31. 12. 90 Official Journal of the European Communities No C 330/1 
II 
(Preparatory Acts) 
COMMISSION 
Proposal for a Council Regulation (EEC) laying down Community procedures for the authorization 
and supervision of medicinal products for human and veterinary use and establishing a European 
Agency for the Evaluation of Medicinal Products 
COM(90) 283 final — SYN 309 
(Submitted by the Commission on 14 November 1990) 
(90/C 330/01) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 100a 
thereof, 
Having regard to the proposal from the Commission, 
In cooperation with the European Parliament, 
Having regard to the opinion of the Economic and Social 
Committee, 
Whereas it is important to adopt measures with the aim of 
progressively establishing the internal market over a period 
expiring on 31 December 1992; whereas the internal market 
shall comprise an area without internal frontiers in which the 
free movement of goods, persons, services and capital is 
ensured; 
Whereas Council Directive 87/22/EEC of 22 December 
1986 on the approximation of national measures relating to 
the placing on the market of high technology medicinal 
products particularly those derived from biotechnology (!) 
has established a Community mechanism for concertation, 
prior to any national decision relating to a high-technology 
medicinal product, with a view to arriving at uniform 
decisions throughout the Community; Whereas the experience acquired as a result of Directive 
87/22/EEC has shown that it is necessary to establish a 
centralized Community authorization procedure for 
technologically advanced medicinal products, in particular 
those derived from biotechnology; whereas this procedure 
should also be available to persons responsible for marketing 
medicinal products containing new active substances which 
are intended for use in human beings or in food-producing 
animals; 
Whereas in the interests of public health it is necessary that 
decisions on the authorization of such medicinal products 
should be based on the objective scientific criteria of the 
quality, the safety and the efficacy of the medicinal product 
concerned to the exclusion of economic or other 
considerations; whereas, however, Member States should 
exceptionally be able to prohibit the use on their territory of 
medicinal products for human use which infringe objectively 
defined concepts of public order or public morality; whereas 
moreover a veterinary medicinal product may not be 
authorized by the Community if its use would contravene the 
rules and objectives laid down by the Community within the 
framework of the common agricultural policy; 
Whereas, in the case of medicinal products for human use, 
the criteria of quality, safety and efficacy have been 
extensively harmonized by Council Directive 65/65/EEC of 
26 January 1965 on the approximation of provisions laid 
down by law, regulation or administrative action relating to 
medicinal products (2), as last amended by Directive 
.../.. ./EEC (3), and Second Council Directive 
(») OJ No L 15, 17. 1. 1987, p. 38. (2) OJ No 22, 9. 2. 1965, p. 369/65. 
H OJ No L ...... . 
No C 330/2 Official Journal of the European Communities 31. 12. 90 
75/319/EEC of 20 May 1975 on the approximation of 
provisions laid down by law, regulation and administrative 
action relating to proprietary medicinal products ('), as last 
amended by Directive .../.. ./EEC (2), and by Council 
Directive 75/318/EEC of 20 May 1975 on the 
approximation of the laws of the Member States relating to 
analytical, pharmaco-toxicological and clinical standards 
and protocols in respect of the testing of medicinal 
products (3), as last amended by Directive 
.../.. ./EEC(4); 
Whereas in the case of veterinary medicinal products, the 
same results have been achieved by Council Directive 
81/851/EEC of 28 September 1981 on the approximation 
of the laws of the Member States relating to veterinary 
medicinal products (5), as last amended by Directive 
.../.. ./EEC (6), and by Council Directive 81/852/EEC 
of 28 September 1981 on the approximation of the laws of 
the Member States relating to analytical, 
pharmaco-toxicological and clinical standards and protocols 
in respect of the testing of veterinary medicinal products (7) 
as last amended by Directive .../.. ./EEC (8); 
Whereas the same criteria must be applied to medicinal 
products which are to be authorized by the Community; 
Whereas only after a single scientific evaluation of the highest 
possible quality of all the benefits and risks of technologically 
advanced medicinal products, should a marketing 
authorization be granted by the Community by a rapid 
procedure ensuring close cooperation between the 
Commission and Member States; 
Whereas Council Directive .../.. ./EEC has provided that 
in the event of a disagreement between Member States about 
the quality, safety or efficacy of a medicinal product which is 
the subject of the decentralized Community authorization 
procedure, the matter should be resolved by a binding 
Community decision following a scientific evaluation of the 
issues involved within a European Medicines Evaluation 
Agency; whereas similar provisions have been laid down in 
respect of veterinary medicinal products by Council Directive 
.../.. ./EEC; 
Whereas the Community must be provided with the means to 
undertake a scientific evaluation of medicinal products 
which are presented for authorization in accordance with the 
centralized Community procedures; whereas, furthermore, 
in order to achieve the effective harmonization of the 
administrative decisions taken by Member States in relation 
to individual medicinal products which are presented for 
authorization in accordance with decentralized procedures, 
it is necessary to provide the Community with a means of 
(') OJ No L 147, 9. 6. 1975, p. 13. 
(*) OJ No L ...... . 
(3) OJ No L 147, 9. 6. 1975, p. 13. 
(4) OJ No L ...... . 
(5) OJNoL317, 6. 11. 1981, p. 1. 
(6) OJ No L ...... . 
(7) OJ No L 317, 6. 11. 1981, p. 16. 
(8) OJ No L ...... . resolving disagreements between Member States about the 
quality, safety and efficacy of medicinal products; 
Whereas it is therefore necessary to establish a European 
Agency for the Evaluation of Medicinal Products ('the 
Agency'); 
Whereas the primary task of the Agency should be to provide 
scientific advice of the highest possible quality to the 
Community Institutions and the Member States for the 
exercise of the powers conferred upon them by Community 
legislation in the field of medicinal products in relation to the 
authorization and supervision of medicinal products; 
Whereas it is desirable to ensure close cooperation between 
the Agency and scientists working within the Member 
States; 
Whereas, therefore, the exclusive responsibility for 
preparing the opinions of the Agency on all matters relating 
to medicinal products for human use should be entrusted to 
the Committee for Proprietary Medicinal Products created 
by Second Council Directive 75/319/EEC; whereas, in 
respect of veterinary medicinal products this responsibility 
should be entrusted to the Committee for Veterinary 
Medicinal Products created by Council Directive 
81/851/EEC; 
Whereas the establishment of the Agency will make it 
possible to reinforce the scientific role and independence of 
these two Committees, in particular through the 
establishment of a permanent technical and administrative 
secretariat; 
Whereas each Committee should be able to request the 
opinion of a Scientific Council consisting of scientists of 
internationally recognized standing on difficult questions of 
a general scientific or ethical nature relating to the 
authorization of medicinal products; 
Whereas it is also necessary to make provision for the 
supervision of medicinal products which have been 
authorized by the Community, and in particular for the 
intensive monitoring of adverse reactions to those medicinal 
products through Community pharmacovigilance activities 
in order to ensure the rapid withdrawal from the market of 
any medicinal product which presents an unacceptable level 
of risk under normal conditions of use; 
Whereas the Agency, working in close cooperation with the 
Commission, should also be entrusted with the task of 
coordinating the discharge of the various supervisory 
responsibilities of Member States and in particular 
monitoring the respect of good manufacturing practices, 
good laboratory practices and good clinical practices; 
Whereas it is necessary to provide for the orderly 
introduction of Community procedures for the authorization 
of medicinal products alongside the national procedures of 
the Member States which have already been extensively 
harmonized by Directives 65/65/EEC, 75/319/EEC and 
31. 12. 90 Official Journal of the European Communities No C 330/3 
81 /851 /EEC; whereas it is therefore appropriate in the first 
instance to limit the obligation to use the new Community 
procedure to medicinal products which are produced by 
means of specified biotechnological processes, and to make 
the procedure available on an optional basis only to 
high-technology medicinal products and to medicinal 
products containing totally new active substances; whereas 
the scope of the Community procedures should be reviewed 
in the light of experience at the latest six years after the entry 
into force of this Regulation, 
HAS ADOPTED THIS REGULATION: 
TITLE I 
DEFINITIONS AND SCOPE 
Article 1 
The objective of this Regulation is to lay down Community 
procedures for the authorization and supervision of 
medicinal products for human and veterinary use and to 
establish a European Agency for the Evaluation of Medicinal 
Products. 
Article 2 
The definitions laid down in Article 1 of Directive 
65/65/EEC and the definitions laid down in Article 1 (2) of 
Directive 81/851/EEC shall apply to this Regulation. 
Article 3 
1. No medicinal product which is referred to in Part A of 
the Annex shall be placed on the market within the 
Community unless authorization has been granted by the 
Community in accordance with the provisions of this 
Regulation. 
2. The person responsible for marketing a medicinal 
product referred to in Part B of the Annex may request that 
authorization to place the medicinal product on the market 
be granted by the Community in accordance with the 
provisions of this Regulation. 
Article 4 
1. In order to obtain the authorization referred to in 
Article 3, the person responsible for marketing shall submit 
an application to the European Agency for the Evaluation of 
Medicinal Products, hereinafter referred to as 'the 
Agency'. 
2. The Community shall issue and supervise 
authorizations to place medicinal products for human use on 
the market in accordance with Title II. 
3. The Community shall issue and supervise 
authorizations to place veterinary medicinal products on the 
market in accordance with Title HI. TITLE II 
AUTHORIZATION AND SUPERVISION OF MEDICINAL 
PRODUCTS FOR HUMAN USE 
Chapter 1 
Submission and examination of applications — 
authorizations — renewal of authorization 
Article 5 
The Committee for Proprietary Medicinal Products 
established by Article 8 of Directive 75/319/EEC, in this 
title referred to as 'the Committee', shall be responsible for 
formulating the opinion of the Agency on any question 
relating to the grant, amendment, suspension or withdrawal 
of an authorization to place a medicinal product for human 
use on the market arising in accordance with the provisions 
of this Regulation. 
Article 6 
1. An application for authorization for a medicinal 
product for human use shall be accompanied by the 
particulars and documents referred to in Articles 4 and 4a 
of Directive 65/65/EEC and Article 2 of Directive 
75/319/EEC. 
2. The application shall also be accompanied by the fee 
payable to the Agency for the examination of the 
application. 
3. The Agency shall ensure that the opinion of the 
Committee is given within 210 days of the receipt of a valid 
application. 
4. The Agency shall, in consultation with Member States, 
the Commission and interested parties, draw up detailed 
guidance on the form in which applications for authorization 
are to be presented. 
Article 7 
In order to prepare its opinion, the Committee: 
(a) shall verify that the particulars and documents 
submitted in accordance with Article 6 comply with the 
requirements of Directives 65/65/EEC, 75/318/EEC 
and 75/319/EEC, and examine whether the conditions 
for issuing an authorization to place the medicinal 
product on the market specified in this Regulation are 
satisfied; 
(b) may request a laboratory designated for this purpose to 
test the medicinal product, its starting materials, and if 
need be, its intermediate products or other constituent 
materials in order to ensure that the control methods 
employed by the manufacturer and described in the 
application documents are satisfactory; 
(c) may, where appropriate, request the applicant to 
supplement the particulars accompanying the 
application. Where the Committee avails itself of this 
option, the time limit laid down in Article 6 shall be 
No C 330/4 Official Journal of the European Communities 31. 12. 90 
suspended until such time as the supplementary 
information requested has been provided. Likewise, this 
time limit shall be suspended for the time allowed to the 
applicant to prepare oral or written explanations. 
Article 8 
1. Upon receipt of a written request from the Committee, 
a Member State shall forward the information necessary to 
verify that the manufacturer of a medicinal product or the 
importer from a third country is able to manufacture the 
medicinal product concerned and/or carry out the necessary 
control tests in accordance with the particulars and 
documents supplied in accordance with Article 6. 
2. Where it considers it necessary in order to complete its 
examination of an application, the Committee may request 
the applicant to submit to an inspection of the manufacturing 
site of the medicinal product concerned. The inspection, 
which shall be completed within the time limit referred to in 
Article 6, shall be undertaken by qualified pharmaceutical 
inspectors from the Member States who may, if appropriate, 
be accompanied by an inspector from the Agency. 
Article 9 
1. Where the opinion of the Committee is that: 
— the application does not satisfy the criteria for 
authorization set out in this Regulation, or 
— the summary of product characteristics proposed by the 
applicant in accordance with Article 6 should be 
amended, or 
— the labelling or package insert of the product is not in 
compliance with Directive .../.. ./EEC, or 
— the authorization should be granted subject to the 
conditions provided for in Article 13 (2), 
the Agency shall forthwith inform the applicant. 
Within 15 days of the receipt of the opinion, the applicant 
may provide written notice to the Agency that he wishes to 
appeal. Within 60 days of the receipt of the grounds for 
appeal, the Committee shall consider whether its opinion 
should be revised, and the reasons for the conclusions 
reached on the appeal shall be annexed to the assessment 
report referred to in paragraph 2. 
2. Within 30 days of its adoption, the Agency shall 
forward the final opinion of the Committee to the 
Commission, the Member States and the applicant together 
with a report describing the assessment of the medicinal 
product by the Committee and stating the reasons for its 
conclusions. 3. In the event of an opinion in favour of granting 
authorization to market the medicinal product concerned, 
the following documents shall be annexed to the opinion: 
(a) a draft summary of the product characteristics, as 
referred to in Article 4a of Directive 65/65/EEC; 
(b) details of any conditions or restrictions which should be 
imposed on the supply or use of the medicinal product 
concerned, including the conditions under which the 
medicinal product may be made available to patients, 
having regard to the criteria laid down in Council 
Directive .../.. ./EEC concerning the legal status for 
the supply of medicinal products for human use; 
(c) the draft text of the labelling and package leaflet 
proposed by the applicant, presented in accordance with 
Council Directive .../.. ./EEC on the labelling of 
medicinal products for human use and on package 
leaflets. 
Article 10 
1. Within 30 days of the receipt of the opinion, the 
Commission shall prepare a draft of the Decision to be taken 
in respect of the application, taking into account the 
objectives of Community policies and considering all the 
relevant information. In the event of a draft Decision which 
envisages the granting of a marketing authorization, the 
documents referred to in points (a), (b) and (c) of Article 9 (3) 
shall be annexed. The Commission shall transmit the draft 
Decision to the Member States and to the applicant. 
The Commission shall explain in detail the reasons for any 
differences between the draft Decision and the opinion of the 
Committee. 
2. The Commission shall adopt the Decision to be taken 
in respect of the application unless, within 30 days, it has 
received a reasoned request from a Member State to 
reconsider the matter. The Member State concerned shall 
also transmit a copy of its request to the other Member States 
and the applicant within the same time limit. 
3. Within the time limit referred to in paragraph 2, the 
applicant may submit written observations on the draft 
Decision for consideration by the Commission. 
4. The Commission shall examine any reasoned request 
received in accordance with paragraph 2, in consultation 
with the Agency, and after consideration of any further 
observations submitted by the applicant. 
If the Commission considers that the request raises questions 
of a scientific or technical nature requiring further 
examination, it may remit the matter to the Agency. In this 
case the Committee shall give a second opinion within a time 
limit of 60 days. Within 30 days of the receipt of the opinion, 
the Commission shall adopt the Decision to be taken in 
respect of the application. 
31. 12. 90 Official Journal of the European Communities No C 330/5 
Otherwise the Decision shall be taken in accordance with the 
procedure laid down in Article 2 b and 2 c of Directive 
75/318/EEC. 
Article 11 
Without prejudice to other provisions of Community law, 
the authorization provided for in Article 3 ahall be refused if, 
after verification of the information and particulars 
submitted in accordance with Article 6, it appears that the 
quality, the safety or the efficacy of the medicinal product 
have not been adequately demonstrated by the applicant. 
Authorization shall likewise be refused if the particulars and 
documents provided by the applicant in accordance with 
Article 6 of this Regulation are incorrect or if the labelling 
and package leaflets proposed by the applicant are not in 
accordance with Directive .../.. ./EEC. 
Article 12 
1. Without prejudice to Article 6 of Directive 
65/65/EEC, a marketing authorization which has been 
granted in accordance with the procedure laid down in this 
Regulation shall apply throughout the Community. It shall 
confer the same rights and obligations in each of the Member 
States as a marketing authorization granted by that Member 
State in accordance with Article 3 of Directive 
65/65/EEC. 
2. The refusal of a Community marketing authorization 
shall constitute a prohibition on the marketing of the 
medicinal product concerned throughout the Community. 
3. An announcement that authorization has been granted 
shall be published for information purposes in the Official 
Journal of the European Communities. 
4. Upon request from any interested person, the Agency 
shall make available a detailed summary of the evaluation of 
the medicinal product by the Committee and the reasons for 
its opinion in favour of granting authorization after deletion 
of any information of a commercially confidential nature. 
Article 13 
1. Authorization shall be valid for five years and shall be 
renewable for five year periods, on application by the holder 
at least three months before the expiry date. 
2. In exceptional circumstances and following 
consultation with the applicant, an authorization may be 
granted subject to such conditions as appear necessary to 
ensure the protection of public health, including specific 
obligations to conduct further studies following the granting 
of authorization and specific obligations in respect of the 
reporting of adverse reactions to the medicinal product. 
3. Medicinal products which have been authorized by the 
Community in accordance with the provisions of this Regulation shall benefit from the 10-year period of 
protection referred to in point 8 of Article 4 (2) of Directive 
65/65/EEC. 
Article 14 
The granting of authorization shall not diminish the general 
civil and criminal liability in the Member States of the 
manufacturer and, where applicable, of the person 
responsible for placing the medicinal product on the 
market. 
Chapter 2 
Supervision and sanctions 
Article 15 
1. After an authorization has been issued, the person 
responsible for placing the medicinal product on the market 
must, in respect of the methods of production and control 
provided for in points 4 and 7 of Article 4 (2) of Directive 
65/65/EEC, take account of technical and scientific 
progress and introduce any changes that may be required to 
enable the medicinal product to be manufactured and 
checked by means of generally accepted scientific methods. 
These changes must be approved in accordance with this 
Regulation. 
2. The person responsible for marketing shall forthwith 
inform the Agency of any new information which might 
entail the amendment of the particulars and documents 
referred to in Article 6 or in the approved summary of the 
product characteristics. In particular the person responsible 
for marketing shall forthwith inform the Agency of any 
prohibition or restriction imposed by the competent 
authorities of any country in which the medicinal product is 
marketed and of any other new information which might 
influence the evaluation of the benefits and risks of the 
medicinal product concerned. 
3. If the person responsible for marketing proposes to 
make any alteration to the information and particulars 
referred to in Article 6, he shall submit an application to the 
Agency. 
4. The Agency shall, in consultation with the 
Commission, adopt appropriate arrangements for the 
examination of amendments and variations to the terms of a 
marketing authorization. 
Article 16 
When a marketing authorization is granted in accordance 
with this Regulation, one or more of the Member States shall 
act as the competent supervisory authorities to exercise the 
responsibilities referred to in Article 17. 
No C 330/6 Official Journal of the European Communities 31. 12. 90 
In the case of medicinal products manufactured within the 
Community, the supervisory authorities shall normally be 
the competent authorities of the Member State or Member 
States which have granted the manufacturing authorization 
provided for in Article 16 of Directive 75/319/EEC in 
respect of the manufacture of the medicinal product 
concerned. 
In the case of medicinal products imported from third 
countries, the supervisory authorities shall be the competent 
authorities of the Member States in which the controls 
referred to in Article 22 (1) (b) of Directive 75 / 319 / EEC are 
carried out unless appropriate arrangements have been made 
between the Community and the exporting country to ensure 
that those controls are carried out in the exporting country 
and that the manufacturer applies standards of good 
manufacturing practice at least equivalent to those laid down 
by the Community. 
Article 17 
1. The supervisory authorities shall have responsibility 
for verifying on behalf of the Community that the 
manufacturer or the importer from third countries satisfies 
the requirements laid down in Chapter IV of Directive 
75/319/EEC, and for exercising supervision over persons 
responsible for marketing medicinal products in accordance 
with Chapter V of Directive 75/319/EEC. 
2. Upon receipt of a reasoned request by any Member 
State, or on its own initiative, the Commission may request 
the manufacturer or importer to submit to an inspection of 
the manufacturing site of the medicinal product concerned, 
giving its reasons. The inspection shall be undertaken by 
qualified pharmaceutical inspectors from the Member States 
who may, if appropriate, be accompanied by an inspector 
from the Agency. The report of the inspectors shall be made 
available to the Commission, the Committee and the 
applicant. In the case of an inspection conducted within the 
Community, the host Member State shall provide all the 
practical support necessary to enable the inspectors to 
discharge their responsibilities. 
Article 18 
1. Where the supervisory authorities or the competent 
authorities of any other Member State are of the opinion that 
the manufacturer or importer from third countries is no 
longer fulfilling the obligations laid down in Chapter IV of 
Directive 75/319/EEC, they shall forthwith inform the 
Committee and the Commission, stating their reasons in 
detail and indicating the course of action proposed. 
The same shall apply where a Member State considers that 
one of the measures envisaged in Chapter V of Directive 
75/319/EEC should be applied in respect of the medicinal 
product concerned. 2. The Commission shall in consultation with the Agency 
forthwith examine the reasons advanced by the Member 
State concerned. It may request the opinion of the Committee 
within a time limit to be determined by the Commission 
having regard to the urgency of the matter. Whenever 
practicable, the person responsible for marketing shall be 
invited to provide oral or written explanations. 
3. The Commission shall prepare a draft of the Decision 
to be taken which shall be adopted in accordance with the 
procedure laid down in Article 10. 
However, where a Member State has invoked the provisions 
of paragraph 4, the time limit provided for in Article 2 c (3) 
of Directive 75/318/EEC shall be reduced to 15 calendar 
days. 
4. In exceptional cases, where action is urgently necessary 
to protect public health, a Member State may suspend the use 
on its territory of a medicinal product which has been 
authorized in accordance with this Regulation. It shall 
inform the Commission no later than the following working 
day of the reasons for its action. The Commission shall 
immediately consider the reasons given by the Member State 
in accordance with paragraph 2 and shall initiate the 
procedure provided for in paragraph 3. 
5. A Member State which has adopted the suspensive 
measures referred to in paragraph 4 may maintain them in 
force until such time as a definitive Decision has been reached 
in accordance with the procedure laid down in 
paragraph 3. 
Chapter 3 
Pharmacovigilance 
Article 19 
For the purpose of this Chapter, the definitions given in 
Article 29 b of Directive 75/319/EEC shall apply. 
Article 20 
The Agency, acting in close cooperation with the national 
pharmacovigilance centres established in accordance with 
Article 29 a of Directive 75/319/EEC, shall be responsible 
for the collection and evaluation of information about 
adverse reactions to medicinal products which have been 
authorized by the Community in accordance with this 
Regulation. 
The competent authorities of the Member States and the 
person responsible for marketing shall ensure that all 
relevant information about adverse reactions to medicinal 
products authorized in accordance with this Regulation are 
brought to the attention of the Agency in accordance with the 
provisions of this Regulation. 
31. 12. 90 Official Journal of the European Communities No C 330/7 
Article 21 
The person responsible for marketing a medicinal product 
authorized by the Community in accordance with the 
provisions of this Regulation shall have permanently and 
continuously at his disposal a person responsible for 
pharmacovigilance. This person shall be responsible for: 
(a) the establishment and maintenance of a system which 
ensures that information about all adverse reactions 
which are reported to the personnel of the company, 
including its sales personnel and medical 
representatives, is collected and collated so that it may 
be accessed at a single point within the Community; 
(b) the preparation and submission of the reports referred to 
in Article 22 to the competent authorities of the Member 
States and the Agency in accordance with the 
requirements of this Regulation; 
(c) ensuring that any request for the provision of additional 
information necessary for the evaluation of the benefits 
and risks of a medicinal product is answered fully and 
promptly, including the provision of information about 
the volume of sales or prescriptions for the medicinal 
product concerned where relevant. 
Article 22 
1. The person responsible for marketing shall ensure that 
all suspected serious adverse reactions to a medicinal product 
authorized in accordance with the provisions of this 
Regulation which are brought to his attention by a qualified 
health care professional, whether arising within the 
Community or a third country, are recorded and reported to 
the Agency within 15 days. 
2. In addition, the person responsible for marketing shall 
be required to maintain detailed records of all other adverse 
reactions arising within the Community which are reported 
to him by a qualified health care professional. Unless other 
requirements have been laid down as a condition of the 
granting of authorization by the Community, these records 
shall be submitted to the Agency immediately upon request 
or at least every six months during the first two years 
following authorization and once a year for the following 
three years. Thereafter, the records shall be submitted at 
five-yearly intervals together with the application for renewal 
of the authorization, or immediately upon request. 
Article 23 
Each Member State shall report any suspected serious 
adverse reaction arising within its territory to a medicinal 
product authorized in accordance with this Regulation to the 
Agency and the person responsible for marketing within 15 
days of receipt of a report from a qualified health care 
professional. Article 24 
The Agency shall, in consultation with Member States, the 
Commission and interested parties, draw up detailed 
guidance on the collection, verification and presentation of 
adverse reaction reports. 
Article 25 
1. The Agency shall publish an annual report on the 
operation of the procedures laid down in this Chapter. 
2. Within six years of the entry into force of this 
Regulation, the Commission shall publish a detailed review 
of the operation of the procedures laid down in this Chapter 
and shall propose any amendments which may be necessary 
to improve the operation of these procedures. 
The Council shall decide on the Commission proposal within 
one year. 
TITLE III 
AUTHORIZATION AND SUPERVISION OF VETERINARY 
MEDICINAL PRODUCTS 
Chapter 1 
Submission and examination of applications — 
authorization — renewal of authorization 
Article 26 
The Committee for Veterinary Medicinal Products 
established by Article 16 of Directive 81/851/EEC, in this 
title referred to as 'the Committee', shall be responsible for 
formulating the opinion of the Agency on any question 
relating to the grant, amendment, suspension or withdrawal 
of an authorization to place a veterinary medicinal product 
on the market arising in accordance with the provisions of 
this Regulation. 
Article 27 
1. An application for authorization for a veterinary 
medicinal product shall be accompanied by the particulars 
and documents referred to in Articles 5,5 a and 7 of 
Directive 81/851/EEC. 
2. The application shall also be accompanied by the fee 
payable to the Agency for the examination of the 
application. 
3. The Agency shall ensure that the opinion of the 
Committee is given within 210 days of the receipt of a valid 
application. 
4. The Agency shall, in consultation with Member States, 
the Commission and interested parties, draw up detailed 
guidance on the form in which applications for authorization 
are to be presented. 
No C 330/8 Official Journal of the European Communities 31. 12. 90 
Article 28 Article 30 
In order to prepare its opinion, the Committee: 
(a) shall verify that the particulars and documents 
submitted in accordance with Article 27 comply with 
the requirements of Directives 81/851/EEC and 
81/852/EEC, and examine whether the conditions for 
issuing an authorization to place the veterinary 
medicinal product on the market specified in this 
Regulation are satisfied; 
(b) may request a laboratory designated for this purpose to 
test the veterinary medicinal product, its starting 
materials, and if need be, its intermediate products or 
other constituent materials in order to ensure that the 
control methods employed by the manufacturer and 
described in the application documents are 
satisfactory; 
(c) may request a laboratory designated for this purpose to 
verify, using samples provided by the applicant, that the 
analytical detection method proposed by the applicant 
in accordance with point 8 of Article 5 (2) of Directive 
81/851/EEC is suitable for use in routine checks to 
reveal the presence of residue levels above the maximum 
residue level accepted by the Community in accordance 
with the provisions of Council Regulation (EEC) 
No 2377/90 of 26 June 1990 laying down a 
Community procedure for the establishment of 
maximum residue levels for veterinary medicinal 
products (*); 
(d) may, where appropriate, request the applicant to 
supplement the particulars accompanying the 
application. Where the Committee avails itself of this 
option, the time limit laid down in Article 28 shall be 
suspended until such time as the supplementary 
information requested has been provided. Likewise, this 
time limit shall be suspended for the time allowed to the 
applicant to prepare oral or written explanations. 
Article 29 
1. Upon receipt of a written request from the Committee, 
a Member State shall forward the information necessary to 
verify that the manufacturer of a veterinary medicinal 
product or the importer from a third country is able to 
manufacture the veterinary medicinal product concerned 
and /or carry out the necessary control tests in accordance 
with the particulars and documents supplied in accordance 
with Article 27. 
2. Where it considers it necessary in order to complete its 
examination of an application, the Committee may request 
the applicant to submit to an inspection of the manufacturing 
site of the veterinary medicinal product concerned. The 
inspection, which shall be completed within the time limit 
referred to in Article 27, shall be undertaken by qualified 
pharmaceutical inspectors from the Member States, who 
may, if appropriate be accompanied by an inspector from the 
Agency. 1. Where the opinion of the Committee is that: 
— the application does not satisfy the criteria for 
authorization set out in this Regulation, or 
— the summary of product characteristics proposed by the 
applicant in accordance with Article 27 should be 
amended, or 
— the labelling or package insert of the product is not in 
compliance with Directive 81/851 /EEC, or 
— the authorization should be granted subject to the 
conditions provided for in Article 34 (2), 
the Agency shall forthwith inform the applicant. 
Within 15 days of the receipt of the opinion, the applicant 
may provide written notice to the Agency that he wishes to 
appeal. Within 60 days of the receipt of the grounds for 
appeal, the Committee shall consider whether its opinion 
should be revised, and the reasons for the conclusions 
reached on the appeal shall be annexed to the assessment 
report referred to in paragraph 2. 
2. Within 30 days of its adoption, the Agency shall 
forward the opinion of the Committee to the Commission, 
the Member States and the applicant together with a report 
describing the assessment of the veterinary medicinal product 
by the Committee and stating the reasons for its 
conclusions. 
3. In the event of an opinion in favour of granting 
authorization to market the veterinary medicinal product 
concerned, the following documents shall be annexed to the 
opinion: 
(a) a draft summary of the product characteristics, as 
referred to in Article 5 a of Directive 81/851/EEC; 
(b) in the case of a veterinary medicinal product intended 
for administration for food-producing animals, a 
statement of the maximum residue level which may be 
accepted by the Community in accordance with 
Regulation (EEC) No /90; 
(c) details of any conditions or restrictions which should be 
imposed on the supply or use of the veterinary medicinal 
product concerned, including the conditions under 
which the medicinal product may be made available to 
users; 
(d) the draft text of the labelling and package leaflet, 
proposed by the applicant, presented in accordance with 
Chapter VII of Directive 81/851/EEC. 
Article 31 
(>) OJ No L 224, 18. 8. 1990, p. 1. 1. Within 30 days of the receipt of the opinion, the 
Commission shall prepare a draft of the Decision to be taken 
31. 12. 90 Official Journal of the European Communities No C 330/9 
in respect of the application taking into account the 
objectives of Community policies and considering all 
relevant information. In the event of a draft Decision which 
envisages the granting of a marketing authorization, the 
documents referred to in points (a), (b), and (c) of Article 30 
(3) shall be annexed. The Commission shall transmit the 
draft Decision to the Member States and to the applicant. 
The Commission shall explain in detail the reasons for any 
differences between the draft Decision and the opinion of the 
Committee. 
2. The Commission shall adopt the Decision to be taken 
in respect of the application unless, within 30 days, it has 
received a reasoned request from a Member State to 
reconsider the matter. The Member State concerned shall 
also transmit a copy of its request to the other Member States 
and the applicant within the same time limit. 
3. Within the time limit referred to in paragraph 2, the 
applicant may submit written observations on the draft 
Decision for consideration by the Commission. 
4. The Commission shall examine any reasoned request 
received in accordance with paragraph 2, in consultation 
with the Agency, and after consideration of any further 
observations submitted by the applicant. 
If the Commission considers that the request raises questions 
of a scientific or technical nature requiring further 
examination, it may remit the matter to the Agency. In this 
case the Committee shall give a second opinion within a time 
limit of 60 days. Within 30 days of the receipt of the opinion, 
the Commission shall adopt the Decision to be taken in 
respect of the application. 
Otherwise the Decision shall be taken in accordance with the 
procedure laid down in Article 2 b and 2 c of Directive 
81/852/EEC. 
Article 32 
Without prejudice to other provisions of Community law, 
the authorization provided for in Article 3 shall be refused if, 
after verification of the information and particulars 
submitted in accordance with Article 27, it appears that: 
1. the veterinary medicinal product is harmful under the 
conditions of use stated at the time of the application for 
authorization, is not efficacious or the applicant has not 
provided sufficient proof of efficacy as regards the 
species of animal which is to be treated, or its qualitative 
and quantitative composition is not as stated; 
2. the withdrawal period recommended by the applicant is 
not long enough to ensure that foodstuffs obtained from treated animals do not contain residues which might 
constitute a health hazard for the consumer or is 
insufficiently substantiated; 
3. the veterinary medicinal product is offered for sale for a 
use prohibited under other Community provisions. 
Authorization shall likewise be refused if the particulars and 
documents provided by the applicant in accordance with 
Article 27 of this Regulation are incorrect or if the labelling 
and package leaflets proposed by the applicant are not in 
accordance with Chapter VII of Directive 81/851/EEC. 
Article 33 
1. Without prejudice to Article 4 of Council Directive 
.../.. ./EEC extending the scope of Directive 
81/851/EEC on the approximation of the laws of the 
Member States relating to veterinary medicinal products, 
and laying down additional provisions for immunological 
veterinary medicinal products, a marketing authorization 
which has been granted in accordance with the procedure 
laid down in this Regulation shall apply throughout the 
Community. It shall confer the same rights and obligations in 
each of the Member States as a marketing authorization 
granted by that Member State in accordance with Article 4 of 
Directive 81/851/EEC. 
2. The refusal of a Community marketing authorization 
shall constitute a prohibition on the marketing and 
administration to animals of the veterinary medicinal 
product concerned throughout the Community. 
3. An announcement that authorization has been granted 
shall be published for information purposes in the Official 
Journal of the European Communities. 
4. Upon request from any interested person, the Agency 
shall make available a detailed summary of the evaluation of 
the veterinary medicinal product by the Committee and the 
reasons for its opinion in favour of granting authorization, 
after deletion of any information of a commercially 
confidential nature. 
Article 34 
1. Authorization shall be valid for five years and shall be 
renewable for five-year periods, on application by the holder 
at least three months before the expiry date. 
2. In exceptional circumstances, and following 
consultation with the applicant, an authorization may be 
granted subject to such conditions as appear necessary to 
ensure the protection of human or animal health, including 
specific obligations to conduct further studies following the 
granting of authorization and specific obligations in respect 
of the reporting of adverse reactions to the veterinary 
medicinal product. 
3. Veterinary medicinal products which have been 
authorized by the Community in accordance with the 
No C 330/10 Official Journal of the European Communities 31. 12. 90 
provisions of this Regulation shall benefit from the 10-year 
period of protection referred to in point 10 of Article 5 (2) of 
Directive 81/851 /EEC. 
Article 35 
The granting of authorization shall not diminish the general, 
civil and criminal liability in the Member States of the 
manufacturer and, where applicable, of the person 
responsible for placing the veterinary medicinal product on 
the market. 
Chapter 2 
Supervision and sanctions 
Article 36 
1. After an authorization has been issued, the person 
responsible for placing the veterinary medicinal product on 
the market must, in respect of the methods of production and 
control provided for in points 4 and 9 of Article 5 (2) of 
Directive 81/851/EEC, take account of technical and 
scientific progress and introduce any changes that may be 
required to enable the veterinary medicinal product to be 
manufactured and checked by means of generally accepted 
scientific methods. These changes must be accepted by the 
Community. 
Upon request from the Commission, the person responsible 
for placing the veterinary medicinal product on the market 
shall also review the analytical detection methods provided 
for in point 8 of Article 5 (2) of Directive 81/851 /EEC and 
propose any changes which may be necessary to take account 
of technical and scientific progress. 
2. The person responsible for marketing shall forthwith 
inform the Agency of any new information which might 
entail the amendment of the particulars and documents 
referred to in Article 27 or in the approved summary of the 
product characteristics. In particular the person responsible 
for marketing shall forthwith inform the Agency of any 
prohibition or restriction imposed by the competent 
authorities of any country in which the veterinary medicinal 
product is marketed and of any other new information which 
might influence the evaluation of the benefits and risks of the 
medicinal product concerned. 
3. If the person responsible for marketing proposes to 
make any alteration to the information and particulars 
referred to in Article 27, he shall submit an application to the 
Agency. 
4. The Agency shall, in accordance with the Commission, 
adopt appropriate arrangements for the examination of 
amendments and variations to the terms of a marketing 
authorization. Article 37 
When a marketing authorization is granted in accordance 
with this Regulation, one or more of the Member States shall 
act as the competent supervisory authorities to exercise the 
responsibilities referred to in Article 38. 
In the case of veterinary medicinal products manufactured 
within the Community, the supervisory authorities shall 
normally be the competent authorities of the Member State 
or Member States which have granted the manufacturing 
authorization provided for in Article 24 of Directive 
81/851/EECin respect of the manufacture of the veterinary 
medicinal product concerned. 
In the case of veterinary medicinal products imported from 
third countries, the supervisory authorities shall be the 
competent authorities of the Member States in which the 
controls referred to in Article 30 (1) (b) of Directive 
81/851/EEC are carried out unless appropriate 
arrangements have been made between the Community and 
the exporting country to ensure that those controls are 
carried out in the exporting country and that the 
manufacturer applies standards of good manufacturing 
practice at least equivalent to those laid down by the 
Community. 
Article 38 
1. The supervisory authorities shall have responsibility 
for verifying on behalf of the Community that the 
manufacturer or the importer from third countries satisfies 
the requirements laid down in Chapter V of Directive 
81/851/EEC, and for exercising supervision over persons 
responsible for marketing medicinal products in accordance 
with Chapter VI of Directive 81/851/EEC. 
2. Upon receipt of a reasoned request of any Member 
State, or on its own initiative, the Commission may request 
the manufacturer or importer to submit to an inspection of 
the manufacturing site of the veterinary medicinal product 
concerned, giving its reasons. The inspection shall be 
undertaken by qualified pharmaceutical inspectors from the 
Member States who may, if appropriate, be accompanied by 
an inspector from the Agency. The report of the inspectors 
shall be made available to the Commission, the Committee 
and the applicant. In the case of an inspection conducted 
within the Community, the host Member State shall provide 
all the practical support necessary to enable the inspectors to 
discharge their responsibilities. 
Article 39 
1. Where the supervisory authorities or the competent 
authorities of any other Member State are of the opinion that 
the manufacturer or importer from third countries is no 
longer fulfilling the obligations laid down in Chapter V of 
Directive 81/851 /EEC they shall forthwith inform the 
Committee and the Commission, stating their reasons in 
detail and indicating the course of action proposed. 
31. 12. 90 Official Journal of the European Communities No C 330/11 
The same shall apply where a Member State considers that 
one of the measures envisaged in Chapter VI of Directive 
81/851 /EEC should be applied in respect of the veterinary 
medicinal product concerned. 
2. The Commission shall in consultation with the Agency 
forthwith examine the reasons advanced by the Member 
State concerned. It may request the opinion of the Committee 
within a time limit to be determined by the Commission 
having regard to the urgency of the matter. Whenever 
practicable, the person responsible for marketing shall be 
invited to provide oral or written explanations. 
3. The Commission shall prepare a draft of the Decision 
to be taken which shall be adopted in accordance with the 
procedure laid down in Article 31. 
However, where a Member State has invoked the provisions 
of paragraph 4, the time limit provided for in Article 2 c (3) 
of Directive 81/852/EEC shall be reduced to 15 calendar 
days. 
4. In exceptional cases, where action is urgently necessary 
to protect human or animal health, a Member State may 
suspend the use on its territory of a veterinary medicinal 
product which has been authorized in accordance with this 
Regulation. It shall inform the Commission no later than the 
following working day of the reasons for its action. The 
Commission shall immediately consider the reasons given by 
the Member State in accordance with paragraph 2 and shall 
initiate the procedure provided for in paragraph 3. 
5. A Member State which has adopted the suspensive 
measures referred to in paragraph 4 may maintain them in 
force until such time as a definitive Decision has been reached 
in accordance with the procedure laid down in 
paragraph 3. 
Chapter 3 
Pharmacovigilance 
Article 40 
For the purpose of this Chapter, the definitions given in 
Article 42 b of Directive 81/851/EEC shall apply. 
Article 41 
The Agency, acting in close cooperation with the national 
pharmacovigilance centres established in accordance with 
Article 42 a of Directive 81/851/EEC, shall be responsible 
for the collection and evaluation of information about 
adverse reactions to veterinary medicinal products which 
have been authorized by the Community in accordance with 
this Regulation. 
The competent authorities of the Member States and the 
person responsible for marketing shall ensure that all relevant information about adverse reactions to veterinary 
medicinal products authorized in accordance with this 
Regulation are brought to the attention of the Agency in 
accordance with the provisions of this Regulation. 
Article 42 
The person responsible for marketing a veterinary medicinal 
product authorized by the Community in accordance with 
the provisions of this Regulation shall have permanently and 
continuously at his disposal a person responsible for 
pharmacovigilance. This person shall be responsible for: 
(a) the establishment and maintenance of a system which 
ensures that information about all adverse reactions 
which are reported to the personnel of the company, 
including its sales personnel, is collected and collated so 
that it may be accessed at a single point within the 
Community; 
(b) the preparation and submission of the reports referred to 
in Article 44 to the competent authorities of the Member 
States and the Agency in accordance with the 
requirements of this Regulation; 
(c) ensuring that any request for the provision of additional 
information necessary for the evaluation of the benefits 
and risks,of a veterinary medicinal product is answered 
fully and promptly, including the provision of 
information about the volume of sales or prescriptions 
for the veterinary medicinal product concerned, where 
relevant. 
Article 43 
1. The person responsible for marketing shall ensure that 
all suspected serious adverse reactions to a veterinary 
medicinal product authorized in accordance with the 
provisions of this Regulation which are brought to his 
attention by a veterinarian, whether arising within the 
Community or a third country, are recorded and reported to 
the Agency within 15 days. 
2. In addition, the person responsible for marketing shall 
be required to maintain detailed records of all other adverse 
reactions arising within the Community which are reported 
to him by a veterinarian. Unless other requirements have 
been laid down as a condition of the granting of 
authorization by the Community, these records shall be 
submitted to the Agency immediately upon request or at least 
every six months during the first two years following 
authorization and once a year for the following three years. 
Thereafter, the records shall be submitted at five-yearly 
intervals together with the application for renewal of the 
authorization, or immediately upon request. 
Article 44 
Each Member State shall report any suspected serious 
adverse reaction arising within its territory to a veterinary 
No C 330/12 Official Journal of the European Communities 31. 12. 90 
medicinal product authorized in accordance with this 
Regulation to the Agency and the person responsible for 
marketing within 15 days of receipt of a report from a 
qualified health care professional. 
Article 45 
The Agency shall, in consultation with Member States, the 
Commission and interested parties, draw up detailed 
guidance on the collection, verification and presentation of 
adverse reaction reports to veterinary medicinal products. 
Article 46 
1. The Agency shall publish an annual report on the 
operation of the procedures laid down in this Chapter. 
2. Within six years of the entry into force of this 
Regulation, the Commission shall publish a detailed review 
of the operation of the procedures laid down in this Chapter 
and shall propose any amendments which may be necessary 
to improve the operation of these procedures. 
The Council shall decide on the Commission proposal no 
later than one year after its submission. 
TITLE IV 
THE EUROPEAN AGENCY FOR THE EVALUATION OF 
MEDICINAL PRODUCTS 
Chapter 1 
Tasks of the Agency 
Article 47 
A European Agency for the Evaluation of Medicinal 
Products, hereinafter referred to as 'the Agency', is hereby 
established. In particular, the Agency shall undertake the following 
tasks: 
(a) the coordination of the scientific evaluation of the 
quality, safety and efficacy of medicinal products which 
are subject to Community marketing authorization 
procedures; 
(b) the presentation of assessment reports, summaries of 
product characteristics, labels and package inserts for 
these medicinal products; 
(c) the continuing supervision, under practical conditions 
of use, of medicinal products which have been 
authorized within the Community and the provision of 
advice on the measures necessary to ensure the safe and 
effective use of these products, in particular following 
the evaluation of reports of adverse reactions 
(pharmacovigilance); 
(d) coordinating the discharge of the various supervisory 
responsibilities which have been conferred on the 
Community and the Member States in particular in 
respect of the verification of compliance with the 
principles of good manufacturing practice, good 
laboratory practice and good clinical practice; 
(e) to provide technical assistance for the maintenance of a 
data base on medicinal products which is available for 
public use; 
(f) to promote technical cooperation between the 
Community, its Member States, international 
organizations and third countries on scientific and 
technical issues relating to the evaluation of medicinal 
products; 
(g) to assist the Community and the Member States in the 
provision of information about medicinal products to 
the public; 
(h) where necessary, to advise and to allow for direct 
dialogue between the applicant and the Agency on the 
conduct of the various tests and trials necessary to 
demonstrate the quality, safety and efficacy of medicinal 
products. 
(i) advising on the maximum levels for residues of 
veterinary medicinal products which may be accepted in 
foodstuffs of animal origin in accordance with 
Regulation (EEC) No 2377/90. 
Article 48 
In order to promote the protection of public health 
throughout the Community and the adoption of uniform 
regulatory decisions based on scientific criteria concerning 
the marketing and use of medicinal products, the objective of 
the Agency shall be to provide the Member States and the 
Institutions of the Community with the best possible 
scientific advice on any question relating to the evaluation of 
the quality, the safety or the efficacy of medicinal products 
for human or veterinary use which is referred to it in 
accordance with the provisions of Community legislation 
relating to medicinal products. Chapter 2 
Structure of the Agency 
Article 49 
1. The opinion of the Agency on any question relating to 
the quality, safety or efficacy of medicinal products for 
human use shall be given by the Committee for Proprietary 
Medicinal Products. 
31. 12. 90 Official Journal of the European Communities No C 330/13 
2. The opinion of the Agency on any question relating to 
the quality, safety or efficacy of veterinary medicinal 
products shall be given by the Committee for Veterinary 
Medicinal Products. 
3. In addition to a permanent technical and 
administrative secretariat, each Committee may arrange to 
be assisted by working parties and expert groups. 
The secretariat shall ensure appropriate coordination 
between the work of the two Committees. 
4. The Committee for Proprietary Medicinal Products 
and the Committee for Veterinary Medicinal Products may, 
if they consider it appropriate, seek guidance from the 
Scientific Council referred to in Article 65 on important 
questions of a general scientific or ethical nature. 
Article 50 
1. The Committee for Proprietary Medicinal Products 
and the Committee for Veterinary Medicinal Products shall 
each consist of scientific advisors nominated by Member 
States for a term of three years which shall be renewable. 
They shall be chosen by reason of their scientific expertise 
and their role and experience in the evaluation of medicinal 
products for human and veterinary use as appropriate. 
Before nominating members to the Committee, the Member 
States shall consult to ensure that the composition of each 
Committee reflects the various scientific disciplines necessary 
for the evaluation of medicinal products. 
The executive director or his representative and 
representatives of the Commission shall be entitled to attend 
all meetings of the Committees, their working parties and 
expert groups. 
Members of each Committee may arrange to be accompanied 
by experts. 
2. In addition to their task of providing an objective 
scientific advice to the Community and Member States on the 
questions which are referred to them, the members of each 
Committee shall ensure that there is appropriate 
coordination between the work of the Agency and the work 
of scientific advisory bodies established in Member States. 
3. The Member States shall refrain from giving any 
instruction to Members of the Committees which is 
incompatible with the tasks referred to in paragraph 2. 
Article 51 
1. The Member States shall transmit to the executive 
director a list of rapporteurs and experts with proven 
experience in the evaluation of the quality, safety and efficacy of medicinal products, together with an indication of 
their qualifications and specific areas of expertise. 
This list shall be updated as necessary. 
2. On a proposal from the Committee for Proprietary 
Medicinal Products or the Committee for Veterinary 
Medicinal Products, the executive director may entrust 
specific tasks to rapporteurs or experts. The provision of 
services by rapporteurs or experts shall be governed by a 
written contract between the Agency and the person 
concerned, or where appropriate between the Agency and.his 
employer. The person concerned, or his employer, shall be 
remunerated in accordance with a fixed scale of fees to be 
established by the financial regulation adopted by the 
management board. 
3. The executive director may also have recourse to the 
services of experts for the discharge of other specific 
responsibilities of the Agency, in particular the inspections 
referred to in Articles 8, 17, 29 and 38. 
Article 52 
1. The Membership of the Committee for Proprietary 
Medicinal Products and the Committee for Veterinary 
Medicinal Products shall be made public. When each 
appointment is published, the professional qualifications of 
each member shall be specified. 
2. Committee members, rapporteurs or experts may not 
hold financial or other interests in the pharmaceutical 
industry which could affect their impartiality. All indirect 
interests which could relate to this industry shall be entered in 
a register held by the executive director which the public may 
consult. 
Article 53 
1. The executive director shall be appointed by the 
management board, on a proposal from the Commission, for 
a period of five years, which shall be renewable. 
2. The executive director shall be the legal representative 
of the Agency. He shall be responsible: 
— for the day to day administration of the Agency, 
— for the provision of appropriate scientific and technical 
support for the Committee for Proprietary Medicinal 
Products and the Committee for Veterinary Medicinal 
Products, and their working parties and expert 
groups, 
— for ensuring that the time limits laid down in Community 
legislation for the adoption of opinions by the Agency are 
respected, 
— for ensuring appropriate coordination between the 
Committee for Proprietary Medicinal Products and the 
Committee for Veterinary Medicinal Products, 
No C 330/14 Official Journal of the European Communities 31. 12. 90 
— for the preparation of the statement of revenue and 
expenditure and the execution of the budget of the 
Agency, 
— for all staff matters. 
3. Each year, the executive director shall submit to the 
management board for approval: 
— a draft report covering the activities of the Agency in the 
previous year, including information about the number 
of applications evaluated within the Agency, and the time 
taken for the completion of the evaluation, 
— a draft programme of work for the coming year, 
— the draft annual accounts for the previous year, 
— the draft budget for the coming year. 
4. The executive director shall approve all financial 
expenditure of the Agency. 
Article 54 
1. The management board shall consist of two 
representatives from each Member State and two 
representatives of the Commission. One representative shall 
have specific responsibilities relating to medicinal products 
for human use and one relating to veterinary medicinal 
products. 
2. The term of office of the representatives shall be three 
years. It shall be renewable. 
3. The management board shall elect its chairman for a 
term of three years and shall adopt its rules of procedure. 
Decisions of the management board shall be adopted by a 
two-thirds majority. 
4. The executive director shall provide the secretariat of 
the management board and shall be entitled to attend the 
meetings of the board unless it decides otherwise. In this case, 
a representative of the Commission shall prepare the record 
of the meeting. 
5. Before 31 January each year, the management board 
shall adopt the general report on the activities of the Agency 
for the previous year and its programme of work for the 
coming year and forward them to the Member States, the 
Commission, the Council, the European Parliament and the 
Scientific Council. 
Chapter 3 
Financial provisions 
Article 55 
1. The revenues of the Agency shall consist of a 
contribution from the Community, and the fees paid by undertakings for obtaining a Community marketing 
authorization and for other services provided by the 
Agency. 
2. The expenditure of the Agency shall include the staff, 
administrative, infrastructure and operational expenses and 
expenses resulting from contracts entered into with third 
parties. 
3. Before 31 January each year the management board 
shall draw up an estimate of revenue and expenditure which 
shall be in balance for each financial year which shall be the 
same as a calendar year. This estimate shall be forwarded to 
the Commission and the Member States. 
4. The Commission shall include an appropriate 
contribution to the Agency in the preliminary draft budget of 
the European Communities. The budget of the European 
Communities shall each year under a specific heading in the 
operational part include a contribution to the Agency. 
5. The management board, after obtaining the opinion of 
the Commission, shall adopt the statement of revenue and 
expenditure at the beginning of the financial year adjusting it 
to the contribution granted to the Agency and to its other 
resources. 
6. The management board shall adopt the financial 
regulations of the Agency, in agreement with the 
Commission. 
7. Before 31 March each year, the management board 
shall transmit to the Commission and to the Court of 
Auditors the accounts for all revenues and expenditure by the 
Agency during the preceding year. The Court of Auditors 
shall examine the accounts in accordance with the provisions 
of Article 206 a of the EEC Treaty. 
8. Before 31 October each year, the Commission shall 
submit the accounts and the report of the Court of Auditors 
to the Council together with its own observations. The 
management board shall be discharged in respect of the 
implementation of the budget in accordance with the 
procedure laid down in Article 206 b of the EEC Treaty. 
Article 56 
The fees referred to in Article 55 (1) shall be established by 
the Council on a proposal from the Commission, following 
consultation of organizations representing the interests of the 
pharmaceutical industry at the Community level. 
Chapter 4 
General provisions governing the Agency 
Article 57 
The Agency shall have legal personality. In all Member States 
it shall benefit from the widest powers granted by law to legal 
31. 12. 90 Official Journal of the European Communities No C 330/15 
persons. In particular it may acquire and dispose of real 
property and chattels and institute legal proceedings. 
Article 58 
1. The contractual liability of the Agency shall be 
governed by the law applicable to the contract in question. 
The Court of Justice of the European Communities shall 
have jurisdiction to give judgment pursuant to any 
arbitration clause contained in a contract concluded by the 
Agency. 
2. In the case of non-contractual liability, the Agency 
shall, in accordance with the general principles common to 
the laws of the Member States, make good any damage 
caused by itself or by its servants in the performance of their 
duties. 
The Court of Justice shall have jurisdiction in any dispute 
relating to compensation for such damages. 
3. The personal liability of its servants towards the 
Agency shall be governed by the relevant conditions applying 
to the staff of the Agency. 
Article 59 
Member States, members of the management board and 
third parties directly involved may refer to the Commission 
any act of the Agency, whether express or implied, for the 
Commission to examine the legality of that Act. 
Referral to the Commission shall be made within 15 days of 
the day on which the party concerned first became aware of 
the act in question. 
The Commission shall take a decision within one month. If 
no decision has been taken within this period, the case shall 
be deemed to have been dismissed. 
Article 60 
The Protocol on the Privileges and immunities of the 
European Communities shall apply to the Agency. 
Article 61 
1. Apart from officials and other staff seconded by an 
institution of the European Communities, the Agency shall 
have its own personnel to whom will be applied a special 
regime, to be decided by a Council Regulation, adopted by a 
qualified majority on a proposal from the Commission. 
2. In respect of its personnel, the Agency shall exercise the 
powers which have been devolved to the Authority invested 
with the power of nomination. 3. The management board, in agreement with the 
Commission, shall adopt the necessary implementing 
provisions. 
Article 62 
Members of the management board, the executive director, 
the staff of the Agency, the members of Committees attached 
to the Agency and their working parties, experts and any 
other persons participating in the work of the Agency, 
including observers, shall be obliged, even after their duties 
have ceased, not to disclose information of the kind covered 
by the obligation of professional secrecy. 
Article 63 
The management board may, in agreement with the 
Commission, invite representatives of international 
organizations with interest in the scientific and technical 
evaluation of medicinal products such as: 
— the European Pharmacopoeia, 
— the European Free Trade Association, 
— the Nordic Council on Medicines, 
— the World Health Organization, 
to participate as observers in the work of the Agency. 
Article 64 
The management board shall, in agreement with the 
Commission, develop appropriate contacts between the 
Agency and the representatives of the industry, consumers 
and patients and the professions. 
Article 65 
1. A Scientific Council shall be established and attached 
to the Agency. 
2. The Scientific Council shall consist of not less than five 
and not more than nine persons of outstanding and 
internationally recognized ability with particular knowledge 
of scientific and ethical issues relating to medicinal products 
for human or veterinary use. 
3. The members of the Scientific Council shall be 
nominated by the Council on a proposal from the 
Commission for a term of four years. Their appointments 
shall be renewable. 
4. The Scientific Council shall advise for the Committee 
for Proprietary Medicinal Products or the Committee for 
Veterinary Medicinal Products on any question which is 
submitted to it in accordance with Article 49. In addition, the 
Scientific Council shall be able to comment on the annual 
report on the operation of the Agency prepared in accordance 
with Article 55. 
No C 330/16 Official Journal of the European Communities 31. 12. 90 
Article 66 
The Agency shall take up its responsibilities on 1 January 
1993. 
TITLE V 
GENERAL AND FINAL PROVISIONS 
Article 67 
Al Decisions to grant, refuse, amend, suspend, withdraw or 
revoke a marketing authorization which are taken in 
accordance with this Regulation shall state in detail the 
reasons on which they are based. Such Decisions shall be 
notified to the party concerned, who shall be able to exercise 
the remedies conferred upon him under the EEC Treaty. 
Article 68 
1. An authorization to market a medicinal product 
coming within the scope of this Regulation shall not be 
refused, amended, suspended, withdrawn or revoked except 
on the grounds set out in this Regulation. 
2. An authorization to market a medicinal product 
coming within the scope of this Regulation shall not be 
granted, refused, amended, suspended, withdrawn or 
revoked except in accordance with the procedures set out in 
this Regulation. 
Article 69 
In respect of medicinal products coming within the scope of 
this Regulation, and in order to exercise the responsibilities 
imposed upon them by this Regulation, the competent 
authorities of the Community shall be able to exercise all the 
powers conferred on the competent authorities of the 
Member States by Directives 65/65/EEC, 75/319/EEC, 
and81/851/EEC. 
Article 70 
Without prejudice to Article 68, and without prejudice to the 
Protocol on the Privileges and Immunities of the European 
Communities, each Member State shall determine the penalties to be applied for the infringement of the provisions 
of this Regulation. The penalties shall be sufficient to 
promote compliance with those measures. 
Member States shall forthwith inform the Commission of the 
institution of any infringement proceedings. 
Article 71 
Within three years of the entry into force of this Regulation 
the Commission shall produce a report on whether the level 
of harmonization achieved by the present Regulation and by 
Council Directive 90/167/EEC of 26 March 1990 laying 
down the conditions governing the preparation, placing on 
the market and use of medicated feedingstuffs (*) is 
equivalent to that provided for in Council Directive 
70/524/EEC of 23 November 1970 concerning additives in 
animal feedingstuffs (2), accompanied if necessary by the 
proposals to modify the status of the coccidiostats and other 
medicinal substances covered by that Directive. 
The Council shall decide on the Commission proposals no 
later than one year after their submission. 
Article 72 
Within six years of the entry into force of this Regulation, the 
Commission shall publish a general report on the experience 
acquired as a result of the operation of the procedures laid 
down in this Regulation, in Chapter HI of Directive 
75/319/EEC and in Chapter IV of Directive 81/851/EEC 
together with any appropriate proposals for amendments, to 
Article 3 and the Annex in order to extend the scope of the 
procedures laid down in this Regulation to other categories 
of medicinal products, on an obligatory or a voluntary 
basis. 
The Council shall decide on the Commission proposals no 
later than one year after their submission. 
Article 73 
This Regulation shall enter into force on the third day 
following its publication in the Official Journal of the 
European Communities. 
Titles I, II, III and V shall apply from 1 January 1993. 
This Regulation shall be binding in its entirety and directly 
applicable in all Member States. 
0) OJ No L 92, 7. 4. 1990, p. 42. 
(*) OJ No L 270, 14. 12. 1970, p. 1. 
31. 12. 90 Official Journal of the European Communities No C 330/17 
ANNEX 
PART A 
Medicinal products developed by means of one of the following biotechnological processes: 
— recombinant DNA technology, 
— controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including 
transformed mammalian cells, 
— hybridoma and monoclonal antibody methods. 
Veterinary medicinal products, including those not derived from biotechnology, intended primarily for use as 
performance enhancers in order to promote the growth of treated animals or to increase yields from treated 
animals. 
PARTB 
Medicinal products developed by other biotechnological processes, which, in the opinion of the Agency, constitute 
a significant innovation. 
Medicinal products administered by means of new delivery systems which, in the opinion of the Agency, constitute 
a significant innovation. 
Medicinal products presented for an entirely new indication which, in the opinion of the Agency, is of significant 
therapeutic interest. 
Medicinal products based on radio-isotopes which, in the opinion of the Agency, are of significant therapeutic 
interest. 
New medicinal products derived from human blood or human plasma. 
Medicinal products the manufacture of which employs processes which, in the opinion of the Agency, demonstrate 
a significant technical advance such as two-dimensional electrophoresis under micro-gravity. 
Medicinal products intended for administration to human beings containing a new active substance which, on the 
date of entry into force of this regulation, was not authorized by any Member State for use in a medicinal product 
intended for use in human beings. 
Veterinary medicinal products intended for use in food-producing animals containing a new active substance 
which, on the date of entry into force of this Regulation, was not authorized by any Member State for use in 
food-producing animals.