeguard human health, the Agency may grant an exemption from the obligation that certain information must be provided on the labeling and in the
instructions about the drug.
(2) In the cases referred to in paragraph 1 of this Article, the Agency may approve in whole or in part an exemption from the obligation to label and package leaflet
they must be in the Croatian language, provided that the text is in Latin script, on the basis of the applicant's written reasoned request.
Article 103
(1) The outer box and container of radiopharmaceuticals must be labeled in accordance with the regulations on the safe transport of radioactive materials.
(2) The label on the radiopharmaceutical protective container shall contain the information specified in Article 92 of this Act.
(3) In addition to the information referred to in Article 92 of this Act, the following information must be provided on the protective container of radiopharmaceuticals:
- full explanations of the labels on the bottle
- the amount of radioactivity per dose or vial for a specified period, as appropriate
- the number of capsules or, for liquids, the number of milliliters in the container.
(4) The labeling of a radiopharmaceutical bottle contains the following information:
- the name or designation of the medicinal product, including the name or chemical symbol of the radionuclide,
- the series designation and expiry date,
- international symbol for radioactivity,
- the name and address of the manufacturer,
- the amount of radioactivity per dose or vial for a specified period.
Article 104
(1) The marketing authorization holder shall ensure that a comprehensive package leaflet is attached to the packaging of radiopharmaceuticals, radionuclide generators,
radionuclide kit or radionuclide precursor.
(2) The instruction referred to in paragraph 1 of this Article must contain the information referred to in Article 98 of this Act, as well as precautions to be taken by the user and the patient for
the time of preparation and administration of the medicinal product and special precautions for disposal of the medicinal product packaging and unused contents.
Article 105
It is forbidden on the outside, on the inner packaging of the product and on the instructions to indicate therapeutic indications if that product is not approved for
placing on the market as a cure or a homeopathic remedy.
8. CLASSIFICATION OF MEDICINES
Article 106
(1) The manner of dispensing of a medicinal product shall be determined by a decision on the granting of a marketing authorization.
(2) Given the mode of dispensing, the medicinal products shall be classified into:
- prescription drugs,
- over-the-counter medicines.
Article 107
Depending on the place of issue, the medicines are classified into the following groups:
1. prescription drugs at the pharmacy,
2. over-the-counter medications at the pharmacy and
3. over-the-counter medicines in pharmacies and specialized retail stores.
Article 108
(1) In the process of granting, renewing or amending a marketing authorization, the Agency may determine the method of prescribing:
1. a repeatable recipe
2. an unrepeatable recipe
3. special recipe
4. Limited recipe.
(2) A prescription drug authorized in the Republic of Croatia may be issued in accordance with the provisions of this Act, which is
prescribed by an authorized person from another Member State of the European Union.
(3) The Minister shall prescribe more detailed criteria for classification, prescribing and dispensing of medicines.
Article 109
(1) Medicines shall be dispensed only on medical prescription if:
- may present a danger, directly or indirectly, even when administered properly and used without the supervision of a physician, or
- they are often, and to a large extent, misapplied and could therefore pose a direct or indirect threat to human health, or
- contain substances or their preparations whose action and / or side effects need further investigation, or
- usually prescribed by a doctor for parenteral administration.
(2) Medicines not covered by the criteria referred to in paragraph 1 of this Article may be dispensed without a medical prescription.
Article 110
Upon finding out the new facts, the Agency will review the current drug classification using the criteria set out in Article 109 of this Act and the Rulebook referred to in Article
108, paragraph 3 of this Law.
Article 111
(1) The Agency shall publish the list of medicinal products subject to medical prescription in the Republic of Croatia on its website.
(2) The list of medicines referred to in paragraph 1 of this Article shall be updated at least once a year.
(3) The Agency shall submit the list of medicines referred to in paragraph 1 of this Article as amended once a year to the European Commission and the Member States of the European Union.
Article 112
After first authorizing the change of the prescription drug to non-prescription based on significant non-clinical or clinical
tests The Agency shall not use the results of those tests for a year after its approval, acting on a request from another marketing authorization holder
modifying the dispensing method for a drug with the same active substance.
9. MEDICINAL TRANSPORT
Article 113
(1) In the Republic of Croatia, only the medicinal product authorized for marketing in accordance with Article 22, paragraph 1 of this Act may be marketed.
and a medicinal product authorized for parallel import or for parallel marketing.
(2) By way of derogation from the provision of paragraph 1 of this Article, a batch of a medicinal product may be in circulation for a maximum of 18 months after the expiry or withdrawal of the marketing authorization.
traffic unless its expiry date expires.
Article 114
(1) All legal and legal persons and state bodies which in any way come into possession of medicines must ensure their transportation, accommodation and storage in
in accordance with the prescribed conditions, in order not to change the quality and misuse of the drug.
(2) The Ordinance on good practice in the wholesale of medicinal products shall be adopted by the Minister.
Article 115
Wholesale medicines can be marketed by:
- natural persons and legal entities established in the Republic of Croatia with a wholesale marketing authorization for medicinal products provided by the Agency (wholesale
drugs),
- natural persons and legal entities established outside the Republic of Croatia and in a Member State of the European Union authorized for wholesale trade in medicinal products, and
qualify for the wholesale trade of medicines in the country of establishment and are beginning business in the territory of the Republic
Croatia reported to the Agency,
- manufacturers of medicinal products established in the Republic of Croatia, in a Member State of the European Union for those medicinal products which they manufacture and for which they are authorized
placing on the market in the Republic of Croatia.
Article 116
Mediation can be performed by legal and legal entities established in the Republic of Croatia and in a Member State of the European Union with permanent
address and contact in the Republic of Croatia and in the Member State of the European Union to ensure identification, location, communication and performance monitoring
their activities.
Article 117
(1) Wholesalers may procure medicinal products directly from the manufacturer, importer, intermediary and other wholesale licensed persons
activities issued by the competent authority.
(2) The wholesale referred to in paragraph 1 of this Article shall be obliged to check whether the manufacturer of the medicinal product, importer, intermediary and other wholesale license is authorized to perform
activities.
(3) The provisions of paragraphs 1 and 2 of this Article shall also apply to the intermediary.
Article 118
(1) The wholesaler and the manufacturer of the medicinal product may supply the following medicinal products:
- pharmacies and drug stores,
- specialized retail stores for medicines,
- other wholesale,
- health care institutions, or other legal entities authorized to carry out health care activities,
- private practice in the quantities needed to treat acute conditions.
(2) The Minister shall issue the list and necessary quantities of medicines that the offices referred to in paragraph 1, subparagraph 5 of this Article may have.
(3) Wholesalers are obliged to secure the supply of medicines as soon as possible.
(4) The conditions for the export of medicinal products to third countries and the transit of medicinal products from third countries which are not imported shall be prescribed by an ordinance by the Minister.
Article 119
(1) Wholesale shall be obliged to obtain a marketing authorization for each location at which it will carry out wholesale trade in the Republic of Croatia.
wholesale.
(2) In order to obtain a wholesale marketing authorization, an applicant must, in addition to the general conditions laid down for wholesale trade, satisfy the following
minimum requirements:
- have adequate facilities, facilities and equipment to ensure the proper storage and circulation of wholesale medicines,
- be eligible for employed persons, in particular as regards the qualifications of the person responsible for wholesale medicinal products and the examination
documentation,
- comply with the rules of good practice in the wholesale of medicines.
Article 120
(1) The holder of a wholesale marketing authorization for medicinal products must fulfill the following conditions:
- have a plan for the immediate withdrawal of the medicinal product from the market at the discretion of the Agency or in agreement with the manufacturer or the marketing authorization holder
and keep documentation that will allow such withdrawal,
- keep records of orders, deliveries and brokering in written, electronic or other form,
- have a quality assurance system in place that defines processes, responsibilities and risk management,
- systematically check medicines which they receive are not forged using the safety label on the packaging, in accordance with Article 92 (2).
of this Act.
- immediately inform the Agency of the counterfeit medicinal product they have received or have been offered or of a suspected counterfeit drug,
- ensure timely, durable and appropriate supply of medicines in the territory of the Republic of Croatia.
(2) The conditions laid down in paragraph 1, subparagraphs 1, 2, 3 and 5 of this Article shall apply mutatis mutandis to legal entities and legal entities performing
drug intermediation activity.
(3) The Minister shall, by an ordinance, prescribe in more detail the conditions, documents and data for granting a license for the wholesale distribution of medicinal products, for
mediation of medicines, as well as the application procedure referred to in Article 121 of this Act.
Article 121
Natural and legal persons established outside the Republic of Croatia and in a Member State of the European Union who qualify for the activity
wholesale of medicines or mediation in the country of establishment, are obligatory upon commencement of activities in the territory of the Republic of Croatia
report to the Agency.
Article 122
(1) At the request of the European Commission or an individual Member State of the European Union, the Agency shall provide information on the licenses referred to in Article 115 of this Act which
gave.
(2) Data on wholesale marketing authorizations for medicinal products, as well as data on the withdrawal of a wholesale marketing authorization for medicinal products shall be entered in the database.
of EMA data.
Article 123
(1) The Agency shall grant a marketing or brokerage license within 90 days from the date of receipt of a duly requested request.
(2) If the Agency determines that the request is not correct or that the prescribed data and documents have not been submitted with the request, the decision shall be submitted by the applicant.
request to rectify or supplement the request within the time limit set by the Agency.
(3) During the permitting procedure referred to in paragraph 1 of this Article, the Agency may, by a conclusion, request from the applicant additional documentation,
that is, information or documents, or an adequate justification, for which he is given a deadline for delivery.
(4) If the Agency requests the applicant to rectify or supplement the request, the deadline referred to in paragraph 1 of this Article shall not run until the date of delivery of the corrected one or
amended request. The time limit referred to in paragraph 1 of this Article shall not extend beyond the time allowed for the applicant to provide oral or written reasoning.
(5) Authorization for wholesale or mediation of medicinal products shall be granted or denied by a decision against which no appeal is allowed, but shall be
it may bring an administrative dispute against that decision.
(6) The provisions of paragraphs 2, 3 and 4 of this Article shall apply mutatis mutandis to the procedures for modifying the wholesale marketing authorization and the marketing authorization.
mediation of medicines and revocation procedures.
(7) Costs in the process of granting, denying, amending and revoking the wholesale marketing authorization or mediation of medicinal products with the consent
the Minister shall be appointed by the Agency and be borne by the applicant or the holder of the license.
Article 124
(1) The Agency shall revoke the marketing authorization or the mediation of medicinal products which it has granted to wholesalers or intermediaries established in
Republic of Croatia if the license holder no longer fulfills the conditions on the basis of which the license was granted, ie the prescribed conditions for performing the activity.
(2) On the basis of a written request from the license holder, the Agency shall by a decision revoke the licenses referred to in paragraph 1 of this Article if the license holder ceases
by working.
(3) The Agency shall immediately inform the Member States of the European Union and the European Commission of the revocation of the permit referred to in paragraph 1 of this Article.
(4) The license for wholesale or mediation of medicinal products shall be revoked by a decision against which no appeal is allowed, but against such decision may be
initiate an administrative dispute.
Article 125
If the Agency determines that the wholesale or intermediary performing the activity pursuant to Article 121 of this Law does not fulfill the conditions for performing
activities, shall inform the European Commission and the competent Member State of the European Union thereof.
Article 126
(1) The wholesaler and the intermediary are obliged to notify the Agency in writing of any changes relating to the terms, documents and information on
on the basis of which the permit was granted.
(2) Wholesalers and intermediaries carrying out the activity pursuant to Article 121 of this Act shall be obliged to report any changes that have occurred in the
documents and data after registering to start business in the Republic of Croatia.
(3) If the approved modification of the licenses referred to in paragraph 1 of this Article requires the modification of the decision on the granting of the wholesale marketing authorization and the marketing authorization
mediation, the Agency issues a decision against which an appeal is not allowed, but an administrative dispute can be initiated against that decision.
(4) The Agency shall give the decision referred to in paragraph 3 of this Article within 90 days from the date of receipt of a duly requested request.
Article 127
(1) A certificate on the implementation of good practice in wholesale of medicinal products shall be given by the Ministry of Pharmaceutical Inspection within 90 days after implementation.
oversight of good wholesale practice and at the request of a wholesaler or intermediary.
(2) The Minister shall prescribe an ordinance on the granting of a certificate on the implementation of good practice in wholesale of medicinal products.
Article 128
(1) The consent of the Import or Import Agency is not required for:
- medicinal products authorized by the Agency or the European Commission,
- medicinal products authorized for parallel import or parallel circulation,
- active substances and excipients,
- intermediates or medicines for which the manufacturer carries out certain parts of the production in the Republic of Croatia.
(2) The provision of paragraph 1 of this Article does not refer to the granting of consent for importation or importation:
- medicinal products from human blood or human plasma,
- immunological drugs,
- radiopharmaceuticals.
(3) The Minister shall prescribe in greater detail the conditions for granting consent for the introduction or import of the medicinal product referred to in paragraph 2 of this Article.
Article 129
(1) The Agency may exceptionally give consent for the introduction or import of a medicinal product for which a marketing authorization has not been granted in the Republic of Croatia
in the following cases:
- that it is a medically justified need, for the protection of human health,
- for research purposes,
- for pharmaceutical testing,
- for non-clinical trials,
- in the case of natural disasters or other emergencies,
- for emergencies of individual treatment with a medicine prescribed at his own risk by a doctor of medicine or a doctor of dental medicine who conducts
treatment.
(2) The Minister shall prescribe in greater detail the conditions for granting consent for the introduction or import of the medicinal product referred to in paragraph 1 of this Article.
(3) The import, export, transport and transit of drugs, substances which may be used for the manufacture of drugs and the drugs containing them shall be subject to the provisions of the special
of the law on combating drug abuse.
Article 130
(1) The parallel importation of a medicinal product may be carried out by wholesalers licensed to carry out the wholesale trade of medicinal products and not in a business relationship
with the marketing authorization holder of that medicine.
(2) The Minister shall, by an ordinance, prescribe in more detail the conditions, documents and data for granting authorization for parallel import of a medicinal product.
Article 131
(1) Wholesale of medicines which are not holders of marketing authorization and which, on the basis of the authorization for parallel import of a medicinal product, bring a medicinal product from
other EU Member States in the Republic of Croatia are obliged to inform the Agency and the Marketing Authorization Holder prior to entry.
traffic without delay, and no later than 15 days before listing.
(2) Wholesale of medicinal products referred to in paragraph 1 of this Article, for a medicinal product which has been granted marketing authorization in accordance with Regulation (EC) No 726/2004,
they are required to submit the notification to the authorization holder and to the EMA.
Article 132
(1) The Agency shall authorize the parallel importation of a medicinal product within 90 days from the date of receipt of a valid request.
(2) If the Agency determines that the request is not correct or that the prescribed data and documents have not been submitted with the request, the decision shall be submitted by the applicant.
request to rectify or supplement the request within the time limit set by the Agency.
(3) The Agency may, during the approval procedure referred to in paragraph 1 of this Article, request an additional decision from the applicant
documentation, or data or documents, or appropriate justification, for which he is given a deadline for delivery.
(4) If the Agency requests the applicant to rectify or supplement the request, the deadline referred to in paragraph 1 of this Article shall not run until the date of delivery of the corrected one or
amended request. The time limit referred to in paragraph 1 of this Article shall not extend beyond the time allowed for the applicant to provide written explanation.
(5) The authorization for parallel importation of a medicinal product shall be granted or denied by a decision against which no appeal is allowed, but against such a decision may be
initiate an administrative dispute.
(6) The provisions of paragraphs 2, 3 and 4 of this Article shall apply mutatis mutandis to the procedures for modifying the authorization for parallel import of a medicinal product.
(7) The costs in the procedure of granting, denying and modifying the authorization for parallel import of a medicinal product with the consent of the Minister shall be determined by the Agency and shall be borne by them.
applicant or marketing authorization holder.
Article 133
(1) The Agency shall suspend the authorization for parallel importation of a medicinal product if the holder of the authorization or the medicinal product no longer fulfills the conditions on the basis of which the authorization was granted.
(2) The authorization for parallel imports shall be revoked by a decision against which no appeal is allowed, but an administrative dispute may be instituted against that decision.
Article 134
(1) The holder of the parallel import authorization shall notify the Agency in writing of any changes to the documentation and
the documents and information on the basis of which approval was given.
(2) If the approved modification of the authorization referred to in paragraph 1 of this Article requires modification of the decision on authorization for parallel import of a medicinal product, the Agency shall adopt
decision to amend the authorization by a decision which is not allowed to appeal, but an administrative dispute can be initiated against that decision.
(3) The Agency shall issue a decision amending the authorization for parallel import of a medicinal product within 90 days from the date of receipt of a duly requested request.
Article 135
(1) The retail trade in medicinal products shall be performed by legal and zonal persons who, in accordance with a special law, have been authorized to perform pharmacy activities and
specialized retail stores licensed by the Agency.
(2) Pursuant to Article 106, paragraph 2 of this Act, prescription medicines are allowed to be dispensed exclusively in pharmacies, and dispensing of medicines
over-the-counter dispensers are also allowed in specialized drug stores, in accordance with the Agency's approval decision
placing the drug on the market.
(3) If drug dispensing is permitted in specialized retail stores, the Agency may impose limits on the strength and
the size of the drug pack.
(4) The Ordinance on the conditions for the authorization of specialized retail stores for medicinal products shall be adopted by the Minister.
Article 136
(1) Natural and legal persons engaged in pharmacy activities in the Republic of Croatia may offer online for distance selling, in accordance with
special prescription, over-the-counter drugs.
(2) The natural or legal person referred to in paragraph 1 of this Article who offers remedies for sale via the Internet shall submit the following to the Agency:
data:
- the name or name and permanent address of the place of dispensing,
- date of the start of the sales activity,
- the address of the website used for this purpose and any relevant information necessary to identify the site.
(3) The website referred to in paragraph 2 of this Article, through which medicinal products for distance sale are offered, must contain at least the following:
- contact details of the Agency,
- a link to the Agency's website containing information on legal and natural persons offering distance medicines,
- a common logo in the format prescribed for the European Union, clearly displayed on each website linked to the supply of medicinal products for sale
and a link to the list of legal and natural persons offering distance medicine.
(4) The Ordinance on conditions for the sale of long-distance medicinal products via the Internet shall be adopted by the Minister.
Article 137
The Agency's website contains:
- information on national regulations governing the supply of medicines for distance selling on the Internet, including information on differences
in the classification and conditions of dispensing which may exist among the Member States of the European Union
- information on the purpose of the common logo
- a list of persons offering medicinal products for sale via the Internet in accordance with Article 136 of this Act and the addresses of their internet sites
page
- background information on the risks associated with drugs being sold illegally to the public through unauthorized social information
service
- a link to EMA's website for information on distance selling of medicines.
Article 138
(1) The Agency shall authorize the retail sale of medicines in a specialized store within 90 days from the receipt of a duly requested request.
(2) If the Agency determines that the request is not correct or that the prescribed data and documents have not been submitted with the request, the decision shall be submitted by the applicant.
request to rectify or supplement the request within the time limit set by the Agency.
(3) During the procedure for granting the permit referred to in paragraph 1 of this Article, the Agency may, by a conclusion, request from the applicant additional documentation,
that is, information or documents, or a proper justification, and set a time limit for its delivery.
(4) If the Agency requests the applicant to rectify or supplement the request, the deadline referred to in paragraph 1 of this Article shall not run until the date of delivery of the corrected one or
amended request. The time limit referred to in paragraph 1 of this Article shall not extend beyond the time allowed for the applicant to provide oral or written reasoning.
(5) The authorization for retail sale of medicines in a specialized store shall be granted by a decision against which no appeal is allowed, but against
solutions can be initiated by an administrative dispute.
(6) The provisions of paragraphs 2, 3 and 4 of this Article shall apply mutatis mutandis to the procedures for modifying the marketing authorization for medicinal products in
specialized store and procedures for revocation of the same permit.
(7) The costs in the procedure of granting, denying, modifying and revoking the marketing authorization for medicinal products with the consent of the Minister shall be determined by the Agency, and
they are borne by the applicant or the holder of the license.
Article 139
(1) The Agency shall revoke the license of a specialized retail store for medicinal products if it determines that the holder of the license no longer fulfills the conditions for
on the basis of which the license was given or the prescribed conditions for performing the activity of retail trade of medicines in a specialized store.
(2) On the basis of a written request of the license holder, the Agency shall by a decision revoke the permit referred to in paragraph 1 of this Article if the license holder ceases
by working.
(3) The retail marketing authorization for medicinal products shall be revoked by a decision against which no appeal is allowed, but an administrative action may be instituted against that decision.
dispute.
Article 140
(1) The marketing authorization holder shall notify the Agency in writing of any changes relating to the conditions,
the documents and information on the basis of which the permit was granted.
(2) A natural or legal person who sells medicinal products via the Internet in accordance with Article 136 of this Act shall be obliged to notify in writing
The Agency on any changes in the documents and data on the basis of which they have reported the commencement of the activity.
(3) The Agency shall issue the decision on modification of the marketing authorization for medicinal products in a specialized store within 90 days from the date of receipt
orderly request.
(4) If the approved modification of the authorization referred to in paragraph 1 of this Article requires modification of the decision on granting a marketing authorization for medicinal products to
The Agency issues a decision to a specialized shop against which an appeal is not allowed, but an administrative dispute can be initiated against that decision.
Article 141
(1) All legal entities and legal entities engaged in the wholesale distribution of medicinal products and legal or commercial entities operating in the wholesale market of medicinal products
provide the Agency at least annually with information on the marketing of medicinal products.
(2) The Minister shall prescribe the type of data and the manner of drawing up the reports referred to in paragraph 1 of this Article.
Article 142
The Ordinance on the wholesale and retail trade of drugs, substances which may be used for the manufacture of drugs and medicines containing drugs is adopted by the Minister.
Article 143
(1) Medicines which do not have the proper quality, efficacy and safety of use and which have expired may not be on the market and
they are considered waste.
(2) The regulations governing waste management shall apply to waste management referred to in paragraph 1 of this Article.
10. PHARMACOVIGILANCE
Article 144
(1) For medicines authorized for marketing in the Republic of Croatia, the Agency may order additional monitoring for safety reasons.
profiles.
(2) The medicines referred to in paragraph 1 of this Article must be specifically labeled.
Article 145
(1) The healthcare professional who comes in contact with the patient / drug user, the drug manufacturer, the authorization holder, the holder of the parallel import authorization,
the importer and the wholesaler are obliged to notify the Agency in writing of suspected adverse reactions, in particular serious and unexpected, and in the case of vaccines,
Croatian Institute for Public Health.
(2) Health worker shall report serious side effects to the Agency not later than 30 days from the day of finding out and later if necessary by reporting
reports. Serious side effects resulting in the death of a person should be reported to the Agency without delay in writing or by telephone with subsequent written information.
notice.
(3) If a healthcare professional participates in a clinical trial as an examiner, he shall immediately report all serious adverse events to the client.
clinical trials other than those for which the test plan and examiner's instructions do not require it.
(4) The Pharmacovigilance Ordinance shall be adopted by the Minister.
Article 146
(1) The patient / user of the medicinal product may directly report any suspected adverse reactions to the medicinal products and vaccines to the Agency or the marketing authorization holder.
(2) The suspected adverse reaction may be reported by the patient / user of the medicinal product, and for a business incapable person, a person with severe mental disability or a minor
The suspected side effect can be reported by the parent, legal representative or guardian.
Article 147
(1) The authorization holder shall establish a pharmacovigilance system for carrying out pharmacovigilance duties in accordance with the provisions of this
Of the Act and the ordinance adopted pursuant to this Act.
(2) The marketing authorization holder shall be obliged to evaluate scientifically all pharmacovigilance safety data through the pharmacovigilance system, to consider
opportunities to minimize and prevent risks and take appropriate action if necessary.
(3) The authorization holder shall be obliged to carry out a regular audit of the pharmacovigilance system.
(4) The PSMF shall be obliged to record in the PSMF the main findings of the audit and, on the basis thereof, to ensure the preparation and implementation
appropriate corrective action.
(5) The note referred to in paragraph 4 of this Article may be deleted by the holder of the authorization after full corrective measures have been implemented.
Article 148
(1) The authorization holder shall be obliged under the pharmacovigilance system to:
a) have at their disposal at all times:
- an appropriately qualified person responsible for pharmacovigilance in the European Union, and
- an appropriately qualified person responsible for pharmacovigilance in the Republic of Croatia,
b) maintain the PSMF and make it available to the Agency at the request of the Agency,
c) implement a risk management system for each approved drug,
d) monitor the outcome of the risk minimization measures contained in the RMP or which have been determined as a condition in accordance with Articles 46, 47 and 48 of this Law;
e) supplement the risk management system and monitor pharmacovigilance data to identify new risks, change existing risks, or
changes in the risk / benefit ratio of medication administration.
(2) The duties of the person responsible for pharmacovigilance in the European Union and the Republic of Croatia referred to in paragraph 1, subparagraph (a) of this Article may be performed
one person.
Article 149
(1) For medicinal products authorized before 21 July 2012, the authorization holder is under no obligation to implement a risk management system for each medicinal product
pursuant to Article 148 (1) (c) of this Act.
(2) Where there are doubts about the risks that could affect the risk-benefit ratio of the authorized medicinal product, the Agency may, exceptionally from paragraph 1 of this Article,
specify that the authorization holder implements a risk management system.
(3) In accordance with paragraph 2 of this Article, the Agency shall oblige the authorization holder to submit a detailed description of the risk management system it intends to introduce.
for that medicine.
(4) The Agency may determine the fulfillment of the obligation referred to in paragraphs 2 and 3 of this Article in justified cases, with written notice, with deadlines for submission
a detailed description of the risk management system.
(5) At the request of the authorization holder, the Agency shall enable the authorization holder to make a written statement on the obligation referred to in paragraphs 2 and 3 of this Article in the
within 30 days of receipt of the written notification.
(6) On the basis of a written explanation of the authorization holder, the Agency shall decide on the obligation referred to in paragraphs 2 and 3 of this Article.
(7) If the Agency confirms the decision referred to in paragraph 6 of this Article, it shall issue a decision modifying the authorization with the obligation to implement measures in accordance with Article 46.
paragraph 1, subparagraph 1 of this Act.
Article 150
The marketing authorization holder is obliged to:
- keep a record of all suspected adverse reactions in the Republic of Croatia, other EU Member States and third countries
reported, either spontaneously by patients / drug users or healthcare professionals, or recorded during the post-authorization testing,
- ensure that the information referred to in subparagraph 1 of this paragraph is available at a single location within the European Union.
Article 151
(1) The marketing authorization holder shall electronically report to the Eudravigilance database:
- any suspicion of serious side effects that occurred in the Republic of Croatia within 90 days from the day of finding out,
- any suspected serious adverse reactions that occurred in the Republic of Croatia within 15 days of the date of the finding,
- any suspected adverse reactions that have occurred in the Member States of the European Union within 90 days of the date of the finding,
- any suspected serious adverse reactions that have occurred in the Member States of the European Union within 15 days of the date of the finding,
- any suspected serious adverse reactions that occurred in third countries within 15 days of the date of the finding.
(2) The authorization holder shall establish procedures for obtaining accurate and verifiable information for the scientific assessment of suspected reports.
side effects, as well as collect follow-up reports on these reports and submit them to the Eudravigilance database.
(3) The Marketing Authorization Holder shall cooperate with the Agency and the EMA in detecting duplicate suspected adverse reaction reports.
(4) The marketing authorization holder shall report any suspected adverse reactions referred to in paragraph 1, subparagraphs 1 and 2 of this Article electronically until the
does not establish a functional system for reporting adverse reactions in Eudravigilance.
(5) The Agency shall be obliged to electronically send all reports of suspected adverse reactions received in accordance with paragraph 4 of this Article to Eudravigilance in
in accordance with the time limits referred to in paragraph 1, subparagraphs 1 and 2 of this Article.
Article 152
(1) The client of the clinical trial shall be obliged to:
- keep a thorough record of all adverse events reported to him by the examiner, and provide information at the request of the Agency and / or the Central Ethics
commissions and / or ministries
- without delay, and at the latest within seven days from the day of knowledge, ensure that all information on suspected serious unexpected side effects which are
deadly or life-threatening applications electronically at Eudravigilance
- submit a follow-up report on the findings referred to in subparagraph 2 of this paragraph within eight days of the expiry of the period referred to in subparagraph 2 of this paragraph
- without delay, and at the latest within 15 days from the day of finding out electronically to Eudravigilance, report any other suspected serious
unexpected side effects
- inform the examiners of any suspected serious adverse reactions
- submit to the Agency and the Central Ethics Committee a report for a medicinal product in a clinical trial for a period not exceeding one year, and extraordinary at
a request from the Agency and / or the Central Ethics Committee.
(2) The client of the clinical trial shall be bound by the side effects referred to in paragraph 1, subparagraphs 2, 3 and 4 of this Article that have occurred in the Republic of Croatia.
also electronically report to the Agency.
Article 153
(1) The Agency will operate a pharmacovigilance system to fulfill its pharmacovigilance obligations and participate in pharmacovigilance
activities of the European Union.
(2) The pharmacovigilance system is used to collect information on the risks of administering medicines to patients and / or to protect human health.
(3) The information referred to in paragraph 2 of this Article specifically relates to the side effects arising from the administration of the medicinal product in accordance with the authorization for placing the medicinal product in the
traffic, applying beyond the approved indications and to the side effects associated with occupational exposure.
(4) The Agency shall, through the pharmacovigilance system referred to in paragraph 1 of this Article, expertly evaluate all data regarding the safety of administration of the medicinal product, shall consider
opportunities to minimize and prevent risks and, if necessary, take appropriate measures in relation to the marketing authorization.
(5) The Agency will regularly audit its pharmacovigilance system and report to the European Commission on the findings of the audit by 21 September at the latest
2013, and every two years thereafter.
(6) At the request of the European Commission, the Agency, with the coordination of the EMA, will participate in the international harmonization and standardization of technical measures in the
pharmacovigilance.
Article 154
(1) Within the pharmacovigilance system, the Agency shall:
- keep a record of all reports of suspected adverse reactions that have occurred in the territory of the Republic of Croatia
- involve patients / drug users and healthcare professionals in the provision of follow-up reports for any applications they receive, where appropriate
- take all necessary measures to obtain accurate and verifiable information for the scientific evaluation of the suspected adverse reaction report
- by means of data collection methods and, where necessary, through the follow-up reports, ensure that all appropriate measures are taken with a view to achieving them
identification of any prescribed, issued or marketed biological medicinal product in the territory of the Republic of Croatia which is listed as a suspected medicinal product
report side effects considering the name of the medicine and the batch number of the medicine
- ensure that reports of suspected adverse reactions, in addition to existing reporting methods, can be submitted through the Medicines Portal
- cooperate with the EMA and the MAHs in detecting duplicates of suspected adverse reactions
- submit electronic notifications to the Eudravigilance database within 15 days of receipt of the report of suspected serious adverse reaction, and
suspected transmission of infectious agents via drug
- electronically submit to the Eudravigilance database all reports of suspected serious adverse reactions that occurred in the Republic of Croatia
within 90 days of the date of the finding
- ensure that reports of suspected adverse reactions resulting from the misuse of the medicinal product reported to it are available in the database
Eudravigilance.
(2) The Agency may involve the marketing authorization holder in the collection of follow-up reports on adverse reaction occurrences in the territory of the Republic
Of Croatia.
Article 155
(1) The Agency may delegate any task entrusted to it pursuant to the provisions of this Act relating to pharmacovigilance to the competent
to the body of another Member State of the European Union, subject to its written consent.
(2) The Agency may represent at most one more Member State of the European Union.
(3) In the event that the Agency delegates the tasks referred to in paragraph 1 of this Article, it shall inform the European Commission, EMA and all competent authorities in writing.
other Member States of the European Union and make this information public.
(4) In the event that the Agency performs the tasks referred to in paragraph 1 of this Article for another Member State of the European Union, the costs shall be determined by the Agency.
Article 156
The costs of carrying out pharmacovigilance activities by the Agency shall be determined by the Agency and shall be borne by the authorization holder.
Article 157
(1) The Agency will establish and maintain an online medicines portal linked to the EMA's European medicines portal.
(2) The Agency shall publish the following information and documents through the portal referred to in paragraph 1 of this Article:
- public summary reports of the summary of the product,
- summary of product characteristics and package leaflet,
- summaries of risk management plans,
- a list of medicines subject to additional monitoring after authorization,
- information on different ways of reporting suspected adverse reactions to the Agency by healthcare professionals and patients / drug users
and application forms and electronic applications,
- all other safety information relevant to the use of medicines (news, letters to healthcare professionals, etc.).
Article 158
(1) If the marketing authorization holder intends to publicly disclose pharmacovigilance information affecting the administration of the medicinal product, it shall be obliged to do so before publication.
inform the Agency, EMA and the European Commission in writing.
(2) If he publishes the information referred to in paragraph 1 of this Article, the marketing authorization holder shall ensure that the information to the public is objective and does not specify
to the wrong conclusion.
Article 159
(1) For medicinal products subject to risk minimization measures, the Agency may limit the conditions and measures for prescribing and dispensing if it deems it to be
the introduction of such restrictions in the interest of patients, that is, the safe administration of these drugs.
(2) In the case referred to in paragraph 1 of this Article, the Agency may determine the conditions to be fulfilled by the health care professional for the purpose of prescribing and issuing these
medicines.
Article 160
(1) The Agency shall, except in case of need for urgent public information for the protection of human health, not later than 24 hours before the public
information relating to pharmacovigilance information, inform the Ministry, the other Member States of the European Union and the European Union
commission.
(2) The Agency, in cooperation with the EMA, will issue a joint statement concerning the safety of the administration of active substances in the composition of medicinal products authorized in more than
one Member State of the European Union.
(3) All information of a personal or business confidential nature referred to in paragraphs 1 and 2 of this Article shall be omitted, unless their disclosure is necessary for the sake of
protection of human health.
Article 161
(1) The Agency, in collaboration with the EMA for approved medicines, will undertake the following:
- monitor the outcomes of the risk minimization measures contained in the risk management plans and the conditions referred to in Articles 46, 47 or 48 of this Law,
- evaluate the changed risk management systems,
- monitor data in the Eudravigilance database to determine if there are new risks for the use of the drug, whether they have changed and whether they affect the relationship
risks and benefits of the drug.
(2) If it is determined that there are new risks to the use of the medicinal product or that they have changed, or that they affect the risk-benefit ratio, the Agency shall notify
To the EMA and the authorization holder.
(3) If the marketing authorization holder determines that there are new risks to the use of the medicinal product or that they have changed, that is, affecting the risk-benefit ratio, then
will notify the Agency and the EMA.
Article 162
(1) The marketing authorization holder may conduct a non-interventional safety assessment of the medicinal product after obtaining marketing authorization,
at his own request or on the basis of obligations pursuant to Article 46 or Article 48 of this Act, which includes the collection of security data from
patients and healthcare professionals.
(2) The costs of the examination referred to in paragraph 1 of this Article shall be borne by the authorization holder.
(3) The test referred to in paragraph 1 of this Article shall not be conducted in order to promote the use of a drug.
(4) The compensation to the health care provider for participation in the examination referred to in paragraph 1 of this Article shall be limited to the compensation for the time spent and incurred
costs.
(5) During carrying out the tests referred to in paragraph 1 of this Article, the authorization holder shall monitor the data collected and consider their impact on the
risk-benefit ratio of the investigational drug.
(6) If the authorization holder has new information that could influence the risk / benefit assessment, he shall submit an application to the Agency.
to approve an amendment in accordance with Articles 50, 51 and 52 of this Act.
(7) The holder of the authorization shall submit an application for approval of the change in the case referred to in paragraph 6 of this Article, regardless of the obligation to enter information on
the results of the examination referred to in paragraph 1 of this Article in the PSUR.
Article 163
(1) The marketing authorization holder is obliged to submit to the PRAC the draft safety testing plan for the medicinal product referred to in Article 162, paragraph 1 of this Act, which shall be
to carry out on the basis of obligations in accordance with Article 46 or Article 48 of this Act, except in the case referred to in paragraph 2 of this Article.
(2) The marketing authorization holder shall submit to the Agency a draft safety testing plan for the medicinal product referred to in Article 162, paragraph 1 of this Act, which shall be
implement only in the Republic of Croatia upon request of the Agency in accordance with Article 48 of this Act.
(3) Within 30 days from the receipt of the draft test plan referred to in paragraph 2 of this Article, the Agency shall:
a) to notify in writing the acceptance of the draft test plan; or
b) provide written notice of deficiencies in the following cases:
- when it assesses that the testing promotes the use of the drug,
- when it finds that the test design does not meet the test objectives or
c) send a letter informing the marketing authorization holder that the test is a clinical trial to which the provisions of Directive 2001/20 / EC apply.
(4) The examination referred to in paragraph 1 of this Article may be initiated in the Republic of Croatia on the basis of the written consent of the PRAC, and after the holder of the authorization
submit the approved test plan to the Agency.
(5) The examination referred to in paragraph 2 of this Article may commence on the written approval of the Agency.
Article 164
(1) The holder of the approval shall, upon commencement of the examination referred to in Article 163 (1) of this Act, submit to the PRAC and obtain written consent from the PRAC;
and for any significant amendments to the test plan prior to their implementation.
(2) The holder of the approval shall be obliged to submit the accepted significant amendments to the test plan referred to in paragraph 1 of this Article prior to their implementation.
Agency.
(3) The holder of the authorization is obliged to submit to the Agency after obtaining the examination referred to in Article 163, paragraph 2 of this Act and obtain a written approval
Agencies for any significant changes to the test plan prior to their implementation.
Article 165
(1) Upon completion of the examination referred to in Article 163 (1) of this Act, the holder of the approval shall submit to the PRAC the final test report and
summary of test results within 12 months of completion of data collection, unless approved by PRAC in writing to extend deadline or exclude
from the obligation to submit the final report.
(2) The holder of the approval shall, upon completion of the examination referred to in Article 163, paragraph 2 of this Act, submit to the Agency a final test report and
summary of test results within 12 months of completion of data collection, unless the Agency approves in writing the extension of time or
exemption from the obligation to submit a final report.
(3) If the results of the tests referred to in paragraphs 1 and 2 of this Article affect the approval, the authorization holder shall submit to the Agency an application for approval
amendments in accordance with Articles 50, 51 and 52 of this Law.
Article 166
If the results of the examination referred to in Article 163 (1) of this Act affect the approval in the Republic of Croatia, the Agency shall, in accordance with the conclusion
MRP and DCP Coordination Groups or in accordance with a decision by the European Commission to take appropriate measures regarding the authorization of the medicinal product
traffic.
Article 167
The European Union emergency procedure based on pharmacovigilance information shall be carried out in accordance with the provisions of Articles 107i, 107j and 107k of the Directive.
2001/83 / EC.
Article 168
The holder of the authorization is obliged to submit PSUR without delay, at the request of the Agency, in accordance with the following deadlines:
- if the medicinal product has not been placed on the market, at least every six months after the marketing authorization has been granted, until such medicinal product is placed on the market,
- if the medicinal product is placed on the market, at least every six months during the first two years of its placing on the market, then once a year for the next
two years then for periods of three years.
Article 169
(1) For authorizations given in accordance with Articles 29, 34, 63 and 68 of this Act, the authorization holder shall submit to the Agency PSUR in the following
cases:
- on the basis of obligations under Articles 46 or 48 of this Act, or
- upon a request by the Agency regarding pharmacovigilance data or the absence of a PSUR for the active substance after authorization.
(2) The Agency shall submit reports on the evaluation of the periodic safety reports from paragraph 1 of this Article to the PRAC.
Article 170
(1) In the authorization decision, the Agency shall state the obligation to submit PSURs frequently if the frequency of PSUR submission for that active substance is not
prescribed by the EURD list.
(2) The PSUR submission dates in accordance with a specified frequency shall be counted from the date of granting the authorization.
(3) For authorizations given before July 21, 2012 and for which the frequency and delivery dates of PSURs are not prescribed by the authorization decision,
authorization holders are obliged to submit PSURs in accordance with Article 168 of this Act.
(4) The obligation to submit PSURs in accordance with paragraphs 1 and 3 of this Article shall exist until a different frequency or other dates are prescribed.
submission in the approval decision or until it is determined in accordance with the EURD list.
Article 171
(1) The Agency evaluates PSURs to identify new risks related to the safety of the medicine, to change those risks or to have a change in the relationship
risks and benefits of using the drug.
(2) After the assessment referred to in paragraph 1 of this Article, the Agency may request the marketing authorization holder to initiate the authorization procedure
modification / s or ex officio modify the marketing authorization, withdraw or withdraw the authorization.
Article 172
(1) The Agency may participate in the work of the CMD (h) for the purpose of a single PSUR assessment relating to more than one approval.
(2) If the assessment referred to in paragraph 1 of this Article affects the approval in the Republic of Croatia, the Agency shall, in accordance with the agreement reached by CMD (h), or
in accordance with the decision of the European Commission, take the appropriate approval measures.
(3) If the PSUR's assessment conditions the amendment of the approval, the authorization holder shall submit to the Agency an application for approval of the amendment, including
amended summary of product characteristics and package leaflet.
11. CHECKING THE QUALITY OF THE MEDICINAL PRODUCT
Article 173
(1) The quality control of a medicinal product within the meaning of this Act shall be understood as the procedure for establishing the conformity of a medicinal product with a preset
quality requirements under this Act and regulations adopted pursuant to this Act.
(2) The Agency is authorized for the official territory of the Republic of Croatia to carry out official quality checks of medicinal products and is a member of the European Network of Official Controls
laboratory.
(3) The quality control of a medicinal product may be:
- regular
- special
- from traffic
- extraordinary and
- in the process of granting and renewing the marketing authorization or in the process of approving changes to the product documentation relating to
the quality of the drug.
(4) The regulation on the quality control of the medicinal product referred to in paragraph 1 of this Article shall be adopted by the Minister.
(5) The costs of quality control referred to in paragraph 3 of this Article shall be determined by the Agency with the consent of the Minister.
Article 174
(1) The manufacturer of a medicinal product shall be obliged to carry out regular quality checks of each batch of medicinal products.
(2) For each batch of a medicinal product authorized in the Republic of Croatia, the marketing authorization holder shall be obliged to ensure the batch release
of the medicinal product on the market in the European Union.
(3) For each batch of medicinal product authorized in the Republic of Croatia, the marketing authorization holder shall ensure that the
quality control carried out in the European Union, except in the case referred to in Article 81, paragraph 5 of this Act.
Article 175
(1) The holder of the marketing authorization for a human blood or human plasma or vaccine medicinal product shall ensure that for each batch of human blood medicinal product
or human plasma or vaccines have a special quality check.
(2) The Agency shall carry out special quality checks of each batch of medicinal product from human blood or human plasma and vaccines, except for the batch produced in others.
Member States of the European Union and / or States Parties to the mutual recognition procedure, for which the competent authority has carried out the verification
and issued a European Union-wide Quality Control Certificate (hereinafter referred to as the "European Control Authority Batch Release Certification"):
OCABR certificate).
(3) The Agency shall be obliged to carry out the quality check referred to in paragraph 1 of this Article within 60 days from the date of receipt of the duly requested and prescribed
documentation.
(4) The costs of quality control referred to in paragraph 1 of this Article shall be borne by the applicant for special quality control of the medicinal product.
Article 176
(1) The Agency shall perform a quality check of pharmaceuticals taken from the market by a pharmaceutical inspection, according to the plan at least once every five years for each
pharmaceutical form and strength of the drug.
(2) The Agency may carry out a quality check of galenic preparations taken from the market by a pharmaceutical inspection.
(3) The Agency shall be obliged to carry out quality control of the market within 60 days from the date of receipt of the sample drug or galenic preparation.
(4) The costs of checking the quality and samples of the medicinal product or galenic preparation shall be borne by:
- the marketing authorization holder or the holder of the parallel import authorization, and if the medicinal product does not have the marketing authorization
wholesale or importer who imported it
- a health institution or pharmacy that made the galenic preparation.
Article 177
(1) Extraordinary quality checks shall be carried out at the request of the Ministry or the Agency due to signs of unusual occurrences or doubts about quality, ie
counterfeiting of a particular drug or galenic preparation by the Agency.
(2) The Agency is obliged to carry out an extraordinary check of the quality of the medicine or galenic preparation within 60 days from the date of receipt of the samples and
a record stating quality doubts.
(3) The costs of checking the quality of the medicinal product or galenic preparation referred to in paragraph 1 of this Article shall be borne by:
- proponent of exceptional quality control, ie. Ministry or Agency if the medicine or galenic preparation is correct
- the marketing authorization holder or the holder of the parallel import authorization, and if the medicinal product does not have the marketing authorization
wholesale or importer if medication is defective
- a legal or natural person if the improper treatment in the manufacture, manufacture, marketing or storage caused a defect in the quality of the medicinal product
- a health establishment or pharmacy that manufactured the galenic preparation if the galenic preparation is defective.
(4) The costs of samples of a medicinal product or galenic preparation shall be borne by the authorization holder, ie the health institution or pharmacy which manufactured the galenic
preparation.
Article 178
(1) Quality control of the medicinal product in the process of granting and renewing the marketing authorization and in the granting of authorization for parallel import
of the medicinal product and the procedure for approval of changes in the medicinal product documentation shall be carried out at the request of the Agency, if, based on the opinion of the Agency, the examination of the medicinal product
necessary to make a decision.
(2) The applicant shall bear the costs of checking the quality of the medicinal product referred to in paragraph 1 of this Article.
Article 179
(1) The quality assurance methods described in the product documentation submitted with the application for administration shall be applied in performing the quality control of the medicinal product.
of the marketing authorizations, the granting of authorizations for parallel imports or, if they do not exist, the methods adopted by the Agency shall apply.
(2) The extent of the quality control of an individual medicinal product shall be determined by the Agency.
(3) The quality of the medicinal product and its raw materials for the manufacture of the medicinal product, including its inner packaging materials, must comply with the Croatian Pharmacopoeia,
that is, the drug must be manufactured and of proven quality in accordance with the procedures and requirements of the current European Pharmacopoeia. If the drug is not covered
Croatian Pharmacopoeia or European Pharmacopoeia, its quality must match that of a pharmacopoeia recognized in the European Union or other
internationally recognized standards.
Article 180
(1) The records on the performed quality control of a medicinal product shall be obliged to keep:
- the marketing authorization holder
- the holder of the authorization for the parallel imported product
- wholesale.
(2) The records on the quality control of the galenic preparation shall be kept by the health institution or pharmacy which made the galenic preparation.
preparation.
(3) The Agency is obliged to keep a record of each quality check performed.
(4) The records referred to in paragraphs 1, 2 and 3 of this Article must be kept for one year longer than the expiry date of the medicinal product or galenic preparation on which
relationships.
(5) The content and manner of keeping the records referred to in paragraphs 1, 2 and 3 of this Article shall be prescribed by an ordinance by the Minister.
Article 181
(1) Health care professionals who come into contact with a medicinal product or a user of a medicinal product, and legal and natural persons producing or marketing the medicinal product are obliged
are of a defect in the quality of the medicine they have learned in writing to the Agency.
(2) In case of suspected counterfeit medicinal product, the persons referred to in paragraph 1 of this Article shall notify the Agency within 24 hours of the suspicion.
(3) The Minister shall issue an ordinance on the manner of monitoring a defect in the quality of a medicinal product.
12. ADVERTISING ON MEDICINE
Article 182
For the purposes of this Act, advertising for a medicinal product shall mean any form of communication intended to encourage their prescription,
publishing, sales and consumption in written, oral, pictorial, audio, electronic, digital or other form.
Article 183
(1) Advertising on medicinal products referred to in Article 106, paragraph 2, subparagraphs 1 and 2 of this Act shall be allowed in the professional literature, in the professional and scientific fields.
rallies and towards healthcare professionals.
(2) Advertising on medicinal products referred to in Article 106, paragraph 2, subparagraph 2 of this Act shall be allowed to the public.
(3) Advertising on medicinal products referred to in Article 106, paragraph 2, subparagraph 1 of this Act shall be prohibited to the population.
(4) The prohibition referred to in paragraph 3 of this Article shall not apply to public health activities for the promotion of immunization, seropro and chemopro
a program adopted by the Minister in accordance with the Law on the Protection of Populations from Infectious Diseases.
(5) It is prohibited to advertise on a medicinal product that is not authorized for marketing in the Republic of Croatia, except at professional and scientific meetings
and in the professional literature, provided that the procedure for marketing authorization in accordance with this Act has been initiated and used
just the usual name for the drug name, without specifying the manufacturer.
(6) The restrictions referred to in paragraph 5 of this Article shall not apply to scientific and professional international conferences held in the Republic of Croatia.
Article 184
(1) The advertising of a medicinal product must be given objectively, with the purpose of promoting rational pharmacotherapy and must not be misleading.
(2) The Minister shall prescribe the manner of advertising the medicinal product by an ordinance.
Article 185
It is forbidden to state in a product advertisement that a product has medicinal properties if it is not authorized for marketing as a medicine, or if it is not
registered as a traditional herbal remedy.
13. SUPPLY OF THE CROATIAN MEDICINAL MARKET
Article 186
(1) The holder of the marketing authorization, as well as legal persons and legal entities engaged in the marketing of the medicinal product in the territory of the Republic of Croatia
they are obliged, within the scope of their responsibilities, to ensure an adequate and uninterrupted supply of medicinal products.
(2) The Agency is responsible for monitoring the supply of medicinal products for the territory of the Republic of Croatia.
(3) The marketing authorization holder shall be bound by the circumstances that may lead to a disruption of the Croatian market supply of the medicinal product or
inform the Agency and the Ministry without delay in writing about the deficiency of the medicinal product, and for the medicinal product included in the Croatian Institute for Medicinal Products list
Health Insurance and the Croatian Institute for Health Insurance (hereinafter: the Institute).
(4) The Ministry and the Agency shall take appropriate measures to ensure a regular supply of medicines in the Republic of Croatia.
Article 187
(1) The Agency monitors the consumption of medicines in the Republic of Croatia.
(2) The Agency shall submit a report to the Minister on the consumption of medicines referred to in paragraph 1 of this Article and propose to the Minister measures of control over the consumption of medicines.
(3) The ordinance on the manner of drawing up reports and the type of data referred to in paragraph 2 of this Article shall be adopted by the Minister.
Article 188
(1) The holder of the marketing authorization shall submit to the Institute a proposal for the price of the medicinal product on the basic or supplementary list of medicinal products
Of the Institute, that is, the proposal of the price of the medicine when placing a new medicine on the basic or supplementary list of medicines of the Institute.
(2) On the proposal of the price of a medicine which is on the basic or supplementary list of medicines of the Institute, or when placing a new medicine on
the basic or supplementary list of medicines of the Institute, the Institute is obliged, based on the decision of the Administrative Council of the Institute, to issue a decision within 90 days
from the date of receipt of the duly submitted proposal.
(3) No appeal shall be allowed against the decision of the Office referred to in paragraph 2 of this Article, but an administrative dispute may be instituted against that decision.
(4) The Institute shall annually inform the European Commission of the adoption of the basic and supplementary list of medicines of the Institute.
(5) The minister shall prescribe the criteria and the method of fixing the prices of wholesale medicines and the manner of reporting with an ordinance.
Article 189
(1) The holder of the marketing authorization for a medicinal product that is on the basic or supplementary list of medicinal products of the Institute may refer to the Institute
a proposal to raise the prices of these drugs.
(2) On the basis of the proposal referred to in paragraph 1 of this Article, the Institute shall, taking into account the need for an optimal supply of medicines necessary for the
health care, to seek the consent of the Minister to increase the price of the medicine referred to in paragraph 1 of this Article.
(3) The Office shall be obliged to issue a decision on the proposal referred to in paragraph 1 of this Article within 90 days of receipt of the proposal.
(4) The term referred to in paragraph 3 of this Article may be extended by a maximum of 60 days.
(5) No appeal shall be allowed against the decision referred to in paragraph 3 of this Article, but an administrative dispute may be instituted against that decision.
(6) The Institute is obliged to submit annually to the European Commission a list of medicines authorized for price increases.
Article 190
(1) The marketing authorization holder may submit to the Institute a proposal for placing the medicinal product on the basic or supplementary list of medicinal products.
Of the Institute.
(2) In addition to the person referred to in paragraph 1 of this Article, a proposal to change the status, or to amend or supplement the indication for application or the prescribing guidelines
of a medicinal product already placed on the basic or supplementary list of medicinal products of the Institute may also be submitted by the Committee for Medicinal Products of the Institute,
medicines of hospital health institutions, professional societies of the Croatian Medical Association, or other professional bodies and reference centers of the Ministry.
(3) The Committee for Medicines of the Institute and the Commissions for Medicinal Products of the hospital health institutions may propose placing the drug in the primary, ie
supplementary list of medicines of the Institute under a non-protected name if there is a justified need for its use.
(4) On the proposal referred to in paragraphs 1 and 2 of this Act, the Office shall be obliged to issue a decision within 90 days from the decision of the Administrative Council of the Institute.
on the day of receipt of the orderly proposal.
(5) The deadline for issuing the decision referred to in paragraph 4 of this Article and the deadline for issuing the decision referred to in Article 188 of this Act together may not exceed 180
days.
(6) No appeal shall be allowed against the decision of the Office referred to in paragraph 4 of this Article, but an administrative dispute may be instituted against that decision.
(7) The criteria for placing medicinal products on the basic or supplementary list of medicinal products of the Institute shall be prescribed by an ordinance by the Minister.
Article 191
(1) The Administrative Board of the Institute shall adopt the Decision on the deletion of medicinal products from the basic or supplementary list of the Institute on the basis of previously obtained opinion
Bureau of Medicines Commissions.
(2) If the medicine is deleted from the basic or supplementary list of medicines of the Institute, and there is a justified need for its further use, the drug may be placed
to the basic list of medicines of the Institute under an unprotected name.
(3) The Institute shall issue a decision on the deletion of the medicinal product from the basic or supplementary list of medicinal products of the Institute.
(4) No appeal shall be allowed against the decision referred to in paragraph 3 of this Article, but an administrative dispute may be instituted against that decision.
Article 192
Natural and legal persons licensed for wholesale marketing of medicinal products are obligatory medicines on the basic or supplementary list
of the Institute's medicines, to sell at the prices determined in accordance with the regulation on standards and methods of wholesale drug pricing and method
reporting on them.
III. SURVEILLANCE
Article 193
(1) Supervision of the implementation of the provisions of this Act relating to medicines, investigational medicines, active and auxiliary substances, in particular supervision of testing,
production, marketing, mediation, quality control and advertising of the medicinal product is carried out by the Ministry of Pharmaceutical Inspection.
(2) Supervision of the implementation of the provisions of this Act in connection with the supervision of the production of medicines, tested medicines, active and auxiliary substances
pharmacovigilance monitoring is carried out by the Agency's inspection.
(3) The activities of pharmaceutical inspection referred to in paragraph 1 of this Article may be performed by a senior pharmaceutical inspector and a pharmaceutical inspector.
(4) The costs of carrying out the supervision referred to in paragraphs 1 and 2 of this Article shall be determined by the Minister.
Article 194
(1) The activities of pharmaceutical inspector may be carried out by persons with completed undergraduate or graduate university degree or integrated
undergraduate and graduate university degree in health or other relevant field, with three years of work experience at
appropriate jobs and passed the state examination.
(2) The activities of the Agency's inspector may be performed by persons with completed undergraduate or graduate university studies or integrated
undergraduate and graduate university degree in health or other relevant field, with three years of work experience at
appropriate jobs.
(3) Pharmaceutical inspectors are obliged to continue their education in the field of good practice in laboratory testing, clinical trials and
wholesale medicines.
(4) The Agency's inspectors are obliged to continue their education in the field of good manufacturing and pharmacovigilance practice.
Article 195
The Minister may authorize experts in the field of medicines to carry out certain professional activities in conducting inspection supervision, if for his / her
performing the required special expertise.
Article 196
(1) The pharmaceutical inspector and the inspector of the Agency shall have an official identity card and a badge proving his official capacity, identity and authority.
(2) The form and contents of the form of the official ID card and badge, as well as the manner of issuing and keeping the register of issued official ID cards, shall be prescribed by an ordinance
the minister.
Article 197
The pharmaceutical inspector and the inspector of the Agency are independent in carrying out inspection supervision, leading the procedure, making decisions and taking measures in
within the rights, duties and powers established by this Act and other regulations.
Article 198
Legal and natural persons are obliged to enable the pharmaceutical inspector and the inspector of the Agency to carry out inspection supervision and at his request
make available the required quantity of samples for quality control medication and provide the necessary information and notifications.
Article 199
(1) The pharmaceutical inspector and the inspector of the Agency in carrying out inspection supervision shall have the right to:
- inspect business premises, facilities, installations, appliances, equipment,
- examine raw materials, active substances, excipients, intermediates, medicines,
- review contracts, records, records, as well as other quality system documents and other business documents. If the documentation is in
they can request electronic insight and print,
- take copies of documents with record in the minutes,
- take samples of the drug and raw materials free of charge for quality control purposes,
- obtain and use free of charge data from official records and other databases relating to persons, if necessary for enforcement
inspection supervision,
- review personal documents for the purpose of identifying persons,
- photograph or record on other visual media information about the person, space, object, installation, accessory and other referred to in subparagraph 1 of this paragraph in
the purpose of giving evidence.
(2) In addition to the rights referred to in paragraph 1 of this Article, the pharmaceutical inspector shall also have the right to exclude medicinal products from the market which are not in accordance with the provisions of this Act.
(3) The pharmaceutical inspector and the inspector of the Agency shall have the right to carry out supervision at any time without notice.
Article 200
If physical inspections are provided to the pharmaceutical inspector and the Agency inspector, police assistance may be sought.
Article 201
(1) In carrying out the inspection supervision referred to in Article 193, paragraph 1 of this Act, the pharmaceutical inspector shall have the right and duty:
1. order the pursuit of the activity in accordance with the conditions laid down in this Act and other regulations
2. order the elimination of identified irregularities and deficiencies within the specified deadline
3. prohibit the implementation of actions contrary to this Law and other regulations
4. temporarily prohibit work for legal and natural persons if they do not meet the requirements regarding employees, equipment, devices and premises
5. prohibit the work of legal and legal persons if they are engaged in testing, production, marketing, mediation and quality control of a medicinal product without authorization,
that is, the Agency's permits
6. order the prohibition of placing the medicinal product on the market:
- if the medicine is counterfeit
- if the medicine has expired
- if it has been established that the medicine is being stored improperly and that it is being improperly handled
- in cases where this Law provides for the suspension and withdrawal of a medicinal product from the market
- prohibit the conduct of a clinical trial of a medicinal product or the conduct of a clinical trial in a particular study site if not conducted in accordance with
the provisions of this Act, the regulations made pursuant to this Act and the principles of good clinical practice
7. submit a request to the Agency for suspension or withdrawal of a series of medicines which do not meet the conditions prescribed by this Law and others
regulations
8. declare the product identified as defective and order the delivery of the waste to a person authorized in accordance with the regulations governing waste
waste management
9. prohibit work and submit a proposal to the Agency for revocation of the license for performing activities, if they do not observe the conditions laid down by this Law and
by another regulation, it can endanger human life and health
10. prohibit the sale of a product if the outer or inner packaging states that the product has therapeutic indications and is not authorized
placing on the market as a medicine, ie, a homeopathic remedy
11. prohibit the advertising of products attributable to medical indications other than medicines within the meaning of this Act
12. prohibit the marketing of a product which is found to have an active substance or substance related to the active substance in its composition, and is not a medicinal product for the purposes of this
Of the law
13. temporarily suspend the execution of the decision on the marketing authorization for the violation of the provisions of this Act
14. order the taking of other measures for which it is authorized by this Law and other regulations.
(2) In carrying out the inspection supervision referred to in Article 193, paragraph 2 of this Act, an Agency inspector shall have the right and duty:
1. to prohibit the work of legal and natural persons if they are engaged in production without the approval or authorization of the Agency
2. order the performance of activities in accordance with the conditions laid down in this Act and other regulations
3. order the elimination of identified irregularities and deficiencies within the specified deadline
4. prohibit the implementation of actions contrary to this Law and other regulations
5. temporarily prohibit the work of legal and natural persons if they do not meet the requirements regarding employees, equipment, devices and premises
6. submit a proposal for withdrawal of a marketing authorization if the marketing authorization holder does not have a pharmacovigilance system in place,
pharmacovigilance person responsible or not fulfilling other pharmacovigilance obligations prescribed by the provisions of this Act
7. order to take other measures for which it is authorized by this Law and other regulations.
Article 202
If, during the inspection, the sampling drug is found to be defective, the cost of quality determination, withdrawal, or
disposal of the defective product shall be borne by the legal or natural person who placed on the market or imported the defective product or legal and legal person who
improper storage or handling caused the product to malfunction.
Article 203
If the pharmaceutical inspector and the inspector of the Agency, in the course of supervision, determine that a violation or a regulation has committed a misdemeanor or a criminal offense, they shall
without delay, and at the latest within 15 days from the end of the supervision, submit an indictment or report to the competent authority.
Article 204
(1) The pharmaceutical inspector may also carry out inspection supervision at the request of the Agency, the European Commission or the EMA in the Republic of Croatia,
Member States of the European Union or third countries.
(2) The Agency inspector may also carry out inspection supervision at the request of the Ministry, the European Commission or the EMA in the Republic of Croatia, other
Member States of the European Union or third countries.
Article 205
(1) In carrying out inspection supervision, the pharmaceutical inspector and the inspector of the Agency are obliged to act in accordance with special regulations on keeping
secrets.
(2) The legal and natural person shall be obliged to inform the pharmaceutical inspector and the inspector of the Agency about what is considered secret by their general acts.
Article 206
(1) The pharmaceutical inspector and the inspector of the Agency shall issue an oral decision in the following cases:
- when the danger to human health or life requires that a certain measure be taken without delay
- where there is a risk of concealment, replacement or destruction of evidence, if the measure is not taken immediately.
(2) The pharmaceutical inspector and the inspector of the Agency may order the execution of the oral decision immediately. The decision must be entered in the progress report
control.
(3) The pharmaceutical inspector and the inspector of the Agency are obliged to make a written revision of the decision within eight days from the day of the oral decision.
solutions.
Article 207
No appeal shall be allowed against the decision of the pharmaceutical inspector and the Agency inspector, but an administrative dispute may be instituted against that decision.
Article 208
(1) A pharmaceutical inspector and inspector shall carry out the supervision, the condition established and the measures taken or ordered and the actions performed
Agencies shall draw up minutes.
(2) A copy of the minutes referred to in paragraph 1 of this Article shall be delivered to the natural person, or to the responsible person in the legal entity for which the inspection was performed.
Article 209
The provisions of the General Administrative Procedure Act shall apply to the procedure of pharmaceutical inspectors and inspectors of the Agency.
Article 210
(1) The pharmaceutical inspector and the inspector of the Agency shall keep a record of the inspections carried out.
(2) The Minister shall prescribe the manner of keeping the register.
Article 211
The pharmaceutical inspector or the inspector of the Agency is responsible for:
- if during the supervision he fails to take, or to order, the measures which he was obliged to take or order
- if he exceeds his authority
- if he does not submit a request or report to the competent authorities regarding the identified irregularities or deficiencies.
IV. AGENCY FOR MEDICINAL PRODUCTS AND MEDICAL PRODUCTS
Article 212
(1) The Agency's activities include the following activities:
- approves the marketing of the medicine and homeopathic medicine
- carries out the registration procedure for a traditional herbal and homeopathic remedy
- authorizes the parallel import of the medicinal product
- gives an expert assessment of the quality, efficacy and safety of administration of the drug
- performs laboratory testing of a medical device
- performs the tasks of the official quality assurance laboratory for the Republic of Croatia
- performs drug and homeopathic drug quality checks and reports on quality checks performed
- analyzes and evaluates the side effects and safety of subjects in clinical trials
- makes the Croatian Pharmacopoeia
- publishes the Croatian Pharmacopoeia and other professional publications in the field of his work
- performs pharmacovigilance activities
- gives a manufacturing license to the manufacturers and importers of the medicinal product or the investigational medicinal product
- keeps a register of manufacturers, importers and wholesalers of active substances and auxiliaries
- authorizes the wholesale distribution of medicines
- authorizes the retail sale of medicines in specialized stores
- gives permission for mediation of medicines
- gives consent for the intake and import of the medicinal product
- gives consent for emergency drug intake and import
- monitors the side effects and malfunctions of medicines
- initiates the procedure of suspending the marketing of the medicinal product and withdrawing the medicinal product from the market
- monitors drug supply
- monitors drug consumption and promotes rational drug use
- proposes to the Minister measures of control over consumption of medicines
- performs waste management (for own needs)
- performs information and education activities on medicines
- provides expert advice in the field of its activity
- provides expert guidance in the field of its activity
- proposes the harmonization of medicines regulations with those of the European Union and those of international institutions
- realizes international cooperation in the field of medicines
- carries out inspection supervision over the production of medicines, investigational drugs, active and auxiliary substances and inspection supervision over
pharmacovigilance
- maintains the register of manufacturers of medical devices, the register of medical devices and the register of wholesale medical devices
- analyzes and evaluates adverse events in clinical trials of medical devices
- gives permission for retail sale of medical products in specialized stores
- keeps records of medicinal products on the market in the Republic of Croatia
- monitors the vigilance and safety of medical devices
- carries out the process of classification of the medical device
- gives a free sale certificate for a medical device
- performs information and education activities on medical devices
- realizes international cooperation in the field of medical devices
- proposes the harmonization of regulations in the field of medical devices with those of the European Union and those of international institutions
- performs other tasks in the field of medicines in accordance with this Act and regulations adopted pursuant to this Act and in the field of medical
products in accordance with the Medical Devices Act and the regulations made thereunder.
(2) Representatives of the Agency shall participate in the work of the bodies of the European Union for the field of medicines and medicinal products for the activities referred to in paragraph 1 of this Article.
Article 213
(1) The Agency shall have a Statute which, in accordance with this Law, defines in detail the structure, powers and method of decision-making of individual bodies and the conditions and procedure
appointing directors and regulating other matters of importance for the performance of the Agency's activities and operations.
(2) The Statute of the Agency shall be adopted by the Management Board of the Agency with the consent of the Government of the Republic of Croatia.
Article 214
(1) In addition to the Statute, the Agency shall have general acts in accordance with this Act and other regulations.
(2) The Rules of Procedure shall regulate the rights and obligations and other issues arising from the employment of employees of the Agency.
(3) The Rules of Procedure and other general acts of the Agency shall be adopted by the Management Board of the Agency, unless this Law and the Statute prescribe that they are adopted by the Director.
Agencies.
Article 215
The bodies of the Agency are the Governing Council, the Director, the Expert Council and other bodies in accordance with the Statute.
Article 216
(1) The Agency shall be managed by the Governing Council.
(2) The Management Board of the Agency shall have five members.
(3) The President and members of the Governing Council shall be appointed by the Government of the Republic of Croatia at the proposal of the Minister.
(4) The members of the Governing Board shall be appointed for a term of four years.
Article 217
The Government of the Republic of Croatia may dismiss a member of the Management Board of the Agency before the expiration of his / her appointment in the following cases:
- if required
- if their work tends to violate or repeatedly violate the law and other regulations related to the work and performance of the Agency's activities
- if it causes damage to the Agency through its work
- in other cases stipulated by law and the Statute.
Article 218
Governing Council:
- adopts the Rules of Procedure and other general acts of the Agency
- adopts the Agency's business and financial plan
- adopts annual accounts and business reports of the Agency
- appoints and dismisses the Director of the Agency
- decides on the internal organization of the Agency
- decide on other issues set out in the Statute of the Agency.
Article 219
(1) The activities of the Agency shall be managed by the Director of the Agency.
(2) The Director of the Agency shall be appointed for a term of four years. Once the term of office expires, the Director may be reappointed, without limitation on the number of terms.
Article 220
Director of the Agency:
- manages and manages the Agency's operations
- represents and represents the Agency
- propose to the Governing Board the adoption of acts within its competence
- decide on other issues set out in the Statute.
Article 221
The Governing Board must dismiss the Director before the expiration of his / her appointment:
- if he asks for it
- if he does not comply with the regulations and general acts of the Agency
- if it unreasonably refuses to execute decisions of the Management Board of the Agency made within the scope of their competence
- if it causes serious damage to the Agency through its negligent and improper work
- if he repeatedly neglects or negligently performs his duties, which causes difficulties in performing the activities of the Agency.
Article 222
(1) The assets of the Agency shall consist of funds for work obtained from the founders of the Agency, acquired through the provision of services or obtained from other sources.
(2) Funds for the Agency's operations shall be provided by:
- from the revenue generated by the Agency through its operations (by charging for services and annual fees), and
- from other sources in accordance with this Law and other regulations.
(3) The Agency shall charge an annual fee for the solutions given under the provisions of this Act and the Medical Devices Act.
(4) The amount of the annual fee referred to in paragraphs 2 and 3 of this Article shall be determined by the Agency with the consent of the Minister and shall be borne by the legal or legal person to whom it is
pursuant to the provisions of this Act and of the Medical Devices Act, a resolution was given.
Article 223
The Ministry shall supervise the legality of the Agency's work.
Article 224
The Agency submits its annual report to the Minister and the Government of the Republic of Croatia.
Article 225
On the legal position of the employees of the Agency, conditions for employment, salaries and other issues not regulated by this Law
general labor regulations and collective agreement apply.
V. INFRINGEMENTAL PROVISIONS
Article 226
(1) A fine in the amount of HRK 100,000.00 to HRK 150,000.00 shall be imposed on a natural or legal person for an offense:
1. if he places on the market a medicine without a test and if he carries out a test of the medicine contrary to the provisions of this Act and the regulations adopted on
pursuant to this Act (Article 8, paragraph 1)
2. fails to notify the Central Ethics Committee and the Ministry of any significant changes to the clinical trial (Article 16, paragraph 1)
3. if he conducts a clinical trial without the informed consent of the person to be tested (Article 17 (1))
4. if he pays compensation to examiners and respondents contrary to the provision of Article 18, paragraph 4 of this Law
5. if the medicinal product requiring a marketing authorization is placed on the market in the Republic of Croatia without the marketing authorization previously given
(Article 22 (1), (3) and (5) and Article 113 (1))
6. if he / she provides incorrect information in the product documentation with the application for marketing authorization (Article 26 (3), Article 28,
Article 29, Article 32, Article 33, Article 34, Article 35 and Article 36)
7. if he fails to fulfill the conditions and obligations in accordance with the conditions laid down in Article 46 (1), Article 47 (1) and Article 48 (1) of this Act
8. fails to act in accordance with the provisions of Article 50 (1), Article 51 and Article 55 of this Regulation after the marketing authorization has been granted
Of the law
9. if he does not initiate the suspension of the placing on the market or withdrawal of the medicinal product (Article 62, paragraphs 6 and 7)
10. if it markets a traditional herbal or homeopathic medicinal product without the Agency's prior approval or the Agency's registration decision (Article 63;
Article 66 and Article 68 (1)
11. if they provide incorrect information in the documentation accompanying the application for registration of the homeopathic medicine (Article 69, paragraphs 2 and 3)
12. if he manufactures a medicinal product, an investigational medicinal product, active substances or excipients in the Republic of Croatia without a manufacturing license (Article 72)
13. if he / she gives incorrect information in the application for production authorization and if he / she does not inform the Agency about changes in the data based on
which has been granted a production license (Article 75 (2) and Article 79 (1))
14. if he deals with the importation of medicines contrary to the provisions of Article 81 of this Law
15. if the production of the active substance does not meet the requirements of good manufacturing practice for the active substances (Article 82)
16. if he imports active substances contrary to the provisions of Article 83 of this Law
17. if he does not designate a radiopharmaceutical in accordance with the provision of Article 103 of this Act
18. if on the outer, on the inner packaging of the product and on the instructions it states therapeutic indications if that product is not authorized for placing in the
circulation as a medicine or homeopathic medicine (Article 105)
19. if he is engaged in the wholesale or retail sale of a medicinal product without a marketing authorization (Article 115, Article 119 (1) and Article 135)
20. if he deals with the mediation of medicines but does not have a license to mediate (Article 116)
21. if there is no authorization for parallel importation of the medicinal product (Article 130 (1))
22. if he dispenses a medicinal product in a place contrary to the one approved in the marketing authorization (Article 135 (2) and (3))
23. if he offers remedies without a prescription online remotely in contravention of the provisions of this Law and the regulations made pursuant to this Act
Of the Act (Article 136, paragraphs 1, 2 and 3)
24. Failure to carry out regular quality checks of each batch of medicinal products (Article 174 (1))
25. Failure to ensure the marketing of a batch of medicinal products in the European Union for each batch of medicinal products authorized in the Republic of
Croatia (Article 174 (2))
26. failing to ensure that a quality check is carried out in the European Union for each batch of the medicinal product authorized in the Republic of
Croatia (Article 174 (3))
27. if he does not undergo a special quality check (Article 175 (1))
28. if he advertises about a medicine contrary to the provisions of this Act and the regulations made pursuant to this Act (Article 183)
29. if the advertisement states that the product has medicinal properties, if the product is not authorized for marketing as a medicine, or if it is not
registered as a traditional herbal remedy (Article 185)
30. if he acts contrary to the provisions of Article 186, paragraphs 1 and 3 of this Act
31. if he does not sell the medicines at the prices determined in accordance with the regulation on the criteria for wholesale pricing of medicines and the manner of reporting
them (Article 192)
32. if it does not enable the pharmaceutical inspector and the inspector of the Agency to carry out supervision in accordance with the provisions of this Law and the regulations adopted on
pursuant to this Act (Articles 198 and 199)
33. if he does not act within the time limit of the final decision of the pharmaceutical inspector and the inspector of the Agency ordering the taking of certain
measures and actions or prohibited work (Article 201).
(2) A responsible person in a legal person shall also be fined from HRK 10,000.00 to HRK 15,000.00 for the offense referred to in paragraph 1 of this Article.
Article 227
(1) A natural or legal person shall be fined in the amount of HRK 70,000.00 to HRK 100,000.00 for an offense:
1. if he conducts a clinical trial of the medicinal product or a non-interventional study of the medicinal product without authorization (Article 9 (2) and Article 12 (2) and (3))
2. if he performs or allows a clinical trial of a medicinal product contrary to the provisions of Article 18, paragraph 2 of this Law
3. if he is marketing a medicinal product for which a marketing authorization was not valid (Article 53, paragraph 1)
4. if he advertises a homeopathic medicine referred to in Article 71, paragraphs 3 and 4 of this Act
5. if he manufactures, imports or supplies active substances, but is not entered in the register of manufacturers, importers or wholesale of active substances (Article 84)
6. if in the documentation with the request for entry in the register of manufacturers, importers or wholesale of active substances he / she gives incorrect information (Article 85.
paragraph 2)
7. fails to report annually to the Agency all changes in the documentation, that is, data and documents on the basis of which the entry in the
register of manufacturers, importers or wholesalers of active substances or does not apply for approval of the amendment (s) (Article 88 (1) and (2))
8. if it has placed on the market in the Republic of Croatia a medicinal product which is not labeled or does not contain a leaflet in accordance with the provisions of this Act and the regulations adopted on
pursuant to this Act (Article 92, paragraphs 1 and 2, Article 93, paragraphs 2 and 3, Article 95, Article 96, paragraph 1 and Article 98, paragraphs 1 and 2)
9. failing to check the readability and simplicity of the medication instruction in the target groups of patients (Article 98, paragraph 4)
10. if the package of radiopharmaceuticals is not accompanied by a comprehensive package leaflet (Article 104)
11. if he dispenses the medicinal product in a manner and place contrary to the marketing authorization granted (Articles 106 and 107)
12. fails to provide transport, accommodation and storage of medicines in accordance with the prescribed conditions (Article 114, paragraph 1)
13. fails to notify the Agency of the commencement of activities in the Republic of Croatia (Article 121)
14. Failure to notify the Agency of any changes relating to the terms, documents and information under which the wholesale marketing authorization is granted, and
license for mediation of days (Article 126, paragraphs 1 and 2)
15. if he introduces or imports a medicinal product without the prescribed consent (Article 128 (1) and (2) and Article 129 (1))
16. fails to inform the Agency and the marketing authorization holder within 15 days prior to entry of the medicinal product on the basis of the parallel import authorization
traffic (Article 131)
17. Failure to notify the Agency of any changes relating to the documentation and the documents and information on the basis of which the parallel import license is granted
medicine of the day (Article 134 (1))
18. Failure to notify the Agency of any changes relating to the conditions, documents and information on the basis of which the permit was granted (Article 140 (1))
19. Failure to provide the Agency with information on the circulation of medicinal products (Article 141 (1))
20. if he does not act in accordance with Article 143 of this Law
21. Failure to establish a pharmacovigilance system for carrying out pharmacovigilance duties in accordance with Article 147 and Article 148 (1) of this
Of the law
22. if it does not fulfill the obligations under section 150 of the Act
23. if he fails to fulfill the obligation referred to in Article 151, Paragraphs 1, 2, 3 and 4 and Article 152 of this Law
24. if he does not notify the Agency in writing of the pharmacovigilance information regarding the administration of the medicinal product before the public announcement (Article 158)
25. if he fails to comply with the provisions of Article 163, paragraphs 1 and 2, Article 164 and Article 165 of this Act
26. Failure to provide PSUR to the Agency in the prescribed cases and in accordance with the prescribed deadlines (Article 168 and Article 169 (1))
27. if it places on the market in the Republic of Croatia a medicinal product of which the quality, including the quality of all raw materials for the manufacture of the medicinal product, as well as materials for internal use
the packaging does not comply with the Croatian Pharmacopoeia or other pharmacopoeia in accordance with Article 179, paragraph 3 of this Act
28. if the record, in accordance with the provisions of this Law and the regulations adopted on the regular, extraordinary and special quality control of the medicinal product, is not kept by the register.
under this Act (Article 180, paragraphs 1, 2 and 4).
(2) The responsible person in the legal person shall also be fined from HRK 7,000.00 to 10,000.00 for the offense referred to in paragraph 1 of this Article.
Article 228
(1) A fine in the amount of HRK 50,000.00 to HRK 70,000.00 shall be imposed for a misdemeanor by a legal or legal person if he / she provides an incorrect information in the
the procedure for granting approval for the entry or import of a medicinal product for which a marketing authorization has not been granted in the Republic of Croatia (Article 129 (1)).
(2) A responsible person in a legal person shall also be fined from HRK 5,000.00 to HRK 7,000.00 for the offense referred to in paragraph 1 of this Article.
(3) A fine in the amount of HRK 5,000.00 to HRK 7,000.00 shall be imposed for a misdemeanor by a doctor of medicine, or a doctor of dental medicine who
contrary to Article 129, paragraph 1 of this Act and the ordinance referred to in Article 129, paragraph 2 of this Act, prescribe a medicinal product for which no authorization has been given
traffic in the Republic of Croatia.
Article 229
(1) A natural or legal person shall be fined in the amount of HRK 30,000.00 to HRK 50,000.00 for an offense:
1. if he places on the market a homeopathic remedy which is not labeled and which does not have instructions in accordance with this Act (Articles 70 and 71 (1) and (2))
2. if he does not inform the Agency in writing, and in the case of the vaccine, the Croatian Institute of Public Health about the side effects of the medicine in accordance with the provisions of this Act, and
regulations made pursuant to this Act (Article 145, paragraphs 1, 2 and 3)
3. if he does not inform the Agency in writing of a defect in the quality of the medicinal product or of a suspected counterfeit drug contrary to Article 181, paragraphs 1 and 2 of this Law
and the ordinance issued pursuant to this Act.
(2) A responsible person in a legal person shall also be fined from HRK 3,000.00 to HRK 5,000.00 for the offense referred to in paragraph 1 of this Article.
VI. TRANSITIONAL AND FINAL PROVISIONS
Article 230
The Agency shall make the list of interchangeable medicinal products in accordance with the provision of Article 6 of this Act within 18 months from the date of its entry into force.
the force of this Act.
Article 231
For medicinal products authorized up to the date of entry into force of this Act, the Agency shall assign the number referred to in Article 38 of this Act in the course of the authorization renewal procedure or
change approvals.
Article 232
For medicinal products authorized under the Medicines Act (Official Gazette 71/07, 45/09 and 124/11), which expire in the period from
From 1 January to 31 March 2014, the authorization holders shall submit to the Agency an application for renewal of the authorization no later than six months before the deadline.
the validity of the marketing authorization.
Article 233
For medicinal products authorized in the Republic of Croatia before the entry into force of this Act, Commission Regulation (EC) No 1234/2008 will apply to applications
approving the amendment submitted on 1 July 2013 pending the entry into force of the provisions of Commission Regulation (EU) No 712/2012 relating to approval
modification for medicines approved by national procedure.
Article 234
(1) On the day this Act enters into force, the Agency shall initiate the procedures for revocation of the marketing authorization for medicinal products given on the basis of
Of the Medicines Act (Official Gazette 71/07, 45/09 and 124/11) for medicinal products authorized in the European Union by a centralized procedure.
(2) The series of the medicinal product referred to in paragraph 1 of this Article, manufactured in accordance with the marketing authorization given before the entry into force of this Act may
be entered and placed on the market in the Republic of Croatia until the expiry date or for a maximum of 12 months from the day this Law enters into force.
Article 235
(1) For the reference medicinal product for which a request for the first authorization of a CP procedure was submitted before 20 November 2005, the period shall apply
data protection for a period of 10 years within the meaning of the protection period referred to in Article 29, paragraph 1 of this Act, and the protection periods referred to in Article 10 shall not apply
29, paragraphs 1, 2 and 3 of this Law.
(2) For the reference medicine for which an application for a first authorization was granted in an EU Member State before the date on which it was submitted
the period of protection prescribed by that Member State in accordance with Article 29 (1), (2) and (3) of this Act shall apply the data protection period
for a period of 6 or 10 years in terms of the protection period referred to in Article 29, paragraph 1 of this Act, depending on the regulation of the Member State in force at that time and
they shall not apply the protection periods referred to in Article 29, paragraphs 1, 2 and 3 of this Act.
Article 236
(1) On the day this Law enters into force, the Agency shall initiate the procedures for revocation of the marketing authorization granted on the basis of
Of the Medicines Act (Official Gazette 71/07, 45/09 and 124/11), for which the reference medicine approved in the European Union is centralized
the procedure did not expire the data protection period.
(2) A batch of a medicinal product authorized under the Medicinal Products Act (Official Gazette 71/07, 45/09 and 124/11) does not
may be placed on the market after the entry into force of this Act if the reference medicinal product authorized in the European Union is not subject to a centralized procedure
the period of protection for placing the medicinal product on the market in accordance with Article 29, paragraphs 2 and 3 of this Act has expired.
Article 237
(1) For homeopathic medicinal products which do not have the marketing authorization or do not have the decision on entry in the register provided by the Agency pursuant to
Of the Medicines Act (Official Gazette 71/07, 45/09 and 124/11), on the day this Act enters into force, it is obligatory to submit a request for
authorizations or decisions in accordance with the provisions of this Act no later than six months from the day this Law enters into force.
(2) Holders of entry in the register of homeopathic products of the Agency in accordance with the provisions of the previous regulations are obligatory in the procedures of amendment and renewal
entry in the register of homeopathic products to obtain a decision on the registration of a homeopathic medicine in accordance with this Law.
Article 238
Wholesalers and manufacturers of medicinal products that carry out production and marketing of medicinal products on the day this Act enters into force shall be obliged to harmonize
its operations with the provisions of this Act and the ordinances adopted pursuant to this Act within 12 months from the date of entry into force of this Act.
Of the law.
Article 239
(1) Holders of marketing authorizations for medicinal products authorized pursuant to the Ordinance on special conditions for the marketing of medicinal products
of a marketing authorization in the Republic of Croatia authorized in the countries of the European Union (Official Gazette 10/08) may
initiate summary retrial no later than 12 months from the day this Law enters into force.
(2) Until the procedure referred to in paragraph 1 of this Article is initiated, the authorization holders shall act in accordance with the provisions of the Ordinance referred to in paragraph 1 of this Article.
article.
Article 240
Legal entities that, on the day this Law enters into force, perform the activity of importing and exporting medicinal products are obliged to harmonize their business with
the provisions of this Act not later than 90 days from the day this Law enters into force.
Article 241
(1) For medicinal products on the List of Medicinal Products referred to in Annex V of the Treaty on the Accession of the Republic of Croatia to the European Union, the marketing authorization holders are obliged to the Agency
submit an application for the upgrading of the medicinal product dossier in the first authorization renewal process no later than three years from the date of accession
Of the Republic of Croatia to the European Union.
(2) If the marketing authorization holder fails to comply with the provision of paragraph 1 of this Article, or does not upgrade the documentation for the medicinal product, the Agency shall, by decision
revoke the marketing authorization.
Article 242
(1) The Regulations referred to in Article 6 (4), Article 7 (2), Article 8 (3), Article 13, Article 18 (1), Article 26 (7), Article 43 (9). ,
Article 52, paragraph 5, Article 53, paragraph 6, Article 56, paragraph 3, Article 60, paragraph 4, Article 62, paragraph 8, Article 63, paragraph 6, Article 69, paragraph 4, Article
73 (2), Article 74 (2) and (3), Article 83 (5), Article 89 (2), Article 92 (2), Article 94 (5), Article 98 (5) , article
100 (4), Article 108 (3), Article 114 (2), Article 118 (4), Article 120 (3), Article 127 (2), Article 128 (3), Article
129 (2), Article 135 (4), Article 136 (4), Article 141 (2), Article 142, Article 145 (4), Article 173 (4), Article 180
Paragraph 5, Article 181, Paragraph 3, Article 184, Paragraph 2, Article 188, Paragraph 5, Article 190, Paragraph 7, Article 196, Paragraph 2, and Article 210, Paragraph 2 of this
The Minister, whose adoption is authorized by this Law, shall be adopted by the Minister within 12 months from the day this Law enters into force.
(2) The Minister shall adopt the regulations concerning the safety label of a medicinal product and distance selling after the adoption and entry into force of implementing laws.
regulations concerning the safety label of a medicinal product and distance selling in the European Union.
Article 243
Until the ordinance referred to in Article 242 of this Act enters into force:
1. Ordinance on the procedure and method of granting marketing authorization for a finished medicinal product (Official Gazette 113/08 and 155/09)
2. Ordinance on special conditions for the marketing of a finished medicinal product in the Republic of Croatia authorized in the countries
Of the European Union (Official Gazette 10/08.)
3. Ordinance on the conditions for the authorization of specialized retail stores for medicinal products (Official Gazette 134/08 and 119/10)
4. Ordinance on the conditions and procedure for determining the requirements of good manufacturing practice and on the procedure for granting a production license and a certificate of performance
good manufacturing practices (Official Gazette 74/09.)
5. Ordinance on the manner of advertising medicinal products and homeopathic products (Official Gazette 118/09 and 140/09)
6. Pharmacovigilance Ordinance (Official Gazette 125/09)
7. Ordinance on the criteria for the classification of medicinal products and on the prescription and dispensing of prescription medicines (Official Gazette 82/10)
8. Ordinance on the placing on the market and on the labeling and advertising of traditional herbal medicinal products (Official Gazette 89/10)
9. Ordinance on clinical trials of medicinal products and good clinical practice (Official Gazette, Nos. 1 4/10 and 127/10)
10. Ordinance on the method of quality control of medicinal products (Official Gazette 56/05)
11. Ordinance on the manner of monitoring defects in the quality of the medicinal product (Official Gazette 36/05)
12. Ordinance on the type of data and the method of producing reports on the circulation of finished medicines (Official Gazette 29/05)
13. Ordinance on the conditions for production and placing on the market, and methods of checking the quality and keeping records of homeopathic products
(Official Gazette 62/05.)
14. Ordinance on good practice in the wholesale of medicinal products (Official Gazette 29/05)
15. Ordinance on the conditions and procedure for granting a license for the wholesale distribution of medicinal products and the import and export of medicinal products (Official Gazette, No.
29/05.)
16. Ordinance on good laboratory practice (Official Gazette 73/12)
17. Ordinance on the study of bioavailability and bioequivalence of medicinal products (Official Gazette 71/99)
18. Ordinance on the criteria for determining the prices of wholesale medicines and on the method of reporting wholesale prices (Official Gazette 155/09 and 22/10)
19. Ordinance on the criteria for placing medicinal products on the basic and supplementary list of medicinal products of the Croatian Health Insurance Institute (Official Gazette,
no. 155/09).
Article 244
On the day this Act enters into force, the Medicines Act (Official Gazette 71/07, 45/09 and 124/11) shall cease to have effect.
Article 245
This Law shall enter into force on the eighth day after its publication in the Official Gazette, with the exception of Articles 1 to 25, Article 26, Paragraphs 1 to 6, Articles 27 to
42, Articles 43 (1) to (8), Articles 44 to 51, Article 52 (1) to (4), Article 53 (1) to (5), Articles 54 and 55, Article 56 paragraphs 1 and 2,
Articles 57 to 59, Article 60 (1) to (3), Articles 61 to 68, Article 69 (1) to (3), Articles 70 to 72, Article 73 (1), Article 74 item
1, Articles 75 to 82, Article 83 (1) to (4), Articles 84 to 88, Article 89 (1), Articles 90 to 93, Article 94 (1) to (4). , Articles 95 to
97, Articles 98 (1) to (4), Article 99, Article 100 (1) to (3), Articles 101 to 107, Article 108 (1) and (2), Articles 109 to 113. , Article 114.
Paragraphs 1, Articles 115 to 119, Article 120, Paragraphs 1 and 2, Articles 121 to 126, Article 127, Paragraph 1, Articles 128 to 144, Article 145, Paragraphs 1 to 3 .,
Articles 146 to 187, Article 188 (1) to (4), Article 189, Article 190 (1) to (6) and Articles 191 to 244, which shall take effect on
of accession of the Republic of Croatia to the European Union, and of Article 55, paragraphs 4 and 5, which enter into force on 28 October 2013.
Class: 022-03 / 13-01 / 122
Zagreb, 14 June 2013
CROATIAN PARLIAMENT
The President
Of the Croatian Parliament
Josip Leko, Ph.D. r.
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