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Overview (table of contents) LBK no. 506 of 20/04/2013 Historical
(Medicines Act)
Publication date: 25-05-2013
Ministry of Health and Elderly
Chapter 1 Purpose and Area
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Chapter 2 Marketing Authorization and Other Sales and Delivery Permits
Chapter 3 Manufacture, import, negotiation, dissemination, etc. of pharmaceuticals and intermediates Later amendments to the regulation
LAW No. 518 of 26/05/2014 § 1
Chapter 3 a Prohibition, warning, revocation, etc. LAW No. 542 of 29/04/2015 Section 2
LAW No. 620 of 08/06/2016 Section 38
LAW No. 426 of 18/05/2016 Section 36
Chapter 3 b Manufacture, import and distribution, etc. of active substances LOV No. 1736 of 27/12/2016 § 2
LAW No. 285 of 29/03/2017 Section 18
Chapter 4 Quality of medicines Act No. 388 of 26/04/2017 § 1
LBK No. 99 of 16/01/2018
Chapter 5 Side effects of drugs
Chapter 6 Labeling, reservations and dispensing status The document's incorporated regulations
LAW No. 1180 of 12/12/2005
Chapter 7 Advertising, Bonuses, Discounts, etc. LAW No. 538 of 08/06/2006
LAW No. 1557 of 20/12/2006
Chapter 8 Information on medicines Act No. 534 of 17/06/2008
LAW No. 464 of 18/05/2011
LAW No. 593 of 14/06/2011
Chapter 9 Drug Supply Act No. 605 of 18/06/2012
LAW No. 1258 of 18/12/2012
Chapter 10 Prices, assortment, part numbers and statistics Act No. 63 of 29/01/2013
Chapter 11 Experiments
Links to EU directives, cf. note 1
Chapter 12 Certain Substances that Can Be Used as Animal Medicines 31990L0167 html note
32001L0020 html note
Chapter 13 Advice and committees, etc. 32001L0082 html note
32001L0083 html note
Chapter 14 Fees
32004L0009 html note
Chapter 14 a Announcement 32004L0010 html note
Chapter 14 b Complaint
Additional documents:
Chapter 15 Punishment, etc. Regulations implementing the EU
Directive 31990L0167
Chapter 16 Entry into force, amendments and transitional provisions Regulations implementing the EU
Directive 32001L0020
Regulations implementing the EU
Directive 32001L0082
The full text Regulations implementing the EU
Directive 32001L0083
Regulations implementing the EU
1) Directive 32004L0009
Announcement of the Medicines Act Regulations implementing the EU
Directive 32004L0010
All notices etc. and
Hereby Act No. 1180 of December 12, 2005 on Medicines with the amendments that follows from section 81 of Act No. Circulars etc. is announced. to this one
Consolidation Act
538 of June 8, 2006, § 1 of Act No. 1557 of December 20, 2006, § 1 of Act No. 534 of June 17, 2008, § 1 of Act No. 464 of May 18 Decisions taken pursuant thereto
provision
2011, § 46 of Act No. 593 of June 14, 2011, § 1 of Act No. 605 of June 18, 2012, § 1 of Act No. 1258 of December 18, 2012, and § 1 of the Act.
applying this legal regulation
No. 63 of January 29, 2013.
Chapter 1
Purpose and area
§ 1. The purpose of the Act is to ensure that citizens
1) have access to high quality safe and effective medicines;
2) have access to objective and complete information on medicines and
3) be protected against misleading drug advertising and other illegal marketing of drugs.
Section 2. For the purposes of this Act:
1) Drug: Any item that
(a) presented as a suitable remedy for the treatment or prevention of human or animal disease; or
(b) may be used in or given to humans or animals either to restore, alter or affect physiological functions
by exerting a pharmacological, immunological or metabolic effect or by making a medical diagnosis.
2) Intermediate: A mixture of active substances and excipients intended for further processing into a drug.
(3) Active substance: Any substance or mixture of substances intended to be used in the manufacture of a medicinal product and which
by being part of the production becomes an active ingredient of the drug which is to exert a pharmacological, immunological or
metabolic effect for the purpose of restoring, altering or affecting physiological functions or providing a medical
diagnosis.
4) Excipient: Any component of a drug other than the active substance and its packaging materials.
Section 3. The Act covers medicines for humans and animals.
PCS. 2. Provisions on medicines also include contraceptives which are not covered by section 2 (1).
or of the Medical Devices Act.
PCS. 3. The Act shall also, to the extent provided for in the individual provisions, apply to the following goods which:
not covered by section 2 (1):
1) Intermediates intended for further processing into a drug.
2) Active substances and excipients.
3) Certain substances that can be used as medicines for animals.
PCS. 4. Sections 65 and 71 of the Act also include advertising of certain goods other than medicines.
Section 4. The Act does not apply to foods and supplements, feed, cosmetics, biocides, radionuclides in the form of closed
sources, medical devices, unprocessed tissues and cells of human origin as well as whole blood, blood cells and plasma of
except for plasma, which is included as a commodity in pharmaceutical manufacture, cf. 2 and sections 65 and 71.
PCS. 2. In cases where a product based on an overall assessment of its characteristics may be covered by the definition as well
of a drug as the definition of a product in another area of ​​law and there is doubt as to which legislation
the item must be regulated according to, the National Board of Health can decide that the product or group of goods in question only
is governed by this Act. The Minister of Health and Prevention can negotiate with the Minister concerned
lay down specific rules for such goods or groups of goods.
§ 4 a. Notwithstanding § 3, subs. 1 and § 4 (2). 2, the law does not apply to advanced therapy drugs manufactured on
a hospital in Denmark specially adapted to a specific patient according to the individual instructions of a doctor.
Section 5. Specified goods or groups of goods covered by section 2 (1) may, according to health and
the provision of the Minister of Prevention, in whole or in part, is exempted from the law, when deemed appropriate by their
properties. The Minister of Health and Prevention sets special rules for such goods or groups of goods.
Section 6. The Minister of Health and Prevention may lay down rules that the law or parts of the law shall not apply.
on medicinal products which are authorized or to be authorized for marketing in the European Union in accordance with rules laid down by the
European Community, and may lay down rules for such exceptions.
Chapter 2
Marketing and other sales and delivery permits
Issue of marketing authorization
§ 7. A drug may only be marketed or supplied in this country when a marketing authorization has been issued either by
The National Board of Health pursuant to this Act or by the European Commission pursuant to EU legal rules laying down
Community procedures for the approval and monitoring of medicinal products for human and veterinary use, etc.
(Community Marketing Authorization), cf. 2, and Sections 11 and 29-32.
PCS. 2. A medicinal product may only be marketed online to users in other EU / EEA countries when, in addition to being covered by a
marketing authorization as mentioned in subsection (1). 1 is subject to a marketing authorization valid in the country of destination of
in accordance with Article 6 (2). 1 of Directive 2001/83 / EC or Article 6 (2). 1 of Directive 2001/82 / EC.
Section 8. On application, the National Board of Health will issue a marketing authorization for a drug if the ratio of benefits
and risks of the drug are favorable and there are no other grounds for refusal as mentioned in sections 12 and 13.
PCS. 2. In balancing the benefits and risks of a drug, the positive therapeutic effect of the drug is assessed.
effects related to risks associated with the quality, safety and efficacy of the drug and risks of adverse effects on
the environment, cf., however, section 12 (2). 2nd
PCS. 3. Where the application relates to a veterinary medicinal product for use other than disease treatment or prevention
(zootechnical use), shall be taken at the trade-off referred to in para. 2, in particular taking into account the advantages of the animals
health and welfare, as well as consumer safety.
Section 9. The National Board of Health may attach terms to the marketing authorization in connection with its issuance.
PCS. 2. Where special circumstances so require, the Management Board may also attach terms to a marketing authorization
after its issue.
PCS. 3. The Minister of Health and Prevention shall lay down rules on the National Board of Health's assessment of conditions laid down in
pursuant to para. First
Section 10. In connection with the issuing of a marketing authorization, the National Board of Health shall approve a summary of
properties of the drug (summary of product characteristics).
§ 11. Notwithstanding the provision in § 7 (2). 1, marketing authorization for the following medicinal products is not required:
1) Medicines prepared at a pharmacy for each patient or animal on the prescription of a physician or a
veterinarian (magistral medicines).
2) Inactivated and inactivated immunological drugs for animals made of pathogenic organisms and antigens
derived from an animal or animal husbandry and used at the same site for the treatment of that animal or animal husbandry.
3) Medicines for non-clinical trials and clinical trials, cf. Chapter 11.
4) Feed medicines.
Refusal and amendment, suspension and revocation of marketing authorization
Section 12. The National Board of Health refuses to grant marketing authorization for a drug if
1) the relationship between benefits and risks is not favorable, cf. 2
(2) the therapeutic effect is lacking or insufficiently demonstrated by the marketing authorization applicant; or
3) the drug does not have the specified qualitative or quantitative composition.
PCS. 2. For medicinal products for humans, the risk of adverse effects on the environment cannot, in isolation, justify a refusal to
marketing.
Section 13. In addition to the cases mentioned in section 12, the National Board of Health refuses to grant marketing authorization for a drug to
animals, if
1) labeling or package leaflet does not comply with the rules laid down in accordance with section 57;
2) the stated retention time is insufficient to ensure that foods derived from the treated animal do not
contains residues which may endanger the health of the consumer or the retention time is
insufficiently reimbursed,
(3) the medicinal product will be offered for sale for use prohibited by other Community legislation;
(4) it is necessary to ensure the protection of public, consumer or animal health for as long as Community law;
regulations on this are being drafted, or
5) the drug is intended for administration to one or more food-producing animal species and the pharmacologically active substances;
contained in the medicinal product are not listed in Annexes I, II or III to a Regulation laying down a common procedure for determining
of maximum residue limits for veterinary medicinal products in animal foods
(Product remaining regulation).
PCS. 2. Notwithstanding paragraph 1. 1, no. 5, the National Board of Health may lay down detailed rules on the granting of marketing authorization
for medicines intended for specified animals of the genus.
Section 14. The National Board of Health will change, suspend or revoke a marketing authorization for a drug if it
turns out that
1) the benefit-risk ratio is not favorable;
3) the drug does not have the qualitative or quantitative composition indicated;
(4) material information provided by the applicant in support of the marketing authorization application is incorrect;
or
5) the self-examination in accordance with rules laid down in accordance with section 39 b, points 1-3, has not been carried out.
PCS. 2. The National Board of Health may change, suspend or revoke a marketing authorization for a drug if:
1) the marketing authorization holder does not comply with the terms of the permit established pursuant to section 9 (1). 1
(2) the labeling or package leaflet does not comply with rules laid down by section 57 or
3) the marketing authorization holder changes the summary of the product or the documents on which it is based
the marketing authorization, without the permission of the National Board of Health, cf. First
§ 15. In addition to the cases referred to in section 14, the Danish Health and Medicines Agency changes, suspends or revokes a
marketing authorization for a drug for humans if
1) the marketing authorization holder has not taken into account new technical and scientific information
development in accordance with section 21 or
2) the marketing authorization holder has not informed the National Board of Health of new information about the situation
between the benefits and risks of the drug in accordance with section 25 (2). First
PCS. 2. The National Board of Health may change, suspend or revoke a marketing authorization for a drug to
people whose
1) the drug is not manufactured in accordance with the description of the method of preparation disclosed in
the application for the marketing authorization and subsequent amendments thereto; or
2) the marketing authorization holder does not carry out checks in accordance with the control methods set out
of the marketing authorization application and subsequent amendments thereto.
§ 16. In addition to the cases mentioned in section 14, the Danish Health and Medicines Agency changes, suspends or revokes a
marketing authorization for a veterinary medicinal product if
(1) the stated retention time is insufficient to ensure that foods derived from the treated animal do not;
contains residues which may endanger consumer health,
2) the drug is or will be offered for sale for a use prohibited by other Community legislation; or
3) the marketing authorization holder does not take the necessary steps pursuant to section 26 (2). 2nd
PCS. 2. The National Board of Health may amend, suspend or revoke a marketing authorization for a veterinary medicinal product,
whose
1) the marketing authorization holder has not taken into account new technical and scientific information
development in accordance with section 21,
2) the marketing authorization holder has not informed the National Board of Health of new information about the situation
between the benefits and risks of the drug in accordance with section 25 (2). 1, or
(3) it is necessary to ensure the protection of public, consumer or animal health for as long as Community law;
regulations on this are under preparation.
§ 17. The Danish Medicines Agency shall inform the European Medicines Agency, the European Commission and
pharmaceutical authorities in the other EU / EEA countries when prompt action is considered necessary as a result of assessment
information from drug monitoring if
1) The National Board of Health is considering suspending or revoking a marketing authorization for a human drug,
2) The National Board of Health is considering banning the delivery of a drug to humans,
3) The National Board of Health is considering rejecting an extension of a marketing authorization for a drug for humans,
4) The National Board of Health of the marketing authorization holder for a medicinal product for humans is informed that
due to safety concerns, has stopped the marketing of the drug or has taken steps to
waive the marketing authorization or intend to do so; or
5) The National Board of Health considers that a new contraindication, a reduction in the recommended dose is necessary or
a restriction on the indications of a drug for humans.
PCS. 2. A prompt processing of a medicinal product covered by paragraph 1. 1 shall be handled by the National Board of Health if
the drug is only approved for negotiation or delivery in this country. If the drug is approved for negotiation or
delivery in more than one EU / EEA country, the evaluation of the drug is processed according to a special EU emergency procedure.
PCS. 3. The Minister of Health and Prevention may lay down detailed rules on the treatment of medicinal products pursuant to subsection (1). 2
2 pt.
PCS. 4. If the National Board of Health suspends a marketing authorization for a drug with immediate effect
people in order to protect human health, cf. 1 as a result of assessment of information from
pharmacovigilance, the Agency shall notify the European Medicines Agency no later than the following working day,
The European Commission and the pharmaceutical authorities in the other EU / EEA countries.
§ 17 a. The Danish Medicines Agency shall inform the European Medicines Agency if the Agency initiates a case concerning
suspending or revoking a marketing authorization for a human drug.
PCS. 2. The National Board of Health shall inform the European Medicines Agency, the pharmaceutical authorities of the others
EU / EEA countries and marketing authorization holder if new or changed risks or changes in
the relationship between benefits and risks of a drug.
§ 17 b. The Danish Medicines Agency shall inform the European Medicines Agency if the Agency initiates a case concerning
suspending or revoking a marketing authorization for a veterinary medicinal product.
PCS. 2. If the National Board of Health suspends a marketing authorization for a veterinary medicinal product with immediate effect
to protect human and animal health, cf. 1, the Management Board shall inform the European Union by the following day at the latest
The European Medicines Agency, the European Commission and the pharmaceutical authorities in the other EU / EEA countries.
Marketing Authorization Requirements
§ 18. The applicant for and the holder of a marketing authorization must be established in an EU / EEA country. The holder can
appoint a representative.
§ 19. The holder of a marketing authorization's liability under other legislation is not affected by the fact that a
marketing.
PCS. 2. The marketing authorization holder is responsible for the marketing of the medicinal product. Designation of one
a representative, cf. section 18, does not exempt the holder of the marketing authorization from liability.
Section 20. The applicant for or the holder of a marketing authorization must ensure that documents and data submitted to
The National Board of Health is adequate and fair.
§ 21. The marketing authorization holder must take into account technical and scientific developments and
make the changes necessary for the product to be manufactured and controlled according to generally accepted standards
scientific methods.
PCS. 2. The holder of a marketing authorization for a medicinal product for humans shall update the information contained in
summary of product characteristics, package leaflet and labeling with current knowledge, including conclusions of assessments and
recommendations published on the European Medicines Agency's web portal on medicines.
Section 22. The holder of a marketing authorization must as soon as possible notify the National Board of Health of when
marketing of the drug begins and when the marketing is temporarily or permanently discontinued.
PCS. 2. Reporting at Medication prices, cf. section 82, and notification according to rules established pursuant to section 78 are considered a
notification pursuant to paragraph 1. First
Section 23. The holder of a marketing authorization must notify the National Board of Health of the cause in cases where
the holder decides to withdraw a marketing authorization and withdrawal of residual stock
temporary or permanent cessation of marketing where this is justified by the quality, safety or efficacy of the medicinal product.
Section 24. The holder of a marketing authorization must immediately notify the National Board of Health if errors are found
in the production of a drug that may affect the quality, safety and efficacy of the drug.
§ 25. The holder of a marketing authorization for a drug must immediately notify the Danish Health and Medicines Authority of all
substantially new information on the relationship between the drug's benefits and risks, which does not come to the Board's knowledge after
the procedure for approving changes to marketing authorizations or in the form of periodic security updates. Whose
if the information relates to a medicinal product for humans, notification must also be made to the European Medicines Agency.
PCS. 2. The National Board of Health may at any time order the marketing authorization holder to prove that the relationship
between benefits and risks remains favorable.
PCS. 3. The National Board of Health shall verify that the requirement in subsection (1). 1 is complied with and the representatives of the Board have due regard
identification and, without court order, access to businesses for the purpose of carrying out such checks.
Section 26. The holder of a marketing authorization issued by the National Board of Health shall apply for the board's permission to
any change in the SPC and the documents on which the marketing authorization is based
(Variation application).
PCS. 2. If amendments are made to the Annexes to the Medicines Residue Regulation, the marketing authorization holder shall have one
drug for animals within 60 days of publication thereof apply to the National Board of Health to have them
make any necessary changes or even withdraw the marketing authorization.
Duration, extension and expiry of marketing authorizations
§ 27. A marketing authorization for a drug is valid for 5 years, cf. 2 and §§ 14-16.
PCS. 2. The National Board of Health may extend the marketing authorization if the relationship between benefits and risks remains
favorable. A marketing authorization that has been renewed has unlimited validity, cf. 3 and §§ 14-16.
PCS. 3. The National Board of Health may decide that the marketing authorization will only be extended for a new period of 5 years if
the relationship between benefits and risks of the drug indicates this, including as a result of assessment of information from
pharmacovigilance.
PCS. 4. An application for the extension of a marketing authorization for a medicinal product for human use must be submitted to
The National Board of Health of the marketing authorization holder no later than 9 months before the expiry of the permit.
PCS. 5. An application for the extension of a marketing authorization for a veterinary medicinal product must be submitted to
The Board of Health of the marketing authorization holder no later than 6 months before the expiry of the permit.
Section 28. A marketing authorization shall lapse if the license has not been used for 3 consecutive years.
PCS. 2. The National Board of Health may, in special circumstances and for human and animal health, derogate
the provision of para. First
Other permits for sale or delivery of medicines
Section 29. On application, the National Board of Health may in special cases permit the sale or delivery in a limited quantity of
medicines that are not covered by a marketing authorization or not marketed in Denmark (distribution license).
PCS. 2. The National Board of Health may attach terms to the extradition permit and may revoke a permit if these conditions
not complied with or serious problems with the quality, safety or efficacy of the medicinal product, including serious ones
side effects.
PCS. 3. The National Board of Health may lay down rules on distribution of medicinal products subject to a permit pursuant to subsection (1). First
Section 30. The State Serum Institute and the Veterinary Institute at the Technical University of Denmark may, on request, in special
cases and in limited quantities sell or deliver sera, vaccines, specific immunoglobulins and other immunological
test preparations not covered by a marketing authorization. The Board of Health must be notified of each sale or
disclosure.
Section 31. The Health Board may, when required by health or other special considerations, in accordance with rules laid down by
the Minister of Health and Prevention approves the use and marketing of medicines not covered by one
marketing authorization in Denmark. The Minister may also lay down rules on amendment, suspension and revocation
of such approvals.
PCS. 2. The National Board of Health shall inform the European Commission of permits pursuant to subsection (1). First
§ 32. If there is suspicion or confirmation of the spread of pathogenic agents, toxins, chemical agents
or nuclear radiation, the National Board of Health may temporarily allow the delivery of a drug, regardless of whether the drug is not
covered by a marketing authorization.
PCS. 2. The Minister of Health and Prevention may lay down rules on marketing authorization holders,
manufacturers and health professionals in the situations referred to in paragraph 1; 1, shall not be liable for the consequences that
had to follow from the use of
(1) a drug outside its approved indications or
2) a drug not covered by a marketing authorization.
PCS. 3. Rules established pursuant to subsection (1). 2 does not exempt liability under the Product Liability Act.
The Board of Health 's handling of cases concerning marketing permits and other permits for sale and delivery of
drugs
Section 33. In this country, the National Board of Health carries out the tasks relating to the processing of applications
marketing authorization under the mutual recognition procedure and the decentralized procedure resulting from the rules of
Directives of the European Parliament and of the Council establishing a Community code on medicinal products for human use and
veterinary medicines.
Section 34. The Minister for Health and Prevention shall lay down rules on:
(1) the information to accompany an application for the granting or renewal of a marketing authorization, including:
information on the quality, safety and efficacy of the drug and its possible environmental impact, as well as the requirements for an application
whether to issue or renew a marketing authorization otherwise.
2) Special conditions for granting marketing authorization to
(a) herbal remedies;
(b) vitamin and mineral preparations; and
(c) homeopathic medicines.
3) Special conditions for the registration of homeopathic medicines and traditional herbal medicines.
4) What special conditions must be met in order for a radioactive drug to obtain a marketing authorization.
5) The Board of Health's handling of marketing authorization cases and information on the European
Medicines Agency on the stipulated conditions of the Board in connection with the processing of the case.
6) The Board of Health examines the cases and cases mentioned in section 33 regarding community marketing permits.
Section 35. For use by the National Board of Health in processing applications for marketing authorization and issuing cases,
extension, modification, suspension or revocation of a marketing authorization may be ordered by the National Board of Health
the applicant or marketing authorization holder to provide necessary information, including in writing
material, samples of the drug, including its packaging, and samples of intermediates, active substances and excipients.
Section 36. The National Board of Health may lay down detailed rules on what information must be contained in applications and
notifications pursuant to sections 22-27, 29 and 30 and deadlines for submitting them.
Section 37. The National Board of Health may lay down formal requirements for submitting applications and notifications in accordance with the regulations
of this chapter, including submission by electronic means.
§ 38. The National Board of Health maintains a register of the medicines that are applied for and which are approved by a
marketing authorization under the provisions of this chapter.
Chapter 3
Manufacture, import, negotiation, dissemination, etc. of pharmaceuticals and intermediates
§ 38 a. No manufacture, import, export, storage, negotiation, dissemination or delivery of
counterfeit medicines, cf. 2nd
PCS. 2. The person who is authorized under section 7 (2). 1, may introduce, export and store medicines that are in limited quantities
purchased to investigate the presence of counterfeit medicines among the drugs covered by the permit.
Section 39. Manufacture, import, export, warehousing, negotiation, distribution, delivery, splitting and packaging of
Medicines may only be taken with the permission of the National Board of Health.
PCS. 2. Manufacture, import, export, storage, negotiation and distribution of intermediate products intended for later use
Processing for a drug may only take place with the permission of the National Board of Health.
PCS. 3. The rule in para. 1 does not apply to the following:
1) Distribution, break-up and delivery of medicines to be used in hospitals and other treatment institutions
treatment.
2) Distribution, splitting and delivery of medicines for use by doctors, veterinarians and dentists in practice.
3) Private individuals' imports and exports for their own consumption of medicines for human use.
4) Distributing, splitting and delivery of medicinal products for human use on board as well as importation by shipowners and shipowners
of such drugs when calling at a foreign port.
5) Companies' import, export and storage of medicines as mentioned in section 38 a (2). 2nd
PCS. 4. The National Board of Health may lay down rules on the handling of medicines mentioned in subsection (1). 3, Nos. 1-5.
Section 39 a. The Minister of Health and Prevention shall lay down rules on:
1) The information that must accompany an application for a permit under section 39 (1). 1 and 2, and on the conditions for obtaining one
permission.
2) Form requirements for the applications referred to in point 1, including that applications must be made electronically.
3) The National Board of Health's treatment of applications for permission pursuant to section 39 (1) 1 and 2.
4) The Health Board's disclosure of information on permits issued pursuant to section 39 (2). 1 and 2, on amendment, suspension
and revocation of such permits and of control activities carried out under section 44 of the European
Pharmaceutical Agency, European Commission and pharmaceutical authorities in other EU / EEA countries.
PCS. 2. In order to ensure compliance with the conditions laid down in paragraph 1. 1, no. 1, the National Board of Health may attach terms
to the permit, including time limit it.
Section 39 b. The National Board of Health shall lay down rules on:
1) Requirements for technical management, professional knowledge, layout and operation for the person who is authorized under section 39 (1). 1 and 2.
2) Requirements for the active substances and excipients, such as the one authorized by section 39 (2). 1 or 2, used in the manufacture of
drugs or intermediates.
3) The actions taken by the person authorized under section 39 (2). 1 or 2, for the manufacture of pharmaceuticals or intermediates, shall
perform to ensure that the active substances and excipients used in the manufacture of medicines or
intermediate products meet the requirements laid down in paragraph 2.
4) Shipping of medicines to the users for the person authorized under section 39 (2). 1, including rules on mandatory
information on the drug shipment.
Section 40. The National Board of Health may amend, suspend or revoke a permit pursuant to section 39 (2). 1 and 2 if the conditions
for the permit or the terms attached thereto are not fulfilled or if the holder of the permit is gross or repetitive
has repeatedly violated rules issued pursuant to section 39 b, points 1-3, or section 40 b or refuses to contribute to the National Board of Health
control pursuant to section 44.
Negotiation of pharmaceuticals for production animals
Section 40 a. Anyone who is authorized under Section 39 (2). 1, to negotiate for users of medicinal products for production animals, has the right to
negotiate and supply all non-prescription drugs intended for production animals.
PCS. 2. The person who is authorized under section 39 (2). 1, to negotiate for users of medicinal products for production animals, may not
negotiate or deliver goods other than pharmaceuticals for production animals and may only in special cases and with the Minister of
perform health duties other than those listed in subsection (1). 1 and of rules issued pursuant to
§ 40 b.
PCS. 3. The person who is authorized under section 39 (2). 1, for the negotiation of users of medicinal products for production animals, must not without
The National Board of Health's permission to operate or be associated with another company that is authorized under section 39 (1). 1 or 2, to
other than negotiation for the users of pharmaceuticals for production animals.
Section 40 b. The Minister of Health and Prevention shall lay down detailed rules on the special, supplementary obligations which
it is incumbent on the person authorized under section 39 (2). 1, to negotiate for users of medicinal products for production animals, including rules
about:
1) Provision, negotiation and delivery of prescription drugs to users.
2) Information and guidance of users.
3) Service goals.
4) Collection of remnants of medicine.
5) Compliance with risk management programs, cf. section 62.
6) Presentation of accounts.
Online drug sales
§ 41. The person who is authorized under section 39 (1). 1 and who, within the scope of its authorization, wishes to negotiate medicines
online to users, must notify the National Board of Health of this before or at the same time as the commencement thereof
negotiation.
PCS. 2. The National Board of Health maintains and publishes on its website a list of distributors who have given notice
according to para. 1 and pharmacists who have given notice under section 43a (1). 1 of the Pharmacy Act.
PCS. 3. On its website, the National Board of Health informs about online drug sales, including the risks involved
may be associated with purchasing drugs from Internet domains that are not subject to government control. The Minister
for health and prevention lay down detailed rules on this.
Section 41 a. The National Board of Health shall lay down rules on the special, supplementary obligations of the person who has given
notice pursuant to section 41 (1). 1, including rules on:
1) The information to accompany the announcement and the duty to notify the Danish Health and Medicines Authority of any changes
of this information.
2) Form requirements for the message, including that the message must be submitted electronically.
3) Requirements for the Internet domain from which the drugs are offered for sale, including rules on the information to be disclosed
of the domain, the requirements for its technical layout and the obligation to use a pan-European security logo.
Dissemination of medicines
§ 41 b. The distribution of medicines is only allowed for the person who has registered his business with the National Board of Health, and
which is included in the list referred to in paragraph 1. 2nd
PCS. 2. The National Board of Health shall maintain and publish on its website a list of intermediaries registered under subsection (1). First
PCS. 3. The National Board of Health may delete a provider from the list referred to in subsection (1). 2 if the intermediary is coarse or repetitive
has repeatedly violated rules issued pursuant to section 41 d or refuses to contribute to the Health Board's control pursuant to section 44.
Section 41 c. The Minister of Health and Prevention lays down rules on:
1) The information that must accompany a registration notification pursuant to section 41b (1). 1, and on duty to notify
The National Board of Health on any changes to this information.
2) Form requirements for the sections 41 (b) (2). 1, the notification must be made electronically.
3) The National Board of Health's treatment of notifications pursuant to section 41b (1). First
§ 41 d. The National Board of Health shall lay down rules on the requirements of drug providers, including requirements for technical
management, professional knowledge, layout and operation of the company. The Board also sets rules on what types of
drugs that may be supplied by the person registered under section 41b (1). First
Notification of counterfeit medicines and intermediates
Section 42. The person who is authorized under section 39 (1). 1 or 2, for the manufacture of pharmaceuticals or intermediates, shall immediately
inform the National Board of Health and the marketing authorization holder of the medicinal product, if any
knowledge that a drug or intermediate produced by it is or may have been falsified.
PCS. 2. The person who is authorized under section 39 (2). 1, for the sale of medicines, and the one registered under section 41b (1). 1
shall immediately notify the National Board of Health and, if applicable, the marketing authorization holder thereof
the drug in question if it receives or is offered to buy medicines that are or may be counterfeit.
PCS. 3. The National Board of Health may lay down rules on the content and requirements of the forms referred to in paragraph 1. 1 and 2,
including that the notification must be made electronically.
PCS. 4. The National Board of Health may lay down rules that the holder of a permit pursuant to section 7 (2). 1 shall notify
the Agency for the Finding of Counterfeit Medicines.
§ 42 a. The Danish Health and Medicines Authority may in the event of a finding or suspected finding of counterfeit medicines or intermediate products
disclose all information thereon to the marketing authorization holder or manufacturer thereof
drug or intermediate.
Information on failure to apply for marketing authorization
Section 43. Whoever is authorized under section 39 (1) 1, for the manufacture or export of pharmaceuticals, shall provide upon request
The National Board of Health informs of the reason why no marketing authorization has been applied for for one or more of the
the medicines in Denmark.
records
Section 43 a. Anyone who is authorized under section 39 (2). 1, and pharmacists must keep records of handling, etc. of drugs.
The National Board of Health lays down detailed rules on this.
affiliation
§ 43 b. Anyone who is authorized under section 7 (2). 1, or section 39 (1). 1, must notify the National Board of Health of doctors,
dentists and pharmacists affiliated with the company. However, this does not apply to public hospitals.
PCS. 2. The Minister of Health and Prevention shall lay down rules on the obligation to notify, including rules on:
notice must be given electronically.
Regulatory Control
Section 44. The National Board of Health checks the compliance with requirements laid down in this Act and in rules issued pursuant to the Act to
medicines and intermediates and to the person handling drugs or intermediates.
PCS. 2. To carry out their control tasks in accordance with paragraph 2. 1 or to respond to a request from another EU / EEA
countries, the European Commission or the European Medicines Agency have representatives from the National Board of Health
proper identification and without court order access to:
1) Companies that have a permit under section 7 (1). First
2) Companies that have a permit under section 39 (2). 1 or 2.
3) Companies registered under section 41b (1). First
4) Companies registered under section 50a (1). First
5) Companies that manufacture or introduce auxiliaries.
PCS. 3. The tasks of the National Board of Health are carried out in cooperation with the European Medicines Agency.
In connection with this collaboration, the National Board of Health will exchange information with the European Medicines Agency on
planned and conducted control visits.
PCS. 4. The National Board of Health shall prepare a report on any inspection visit carried out in accordance with subsection (1). 2nd
PCS. 5. Notwithstanding the provisions of subsection (1), the National Board of Health may. 2 (5), carry out inspection visits to a manufacturing undertaking
or introduces auxiliaries if requested.
§ 44 a. To carry out its control tasks pursuant to § 44 (2). 1, the Danish Health and Medicines Agency may charge free of charge against receipt
or require samples of drugs and products that are reasoned to be presumed to be drugs, including
packaging and package leaflet, intermediates, active substances and excipients. In addition, the Board may require everyone
information and materials needed for the control business.
§ 44 b. The National Board of Health may grant the holder of a permit pursuant to section 39 (1). 1 or 2 and the one registered after
§ 41b, par. 1, order to change the tasks, organization, layout or operation and set a deadline for
the implementation of the amendments to ensure compliance with rules issued pursuant to § 39 b, § 40 b, § 41 a, point 3, or § 41 d.
§ 44 c. The National Board of Health may seize medicines and products which are grounds for presumption may be medicines,
which is negotiated to the users in violation of section 7 (2). 1, § 39, par. 1, or section 60 (1). 1. The National Board of Health can also
seize medicines and products that are presumed to be medicines which violate the rules of private
imports of medicines for personal consumption are imported from non-EU or EEA countries.
PCS. 2. Seizure made pursuant to para. 1 shall be made in accordance with Chapter 74 of the Code of Procedure
seizure.
§ 44 d. The representatives of the Danish Veterinary and Food Administration have access to companies against proper identification and without court order.
with a license to negotiate feed medicines for animals or fish in accordance with section 39 (2). 1. The representatives of the Food Board may
require to be presented and provided with a copy of ordering notes on feed medicines prescribed by a veterinarian.
Section 45. The Minister of Health and Prevention may, after negotiation with the Minister concerned, lay down rules that
representatives of authorities under the jurisdiction of the ministers concerned may carry out checks on
On behalf of the National Board of Health and exercise the powers provided for in sections 44a and 44c (1) of this Act. 1, 1st paragraph, is assigned to
The National Board of Health, in order to ensure legal distribution of medicines.
Chapter 3 a
Prohibition, warning, revocation, etc.
Section 46. The National Board of Health may prohibit the negotiation and delivery of a drug and may order that it be withdrawn
from the market if
1) the relationship between the benefits and risks of the drug is not favorable;
2) the therapeutic effect of the drug is lacking;
3) the drug does not have the qualitative or quantitative composition indicated;
4) self-monitoring of the drug, its intermediates, active substances or excipients according to rules laid down by
Section 39b (1-3) has not taken place, or any other requirement in connection with the issue of the permit under section 39 (1). 1 or
2 has not been met,
5) the drug originates from a company that does not have the permission of the National Board of Health pursuant to section 39 (2). 1 or 2 or not
will assist in the National Board of Health's control pursuant to section 44,
6) the medicament is not manufactured in accordance with the description of the method of preparation disclosed in
the marketing authorization and subsequent amendments thereto, or if checks are not carried out in accordance with them
control methods set out in the application for the marketing authorization and subsequent amendments thereto;
7) there is a justified presumption that the drug poses a serious health risk;
8) the marketing authorization of the drug is suspended or revoked pursuant to sections 14-16; or
9) a recommendation to comply with current regulations on labeling of medicines has been unsuccessful.
PCS. 2. The National Board of Health shall immediately notify the European Medicines Agency of decisions under paragraph 1. 1
and about the rationale behind it.
PCS. 3. In special circumstances, the National Board of Health may, during a transitional period, allow the delivery of a drug
according to section 29 for patients who are being treated with the drug in question, even if the drug is covered by a prohibition
or injunction pursuant to subsection (1). First
PCS. 4. The Minister of Health and Prevention may lay down rules on the Board of Health's handling of cases after
PCS. First
Section 46 a. The National Board of Health may require the negotiation and delivery of a drug not covered by a
marketing authorization, cf. section 7, or other licenses for the sale or delivery of medicines, cf. sections 29-32, shall be terminated, and
may require that it be withdrawn from the market.
Prohibition of manufacture and import
Section 47. The National Board of Health may prohibit the manufacture of a drug or its import from a third country if a
an undertaking that is authorized under section 39 (2). 1, violates the rules for the manufacture and import of medicinal products laid down in accordance
of Section 39 b, Nos. 1-3.
Monitoring and warning
Section 47 a. The National Board of Health establishes a system for preventing drugs that may pose a health hazard when
forward to users. The Minister of Health and Prevention shall lay down detailed rules on this.
Section 47 b. In the opinion of the National Board of Health, a drug that is traded or supplied in this country constitutes a serious
In the event of a health hazard, the Agency shall immediately send a rapid alert to the competent authorities of the others
EU / EEA countries and to all relevant actors in the supply chain in this country in accordance with rules laid down by the Minister of
health and prevention. If the National Board of Health considers that such a drug may have reached the users, it must
the Board immediately issued a public warning against the use of the drug.
Import of feed products
Section 48. The National Board of Health may lay down rules on the importation of feed medicines manufactured from premixtures that are permitted in a
other EU / EEA country if the premix qualitatively and qualitatively corresponds to a premix approved by the National Board of Health.
Health professionals access to bring medicines
Section 49. Healthcare professionals and other personnel, including ambulance drivers established or employed in another
EU / EEA country, which is requested to assist in accidents and disasters in this country pursuant to bilateral agreements with
neighboring countries or pursuant to a Nordic health emergency agreement, can to a limited extent bring medicines from
the home country to use for the prehospital effort. Such drugs can be brought, regardless of the individual drug
is not covered by a marketing authorization in Denmark when the drug is approved in the country where the healthcare professional
etc. is established or employed.
Section 50. A veterinarian established in another EU / EEA country may, in accordance with rules laid down by the National Board of Health in limited
bring with it medicines for animals for use in his treatment of animals in this country. Such drugs can
be carried, regardless of whether the individual drug is not covered by a marketing authorization in Denmark.
PCS. 2. A medicinal product brought in accordance with paragraph 1. (B) paragraph 1 must be approved in the country where the veterinarian is established and its
the composition must qualitatively and quantitatively correspond to a drug approved by the National Board of Health.
PCS. 3. Notwithstanding paragraph 1. 1 and 2, sera and vaccines for animals must not be brought.
Chapter 3 b
Manufacture, import and distribution, etc. of active substances
§ 50 a. Manufacture, import and distribution of active substances intended to be used in the manufacture of medicines for
people who are subject to a marketing authorization are only allowed to the person who has registered their business
at the National Board of Health and listed on the list referred to in subsection (1). 2nd
PCS. 2. The National Board of Health maintains and publishes on its website a list of manufacturers, importers and distributors,
registered in accordance with para. First
PCS. 3. The National Board of Health may delete a company from the list referred to in subsection (1). 2 if it is rough or repetitive
sometimes violates rules issued pursuant to section 50 c or refuses to contribute to the Board of Health's control under section 50 e.
Section 50 b. The Minister of Health and Prevention shall lay down rules on:
1) The information that must accompany a registration notification pursuant to section 50a (1). 1, and on duty to notify
The National Board of Health on any changes to this information.
2) When manufacturing, importation and distribution can begin after notification has been submitted.
(3) Form requirements for the notifications referred to in paragraph 1, including the deadlines for filing the notification and whether
notification must be made electronically.
4) The National Board of Health's treatment of the notifications referred to in point 1, including the presentation of any visit to
the company.
5) The Board of Health transmits information which, in accordance with rules issued pursuant to paragraph 1, must accompany a
registration notification pursuant to section 50a (1). 1, to the European Medicines Agency.
§ 50 c. The National Board of Health establishes rules on technical management, professional knowledge, layout and operation for companies that
is registered in accordance with § 50 a, para. 1, including rules on the conditions for the legal import of active substances in the form of, inter alia:
(1) requirements for the manufacture of the substances in the exporting country and
(2) requirements for the exporting country's control and enforcement of good manufacturing practices for active substances and procedures by
finding failure to comply with good manufacturing practice unless the exporting country is included in the list which
is mentioned in Article 111b of Directive 2001/83 / EC.
Notification of counterfeit active substances
Section 50 d. 1 and the person authorized under section 39 (1). 1 or 2, for the manufacture of
drugs or intermediates must immediately notify the National Board of Health if they receive or are offered to
buy active substances that are or may be counterfeit.
Regulatory Control
Section 50 e. The National Board of Health shall check compliance with the requirements stipulated in this chapter and in regulations issued pursuant to section 50 c.
PCS. 2. To carry out their control tasks in accordance with paragraph 2. 1 or to respond to a request from another EU / EEA
countries, the European Commission or the European Medicines Agency have representatives from the National Board of Health
proper identification and, without a court order, access to companies registered under section 50a (2). First
PCS. 3. The National Board of Health shall prepare a report on any inspection visit carried out pursuant to subsection (1). 2nd
§ 50 f. To carry out its control tasks pursuant to § 50 e, par. 1, the Danish Health and Medicines Agency may charge free of charge against receipt
or require samples of active substances delivered. The Board may also require all information and materials that are available
necessary for the control business.
§ 50 g. The National Board of Health may grant a company registered in accordance with § 50 a (2). 1, injunction to change
tasks, organization, layout or operation and set a deadline for the implementation of the changes to ensure
compliance with rules issued pursuant to section 50 c. '
Chapter 4
The quality of medicines
§ 51. A drug, including its packaging, as well as intermediates, active substances and excipients, must be off
satisfactory quality.
PCS. 2. Quality assurance documentation shall include information on
1) the qualitative and quantitative constituents of the drug;
2) the manufacturing method;
3) control methods with associated acceptance criteria (specifications) and
4) durability.
PCS. 3. (2) (2) and (3) must be described in such detail that they can be repeated in control analyzes which
is carried out at the request of the National Board of Health.
§ 52. The National Board of Health may lay down rules on the quality of medicines, including on the quality of packaging of medicines,
as well as the quality of intermediates, active substances and excipients. The National Board of Health may stipulate such requirements
the quality in the form of standards in a pharmacopoeia or the like. like.
Chapter 5
Side effects of drugs
Section 53. The holder of a marketing authorization for a drug shall
1) use a drug monitoring system to monitor the safety of the drug, assess
risk minimization opportunities and, if necessary, take appropriate measures;
2) provide a detailed description of the pharmacovigilance system and provide, on request, a copy of the description to
available to the National Board of Health, cf. 2
3) keep records of suspected adverse reactions;
4) make the records available to the National Board of Health;
5) report suspected adverse reactions to the National Board of Health or the European Medicines Agency;
6) prepare and submit periodic security updates to the National Board of Health and
7) have an expert in pharmacovigilance based in the EU.
PCS. 2 pcs. Paragraph 1 (2) does not apply to medicinal products for animals.
PCS. 3. When required by pharmacovigilance, the National Board of Health may impose on the holder of
the marketing authorization for a drug for humans to designate a contact person in Denmark for the person referred to in para. 1, No. 7,
said expert.
PCS. 4. The Minister of Health and Prevention shall lay down rules on the 1 obligations of the holder of
the marketing authorization, including the reporting of suspected adverse reactions occurring in Denmark or a country respectively
outside the EU and the EEA, and on professional knowledge, business area and contact person for experts in
pharmacovigilance.
PCS. 5. The National Board of Health shall verify that the requirements of subsection (1) 1 and in rules laid down pursuant to subsection (1). 4 are complied with.
The National Board of Health also monitors compliance with the requirements for pharmacovigilance in EU rules on
establishment of Community procedures for the approval and supervision of medicinal products for human and veterinary use, etc.
PCS. 6. Representatives of the National Board of Health have access to companies against proper identification and without court order
for the purpose of implementing it in para. 5. The National Board of Health can order companies to disclose all
information, including written material needed for the inspection company.
PCS. 7. The National Board of Health shall inform the European Medicines Agency, the European Commission,
pharmaceutical authorities in the other EU / EEA countries and the marketing authorization holder if the Board of Directors in the background
of a verification visit concludes that the MAH does not follow the pharmacovigilance system,
which is stated in the description of the system, cf. 1, No. 2.
§ 54. The holder of a marketing authorization for a medicinal product for humans may not without prior or simultaneous
publish notification of the National Board of Health, the European Medicines Agency and the European Commission
information on the safety of the drug based on drug monitoring.
PCS. 2. The holder of a marketing authorization for a veterinary medicinal product may not do so without prior or simultaneous authorization
notification of the National Board of Health to publish information on matters relating to the safety of the drug based on
pharmacovigilance.
PCS. 3. The information referred to in paragraph 1 Paragraphs 1 and 2 must be presented in an objective and not misleading way.
§ 54 a. The National Board of Health may require the holder of the marketing authorization for a drug to publish or to
a particular circle of health professionals or hospitals sends out information about the drug that serves
patient safety purposes, including information on suspected adverse reactions.
PCS. 2. The National Board of Health may impose requirements on the form and content of the one referred to in subsection (2). 1 information. The National Board of Health can
also set a deadline for the publication or dissemination of the information.
§ 55. The Minister of Health and Prevention sets rules on the duty of health professionals to report information
on suspected adverse reactions, including information from medical records and autopsy statements, to the National Board of Health.
PCS. 2. The Minister of Health and Prevention shall lay down rules on the access of patients, relatives and pet owners to:
report information on suspected adverse reactions directly to the National Board of Health.
Section 56. The National Board of Health uses a drug monitoring system to monitor the safety of medicines and maintains a
register of reported adverse reactions. The Minister of Health and Prevention shall lay down detailed rules
The National Board of Health's treatment of the reported information and the processing of periodic security updates.
PCS. 2. The National Board of Health may disclose information on adverse reaction reports to the European Union
The European Medicines Agency, the European Commission, the pharmaceutical authorities in the other EU / EEA countries, the Patient Ombudsman and
the marketing authorization holder. The Minister of Health and Prevention shall lay down detailed rules on this.
Section 56 a. The Minister of Health and Prevention may lay down rules on the form requirements for reporting and periodic
security updates prepared by marketing authorization holders under this chapter, including this
electronically.
Chapter 6
Labeling, pharmacy reservations and delivery status
Section 57. The National Board of Health may lay down rules on and require requirements for the package leaflet, labeling, packaging and
package size. Such requirements may be imposed on the marketing authorization holder and other persons or
companies that bring a drug to market.
§ 58. A drug that is subject to a marketing authorization issued by the National Board of Health may only be negotiated
and is provided under a name approved by the National Board of Health.
PCS. 2. The name must be
1) a special name which must not be confused with the common name;
(2) a common name associated with a trademark or the name of the marketing authorization holder; or
(3) a scientific term relating to a trade mark or the name of the marketing authorization holder.
PCS. 3. The name shall not be misleading as to the composition, effect or characteristics of the goods otherwise and may
may not be suitable to cause confusion with other medicines.
PCS. 4. The Minister of Health and Prevention may lay down rules on the naming of parallel imported medicines.
Section 59. Anyone who places a medicinal product on the market in Denmark must submit the leaflet in force at all times.
for the drug to the National Board of Health.
PCS. 2. The National Board of Health may set deadlines and requirements for the submission of leaflets according to subsection (2). 1, including that
submission must be done electronically.
§ 60. The sale of medicines to users may only be done through pharmacies (reservation of pharmacies), unless otherwise
without prejudice to subsection (2), by law or in regulations laid down by the Minister of Health and Prevention. 2 and 3.
PCS. 2. The Board of Health may, when it is justifiable for health reasons, decide that a non-prescription drug,
including certain pack sizes, pharmaceutical forms or strengths of the drug, may be negotiated to users outside
pharmacies. The National Board of Health can set limits on the number of packs of a drug that can be negotiated
a user.
PCS. 3. Prescription and non-prescription drugs intended for production animals may, according to the National Board of Health
Specifics are negotiated to users outside the pharmacies.
PCS. 4. The National Board of Health may lay down rules that medicines not covered by the pharmacy reservation in subsection (1). 1, only
may be delivered on order from doctors, dentists or veterinarians. The National Board of Health can also lay down rules
drafting, etc. of such orders and rules for the delivery of such drugs.
§ 61. In connection with the granting of a marketing authorization, the National Board of Health shall decide on the extension of
marketing authorization, and when otherwise it is necessary to prescribe a drug.
PCS. 2. The National Board of Health shall lay down rules on which medicinal products may only be dispensed by prescription and on the division of
drugs in delivery groups.
PCS. 3. The National Board of Health shall lay down rules on the preparation of prescriptions, etc. and on extradition and substitution, etc. of
prescription drugs and non-prescription drugs prescribed by prescription. The National Board of Health also determines
rules on the delivery of medicines in special cases without payment security.
Section 62. The National Board of Health may lay down rules on the conditions for prescribing and dispensing of medicines which have
associated with a special program for the management, organization and management of risks (risk management program).
PCS. 2. In special cases, the National Board of Health may decide that there must be specified restrictions
in connection with the prescription and delivery of a drug that has been associated with a risk management program as mentioned in subsection (1). First
Chapter 7
Advertising, bonus, discounts, etc.
Section 63. Advertising of a drug must be adequate and factual and must not be misleading or exaggerated
properties of the drug. Information in the advertisement must be in accordance with the approved product
SPC.
Section 64. No advertising may be made
1) medicines which cannot be legally traded or supplied in this country; and
2) magistral medicines.
§ 65. The word pharmacy may not be used in advertisements for non-pharmacy-related medicines, cf. 1, or other goods
than medicines, unless the person responsible for advertising can prove that the goods are generally traded on the country's
pharmacies.
§ 66. Medicines which are not permitted to advertise to the public
1) are required to prescribe,
2) are unsuitable for use without the patient having previously sought medical attention for diagnosis or monitoring of
the treatment, or
3) is covered by the law on euphoric substances.
PCS. 2. Public means any person who is not a doctor, dentist, veterinarian, pharmacist, nurse,
veterinary nurse, pharmacist, midwife, bioanalyst, clinical dietitian, radiographer or student within one of
these subjects.
PCS. 3. The National Board of Health may provide specialist journals for other than those in subsection (1). 2 health professionals mentioned permission to bring
advertisements for the persons referred to in para. 1, if the subject group has a particular interest in the use of medicines.
PCS. 4. The prohibition in subsection (1). Paragraph 1 does not include vaccination campaigns approved by the National Board of Health.
§ 67. Medicines shall not be provided free of charge to the public. However, the National Board of Health may grant permission
free delivery of medicines to the public if the disclosure is not done for advertising purposes.
PCS. 2. The Minister of Health and Prevention shall lay down rules on the extent to which medicines may be dispensed
free of charge to those referred to in section 66 (2). 2, mentioned health professionals.
PCS. 3. The Minister of Health and Prevention shall lay down rules on the activities of the undertaking
sales representatives.
Section 68. The marketing authorization holder must keep a copy of or other documentation for all advertising
for that drug. The Minister of Health and Prevention sets rules on what information is required
stored, including information about the target audience, content, use, form of publication, and method of distribution.
PCS. 2. 1 material must be stored for 2 years. The material shall be made available upon request
Health.
PCS. 3. If someone other than the marketing authorization holder advertises a drug, the duty is to:
PCS. 1 and 2 the person responsible for advertising.
PCS. 4. The National Board of Health may order the disclosure of all necessary information in order to verify that
advertising for medicines, discounts and other services or practices that may have equivalent effect are in
in accordance with the provisions of this chapter, including with rules laid down pursuant to section 67 (2). 2 and 3, or § 70,
PCS. First
Section 69. The National Board of Health may require that advertisements which contravene sections 63-68 or with rules laid down in accordance with section 67,
PCS. 2 and § 70 (2). 1 is terminated.
PCS. 2. The National Board of Health may require the person responsible for unlawful advertising to publish a decision taken pursuant to subsection (2). 1
or a correction of the advertisement. The National Board of Health can determine the form and content of the publication, including where it is
must take place.
§ 70. The Minister of Health and Prevention may lay down detailed rules on advertising of medicines, discounts and
other services or methods that may have a similar effect.
PCS. 2. The Minister of Health and Prevention may lay down rules that the National Board of Health may, at the request of
companies must express their views on the legality of the proposed advertising measures.
§ 71. The National Board of Health may lay down rules that in special cases it is permissible to advertise that
dental products that are not covered by section 2 are suitable for the prevention of certain diseases in humans.
§ 71 a. No part of trade in a pharmacy-prescription drug, cf. 1, bonus is paid or granted
other financial benefit to the user of the drug. However, when selling pharmacy-related medicines to hospitals
bonus is paid to the hospital owner.
§ 71 b. The holder of a permit pursuant to § 39 (2). 1 (the discount provider), as part of trading in a pharmacy reservation
section 60 (2). 1, to a pharmacist only provide discounts that are offset by a cost savings with
discount giver. The discount must be in proportion to the cost savings and consist of a reduction in the price.
PCS. 2. The creditor shall prepare and publish information on the access to obtain the information referred to in paragraph 1. 1 mentioned discounts from
this as part of the trade in pharmacy-related medicines (mandatory).
PCS. 3. The Minister for Health and Prevention shall lay down detailed rules for granting the benefits referred to in paragraph 1. 1 mentioned discounts and about
the one referred to in para. Paragraph 2 as well as on accounting matters, management's declaration and audit
discounts granted.
PCS. 4. Pharmacists may not, as part of the trade in those referred to in subsection (1). 1. Medicines referred to in paragraph 1 request or receive discounts which:
is not in accordance with the information compiled and published by the taxpayer in accordance with its duty to sign.
PCS. 5. Discounters and pharmacists shall keep documentation for the years referred to in subsection (3). 1 mentioned discounts granted and
received as part of the trade in pharmacy-only medicines. The Minister of Health and Prevention can stipulate
rules on what documentation to keep.
PCS. 6. The National Board of Health may order discount providers and pharmacists to provide all information needed with
for the purpose of checking whether discounts have been granted and received in accordance with paragraph 2; 1 and 4 as well as rules issued in accordance
of par. Third
§ 71 c. Representatives of the National Board of Health shall have access to pharmacies and without legal authorization and without court order.
companies that hold a license under section 39 (1). 1, in order to check compliance with
the provisions of § 71a and § 71b (2). 1, 2 and 4 and par. 5, first paragraph, and in regulations issued pursuant to section 71b (1). 3 and par. 5, 2.
section.
Chapter 8
Information on medicines
Section 72. The National Board of Health shall make the following information available to the public at the National Board of Health
website, cf. 2:
1) The Board of Health's decisions on issuing, suspending and revoking marketing authorizations.
2) Terms attached to marketing authorizations pursuant to section 9 (2). 1 and 2, and information on possible deadlines for
fulfillment of the terms.
3) The product summary for medicines approved by the National Board of Health.
4) An assessment in Danish or English of the material on which marketing authorizations were issued
The National Board of Health, in the form of a public evaluation report. For marketing authorizations for human medicines
must also publish a Danish or English summary of the evaluation report.
5) Package leaflet for medicines covered by a marketing authorization in this country.
6) Summary of risk management plans and programs for human medicines.
(7) The list of medicinal products subject to supplementary surveillance in the EU, in accordance with Article 23 of Regulation (EC) No 726/2004, which
is published on the European Medicines Agency's web portal on medicines.
8) Information on how health professionals and patients can report suspected adverse reactions to the National Board of Health,
including on digital reporting.
9) Rules of procedure, agendas and minutes of meetings accompanied by the decisions taken, voting results and
explanations of vote, including minority opinions, for the councils and boards mentioned in Chapter 13.
PCS. 2. Notwithstanding paragraph 1. 1, the National Board of Health does not make information that is exempt from public disclosure pursuant to
the rules of the Public Access Act, accessible to the public.
PCS. 3. The National Board of Health must also inform the public when special health conditions otherwise do
necessary. In this connection, the National Board of Health may, regardless of subsection (1). 2 publish the name of the legal or natural person,
who has committed an offense.
Section 72 a. The National Board of Health organizes meetings with the participation of patient and consumer organizations in order to
disseminate public information on measures taken to prevent and combat drug counterfeiting.
§ 73. The National Board of Health may inform about medicines and the appropriate use of medicines.
PCS. 2. As a basis for the information activities, the National Board of Health may use all necessary information which
the board has control over its activities.
PCS. 3. The information referred to in paragraph 1 2, may be determined by the Minister of Health and Prevention
provided to associations of doctors, dentists, veterinarians, pharmacists and pharmacists and to companies whose purpose is to provide
health professional information about medicines, but not information attributable to individuals.
PCS. 4. The National Board of Health may publish information on adverse reactions caused by drugs, but not information,
that can be attributed to individuals.
PCS. 5. When the National Board of Health, on the basis of pharmacovigilance, informs about concerns regarding
the safety of a medicinal product for humans according to para. 1 or 4, the board must at least 24 hours before publication of the
the information shall inform the European Medicines Agency, the European Commission and the pharmaceutical authorities in the
other EU / EEA countries. However, the time limit for notification may be waived if faster disclosure is required
for the protection of public health.
Section 74. The Minister of Health and Prevention may order the Danish Health and Medicines Authority to inform health professionals
drugs according to specified rules.
Chapter 9
Medicines Supply
Section 75. Whoever markets a drug to people on the market and wholesale distributors of such a drug shall:
according to rules laid down by the National Board of Health, ensure appropriate and continued delivery of the drug in question, if any
talk about:
1) A drug that is subject to a pharmacy reservation, cf. section 60 (1). First
2) A serum, a vaccine, an immunological test preparation or a drug made from plasma.
3) A radioactive drug.
4) A drug, including certain pack sizes, pharmaceutical forms and strengths of the drug, which after
The National Board of Health's specific provision may be negotiated with users outside the pharmacies, cf. section 60 (2). 2nd
Section 76. The Minister of Health and Prevention may lay down rules on the duty of companies approved by
The National Board of Health pursuant to section 39 (1). 1, for emergency supplies and in case of accidents and disasters, including
acts of war, to take measures to maintain the supply of medicines.
PCS. 2. The rules laid down in accordance with paragraph 1 shall not apply. 2. Paragraph 1 may include:
1. The obligation of undertakings to take measures for the relocation and distribution of inventories which:
used, manufactured or put into business in their normal business.
2) Payment and delivery terms for medicines that are moved or spread in accordance with the rules laid down.
3) Pharmacists and hospital pharmacists' access to supply medicines to pharmacies and hospital pharmacies.
4) The Health Authority's access to give the covered companies specific orders to implement measures;
that deviate from the rules laid down.
PCS. 3. Conducts the rules laid down in paragraph 1. 1, or an order issued by the National Board of Health pursuant to the rules,
which shall be determined in accordance with para. 1, financial loss for a business, the state is liable for damages under the ordinary law
rules.
PCS. 4. The compensation shall be employed in the absence of amicable agreement in accordance with rules laid down by
the Minister of Health and Prevention.
Chapter 10
Prices, assortment, item numbers and statistics
Prices and range
Section 77. Anyone who brings a pharmacy-related drug to the market in Denmark must report to the National Board of Health
the pharmacy purchase price and changes therein for the drug concerned at the packing level, at least 14 days before
the price should take effect. However, the notification requirement does not apply to medicines exempted from the marketing authorization requirement in
pursuant to section 11.
PCS. 2. The Minister for Health and Prevention may lay down rules on notification under subsection (2). 1, including one
minimum threshold for changes in pharmacy purchase prices for medicinal products for humans, and form requirements for notification, including
that notification must be done electronically.
Section 78. The Minister of Health and Prevention may lay down rules that the person who brings a drug that is exempted
from a pharmacy reservation, on the market in Denmark, must report to the National Board of Health, what pack sizes of the drug
is marketed in, including reporting any change in the range.
PCS. 2. The Minister of Health and Prevention may lay down rules for certain medicinal products which are exempted from:
reservation of pharmacy, the person who brings the drug to the market in Denmark must notify the pharmacy purchase price calculated on
packing level for the National Board of Health.
PCS. 3. Notification pursuant to par. 1 and 2 must reach the National Board of Health, no later than 14 days before the price shall come into force
or a gasket is brought to the market, altered or pulled by the market.
PCS. 4. The Minister of Health and Prevention may lay down detailed rules for notification to the Danish Health and Medicines Authority in accordance with
PCS. 1-3, including a minimum threshold for changes in pharmacy purchase prices and notification requirements,
including that notification must be done electronically.
§ 79. The Board of Health's treatment of the pharmacy purchase prices mentioned in section 77 and in rules established pursuant to section 78,
does not imply endorsement thereof.
Section 80. Anyone who places a drug on the market in Denmark must, at the request of the National Board of Health, state where
a large amount of a given drug the company will be able to supply to the market.
PCS. 2. The Minister of Health and Prevention may lay down rules on the person who brings a drug to humans
in the market, and wholesale distributors must notify the National Board of Health of expected and actual delivery failure.
PCS. 3. The Minister of Health and Prevention may lay down detailed rules on the duty to provide information and information
according to para. 1 and 2.
PCS. 4. The National Board of Health may lay down formal requirements for submitting notification pursuant to subsection (1). 2, including that of submission
must be done electronically.
§ 81. The National Board of Health shall notify the pharmacists of the size of the packaging of medicines, including whether
any change to the product range and the consumer price of medicines. The notification is made in Medication prices, cf. section 82.
PCS. 2. However, on the basis of information received pursuant to section 80 (2), the National Board of Health may. 1, fail to notify
the pharmacists on the consumer price of a drug.
PCS. 3. The Minister of Health and Prevention may lay down rules that provide information on medicines that cannot
delivered, not included in Medication prices. In this connection, the Minister may lay down rules on the National Board of Health
informing the pharmacists of changing the reimbursement price, cf. the Public Health Insurance Act, if the drug that forms
basis for setting the grant price in a grant group, cannot be provided.
§ 82. In the Medicines Prizes, the National Board of Health publishes medicines covered by section 77 and rules laid down pursuant to
Section 78, information on
1) delivery group,
2) limit on the number of packages that can be delivered per. non-pharmacy expedition,
3) medical specialties authorized to prescribe the drug; and
4) grant price, including any unit grant price.
PCS. 2. The Minister of Health and Prevention may lay down detailed rules for Medication prices, including
(1) what information, in addition to the information referred to in paragraph 1; 1 may or must be stated in Medication prices,
2) The National Board of Health's disclosure of certain information in Medication Prices prior to publication, including the exact one
time of such transfer, and
3) The Danish Health and Medicines Authority's publication of information on Medicines Prices, including the exact time for such information
disclosure.
PCS. 3. Medication prices are not included in the Law Gazette.
Part numbers
§ 83. Each individual package of medicinal products must bear a unique item number. Item numbers are assigned by
The National Board of Health at the request of the person bringing the drug to the market in Denmark.
PCS. 2. The National Board of Health may lay down detailed rules on item numbers, including that of inner packs from
veterinary medicinal products must be provided with a separate item number that the commissioning of an assigned item number must be reported to.
The National Board of Health and that certain drug groups are exempted from the requirement in subsection (1). 1, 1st paragraph.
PCS. 3. Under conditions laid down by the National Board of Health, the task referred to in subsection (1) may apply. 1, second paragraph, for an agreed period
entrusted to a private institution or the like. like. If the terms are violated, the National Board of Health can deprive the institution of the assigned task.
PCS. 4. The National Board of Health may lay down formal requirements for reporting item numbers to the National Board of Health, cf. 2
including that reporting must be done digitally.
statistics
Section 84. Enterprises that manufacture, import, export, store, trade, distribute, dispense, split or pack
medicines, and the associations and associations of these companies must, according to rules laid down by the Minister of Health
and prevention provide information to the Minister or authority designated by the Minister to receive the information
electronic form of revenue etc. of drugs.
PCS. 2. The Minister of Health and Prevention or the authority designated by the Minister to receive
the information may disclose information subject to rules laid down in accordance with subsection (1). 1 to the public, including
publish statistics on the revenue of all medicines and drug packs.
PCS. 3. The Minister of Health and Prevention may receive from the authority designated by the Minister
the information, receive the same information and disclose it to the same extent as the said authority.
PCS. 4. The companies and associations etc. mentioned in subsection (1). 1, must also, at the request of the National Board of Health
provide the National Board of Health with information in electronic form on revenue etc. of drugs. The information in question may
shall be disclosed in accordance with para. 2. The National Board of Health shall lay down detailed rules for this.
Section 84 a. The Minister of Health and Prevention may lay down rules on what information on medicines, including
confidential information that the National Board of Health must pass on to the authority designated by the Minister to prepare and
publish statistics on the turnover of medicines. The relevant authority may only use the confidential information
information related to the preparation of drug statistics.
Chapter 11
Attempt
Non-clinical trials of drugs
Section 85. Conduct of toxicological and pharmacological tests (non-clinical trials) with a view to assessing the
security for use in clinical trial application, marketing authorization application or maintenance
Marketing authorization may only be done with the permission of the National Board of Health.
PCS. 2. The Minister of Health and Prevention shall lay down rules on the conditions for obtaining a permit to carry out
trial after paragraph. 1 on the information to accompany the application and on the National Board of Health's treatment of
the application.
PCS. 3. To ensure compliance with the conditions laid down in paragraph 1. 2, the National Board of Health can attach special
terms of the permit, including limiting the permit.
PCS. 4. The National Board of Health shall lay down rules on technical management, professional knowledge, layout and operation for companies that
is authorized under subsection (1). First
Section 86. The National Board of Health may revoke or suspend a permit pursuant to section 85 (1). 1 if the conditions of
the permit or the terms attached thereto will not be fulfilled if the company violates rules laid down by
The National Board of Health pursuant to section 85 (1). 4, or if the company refuses to contribute to the National Board of Health's control after
§ 87.
§ 87. The National Board of Health controls companies, etc. with permits under section 85 (1). 1. The check includes
the planning, execution, monitoring, recording, reporting and filing of the experiments. The Minister of
health and prevention lay down detailed rules for this control activity.
PCS. 2. Representatives of the National Board of Health have access to companies against proper identification and without court order
etc. with permits under section 85 (1). 1 for the purpose of implementing the 1 control. The National Board of Health can
take out or order the company, etc. to provide samples of the subject or substance being investigated (test substance). The Board can
Require all information, including written material, necessary for the inspection company. The National Board of Health can
require changes made and set deadlines for the changes to be implemented to ensure compliance
rules laid down pursuant to section 85 (1). 4th
PCS. 3. The National Board of Health may disclose relevant information on permits issued pursuant to section 85 (1). 1, and about
the control undertaking in accordance with paragraph 1; 2 to the European Commission and the pharmaceutical authorities of the other EU / EEA countries and i
third countries.
Clinical trials with drugs etc.
§ 88. A clinical trial of drugs may only be carried out when the National Board of Health has authorized the trial. By trial
human beings must also have a permit for the trial from a scientific ethics committee, cf.
treatment of health science research projects.
PCS. 2. Trials of human medicinal products should be in accordance with good clinical practice.
The National Board of Health establishes rules on good clinical practice, including on quality standards for planning,
conducting and reporting clinical trials.
PCS. 3. Application for permission for a clinical trial must be submitted to the National Board of Health by the person, company or company
institution that assumes responsibility for initiating, leading and possibly funding a clinical trial (sponsor).
PCS. 4. If the National Board of Health has a reasoned objection, the sponsor may change the application once to take
consideration of the objection. If the application does not change in accordance with the objection, the application is rejected.
PCS. 5. The sponsor must, at the same time as the application is submitted to the National Board of Health, inform the manufacturer of the drug or
his representative on the application.
PCS. 6. When applying for a trial on medicinal products for humans, the National Board of Health must announce its decision
permission under subsection (1). 1 or refusing an application for permission to the relevant scientific ethics committee, cf.
science ethical treatment of health science research projects.
PCS. 7. The sponsor or his representative must be domiciled in an EU / EEA country.
PCS. 8. The Minister of Health and Prevention shall lay down detailed rules on the information requested
permission for clinical trials must contain and about the National Board of Health's treatment of such applications.
§ 89. Once an experiment has begun, the sponsor can only change the trial protocol according to rules laid down by the Minister of
health and prevention
PCS. 2. Sponsor must
1) immediately notify the National Board of Health if unexpected and serious suspicions occur during the trial
side effects,
2) within 15 days, notify the Board of Health, if an attempt may be interrupted earlier than planned, and give the Board a clear
justification for the interruption,
(3) compile a list of all serious suspected adverse reactions occurring once a year throughout the trial period;
the trial period, and a report on the safety of the subjects and submit them to the National Board of Health and
4) notify the National Board of Health of the end of the trial, and as soon as possible, within 90 days after the end of the trial;
not later than 1 year submit the test result to the board.
PCS. 3. The Minister for Health and Prevention shall lay down rules on the 2 notifications.
PCS. 4. The Minister of Health and Prevention sets rules on the obligation of sponsors to notify others, including
responsible for clinical trials and drug authorities in the other EU / EEA countries; 2 reported information.
Section 90. The National Board of Health may contact the sponsor and the doctor, dentist or veterinarian responsible for the trial.
practical implementation (investigator), setting conditions for the experiment.
PCS. 2. The Board of Health may, before, during and after the conduct of a clinical trial of medicines, including as
part of processing a marketing authorization application and following up on the issuance of a marketing authorization
marketing authorization, controlling any company, etc. that performs or has performed a clinical trial. The Board can
require disclosure of all information, including written material, necessary for the verification.
PCS. 3. The National Board of Health may, on the basis of a request from a competent authority in another EU / EEA country, apply
supervise a clinical trial control any company etc. that carries out or has performed a clinical trial with
drugs. The Board may require the disclosure of all information, including written material, which is required
control.
PCS. 4. As part of the National Board of Health's control pursuant to subsection (1). Paragraphs 2 and 3 have representatives of the Board against proper identification and
without court order, access to businesses, hospitals, practices and other places affected by the trial.
PCS. 5. Disclosure and processing of information on subjects' health and other purely private matters and
other confidential information may, as part of the National Board of Health's control, cf. 2-4, is done without the subject's consent.
PCS. 6. In the case of trials of medicinal products for human use, the National Board of Health shall carry out checks pursuant to subsection (1). 2 and 3, that good
clinical practice is adhered to. The Minister of Health and Prevention shall lay down detailed rules on such checks.
PCS. 7. An investigator or other party to the test does not fulfill the prescribed obligations for a drug test
to people, the National Board of Health presents these proposals to solve the problem and submits the proposal to it
Scientific Ethics Committee, European Commission and pharmaceutical authorities in the other EU / EEA countries.
PCS. 8. During the trial, the National Board of Health may require the sponsor and investigator to change the trial or temporarily
paused, or the board may prohibit the trial. The Minister of Health and Prevention shall lay down detailed rules on this.
PCS. 9. In deciding to stop or prohibit a trial of drugs for humans, the National Board of Health shall
immediately inform the European Ethics Committee of its decision and the reasons therefor
The European Medicines Agency, the European Commission and the pharmaceutical authorities in the other EU / EEA countries.
§ 91. The National Board of Health shall introduce information on all clinical trials of drugs on humans, such as the National Board
has decided on a European database. The Minister of Health and Prevention shall lay down detailed rules on:
what information the National Board of Health must report and about the Board's processing of the information.
PCS. 2. The National Board of Health may provide relevant information on clinical trials to the European Union
Medicines Agency, European Commission, pharmaceutical authorities in the other EU / EEA countries and the concerned
science ethics committee. The Minister of Health and Prevention shall lay down detailed rules on this.
§ 92. Medicines for clinical trials must comply with applicable standards of good manufacturing practice. Compliance with this
is covered by the National Board of Health's control of clinical trials pursuant to section 90 (1). 2nd
PCS. 2. Upon reasoned request, the National Board of Health may disclose information from the control pursuant to section 90 (2). 2, to Det
European Medicines Agency, pharmaceutical authorities in the other EU / EEA countries and the scientific ethics concerned
committee.
PCS. 3. The National Board of Health shall lay down detailed rules on the manufacture, import, labeling, distribution and control
with drugs for clinical trials.
Formalities
§ 92 a. The Minister of Health and Prevention may lay down rules on the form requirements for applications and notifications pursuant to
this chapter, including application or notification must be made electronically.
Not Intervention Security Studies
Section 92 b. A non-interventional safety study of an approved drug for humans, which is a condition of a
marketing authorization, and which is determined after the marketing authorization has been issued, cf. section 9 (2). 2, must first
shall be initiated when the National Board of Health has authorized the study. The board's permission must be available when
the study should only take place in Denmark.
PCS. 2. The Minister for Health and Prevention shall lay down detailed rules on the information requested
permission under subsection (1). Paragraph 1 shall contain and on the processing of such applications.
PCS. 3. Where a non-intervention safety study is permitted under subsection (1). 1 has begun, the holder of
the marketing authorization will only make significant changes to the trial protocol according to rules laid down by the Minister of
health and prevention.
§ 92 c. The marketing authorization holder must submit a report on the results of a marketing authorization
non-intervention safety study to the National Board of Health. If a study has also been conducted in other EU / EEA
countries, the report must also be forwarded to the countries concerned. Transmission must be made within 12 months of that date
the collection of data from the study has been completed, unless the Danish Health and Medicines Agency has allowed a deviation from it in writing
deadline.
PCS. 2. The Minister for Health and Prevention shall lay down rules on content requirements and transmission of the information referred to in paragraph 1. 1
reports, including separate requirements for nonintervention safety study reports that are a condition of
Marketing.
§ 92 d. Non-intervention safety studies of approved drugs may not be carried out if the use of a
drug thus promoted.
PCS. 2. Remuneration of healthcare professionals who have participated in a non-intervention safety study of an approved
drug, may only include compensation for time spent and expenses associated with the study.
Chapter 12
Certain substances that can be used as medicines for animals
§ 93. Manufacture, import, export, warehousing, negotiation, distribution, distribution, splitting, packaging, possession
or available for substances that can be used as pharmaceuticals for animals and which are more detailed by the National Board of Health
listed properties may only occur when a prior notification has been submitted to the National Board of Health and the company
received a receipt for this. The National Board of Health lays down detailed rules on the procedure for notification etc.
PCS. 2. The provision in para. Paragraph 1 shall also apply to products in which one or more of the substances concerned are included as one
component.
PCS. 3. Private individuals shall also not acquire, possess or dispose of substances and products covered by paragraphs. 1
and 2, unless the substance or product has been acquired through a company that has submitted a notification to
The National Board of Health and has received a receipt for this, cf. 1. The substances and products must not be administered to animals, used on
animals, are transferred or resold, unless the National Board of Health has given special permission in special cases.
The National Board of Health lays down detailed rules on this.
PCS. 4. The National Board of Health may lay down rules on the negotiation and delivery of the substances and products covered by it
PCS. 1 and 2, including that extradition can only take place after requisition endorsed by the local police chief.
The National Board of Health may lay down detailed rules on the formulation and content of the requisition and on the duty of private persons to
to keep copies of the requisition.
PCS. 5. The National Board of Health may lay down rules on form requirements for notifications and applications pursuant to subsection (1). 1 and 3, including that
notification or application must be done electronically.
§ 94. The National Board of Health establishes a register of companies and pharmacies that make notification pursuant to section 93,
PCS. First
PCS. 2. The undertakings and pharmacies referred to in paragraph 1. 1 shall keep accurate records of all transactions with them
substances and products concerned. The National Board of Health lays down detailed rules on this.
Section 95. The National Board of Health controls companies and pharmacies that are covered by section 93 (1). 1 and those pursuant to section 94 (1). 2
kept records.
PCS. 2. After negotiation with the Minister concerned, the Minister of Health and Prevention may lay down rules
the involvement of other authorities or institutions in carrying out control tasks pursuant to subsection (1). First
PCS. 3. Representatives of the supervisory authority shall have access at all times to due identification and without court order
for public and private properties and premises, as well as access to samples of drugs and products, etc.
The supervisory authority may require all information, including written material, necessary for the supervisory authority.
Chapter 13
Advice and boards, etc.
Section 96. The National Board of Health may consult the Medicines Board in cases concerning:
1) Issuing, amending, suspending or revoking marketing authorizations for pharmaceuticals.
2) Monitoring of side effects and other risks of drugs.
3) Weighing a drug's benefits against the risks of the drug.
4) Clinical trials with drugs.
PCS. 2. The Medicines Board consists of a maximum of 15 members, 2 of whom must represent patient and consumer interests.
§ 97. In cases concerning claims for the quality of medicines, cf. section 52, the National Board of Health may consult the Pharmacopoeia Board.
The Pharmacopoeia Board consists of a maximum of 6 members.
§ 98. The members of the committees referred to in sections 96 and 97 shall be appointed by the Minister of Health for four years at a time.
prevention on recommendation from the National Board of Health. The Minister appoints a chairman and one from among the members of each committee
Vice Chairman.
PCS. 2. The Minister for Health and Prevention may assign additional tasks to the boards.
PCS. 3. The boards may obtain opinions from special experts.
PCS. 4. With the approval of the Minister of Health and Prevention, standing committees may be set up under the committees.
To members of these, the Minister may appoint persons who are not members of the committees.
Section 99. The Minister of Health and Prevention shall establish rules of procedure for the boards referred to in sections 96 and 97.
Section 100. Members of the committees referred to in sections 96 and 97 and experts who make statements to the committees are under
liability under section 152 of the Criminal Code required to keep secret from all unauthorized persons what they through their
business becomes knowledgeable when the information is confidential in its nature.
§ 101. In matters of side effects and other risks related to medicines, the National Board of Health may consult the Council for
Pharmacovigilance.
PCS. 2. The Pharmacovigilance Council shall consist of a maximum of 11 members. Among the members there must be
representing healthcare professionals, pharmaceutical companies, pharmacists and other retailers of pharmaceuticals, patients
and consumers.
PCS. 3. The Council for Pharmacovigilance is set up by the National Board of Health following a public announcement. health
appoints one President from among the members of the Council.
PCS. 4. The National Board of Health shall establish a rules of procedure for the Danish Medicines Agency.
Independence of the National Board of Health
§ 102. Employees of the National Board of Health, members of councils, boards and committees established pursuant to this Act and other persons,
The National Board of Health consults with persons involved in the processing of decisions on approval, control and
pharmacovigilance monitoring, must not have financial or other interests in the pharmaceutical industry which may
affect their impartiality.
PCS. 2. The persons referred to in paragraph 1. 1, shall declare each year a statement of their financial interests
pharmaceutical industry.
Chapter 14
fees
§ 103. The Minister of Health and Prevention may lay down rules on payment for the activities of the National Board of Health in
under this Act and pursuant to rules laid down under the Act, including
1) fees for pharmaceuticals and pharmaceutical companies, as well as manufacturers, importers and distributors of active substances,
2) fee for registration as a drug intermediary;
3) payment for allotment etc. of product part numbers,
4) payment of the travel expenses and travel expenses of the National Board of Health if the processing of an application or control of it
approved drug necessitates that the National Board of Health inspects a company located in one
third,
5) fee for notification of prices and notification of pharmacies of prices of pharmacy-related medicines;
6) fee for notification of pack sizes of non-pharmacy-reserved medicines and
7) fee for applications for approval and fee for clinical trial verification.
PCS. 2. Payment pursuant to rules determined in accordance with subsection (2). 1 can be recovered by lien.
§ 103 a. To the person who is authorized under section 39 (1). 1, to negotiate for users of medicines for production animals, charges
The National Board of Health a fee as stipulated in subsection (1). 2-5 to fund food security initiatives and
animal welfare.
PCS. 2. The tax is fixed at 0.77 per cent. of the dealer's conversion of simple narrow-spectrum penicillins to production animals.
PCS. 3. The tax is fixed at 10.77%. of the dealer's turnover of critically important antibiotics to production animals.
PCS. 4. The tax is set at 5.44 per cent. of the dealer's turnover of other antibiotics for production animals.
PCS. 5. The tax is fixed at 0.77 per cent. of the dealer's turnover of other pharmaceuticals for production animals, however
no levy is fixed as regards the dealer's turnover of vaccines for production animals.
Chapter 14 a
announcement
§ 103 b. The Minister of Health and Prevention may lay down rules that standards for the quality of medicines and for
manufacture, control and storage of medicines referred to in regulations issued by the National Board of Health pursuant to
this law, is not introduced in the Law Gazette.
PCS. 2. The Minister of Health and Prevention may lay down rules on how the Danish Health and Medicines Authority is informed
the content of the rules that the Board has issued, cf. First
PCS. 3. The Minister of Health and Prevention may lay down rules to the effect that regulations and technical specifications which
not introduced in the Law Gazette, cf. 1, even if they are not in Danish.
Chapter 14 b
Appeals
§ 103 c. The Minister of Health and Prevention may lay down rules on appeals against decisions of the National Board of Health,
including rules on appeal deadlines.
Chapter 15
Punishment, etc.
§ 104. Unless a higher penalty is imposed under the other legislation, a fine or imprisonment is punishable up to 4 months.
that one
1) violates section 7 (1). 2, § 20, § 21, § 26, § 40 a, para. 2 or 3, section 41 (1). 1, § 41 b, par. 1, § 42, subs. 1 or 2, § 43 a, § 50,
PCS. 3, § 50 a, para. 1, § 50 d, § 53 (1). 1, § 54, § 58, subs. 3, § 59 (2). 1, section 60 (1). 1, section 62 (1). 2, § 63, § 64, § 65, § 66,
PCS. 1, section 67 (1). § 68 (1), first paragraph. 1, first paragraph, par. 2, first paragraph, or par. 3, § 71 a, § 71 b, para. 1, 2 or 4 or par. 5, 1st paragraph,
§ 83 (2). Section 85 (1), first paragraph. 1, § 88 (2). 1, first paragraph, par. 2, first paragraph, or par. 5, § 92 (2). § 92b, par. 1 and 3, § 92
c, para. 1, § 92 d, § 93 (1). 1, first paragraph, or par. 2 or 3, § 94 (2). 2, first paragraph, or Community regulations on medicines and
pharmaceutical companies
2) violates terms set out in a permit or approval under the law or rules laid down under
the law,
3) violates prohibitions imposed under section 46 (2). 1, section 47 or section 90 (1). 8
4) fails to comply with an injunction or disclosure requirement based on section 22 (2). 1, § 23, § 24, § 25, subs. 1 or 2,
§ 35, § 43, § 43 b, subs. 1, 1, § 44 a, § 44 b, § 44 d, 2, § 46, par. 1, § 50 f, § 50 g, § 53, par. 1 piece. 3 or par. 5, 2.
§ 54a, § 68 (2). 2, second paragraph, or par. 4, § 69, § 70 b, para. 6, § 80 (2). 1, § 84, subs. 1 or par. § 87 (4). 2, 2.-
Paragraph 4, section 89 (2). 2, § 90 (2). 2, second paragraph, par. 3, second paragraph, or par. 8, or § 95 (2). 3, 2nd paragraph, or
5) the representatives of the control authority refuse access pursuant to section 25 (2). 3, § 44, par. 2, § 44 d, first paragraph, § 50 e, par. 2
Section 53 (2). § 71 c, § 87, par. Section 90 (2), first paragraph. 4, or § 95 (2). 3, 1st paragraph.
PCS. 2. Unless higher penalties are imposed under the other legislation, fines or imprisonment shall be punishable up to 1 year and 6 years.
months the person who violates section 7 (2). 1, § 38 a, para. 1, or section 39 (1). 1 or 2, or fail to comply with an injunction
issued pursuant to section 46 a.
PCS. 3. Rules laid down by law may impose a penalty of a fine for violation of the provisions of
the rules.
PCS. 4. Companies may be imposed, etc. (legal persons) criminal liability in accordance with the rules of Chapter 5 of the Criminal Code.
§ 104 a. The Minister of Health and Prevention may lay down rules that the Danish National Board of Health in specified cases
on penalty under section 104 (1). 1, or rules laid down by law which are not deemed to result in higher penalties than fines, in a
fines may indicate that the case can be settled without trial if the person who committed the offense declares himself
guilty of the infringement and declares to pay within a specified period which may be extended upon request
a fine as specified in the fine. The Minister of Health and Prevention may also lay down rules requiring that
whether confiscation of drugs seized under section 44c can be similarly adopted without legal prosecution.
PCS. 2. The rules of the Code of Procedure on requirements regarding the content of a writ of indictment and on the fact that a defendant is not obliged to make a statement,
applies similarly to fines.
PCS. 3. If the fine is adopted, further persecution lapses.
§ 105. The National Board of Health may order the person who disregards the order to submit information pursuant to section 84,
PCS. 4, first paragraph, and companies that violate the disclosure obligation in section 84 (1). 1, a charge. The tax is DKK 500 per.
commenced week until the information is properly submitted. The tax payable to the State Treasury is charged with the right of lien.
Chapter 16
Entry into force, amendments and transitional provisions
§ 106. The date of entry into force of the Act or parts of the Act shall be determined by the Minister of Health and Prevention.
PCS. 2. The Minister for Health and Prevention can repeal the Medicines Act, cf. Statutory Order No. 656 of 28 July
1995.
PCS. 3. Rules laid down pursuant to the Medicines Act, cf. Statutory Order No. 656 of 28 July 1995, remain in force until they
be replaced by or repealed by rules laid down by this Act.
PCS. 4. On January 1, 2007, section 81 (2) is amended. 3, second paragraph, "Public Health Insurance Act" to: "Health Act".
§ 107. All approvals and permits issued pursuant to Act No. 327 of June 26, 1975 on Medicinal Products with Later
changes that are valid at the time of entry into force of the law are maintained until they are amended or repealed in
under the rules of the law.
PCS. 2. A marketing authorization for a medicinal product may be valid for an unlimited duration at the earliest, cf. section 27 (2). 2, when
the marketing authorization has been extended under this Act. If a marketing authorization holder has
submitted an application for an extension of the marketing authorization before the entry into force of this Act, the National Board of Health can
require additional information if the application does not meet the requirements of this Act. The National Board of Health can dispense
from the application deadline in section 27 (2). 3, for medicines whose marketing authorization expires within 6 months of the law
entry into force.
PCS. 3. For medicinal products subject to a marketing authorization at the time of entry into force of the Act,
the year-limit in section 28 to run on the entry into force of the Act.
§ 108. (Omitted)
§ 109. (Omitted)
§ 110. The Act does not apply to Greenland and the Faroe Islands.
Ministry of Health and Prevention, April 20, 2013
Astrid Krag
/ Nina Moss
Official notes
1. The Act contains provisions implementing parts of Directive 2001/82 / EC of the European Parliament and of the Council of 6 November 2001 on
establishing a Community code on veterinary medicinal products, Official Journal 2001, No L 311, page 1, as last amended by the European Parliament and
Council Regulation (EC) No 596/2009 of 18 June 2009, Official Journal 2009, No L 188, page 14, parts of the directive of the European Parliament and of the Council
2001/83 / EC of 6 November 2001 establishing a Community code on medicinal products for human use, Official Journal 2001, No L 311, page 67,
as amended i.a. by Directive 2010/84 / EU of 15 December 2010, Official Journal 2010, No L 348, page 74, and Directive 2011/62 / EU of 8 June 2011, EU
Official Journal 2011, No L 174, page 74, parts of Directive 2001/20 / EC of the European Parliament and of the Council of 4 April 2001 on the approximation of
Member States' laws, regulations and administrative provisions for the application of good clinical practice in conducting clinical trials with
medicinal products for human use, Official Journal 2001, No L 121, page 34, parts of Council Directive 90/167 / EEC of 26 March 1990 establishing
the conditions for the preparation, marketing and use of medicated feedingstuffs in the Community, Official Journal 1990, No L 92, page 42, parts of
Directive 2004/9 / EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP), Official Journal
2004, No L 50, page 28, and parts of Directive 2004/10 / EC of 11 February 2004 on the approximation of laws applying the principles of
good laboratory practice and control of their use in chemical substance tests, Official Journal 2004, no. L 50, page 44.
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