31. 12. 90 Official Journal of the European Communities No C 330/25 
Proposal for a Council Directive amending Directives 81/851/EEC and 81/852/EEC in respect of 
veterinary medicinal products 
COM(90) 283 final — SYN 311 
(Submitted by the Commission on 14 November 1990) 
(90/C 330/03) 
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 despite the progress achieved by Directive 
81/851/EEC of 28 September 1981 on the approximation 
of the laws of the Member States relating to veterinary 
medicinal products ('), as last amended by Directive 
.../.. ./EEC of (2), further measures are necessary 
to abolish the remaining barriers to the free movement of 
veterinary medicinal products within the Community; 
Whereas, with the exception of those veterinary medicinal 
products which are subject to the centralized Community 
authorization procedure established by Council Regulation 
(EEC) No... of 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 (3), an authorization to place a 
veterinary medicinal product on the market in one Member 
State ought in principle to be recognized by the competent 
authorities of the other Member States unless there are 
serious grounds for supposing that the authorization of the 
veterinary medicinal product concerned may present a risk to 
human or animal health, or to the environment; whereas, in 
the event of a disagreement between Member States about 
the quality, the safety or the efficacy of a veterinary medicinal 
product, a scientific evaluation of the matter should be 
undertaken by the Committee for Veterinary Medicinal 
Products attached to the European Agency for the 
Evaluation of Medicinal Products, leading to a single 
decision on the area of disagreement, binding on the Member 
States concerned; whereas this Decision should be adopted 
0) OJNoL317, 6. 11. 1981, p. 1. 
(*) OJ No L . . . 
(3) See page 1 of this Official Journal. by a rapid procedure ensuring close cooperation between the 
Commission and the Member States, in particular through 
the Standing Committee and the Member States, in 
particular through the Standing Committee on Veterinary 
Medicinal Products created by Article 2b of Council 
Directive 81/852/EEC of 28 September 1981 on the 
approximation of the laws of Member States relating to 
analytical, pharmacotoxicological and clinical standards and 
protocols in respect of the testing of veterinary medicinal 
products (4), as last amended by Directive 
87/20/EEC(5); 
Whereas in order better to protect human and animal health 
and avoid any unnecessary duplication of effort during the 
examination of applications for authorization to place 
veterinary medicinal products of the market, Member States 
should systematically prepare assessment reports in respect 
of each veterinary medicinal products which is authorized by 
them, and exchange the reports upon request; whereas, 
furthermore, a Member State should be able to suspend the 
examination of an application for authorization to place a 
veterinary medicinal product on the market which is 
currently under active consideration in another Member 
State with a view to recognizing the Decision reached by the 
latter Member State; 
Whereas following the establishment of the internal market, 
specific controls to guarantee the quality of veterinary 
medicinal products imported from third countries can only 
be waived if appropriate arrangements have been made by 
the Community to ensure that the necessary controls are 
carried out in the exporting country; 
Whereas it is desirable to codify and improve the cooperation 
and exchange of information between Member States 
relating to the supervision of veterinary medicinal products 
and in particular the monitoring of adverse reactions under 
practical conditions of use through the national 
pharmacovigilance centres; 
Whereas in order to improve the protection of public health it 
is necessary to specify that foodstuffs for human 
consumption may not be taken from animals which have 
been used in clinical trials of veterinary medicinal products 
unless a provisional maximum residue level has been laid 
down for residues of the veterinary medicinal product 
concerned in accordance with the provisions of Council 
Regulation (EEC) No 2377/90 laying down a Community 
procedure for the establishment of maximum residue levels 
for residues of veterinary medicinal products (6), 
(4) OJNoL317, 6. 11. 1981, p. 16. 
(s) OJ No L 15, 17. 1. 1987, p. 34. 
(6) OJ No L 224, 18. 8. 1990, p. 1. 
No C 330/26 Official Journal of the European Communities 31. 12. 90 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Directive 81/851/EEC is hereby amended as follows: 
1. In Article 4 (1), the first subparagraph is replaced by the 
following: 
'No veterinary medicinal product may be placed on the 
market of a Member State unless an authorization has 
been issued by the competent authority of that Member 
State or by the Community.' 
2. In Article 4 (2), the following subparagraph is inserted 
at the end: 
The Member States shall not permit foodstuffs for 
human consumption to be taken from test animals 
unless a provisional maximum residue level has been 
established by the Community in accordance with the 
provisions of Regulation (EEC) No 2377/90 (*) and 
an appropriate withdrawal period has been established 
to ensure that this level will not be exceeded in the 
foodstuffs. 
(*) OJNoL 224, 18. 8. 1990, p. 1.' 
3. In Articles (2), point 13 is replaced by the 
following: 
'13. Copy of any authorization in another Member 
State or in a third country to place the relevant 
veterinary medicinal product on the market, together 
with a list of those Member States in which an 
application for authorization submitted in accordance 
with this Directive is under examination and copies of 
the summary of product characteristics proposed by the 
applicant in accordance with Article 5a or approved by 
the competent authorities in accordance with 
Article 5b, as appropriate, in respect of each Member 
State concerned. Details of any Decision to refuse 
authorization, whether in the Community or a third 
country and the reasons for that Decision. 
This information shall be updated at regular 
intervals.' 
4. Article 5b is replaced by the following: 
'Article Sb 
When the marketing authorization referred to in 
Article 4 (1) is issued, the person responsible for placing 
that product on the market shall be informed, by the 
competent authorities of the Member State concerned, 
of the summary of the product characteristics as 
approved by them. The competent authorities shall 
take all necessary measures to ensure that the 
information given in the summary is in conformity with 
that accepted when the marketing authorization is 
issued or subsequently. The competent authorities shall 
forthwith forward a copy of the summary to the 
European Agency for the Evaluation of Medicinal 
Products established by Council Regulation (EEC) 
No. . ./. . .(*). Furthermore, the competent authorities shall draw up 
an assessment report and comments on the dossier as 
regards the results of the analytical, 
pharmaco-toxicological tests and the clinical trials of 
the veterinary medicinal product concerned. The 
assessment report shall be updated whenever new 
information becomes available which is of importance 
for the evaluation of the quality, safety or efficacy of the 
medicinal product concerned. 
(*) OJNoL...' 
5. Article 8 is replaced by the following: 
'Article 8 
1. Member States shall take all appropriate 
measures to ensure that the procedure for granting an 
authorization to place a medicinal product on the 
market is completed within 210 days of the date of 
submitting the application. 
2. Where a Member State notes that an application 
for authorization submitted after 1 January 1993 is 
already under active examination in another Member 
State, the former Member State may decide to suspend 
the detailed examination of the application in order to 
await the assessment report prepared by the first 
Member State in accordance with Article 5b.' 
The Member State concerned shall inform the first 
Member State and the applicant of its Decision to 
suspend detailed examination of the application in 
question. 
As soon as it has completed the examination of the 
application and reached a decision, the first Member 
State shall forward a copy of its assessment report to the 
Member State concerned. 
Within the 90 days of the receipt of the assessment 
report, the Member State concerned shall recognize the 
decision of the first Member State. However, if the 
Member State concerned considers that there are 
serious grounds for supposing that the authorization of 
the veterinary medicinal product may present a risk to 
human or animal health or the environment, it shall 
inform the first Member State, the Committee for 
Veterinary Medicinal Products and the applicant 
within the time limit referred to above, stating its 
reasons in detail, and apply the procedures laid down in 
Chapter IV.' 
6. The following Article 8a is inserted: 
'Article 8a 
1. With effect from 1 January 1996, where a Member 
State is informed in accordance with point 13 of 
Article 5(2) that another Member State has authorized 
a veterinary medicinal product which is the subject of 
an application for authorization in the Member State 
concerned, that Member State shall forthwith request 
the authorities of the Member State which has granted 
the authorization to forward to it the assessment report 
referred to in the second paragraph of Article 5b. 
Within 90 days of the receipt of the assessment report, 
31. 12. 90 Official Journal of the European Communities No C 330/27 
the competent authorities of the Member State 
concerned shall recognize the authorization granted by 
the other Member State. 
2. Notwithstanding paragraph 1, if the Member 
State concerned considers that there are serious grounds 
for supposing that the authorization of the veterinary 
medicinal product may present a risk to human or 
animal health or the environment, it shall inform the 
Member State which granted the initial authorization, 
any other Member States concerned by the application 
and the Committee for Veterinary Medicinal Products 
and the applicant within the time limit referred to in 
paragraph 1, stating its reasons in detail, and apply the 
procedures laid down in Chapter IV of this 
Directive.' 
7. In Article 14 (1), the first subparagraph is replaced by 
the following: 
'After an authorization has been issued, the person 
responsible for placing the 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), 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 
competent authorities of the Member States 
concerned.' 
8. Article 15 is replaced by the following: 
'Article IS 
1. Authorization shall be valid for five years and 
shall be renewable for five-years 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 and animal 
health or the environment, 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.' 
9. Chapter IV is replaced by the following: 
'CHAPTER IV 
Committee for Veterinary Medicinal Products 
Article 16 
1. In order to facilitate the adoption of common 
Decisions by Member States on the authorization of 
veterinary medicinal products on the basis of the 
scientific criteria of quality, safety and efficacy, and to 
achieve thereby the free movement of veterinary 
medicinal products within the Community, a 
Committee for Veterinary Medicinal Products, 
hereinafter referred to as 'the Committee', is hereby set 
up. The Committee shall consist of representatives of 
the Member States and of the Commission. The Committee shall be attached to the European Agency 
for the Evaluation of Medicinal Products established by 
Council Regulation .../.. ./EEC, hereinafter 
referred to as the Agency. 
2. In addition to the other responsibilities conferred 
upon it by Community law, the Committee shall 
examine any question relating to the grant, 
amendment, suspension or withdrawal of 
authorization for a veterinary medicinal product which 
is submitted to it in accordance with the provisions of 
this Directive. 
3. The Committee shall adopt its own rules of 
procedure. 
Article 17 
1. In order to obtain the recognition in one or more 
of the Member States of an authorization issued by a 
Member State in accordance with Article 4, the holder 
of the authorization shall submit an application to the 
competent authorities of the Member State or Member 
States concerned, together with the information and 
particulars referred to in Article 5, 5a and 5b. He shall 
testify to the identify of the dossier with that accepted 
by the first Member State, or shall identify any 
conditions or modifications it may contain. In the latter 
case, he shall certify that the summary of product 
characteristics proposed by him in accordance with 
Article 5a is identical to that accepted by the first 
Member State in accordance with Article 5b. 
Moreover, he shall certify that all the dossiers filed as 
part of this procedure are identical. 
2. The holder of the marketing authorization shall 
notify the Committee of this application, inform it of 
the Member States concerned and of the dates of 
submission of the application and send it a copy of the 
authorization granted by the first Member State. He 
shall also send the Committee copies of any marketing 
authorizations which may have been granted by the 
other Member States in respect of the product 
concerned, and shall indicate whether any application 
for authorization is currently under consideration in 
any Member State. 
3. The holder of the authorization shall also inform 
the Member State which granted the initial 
authorization that an application is being made in 
accordance with this Directive and shall notify it of any 
additions to the original dossier; that Member State 
may require the applicant to provide it with all the 
particulars and documents necessary to enable it to 
check the identity of the dossiers filed with the dossier 
on with it took its decision. In addition that Member 
State shall forward to the Member State or Member 
States concerned by the application a copy of the 
assessment report established in accordance with 
Article 5b (2). 
4. Each Member State concerned shall recognize the 
marketing authorization granted by the first Member 
State within 90 days of receipt of the application. It 
No C 330/28 Official Journal of the European Communities 31. 12. 90 
shall inform the Member State which granted the initial 
authorization, the other Member States concerned by 
the application, the Committee, and the person 
responsible for marketing thereof. 
Article 18 
1. Notwithstanding Article 17(4), where a Member 
State considers that there are serious grounds for 
supposing that the authorization of the veterinary 
medicinal product concerned may present a risk to 
human or animal health or the environment, it shall 
forthwith inform the applicant, the Member State 
which granted the initial authorization, any other 
Member States concerned by the application and the 
Committee. The Member State shall state its reasons in 
detail and shall indicate what action may be necessary 
to correct any defect in the application. 
2. All the Member States concerned shall use their 
best endeavours to reach agreement on the action to be 
taken in respect of the application. They shall provide 
the applicant with the possibility to make his point of 
view known orally or in writing. However, if within 60 
days of the expiry of the time limit referred to in 
Article 17 (4), the Member States have not been able to 
reach agreement they shall forthwith refer the matter to 
the Committee for the application of the procedure laid 
down in Article 21. 
3. Within the time limit referred to in paragraph 2, 
the Member State which granted the initial 
authorization and the other Member States concerned 
by the application shall provide the Committee with a 
detailed statement of the matters on which they have 
been unable to reach agreement and the reasons for 
their disagreement. A copy of this information shall be 
provided to the applicant. 
4. As soon as he is informed that the matter has been 
referred to the Committee, the applicant shall forthwith 
forward to the Committee a copy of the information 
and particulars referred to in Article 17 (1). 
Article 19 
If several applications submitted in accordance with 
Articles 5 and 5 a have been made for marketing 
authorization for a particular veterinary medicinal 
product, and Member States have adopted divergent 
decisions concerning the authorization of the veterinary 
medicinal product, or its suspension or withdrawal 
from the market, any Member State or the 
Commission, or the person responsible for marketing 
may refer the matter to the Committee for the 
application of the procedure laid down in Article 21. 
The Member State concerned, the person responsible 
for marketing or the Commission shall clearly identify 
the question which is referred to the Committee for 
consideration and, if necessary, shall inform the person 
responsible for marketing. The Member States and the person responsible for 
marketing shall forward to the Committee all available 
information relating to the matter in question. 
Article 20 
The Member States or the Commission may, in specific 
cases where the interests of the Community are 
involved, refer the matter to the Committee for the 
application of the procedure laid down in Article 21 
before reaching a decision on a request for a marketing 
authorization or on the suspension or revocation of an 
authorization, or on any other amendment to the terms 
of a marketing authorization which appears necessary, 
in particular to take account of the information 
collected in accordance with Chapter Via of this 
Directive. 
The Member State concerned or the Commission shall 
clearly identify the question which is referred to the 
Committee for consideration and shall inform the 
person responsible for marketing. 
The Member States and the person responsible for 
marketing shall forward to the Committee all available 
information relating to the matter in question. 
Article 21 
1. When reference is made to the procedure 
described in this Article, the Committee shall consider 
the matter concerned and issue a reasoned opinion 
within 90 days of the date on which the matter was 
referred to it. 
In case of urgency, on a proposal from its Chairman, 
the Committee may agree to impose a shorter 
deadline. 
2. In order to consider the matter, the Committee 
may appoint one of its Members to act as rapporteur. 
The Committee may also appoint individual experts to 
advise it on specific questions. When appointing 
experts, the Committee shall define their tasks and 
specify the time limit for the completion of these 
tasks. 
3. In the cases referred to in Articles 18 and 19, 
before issuing its opinion, the Committee shall provide 
the person responsible for marketing with an 
opportunity to present written or oral explanations. 
In the case referred to Article 20, the person responsible 
for placing the medicinal product on the market may be 
asked to explain himself orally or in writing. 
If it considers it appropriate, the Committee may invite 
any other person to provide information relating to the 
matter before it. 
The Committee may suspend the time limit referred to 
in paragraph 1 in order to allow the person responsible 
for marketing to prepare explanations. 
31. 12. 90 Official Journal of the European Communities No C 330/29 
4. Where the opinion of the Committee is that: 
— the application does not satisfy the criteria for 
authorization set out in this Directive, or 
— the summary of product characteristics proposed by 
the applicant in accordance with Article 5a should 
be amended, or 
— the labelling or package of the product is not in 
compliance with Chapter VII, or 
— the authorization should granted subject to 
conditions, or 
— an existing marketing authorization should be 
suspended amended or withdrawn, 
the Agency shall forthwith inform the person 
responsible for marketing. Within 15 days of the receipt 
of the opinion, the person responsible for marketing 
may provide written notice to the Agency that the 
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 5. 
5. Within 30 days of its adoption, the Agency shall 
forward the final opinion of the Committee to the 
Commission the Member States and the person 
responsible for marketing together with a report, 
describing the assessment of the veterinary medicinal 
product and the reasons for its conclusions. 
In the event of an opinion in favour of granting or 
maintaining an 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 5a; 
(b) 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 veterinary 
medicinal product may be made available to 
users; 
(c) the draft text to the labelling and package leaflet, 
proposed by the applicant presented in accordance 
with Chapter VII. 
Article 22 
1. Within 30 days of the receipt of the opinion of the 
Committee, 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 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 21 (4), 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 2b and 2c of 
Directive 81/852/EEC. 
5. A Decision adopted in accordance with this 
procedure shall be addressed to the Member States 
concerned by the matter and to the person responsible 
for marketing. The Member States shall either grant or 
withdraw marketing authorization, or make any 
adjustment to the terms of a marketing authorization 
which may be necessary to comply with the Decision 
within 30 days of its notification. They shall inform the 
Commission and the Committee thereof. 
Article 23 
Any application by the person responsible for 
marketing to amend the terms of a marketing 
authorization which has been granted in accordance 
with the provisions of this Chapter shall be submitted to 
all the Member States which have previously authorized 
the medicinal product concerned. 
The Agency shall, in consultation with the 
Commission, adopt appropriate arrangements for the 
examination by the Committee of amendments or 
variations to a marketing authorization which has been 
granted in accordance with the provisions of this 
Chapter. 
No C 330/30 Official Journal of the European Communities 31. 12. 90 
The procedures laid down in Articles 21 and 22 shall 
apply mutatis mutandis to variations and amendments 
of marketing authorizations. 
Article 23a 
1. Where a Member State considers that the 
amendment of the terms of a marketing authorization 
which has been granted in accordance with the 
provisions of this Chapter or its suspension or 
withdrawal is necessary, the Member State concerned 
shall forthwith refer the matter to the Committee for the 
application of the procedures laid down in Article 21 
and and 22. 
2. In exceptional cases, where action is urgently 
necessary to protect human or animal health or the 
environment, until a definitive Decision is adopted, the 
Member States suspend the use of the veterinary 
medicinal product concerned on its territory. It shall 
inform the Commission no later than the following 
working day of the reasons for its action. 
Article 23b 
Articles 23 and 23a shall apply mutatis mutandis to 
medicinal products authorized by Member States 
following an opinion of the Committee given in 
accordance with Article 4 of Directive 87/22/EEC 
before 1 January 1993. 
Article 23c 
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 date referred to in the first 
subparagraph of Article 4 (1), 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 of its submission.' 
10. The third subparagraph of paragraph 1 of Article 30 is 
replaced by the following: 
'In the case of veterinary medicinal products imported 
from a third country, where appropriate arrangements 
have been made by the Community with the exporting 
country to ensure that the manufacturer of the 
veterinary medicinal product applies standards of good 
manufacturing practice at least equivalent to those laid 
down by the Community and to ensure that the controls 
referred to under (b) have been carried out in the 
exporting country, the qualified person may be relieved 
of responsibility for those controls.' 11. The following Chapter Via is inserted after 
Article 42: 
'CHAPTER Vfc 
Pharmacovigilance 
Article 42a 
In order to ensure the adoption of appropriate 
regulatory Decisions concerning the continued 
authorization of veterinary medicinal products within 
the Community, having regard to information obtained 
about adverse reactions to veterinary medicinal 
products under practical conditions of use, the Member 
States shall establish a pharmacovigilance system for 
collecting information about adverse reactions to 
veterinary medicinal products and for the scientific 
evaluation of such information. 
Article 42b 
For the purpose of this Directive, the following 
definitions shall apply: 
— 'adverse reaction' shall mean a reaction which is 
noxious and unintended and which occurs at doses 
normally used in animals in accordance with the 
terms of the marketing authorization for the 
prophylaxis, diagnosis or therapy of disease or for 
the modification of physiological function, 
— 'serious adverse reaction' shall mean an adverse 
reaction which results in death, permanent or 
prolonged signs or lesions in treated animals. 
Article 42c 
The person responsible for marketing 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 at a single point; 
(b) the preparation and submission to the competent 
authorities of the reports referred to in Article 42d, 
in such form as may be laid down by those 
authorities; 
(c) ensuring that any request from the competent 
authority 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 
for the veterinary medicinal product concerned, 
where relevant. 
Article 42d 
1. The person responsible for marketing shall be 
required to record and to report all suspected serious 
31. 12. 90 Official Journal of the European Communities No C 330/31 
adverse reaction which are brought to his attention by a 
qualified veterinarian to the competent authorities 
within 15 days of their receipt. 
2. In addition, the person responsible for marketing 
shall be required to maintain detailed records of all 
other adverse reactions which are reported to him by a 
veterinarian health care professional. Unless other 
requirements have been laid down as a condition of the 
granting of authorization, these records shall be 
submitted to the competent authorities 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 42 e 
The Member States shall take all appropriate measures 
to encourage veterinarians to report adverse reactions 
to the competent authority. 
The Member States may impose specific requirements 
on veterinarians, in particular in respect of the 
reporting of serious or unexpected adverse reactions, or 
where such reporting is a condition of the marketing 
authorization. 
Article 42/ 
The Member States shall ensure that report of serious 
adverse reactions are brought to the attention of the 
Agency and the person responsible for marketing 
within 15 days of their receipt. 
Article 42g 
In order to facilitate the exchange of information about 
pharmacovigilance within the Community, 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 42h 
Where as a result of the evaluation of adverse reaction 
reports, a Member State is considering amending the 
terms of a marketing authorization or its suspension or 
withdrawal, it shall forthwith inform the Agency. 
In case of urgency, the Member State concerned may 
suspend the marketing of a medicinal product, 
provided the Agency is informed at the latest on the 
following working day.' 
Article 2 
In Directive 81/852/EEC, the Committee referred to in 
Article 2b is thereby renamed 'the Standing Committee on 
Veterinary Medicines'. 
Article 3 
Member State shall take all appropriate measures to comply 
with the provisions of this Directive, with the exception of 
Article 1 (6), before 1 January 1993. They shall forthwith 
inform the Commission thereof. 
Member State shall take all appropriate measures to comply 
with Article 1 (6) of this Directive before 1 January 1996. 
They shall forthwith inform the Commission thereof. 
When Member States adopt these provisions, these shall 
contain a reference to this Directive or shall be accompanied 
by such reference at the time of their official publication. The 
procedure for such reference shall be adopted by Member 
States. 
Article 4 
This Directive is addressed to the Member States.