No. 3208
No. 3850, 30.4.2004
Number 452
PI 452/2004
The Medicines for Human Use (Good Clinical Practice) Regulations 2004, issued by
the Council of Ministers pursuant to the provisions of paragraph (h) of subparagraph (2) of Article 103 of
on Medicines for the Quality, Supply and Prices of Human Use Laws by
(No. 3) of 2004, after being tabled and approved by the House of Representatives, is published in
Official Journal of the Republic of Albania pursuant to Article 3 (3) of the Law on Deposition in Parliament
of the Representatives of the Regulations issued
by Law, Law (Law 99 of 1989 as amended by Law 227 of 1990).
THE HUMAN USE MEDICINES (QUALITY CONTROL, SUPPLY AND PRICES) LAWS 2001 TO (NO.3) 2004
Regulations under Article 103 (2) (h)
of 2001
of 2002
2004
2004
2004
Short title
Interpretation.
For the purpose of partial harmonization with the European Community act entitled 'Directive
of the European Parliament and of the Council of 4 April 2001 on the approximation of
legislative, regulatory and administrative.
application of good clinical practice in clinical trials of medicines intended for
Man »121 of 01.05.2001. p.
The Council of Ministers, following a recommendation from the Council of Medicines, exercising the powers vested in it
pursuant to the provisions of paragraph (h) of subparagraph (2) of Article 103 of Human Medicines
Use (Quality Control, Supply and Price Control) Laws of 2001 to (No. 3) of 2004. Issues
the following Regulations:
1. These Regulations will be as for Medicines for Human Use (Good Clinical Practice)
2004 Regulations.
2.-0) In these Regulations, unless the text has a different meaning -
"Adverse event" means any harmful event to a patient or participant in which
a tested medicinal product which is not necessarily related to the treatment is administered
3209
'Indemnity' includes any insurance policy issued pursuant to paragraph (8) of the Regulation
and whatever
plan for compensation for damage as a result of medical and / or clinical
negligence, which is the responsibility of the researcher and / or principal investigator and / or contractor vis-à-vis a participant
and approved by the Council
'Unexpected side effect' means a side effect of a tested medicinal product whose nature is
or the severity does not coincide with information on the medicinal product being tested, such as
brochure for the researcher about-
a marketing authorization and is under trial or, in the case of a tested medicinal product authorized
traffic, the instructions attached to their brief description
characteristics of the drug
'Informed free consent' means the consent obtained in accordance with the Rules of Procedure
"Researcher's brochure" means the collection of clinical and non-clinical data;
concerning a tested medicinal product and which is useful for the study of that tested medicinal product
human medicine-
'Ethics committees' has the meaning ascribed to this term in 2001
Bioethics and National Operation
Commission) Law of 2001;
'Investigator' means a registered physician or a person who has been granted the right to conduct investigations in
Democracy, because of its scientific knowledge and because it has the experience needed for it
care and is responsible for conducting a clinical trial on a particular
3210
'Lead researcher' means the researcher, who is in charge of a group, which
conducts a clinical trial on a particular
'Non-invasive test' means a test in which the 'tested medicinal product
prescribed as usual in accordance with the conditions laid down in the license
adult participant, unable to give informed free consent, means a person other than the participant;
which, by reason of its relationship with that adult or minor, is eligible to become lawful
for the purposes of the clinical trial and agrees to be legal
in the absence of such a person, a legal representative of an adult participant,
incapable "to give informed free consent, means person, excluding participant, contractor,
principal investigator, who is the registered physician or his or her registered physician; or
a person proposed by that registered physician or registered dentist;
"Law" means the Human Medicines (Quality, Supply and Price Control) Laws of the
to (No. 3) of 2004;
"Multicenter clinical trial" means a clinical trial conducted on the basis of the same protocol but
in different centers and therefore more than one
can be - (a) In the Republic,
3211
(b) in the Republic and in one or more Member States;
(c) in the Republic and in one or more third countries, or
(d) in the Republic and in one or more Member States and in one or more thirds
"Protocol" means the purpose, the design, the methodology, the
statistical aspects and clinical trial organization and includes successive forms and
modifications
"Serious adverse event" or "serious side effect of a tested medicinal product"
means any adverse event or side effect of a tested medicinal product that, regardless of
the dose. causes or endangers life requires hospitalization or extension
hospitalization and causes significant or permanent disability or disability or causes congenital anomaly or
'Participant' means a person who is in clinical trial as a recipient of a tested medicinal product
of a product containing the active substance under test or as a recipient of the virtual form of the test
medicinal product
"Sub-committees" means the sub-committees referred to in Article 17 of the Bioethics (Establishment and
Functioning of the National Commission) Law
(2) other terms used in these Regulations and not interpreted
otherwise to them,
3212
have the same meaning assigned to them by the Law.
These Regulations lay down specific provisions for the conduct of clinical trials,
including multicentre trials, which are performed
of human medicinal products, "especially with regard to the proper application of
clinical practice.
Scope.
2001
4 .- (1) Regulations 6 to 26 do not apply to non-interference tests.
(2) Any clinical trial, including bioavailability studies, and
It shall be designed, carried out and notified in accordance with these Regulations.
(3) These Regulations shall apply without prejudice to Bioethics (Establishment and Functioning of National
Commission; Law and the Data Processing of Personnel
of 2003 (Protection of Individuals) Laws of 2001 and 2003.
Non-intervention tests.
5. In the case of non-invasive tests -
(a) The integration of the patient into a particular
strategy is not decided in advance by protocol, but it is part of the current one
medicine
(b) the decision to dispose of a tested medicinal product is clearly separate from that of
decision to participate in the clinical trial;
(c) does not apply to - additional diagnoses or
3213
(d) epidemiological methods are used to analyze the collected data.
for
Free consent.
Know free consent means written decision to participate in a clinical trial, with
date and signature, voluntarily obtained; after being thoroughly informed about nature, the
importance, the risks after receiving appropriate documentation;
(a) A person capable of giving the or
(b) in the case of a person who is incapable of giving it, his legal status.
(2) For the purposes of paragraph (1), any person capable of giving it, who -
(a) It saves and
(b) is not deprived of his ability to give it under any law.
For the purposes of paragraph (2), a person who has the brakes saved if at the time of supply
the nature of the consensus can understand the nature, significance, impact and theirs
risks of clinical trial and to form a reasonable judgment for
'·)
the? of his interests.
(4) which does not usually have the brakes saved, but has
save them as far as it can provide consensus
I.
when you save the brakes.
3214
(5) A person who usually has brakes but does not have breaks at intervals
cannot provide consensus when it does not save the brakes.
(6) Two or more persons agreeing to consent when agreeing to the same
sense.
(7) Consent is free when not caused by.
(8) In case the participant is not able to write,
may provide oral evidence in the presence of at least one witness,
which shall be recorded in writing, with the date and signature of the witness.
Definition For the purposes of Regulation 6 coercion means
coerced perpetration or threat of perpetration prohibited by him
Chapter 154.
Criminal whether in or on
of 1963 ° or its retention or 41 °
1964 threat of retention of person or property, to 1964 damage to any
the intention is to
1965 person consent to attend a 1967 clinic
test.
of 1967
of 1972
1972
of 1973
59 of 1974
3 of 1975
1979
1981
1982
86 of
1986
111 of 1989
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of 1991
1994
1996
1996
1997
1998
1998
1999
1999
1999
1999
30 (l) 2000
of 2000
of 2000
2000
2000
2000
of 2001
of 2002
of 2002
2002
of 2002
of 2003
of 2003
of 2003
of 2003.
Definition of mental pressure.
8 .- (1) For the purposes of the Rules of Procedure 6. consent
that it was provided as a result of mental stress when the relationships between the person and the participant are
such that the person in question is able to dominate her
of the participant and to benefit from it in order to secure an unfair advantage against the participant
participant.
(2) In particular, without prejudice to paragraph (1), that it is capable of dominating
of
participant, any person who has actual or obvious authority over the participant or is in a relationship
trust
3216
against it.
Definition of fraud.
Definition of false representation.
9 .- (1) For the purposes of the Fraud Regulation it shall include any of the following acts -
(a) The representation of an untrue event as true, by a person who does not believe that it is true;
(b) the active concealment of an event by a person who
or believe it,
(c) any act of fraud;
(d) any act or omission that is defined by any law as fraud. "'
(2) Simple silence on events that may affect a person's willingness to provide
not
/ is fraud, unless the circumstances are such that,
thereby the person who is silent has an obligation to declare them or unless the silence
That in itself is equivalent to a statement.
10. For the purposes of Regulation 6, a false representation shall include -
(a) In a manner not justified by the person's information
affirming, untrue, even though the person affirming believes it to be true,
(b) any breach of duty which, without intent to deceive, benefits the offender
or to
3217
who claims by deceiving another to harm it or to harm anyone
who claims through it,
Ί
(c) the challenge, even if it is mistaken, of consent.
Protection A clinical trial is performed only if participants are satisfied.
(2), (3), (4), (5), (6), (7) and (8).
(2) This Regulation shall apply with due regard to the participant's right to respect
his physical and / or mental privacy, in accordance with the provisions
for the protection of his personal
in accordance with the Personal Data Processing (Protection of Individuals) Laws of 2001 and
2003. ''
(3) A clinical trial if the risks and adverse effects are present
weighted against the individual benefit of participants, patients, and future patients.
(4) A clinical trial only begins when the National Bioethics Committee and the Medicines Council
agree that the expected benefits, in terms of public health,
outweigh the risks, and only continue if it is constantly monitored for
This requirement and the Council for Medicinal Products do not provide reasoned information
(5) The participant or, in the event that the participant is not capable of knowingly giving free consent,
the legal one
3218
he should be given the opportunity, through a previous interview with the researcher or research team member, to
Understand the objectives of the clinical trial, the risks and the
disadvantages and the conditions under which it takes place. The participant must also have
be informed * of leaving the clinical trial at any time.
(6) The participant or, if the participant is not. in
legal- '
he has given his informed free consent after being informed of the nature, significance, extent and
the risks of the clinical trial.
(7) The Participant may, at any time and without any adverse consequence, withdraw from it.
from the clinical trial after withdrawing it for free.
(8) Each researcher, principal investigator and contractor shall issue and maintain such
involving liability to a participant for an adverse event or a serious adverse event.
(9) The medical care provided to the participants and the medical decisions taken against them,
are the responsibility of a duly qualified registered doctor or, where appropriate, a duly qualified physician
a registered dentist.
The lead investigator designates a person, from the clinical trial team, as the link to whom
participant
can be contacted for further information.
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Clinical Trials In addition to any relevant restrictions, clinical trial on minors
is carried out if:
(a) An informed free consent has been provided by the parents or the legal representative of the minor;
which reflects the juvenile's alleged will and
can be revoked at any time without adverse consequences for him
a test, in a way he can understand, by staff
minors' experience of study, risks and benefits-
(c) the express desire of the minor to form an opinion and to evaluate
refuse to participate or
withdraw from the clinical trial at any time, be taken into account by the researcher or, where appropriate, by
Mister
(d) no other incentives or financial facilities are provided except
(e) the clinical trial derives immediate benefits for the patient group only if
Specific research is needed to validate clinical data
testing on persons capable of knowingly releasing it or from other research
methods, and
(Ii) this investigation is directly linked to a situation that the minor is or is suffering from
3220
of such a nature that it can only be in
(f) the relevant scientific evidence has been respected
lines issued by the Council on the basis of * its Article
(g) (i) clinical trials are designed in such a way as to minimize
pains, the
risks
related to the disease and its stage, and
(ii) both the risk threshold and the degree of annoyance are defined separately and monitored
(h) the protocol has been approved by the National Bioethics Committee, having regard to the
advice
for its clinical, ethical and social psychosocial field and
(i) his interest always prevails over the interests of science and science
society
\
Clinical trials 13 .- (1) In the case of adults unable to give
adult aware free apply all relevant requirements \ incapable to
',. .
that for persons not to
give it
Consent and the requirements of paragraph (2).
free consensus.
(2) Participation in an adult clinical trial who did not give or refuse to give consciously free
of. before losing its consent, it is possible if:
3221
(a) informed consent has been provided by his or her legal representative who
expresses the expected will of the participant and can be revoked at any time without negative
consequences for the participant
(b) the adult who is not able to give his informed free consent has
be informed, depending on his or her mental state, on research, risks and benefits;
(c) the express desire of a participant to be able to form an opinion and
evaluate this information, refuse to participate in or withdraw from the clinical trial
has at all times been considered by the researcher or, where necessary, by the principal researcher;
(d) no incentives or financial facilities other than compensation are provided;
(e) (i) this investigation is essential for the verification of data originating from
from clinical trials to people capable of giving their informed informed consent or from others
research methods, and
(ii) directly relates to a clinical situation that is life-threatening or degenerative, from which
a specific adult who is unable to give his / her free informed consent;
3222
(f) (i) the clinical trial is designed to minimize pain,
disturbances, fears and other foreseeable risks associated with the disease and its stage
her, and
(Ii) both the risk threshold and the degree of annoyance are explicitly defined and monitored
Bioethics Committee, after being consulted on clinical, ethical and
problems in the field of the disease in question and the group in question
(h) the interest of the patient always outweighs the interests of the official and
and
(i) there are reasonable expectations that its receipt
The product offers the patient benefits that outweigh the risks or that there is no risk whatsoever.
The National Bioethics Committee shall deliver its opinion before
Commission commencement of each clinical trial for which the contractor submits bioethics.
Application
(2) For its opinion, the National Bioethics Committee shall take into account the following:
(a) The suitability of the clinical trial and design
3223
(b) whether the evaluation of the expected benefits and risks, as required by
paragraphs (3) and (4) of the Rules of Procedure are satisfactory and whether the conclusions are
(c)
(d) the competence of the researcher and the collaborators
(e) the brochure for him
(f) the quality of
(g) the correctness and completeness of the written information to be provided, the procedure for
give informed consent and justify the investigation to persons unable to give informed consent
free of charge, with respect to the specific restrictions referred to in paragraph (3) of Regulation 4 and
Rules 6. 7, 8, 9, 10 and 11;
(h) the measures foreseen for damages in the event of loss or attributable to
clinic
(i) any compensation that covers the responsibility of the researcher, the principal investigator and
(j) the amount and method of payment to any researcher and / or principal researcher, or
Compensation - Participants and any relevant information
3224
contract between the contractor of the center where the clinic takes place; and
how to select the participants
(3) (a) Notwithstanding the provisions of these Rules of Procedure, the Minister may delegate to the Council
Examine the particulars referred to in subparagraphs (h), (i) and (j) of paragraph (2) and
issue an opinion thereon.
(b) When the Minister makes use of the option provided in this paragraph, he shall inform
concerning the Commission, the Member States and the European Medicines Agency.
(4) The National Bioethics Committee shall, within days of the date of receipt of the application, notify
its reasoned opinion to the applicant and to the Medicines Council
(5) The National Bioethics Committee may, within the period referred to in paragraph (4), submit
a single request for information, other than that already provided by the
The deadline is suspended until the supplements are received
information.
(6) clinical trials cases of tested medicinal products
gene or
all tested medicinal products containing genetically modified
agencies, the period of 60 days referred to in paragraph (4) may be extended by a further 30 days.
days.
3225
(7) For the tested medicinal products referred to in paragraph (6), the 90-day time limit
may be extended for a further 90 days if the National Bioethics Committee consults
ethics committees or
according to the Bioethics (Establishment and Operation of a National Commission) Law
(8) In the case of xenogeneic cell no. there is a time limit
approval •
Multicenter 15.- (1) In the case of multicenter clinical trials, which
only in the territory of the Republic, the National Commission
Bioethics issues a single opinion.
(2) In the case of multicentre clinical trials conducted simultaneously in the Republic
and in a state
Member State or in the Republic and in the Member States, the National Bioethics Committee shall issue only one opinion on the
conducting multi-center clinical trial in the Republic.
Starting a Clinic 16 .- (1) Before starting any clinical trial in the trial.
In the Republic, the sponsor submits an application for approval to the Council
Medicines.
(2) The contractor may only commence a clinical trial if the request for an opinion submitted to
The National Bioethics Committee, pursuant to paragraph (1) of Regulation 14, is also provided that the Council
He did not notify the medicines
justified objections.
(3) The decision-making procedures referred to in paragraphs (1) and (2) may,
are carried out cm
3226
in parallel, if the contractor so wishes.
(4) Should the Board of Medicines notify the sponsor of the reasoned objections,
contractor may,
only once, to amend the content of the application referred to in paragraph (1),
take into account objections. In case the contractor does not modify the contractor accordingly
due to an application, the application rejected and the clinical trial cannot be started.
(5) The examination of an application for approval by the Medicines Council shall be carried out as soon as possible and not later than 60 days.
days after receipt of the application. The Medicines Board may however notify the
contractor, even before the end of that period, that it has no objections.
(6) clinical trial cases of tested pharmaceuticals
listed in paragraph (2) of Regulation 17, the time limit referred to in paragraph
(5) may be extended for a further 30 days.
(7) For the tested medicinal products referred to in paragraph (6). the
90 days deadline
may be extended for a further 90 days in the event of consultation by the National Commission
Bioethics with ethics committees or subcommittees, according to Bioethics (Establishment and Operation of National
Commission Act 2001.
(8) In the case of a xenogeneic cell there is no time limit for the deadline
approval.
Written 17 .- (1) Without prejudice to the provisions of paragraphs (2) and pre-approval.
The Medicines Board may require such as this
3227
provide written approval for the initiation of clinical trials of tested medicinal products that do not
which are listed in Part A of the Annex to the Law, as well
and for others
specialty pharmaceuticals such as 'tested pharmaceuticals'
products whose active ingredient is a biological product of human or animal origin or contains
biological elements of human or animal origin or the preparation of which requires the presence of such elements.
(2) Written by the Medicines Council is required for the initiation of clinical trials,
relate to tested somatic cellular gene products including
xenogeneic cell line
and tested medicinal products containing genetically modified organisms.
(3) It is prohibited to carry out clinical trials of genes that lead to genetic modification.
identity
of the participant.
(4) Written approval is granted without prejudice to the application of the laws in force
It aims to bring it into line with the Council Directive of 23 April
for genetically restricted use
2003. Modified Micro-organisms and the Genetically Modified Organisms
(Liberalization in the Environment) Law of 2003.
Modification of clinical trial.
18 .- (1) Following the commencement of a clinical trial, the contractor may make changes to the protocol. When
these modifications are substantial and may affect the safety of the participants or
change their interpretation of
3228
scientific evidence on which the clinical trial is based, or otherwise
Importantly, the contractor shall communicate the reasons for and the content of these amendments to the Council.
Medicines and the National Bioethics Committee, in accordance with Regulations 14 and 17.
(2) On the basis of the information referred to in paragraph (2) of Regulation 14 and in accordance with its provisions.
Rule 15, the National Bioethics Committee shall deliver an opinion on.
request for amendment. If this opinion is negative, the Contractor may not modify it
protocol.
(3) If the opinion of the National Bioethics Committee is favorable to the Medicines Council
does not raise reasoned objections to such substantive amendments, O Contractor
continues to conduct the clinical trial in accordance with the modified protocol. Otherwise,
the contractor takes note of the objections and adjusts the planned
modify the protocol or withdraw the request for modification.
(4) Without prejudice to the provisions of paragraphs (1), (2) and
(3) and depending on the circumstances, and in particular in the event of any new incidents involving
conducting the clinical trial or developing the test medicinal product when
this new event may affect the safety of the participants, the contractor and the researcher receive the
appropriate emergency measures to protect participants from immediate
risk. The contractor shall immediately inform the Medicines Council of these new incidents and of the measures taken and
it shall inform the National Bioethics Committee at the same time.
3229
Completion 19 .- (1) Within days of the completion of a clinical trial, fibrin test.
notifies in writing to Medicines and
National Bioethics Committee, that the clinical trial was completed.
(2) If the clinical trial is terminated prematurely, the time limit,
referred to in paragraph (1), is reduced to 15 days the contractor shall state clearly the reasons
of interruption.
Exchange of information.
2O .- (1) The Medicines Council shall ensure the registration of data in a European database.
referred
below, for clinical trials conducted in its territory
Democracy:
(a) Details of the application for authorization referred to in paragraph (1) of Regulation 16;
(b) any amendments to this application pursuant to paragraph {4) of the Rules of Procedure
(c) any amendments to the Protocol in accordance with paragraphs (1), (2) and (3) of the Rules of Procedure
(d) the opinion of the National Commission
(e) the statement of completion of the clinical trial; and
(f) a reference to the inspections carried out pursuant to sections 96 and 96A of the Law for compliance
of good clinical practice.
3230
(2) Medicinal products, at the justified request of a Member State, of the European Union
The Drug Evaluation Agency or the Commission shall provide all supplementary information, in addition to that
that have already been introduced into the European database for this clinical trial.
Suspension .- (1) Where the Medicines Board has
clinical trial reasons that the conditions and infringements are no longer fulfilled.
the application for authorization referred to in paragraph (1) thereof.
the safety or scientific validity of the clinical trial,
may suspend or prohibit such clinical trial by informing the contractor.
(2) The Council for Medicinal Products, before taking a decision pursuant to paragraph (1), unless
imposes an imminent risk, requests the opinion of the contractor and / or the researcher and / or the principal investigator,
which should be given within a week.
(3) The Council for Medicinal Products shall immediately inform the competent authorities of the Member States, the National Commission.
Bioethics, the European Medicines Agency and the Commission in its decision
suspension or prohibition of the clinical trial, as well as the cause.
(4) In the event that the Medicines Council has reasonable grounds to believe that
contractor or researcher or anyone else involved in the clinical trial no longer responds
informs him immediately of his obligations and sets out the action plan to implement for
to correct the situation. The Board of Medicines shall immediately inform the National Bioethics Committee, the others
the competent authorities of the Member States and the Commission on the action plan.
Notification of unwanted events.
3231
22.- (1) The investigator shall immediately notify the sponsor of any serious adverse events, except those which
are listed in the protocol or leaflet for the researcher as being in immediate need
notification. The immediate notification shall be followed by detailed, written reports. So inside
This notification, as in subsequent reports, identifies the participants with
password
unwanted-
the results of the analyzes, which are designated in the Protocol as crucial for the evaluation of safety,
are notified to the contractor, in accordance with the notification requirements and within the time limits specified
in the protocol.
(3) In the case of a notified participant, the researcher shall provide the contractor with and
to the National Bioethics Committee any additional information requested.
(4) The contractor shall keep detailed records of all adverse events reported to him by the investigator.
These records are submitted to the Medicines Council, afterwards
of.
Notification of unexpected serious side effects.
23 .- (1) O
(a) Record and notify to the Medicines Council and to the competent authority of each State concerned
Member, as well as the National Bioethics Committee, as soon as possible and in any case within 7 days of
when updated, all the information about the alleged unexpected serious
3232
side effects, which have caused or can cause and
(b) thereafter, within a new day, announce information on the follow-up.
(2) All other suspected unexpected serious side effects are notified to the Council.
And to the National Bioethics Committee as soon as possible and at the latest.
15
for the first time.
(3) The Medicines Board ensures that all suspected unexpected serious side effects are recorded
notified to the tested medicinal product.
(4) The other researchers shall disclose the information referred to in
paragraphs (1) and (2).
(5) Once a year, throughout the course of the clinical trial, the sponsor shall forward to the Council
And the National Committee on Bioethics, a list of all the alleged serious side effects that
During this time, a report on their safety was presented
of participants.
(6) The Medicines Board shall ensure that any suspected unexpected side effect of a drug is tested.
of a medicinal product of which it is aware shall be registered immediately with a European database.
(7) The Medicines Board shall have access to the information communicated by the contractor to
European Agency
3233
Drug Evaluation.
Free delivery The contractor provides the tested pharmaceuticals free of charge
and, where applicable, their mechanism:
medicinal products.
Provided that, in exceptional cases, the Medicines Council may determine specific and
precise conditions for the provision of the tested medicinal products
where their delivery mechanism.
(2) Where the Council for Medicinal Products makes use of the option reserved to it
of paragraph (1) shall inform it
Responsibility of contractor, researcher and lead researcher.
25. These Regulations do not constitute the civil and criminal liability of the sponsor, the investigator or
of the lead researcher.
Entry into force of those present
26.- (1) Subject to the provisions of paragraph (2), these Regulations shall
effective from the date
in the Official Journal of the Republic.
(2) The provisions -
(a) Paragraph (3) (b) of Regulation 14,
(b) the Rules of Procedure
(c) paragraph (3) of Regulation 21 on the obligation to inform the competent authority
of the Member States, of the European Agency
3234
Evaluation of Medicines and the Commission,
(d) paragraph (4) of Regulation 21 concerning the obligation to inform the competent authorities of the Member States
and the Commission,
(e) subparagraph (a) of paragraph (1) of Regulation 23, concerning the obligation
notification to the competent authorities of
members, •
(f) of paragraph (2) of Regulation 24.
They shall enter into force on the date of its accession
Democracy in the European Union.