10. 3. 89 Official Journal of the European Communities No C 61/11 
Proposal for a Council Directive amending Directive 81/8 51 /EEC on the approximation of the 
laws of the Member States relating to veterinary medicinal products 
COM(88) 779 final — SYN 189 
(Submitted by the Commission on 10 January 1989) 
(89/C 61/08) 
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 Article 23 (2) of Council Directive 
81/8 51/EEC (l) provides that the Commission should 
submit to the Council a proposal containing appropriate 
measures leading towards the elimination of any 
remaining barriers to trade or to the free movement of 
veterinary medicinal products not later than four years 
after the implementation of the abovementioned 
Directive; 
Whereas the Directives on the approximation of laws 
relating to veterinary medicinal products must be 
adapted to scientific progress and improved to take 
account of the experience acquired since their adoption; 
Whereas it is necessary, from the point of view of public 
health and the free movement of veterinary medicinal 
products, for the competent authorities to have at their 
disposal all useful information on authorized veterinary 
medicinal products in the form of approved summaries 
of the characteristics of products; 
Whereas the approximation of laws brought about in this 
connection must enable a veterinary medicinal product, 
manufactured and marketed in one Member State on the 
basis of harmonized provisions, to be allowed into 
another Member State, taking due consideration of the 
initial authorization, save in exceptional cases submitted 
for a binding opinion to the Committee for Veterinary 
Medicinal Products set up by Directive 81/851 /EEC; 
Whereas the system for leaflets accompanying veterinary 
medicinal products should be improved; Whereas it is advisable to stipulate more precisely the 
cases in which the results of pharmacological and toxico-
logical tests or clinical trials do not have to be provided 
with a view to obtaining authorization for a veterinary 
medicinal product which is essentially similar to an inno­
vative product, while ensuring that innovative firms are 
not placed at a disadvantage; whereas, however, there 
are reasons of public policy for not repeating tests 
carried out on animals without over-riding cause; 
Whereas the guarantees of the quality of veterinary 
medicinal products manufactured within the Community 
should be maintained by requiring compliance with the 
principles of good manufacturing practice for medicinal 
products irrespective of the final destination of the 
products; 
Whereas the Commission should be empowered to 
define in detail the principles of good manufacturing 
practice for veterinary medicinal products in close 
cooperation with the Committee for Adaptation to 
Technical Progress of the Directive on the Removal of 
Technical Barriers to Trade in the Veterinary Medicinal 
Products Sector established by Article 2c of 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 (2), as amended by 
Directive 87/20/EEC (3); 
Whereas measures should be taken to improve the 
provision of information for third countries about the 
conditions of use of veterinary medicinal products within 
the Member States and the Community; 
Whereas measures should be taken to ensure that 
distributors of veterinary medicinal products are auth­
orized by Member States and maintain adequate records, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Directive 81/851/EEC is hereby amended as follows: 
1. In Article 1 (2), the first indent is replaced by the 
following: 
'— "veterinary medicinal product" means any 
medicinal product intended for animals. 
(') OJ No L 317, 6. 11. 1981, p. 1. O OJ No L 317, 6. 11. 1981, p. 16. 
O OJ No L 15, 17. 1. 1987, p. 34. 
No C 61/12 Official Journal of the European Communities 10. 3. 89 
However products or substances which are 
intended for long-term use by oral adminis­
tration to healthy animals for nutritional 
purposes shall not be considered as veterinary 
medicinal products.' 
2. Article 1 (5) is replaced by the following: 
'5. Member States shall take all necessary 
measures to ensure that no person shall have on his 
premises or under his control any substance which 
may be used as a veterinary medicinal product unless 
expressly authorized under the legislation of the 
Member State concerned. 
For the purposes of implementing this provision, 
Member States shall maintain a register of producers 
and dealers and other persons who are permitted to 
be in possession of active substances which may be 
used in the manufacture of veterinary medicinal 
products which are available only on veterinary pre­
scription. Such persons shall be required to maintain 
detailed records of all dealings in active substances 
which may be used in the manufacture of veterinary 
medicinal products and to make these records 
available for inspection by the competent authorities 
for a period of at least three years. 
Before the date of implementation of this Directive, 
Member States shall communicate to the 
Commission a list of the veterinary medicinal 
products which are available without veterinary pre­
scription.' 
3. In Article 2, the fourth indent of paragraph 2 is 
deleted. 
4. Article 4 is replaced by the following: 
'Article 4 
1. No veterinary medicinal product may be 
marketed in a Member State unless authorization 
has previously been granted by the competent 
authority of that Member State. 
2. No veterinary medicinal product may be 
administered to animals unless the authorization 
referred to above has been issued, except for the 
tests of veterinary medicinal products referred to in 
point 10 of Article 5 which have been notified to or 
approved by the competent national authorities in 
accordance with the national rules in force. 
3. However Member States may permit veterinary 
medicinal products prepared extemporaneously by a 
veterinarian or in a pharmacy in accordance with the 
terms of a veterinary prescription or an official 
formula to be administered to a particular animal or 
a small number of animals by a veterinarian or under 
his direct personal responsibility. 
Moreover, Member States may permit the adminis­
tration to animals of: — veterinary medicinal products authorized for use 
in the Member State concerned in accordance 
with the provisions of this Directive for use in 
another animal species', 
— medicinal products which have been authorized 
for use in the Member State concerned in 
human beings in accordance with the provisions 
of Council Directive 65/65/EEC of 26 January 
1965 on the approximation of provisions laid 
down by law, regulation or administrative action 
relating to proprietary medicinal products ('), 
which have been prescribed by a veterinarian, 
provided that the animals to be treated have been 
examined by the veterinarian personally and the 
veterinarian concludes that there is no authorized 
therapy which will be effective for the treatment of 
the animals concerned. The veterinarian shall be 
required to maintain adequate records of the date of 
examination of the animals, the clinical diagnosis, 
the medicinal products prescribed, the dosages 
administered, the duration of treatment and the 
withdrawal periods recommended, and to make 
these records available for inspection by the 
competent authorities for a period of at least three 
years. 
Where the administration of such medicinal products 
to food-producing animals is permitted, the veter­
inarian shall be responsible for ensuring that the 
withdrawal period applied is sufficient to ensure that 
foodstuffs derived from treated animals do not 
contain any residues which might constitute a health 
hazard for the consumer. 
4. Notwithstanding paragraph 2, Member States 
shall ensure that veterinarians providing services in 
another Member State can take with them and 
administer to animals under their direct care small 
quantities of veterinary medicinal products other 
than immunological veterinary medicinal products 
which are not authorized for use in the Member 
State in which the services are provided (host 
Member State), providing that the following 
conditions are satisfied: 
(a) The marketing authorization provided for in 
paragraph 1 has been granted by the competent 
authorities of the Member State in which the 
veterinarian is established. 
(b) The veterinary medicinal products are trans­
ported by the veterinarian in the original manu­
facturer's packaging. 
(c) In the case of veterinary medicinal products 
intended for administration to food-producing 
animals, the products carried have the same 
qualitative and quantitative composition in terms 
of active principles as products authorized in 
accordance with paragraph 1 for use in the host 
Member State. 
10. 3. 89 Official Journal of the European Communities No C 61/13 
(d) Prior to the administration of the products to 
animals, the veterinarian shall be required to 
ascertain the conditions for use of the corre­
sponding veterinary medicinal products in the 
host Member State, including the withdrawal 
period, and the veterinarian shall be required to 
take all measures incumbent upon him to ensure 
that the rules applying in the host Member State 
are complied with. 
(e) The veterinarian shall not furnish any veterinary 
medicinal product to the owner or keeper of the 
animals treated in the host Member State unless 
this is permissible on the basis of Community 
law or the law of the Member State concerned. 
(f) The veterinarian shall be required to keep 
detailed records of the animals treated, the 
clinical diagnosis, the veterinary medicinal 
products administered, the dosage administered, 
the duration of treatment and the withdrawal 
period applied. These records shall be available 
for inspection by the competent authorities for a 
period of at least three years. 
(g) The overall range and quantity of veterinary 
medicinal products carried by the veterinarian 
shall not exceed that generally required by good 
veterinary practice. 
(') OJ No 22, 9. 2. 1965, p. 369/65.' 
5. Article 5 is replaced by the following: 
'Article 5 
For the purpose of obtaining the authorization 
provided for in Article 4, the person responsible for 
marketing shall lodge an application with the 
competent authority of the Member State. 
The following particulars and documents shall be 
provided by the applicant: 
1. Name or corporate name and permanent address 
or registered place of business of the person 
responsible for marketing and, if different, of 
the manufacturer or manufacturers involved and 
of the sites where manufacturing operations are 
carried out. 
2. Name of the veterinary medicinal product 
(brand name, non-proprietary name, with or 
without a trademark or name of the manu­
facturer; scientific name or formula, with or 
without a trademark or name of the manu­
facturer). 
3. Qualitative and quantitative particulars of all the 
constituents of the veterinary medicinal product, 
using the usual terminology but not empirical 
chemical formula and giving the international 
non-proprietary name recommended by the 
World Health Organization, if such a name 
exists. 4. Description of the method of preparation. 
5. Therapeutic indications, contra-indications and 
side-effects. 
6. Dosage for the various species of animal for 
which the veterinary medicinal products 
intended, its pharmaceutical form, method and 
route of administration and proposed shelf life. 
7. If applicble, reasons for any precautionary and 
safety measures to be taken for the storage of 
the product, during its administration to 
animals, and for the disposal of waste products, 
together with an indication of any potential risks 
presented by the product to the environment and 
the health of humans, animals or plants. 
8. Indication of the withdrawal period necessary 
between the last administration of the veterinary 
medicinal product to animals under normal 
conditions of use and the production of food­
stuffs from such animals in order to ensure that 
such foodstuffs do not contain any residues 
which might constitute a health hazard to the 
consumer. Where necessary, and in particular in 
the case of veterinary medicinal products 
containing an active substance not previously 
used in veterinary medicine, which are the 
subject of a request for marketing authorization 
in the Member States concerned for the first 
time, the applicant shall propose and justify a 
tolerance level for residues which may be 
accepted in foodstuffs without risk for the 
consumer, together with appropriate validated 
analytical detection methods. 
9. Description of the control testing methods 
employed by the manufacturer (qualitative and 
quantitative analysis of the constituents and the 
finished product, specific tests, e.g. sterility tests, 
test for the presence of pyrogens, for the 
presence of heavy metals, stability tests, bio­
logical and toxicity tests, tests on intermediate 
products). 
10. Results of: 
— physico-chemical, biological or microbio­
logical tests, 
— toxicological and pharmacological tests, 
— clinical trials. 
However, and without prejudice to the law 
relating to the protection of industrial and 
commercial property: 
(a) The applicant shall not be required to 
provide the results of toxicological and 
No C 61/14 Official Journal of the European Communities 10. 3. 89 
pharmacological tests and clinical trials if he 
can demonstrate: 
(i) either that the veterinary medicinal 
product is essentially similar to a 
product authorized in the country 
concerned by the application and that 
the person responsible for the marketing 
of the original veterinary medicinal 
product has consented to the toxico-
logical, pharmacological or clinical 
references contained in the file on the 
original veterinary medicinal product 
being used for the purpose of examining 
the application in question, 
(ii) or by detailed references to the 
scientific literature presented in 
accordance with the second paragraph 
of Article 1 of Directive 81/852/EEC 
that the constituent or constituents of 
the veterinary medicinal product have a 
well established medicinal use, with 
recognized efficacy and an acceptable 
level of safety, 
(iii) or that the veterinary medicinal product 
is essentially similar to a product which 
has been authorized within the 
Community, in accordance with the 
Community provisions in force, for not 
less than ten years and is marketed in 
the Member State for which the 
application is made. 
(b) In the case of new veterinary medicinal 
products containing known constituents not 
hitherto used in combination for therapeutic 
purposes, the results of toxicological and of 
pharmacological tests and of clinical trials 
relating to that combination must be 
provided, but it shall not be necessary to 
provide references relating to each individual 
constituent. 
11. A summary in accordance with Article 5a of the 
product characteristics, one or more specimens 
or mock-ups of the sales presentation of the 
veterinary medicinal product together with a 
package insert where one is to be enclosed. 
12. A document showing that the manufacturer is 
authorized in his own country to produce 
veterinary medicinal products. 
13. Any marketing authorization for the relevant 
veterinary medicinal product which may have 
been obtained in another Member State or in a 
third country together with a list of those 
countries to which an application for marketing 
authorization has been made and an explanation 
of the reasons for which any Member State or 
third country has refused to grant authorization 
for the veterinary medicinal product concerned.' 6. The following Article 5a is inserted: 
'Article 5a 
The summary of the product characteristics referred 
to in point 11 of the second paragraph of Article 5 
shall contain the following information: 
1. Name of the veterinary medicinal product, 
2. Qualitative and quantitative composition in terms 
of the active ingredients and constituents of the 
excipient, knowledge of which is essential for 
proper administration of the medicinal product; 
the international non-proprietary names re­
commended by the World Health Organization 
shall be used, where such names exist, or failing 
this, the usual common name or chemical 
description. 
3. Pharmaceutical form. 
4. Pharmacological properties and, in so far as this 
information is useful for therapeutic purposes, 
pharmacokinetic particulars. 
5. Clinical particulars: 
5.0. target species, 
5.1. therapeutic indications, specifying the target 
species, 
5.2. contra-indications, 
5.3. undesirable effects (frequency and 
seriousness), 
5.4. special precautions for use, 
5.5. use during pregnancy and lactation, 
5.6. interaction with other medicaments and 
other forms of interaction, 
5.7. posology and method of administration, 
5.8. overdose (symptoms, emergency pro­
cedures, antidotes) (if necessary), 
5.9. special warnings for each target species, 
5.10. withdrawal periods, 
5.11. special safety precautions to be taken by the 
person administering the product to 
animals. 
6. Pharmaceutical particulars: 
6.1. Incompatibilities (major), 
6.2. shelf life, when necessary after recon-
stitution of the product or when the 
container is opened for the first time, 
6.3. special precautions for storage, 
6.4. nature and contents of container, 
6.5. name or style and permanent address or 
registered place of business of the holder of 
the marketing authorization, 
6.6. special precautions for the disposal of 
unused product or waste materials, if any.' 
10. 3. 89 Official Journal of the European Communities No C 61/15 
7. The following Article 5b is inserted: 
'Article 5b 
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.' 
8. The last paragraph of Article 7 is amended as 
follows: 
'The experts' detailed reports shall form a part of the 
documentation which the applicant shall lodge with 
the competent authorities. A brief curriculum vitae of 
the expert shall be appended to each expert report.' 
9. Point 2 of Article 9 is replaced by the following: 
'2. may submit the medicinal product, its active prin­
ciples and its necessary intermediate products or 
other constituent materials for testing by a State 
laboratory or by a laboratory designated for that 
purpose, in order to ensure that the control 
testing methods employed by the manufacturer 
and described in the application documents, in 
accordance with point 9 of the second paragraph 
of Article 5, are satisfactory.' 
10. Article 14 is replaced by the following: 
'Article 14 
1. After an authorization has been issued, the 
person responsible for placing the product on the 
market must, in respect of the control methods 
provided for in point 9 of the second paragraph of 
Article 5, take account of technical and scientific 
progress and introduce any changes that may be 
required to enable the veterinary medicinal product 
to be checked by means of generally accepted 
scientific methods. These changes must be accepted 
by the competent authorities of the Member States 
concerned. 
2. The person responsible for marketing shall 
forthwith inform the competent authorities of any 
new information which might entail the amendment 
or further examination of the particulars and 
documents referred to in Article 5 or the approved 
summary of the product characteristics referred to in 
Article 5b. In particular the person responsible for 
marketing shall forthwith inform the competent 
authorities of any prohibition or restriction imposed 
by the competent authorities of any country in which 
the veterinary medicinal product is marketed and of 
any serious unexpected reaction occuring in animals 
or human beings. 3. The person responsible for marketing shall be 
required to maintain records of all reported 
suspected adverse reactions arising in animals and 
human beings. For the purpose of this provision, a 
failure of the veterinary medicinal product to achieve 
the expected therapeutic effect shall be considered 
an adverse reaction. These records shall be kept for 
at least five years and shall be made available to the 
competent authorities upon request. 
4. The person responsible for marketing shall 
immediately inform the competent authorities, with a 
view to authorization, of any alteration he proposes 
to make to the particulars and documents referred to 
in Article 5.' 
11. Chapter IV is replaced by the following: 
'CHAPTER IV 
Committee for Veterinary Medicinal Products 
Article 16 
1. In order to facilitate the adoption of a common 
position by the Member States with regard to 
decisions on the issue of marketing authorizations 
and to promote thereby the free movement of 
veterinary medicinal products, 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. 
2. The Committee's task shall be to examine, at 
the request of a Member State or the Commission 
and in accordance with Articles 17 to 22, questions 
concerning the application of Articles 11, 36 and 49. 
3. The Committee shall draw up its own rules of 
procedure. 
Article 17 
1. In order to make it easier to obtain a marketing 
authorization in at least two other Member States 
taking into due consideration an authorization 
issued in one Member State in accordance with 
Article 4, the holder of the latter authorization may 
submit an application to the competent authorities of 
the Member States concerned together with the 
information and documents referred to in Articles 5, 
5a and 5b. He shall testify to its identity with the 
dossier accepted by the first Member State, spec­
ifying any additions it may contain, and 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 send it a copy of 
this authorization. He shall also inform the Member 
State which granted him the initial authorization and 
No C 61/16 Official Journal of the European Communities 10. 3. 89 
notify it of any additions to the original dossier; that 
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 which it took its decision. 
3. The holder of the marketing authorization shall 
notify the dates on which the dossiers were sent to 
the Member States concerned. As soon as the 
Committee has noted that all the Member States 
concerned are in possession of the dossier, it shall 
forthwith inform all the Member States and the 
applicant of the date on which the last Member State 
concerned received the dossier. The Member State(s) 
concerned shall either grant the authorization valid 
for their markets within a period of 120 days of the 
aforementioned date, taking into due consideration 
the authorization issued within the meaning of 
paragraph 1, or put forward a reasoned objection. 
Article 18 
1. Where a Member State considers that it is 
unable to grant a marketing authorization, it shall 
forward to the Committee and to the person 
responsible for placing the veterinary medicinal 
product on the market its reasoned objection in 
accordance with Article 11, within the time limits 
stipulated in Article 17 (3). 
2. Upon the expiry of this period, the matter shall 
be referred to the Committee and the procedure 
referred to in Article 21 shall be applied. 
3. On receipt of the reasoned objection referred 
to in paragraph 1, the person responsible for placing 
the product on the market shall immediately send 
the Committee a copy of the particulars and 
documents enumerated in Article 17(1). 
Article 19 
If several applications submitted in accordance with 
Articles 5 and 5a have been made for a marketing 
authorization for a particular veterinary medicinal 
product, and one or more Member States have 
granted an authorization while one or more of the 
other Member States have refused it, one of the 
Member States concerned or the Commission may 
refer the matter to the Committee for application of 
the procedure referred to in Article 21. 
The same shall apply where one or more Member 
States have suspended or revoked a marketing auth­
orization while one or more Member States have not 
done so. In both cases, the person responsible for placing the 
veterinary medicinal product on the market shall be 
informed of any decision of the Committee to apply 
the procedure laid down in Article 14. 
Article 20 
The competent authorities of Member States may, in 
specific cases where the interests of the Community 
are involved, refer the matter to the Committee 
before reaching a decision on a request for a 
marketing authorization or on the suspension or 
revocation of an authorization. 
Article 21 
1. The competent authorities shall draw up an 
assessment report and comments on the dossier as 
regards the results of the analytical and toxico-phar-
macological tests on, and clinical trials of, any 
veterinary medicinal products containing a new 
active substance which are the subject of a request 
for a marketing authorization in the Member States 
concerned for the first time. 
2. As soon as the notification referred to in 
Article 17 is received, the competent authorities shall 
immediately communicate to the Member States 
concerned any assessment report accompanied by a 
summary of the dossier relating to a particular 
veterinary medicinal product. This report shall also 
be communicated to the Committee where a matter 
is referred to the Committee pursuant to Article 18. 
The assessment report shall also be forwarded to the 
other Member States concerned and to the 
Committee as soon as a matter is referred to the 
Committee under the procedure laid down in Article 
19. Any assessment report so forwarded shall remain 
confidential. 
The competent authorities shall bring the assessment 
report up to date as soon as it is in possession of 
information which is of importance for the 
evaluation of the balance between effectiveness and 
risk. 
Article 22 
1. Where reference is made to the procedure 
described in this Article, the Committee shall 
consider the matter concerned and issue a reasoned 
opinion within 60 days of the date on which the 
matter was referred to it. 
In the case referred to in Article 18 the person 
reponsible for placing the product on the market 
may, at his request, explain himself orally or in 
writing and provide additional information before 
the Committee issues its opinion. The Committee 
may extend the time limit referred to in the 
preceding paragraph to give the applicant time to 
explain himself orally or in writing. 
In the case referred to in Article 19, the person 
responsible for placing the product on the market 
may be asked to explain himself orally or in writing. 
10. 3. 89 Official Journal of the European Communities No C 61/17 
2. The Committee's opinion shall concern the 
grounds for the objection provided for in Article 
18(1) and the grounds on which the marketing auth­
orization has been refused, suspended or withdrawn 
in the cases described in Article 19. 
The Committee shall immediately inform the 
competent authorities and the person responsible for 
placing the product on the market of its opinion. 
3. The competent authorities shall implement the 
opinion of the Committee with 60 days of its receipt. 
4. Where an application for marketing authori­
zation is submitted in respect of a product which is 
the subject of an opinion of the Committee and the 
competent authorities have reasons for not applying 
the opinion of the Committee, they shall forthwith 
request the Committee to reconsider its opinion, in 
accordance with the procedure laid down in this 
Chapter. 
Article 23 
The Commission shall report to the Council and the 
European Parliament every two years on the 
operation of the procedure laid down in this 
Chapter.' 
12. Article 24 (1) is replaced by the following: 
'1. Member States shall take all appropriate 
measures to ensure that the manufacture of 
veterinary medicinal products is subject to the 
holding of an authorization. This manufacturing 
authorization shall be required notwithstanding that 
the veterinary medicinal products manufactured are 
intended for export.' 
13. The following Article 24a is inserted: 
'Article 24a 
At the request of the manufacturer, the exporter or 
the authorities of an importing third country, 
Member States shall certify that a manufacturer of 
veterinary medicinal products is in possession of the 
authorization referred to in Article 24. When issuing 
such certificates, Member States shall comply with 
the following conditions: 
1. Member States shall have regard to the prevailing 
administrative arrangements of the World Health 
Organization. 
2. For veterinary medicinal products intended for 
export which are already authorized on their 
territory, they shall supply the summary of the 
product characteristics as approved in accordance 
with Article 5b or, in the absence thereof, an 
equivalent document. Where the manufacturer is not in possession of a 
marketing authorization, he shall provide the auth­
orities responsible for establishing the certificate 
referred to in the first paragraph with a declaration 
explaining why no marketing authorization is 
available.' 
14. In Article 27, the following is added: 
'(f) comply with the principles and the guidelines of 
good manufacturing practice for medicinal 
products laid down by Community law.' 
15. In Article 27, the following is added: 
(g) maintain detailed records of all veterinary 
medicinal products supplied by him to whole­
salers or, where this is permitted by the laws of 
the Member State concerned, to retailers, veteri­
narians or farmers. The following information 
shall be recorded in respect of each transaction, 
whether or not it is made for payment: 
— date, 
— name of the veterinary medicinal product 
— quantity supplied, 
— name and address of the recipient. 
These records shall be available for inspection by 
the competent authorities for a period of three 
years. 
16. The following Article 27a is inserted: 
Article 27a 
The principles and guidelines of good manufacturing 
practices for medicinal products referred to in 
Article 27 (f) should be adopted in the form of a 
Directive addressed to Member States in accordance 
with the procedure laid down in Article 2c of 
Council Directive 81/852/EEC, after taking into 
consideration the specific nature of veterinary 
medicinal products; detailed guidelines shall be 
published by the Commission and revised as appro­
priate to take into consideration scientific and 
technical progress.' 
17. In Article 34: 
— The first paragraph is replaced by the following: 
'The competent authority of the Member State 
concerned shall ensure by means of repeated 
inspection that the legal requirements relating to 
veterinary medicinal products are complied with.' 
— The following third paragraph is added: 
No C 61/18 Official Journal of the European Communities 10. 3. 89 
'The officials representing the competent 
authority shall report after each of the 
inspections mentioned in the first paragraph on 
whether the manufacturer complies with the 
principles and guidelines of good manufacturing 
practice laid down by Community law. The 
manufacturer shall be informed of the content of 
such reports and shall be entitled to request a 
second inspection.' 
18. In Article 39, the following second paragraph is 
added: 
'Upon reasoned request, Member States shall 
forthwith communicate the reports referred to in the 
third paragraph of Article 34 to the competent auth­
orities of another Member State. If, after considering 
the reports, the Member State receiving the reports 
considers that it cannot accept the conclusions 
reached by the competent authority of the Member 
State in which the report was established, it shall 
inform the competent authority concerned of its 
reasons and may request further information. In the 
case of prolonged disagreement between Member 
States, the Member State(s) shall inform the 
Commission.' 
19. Article 42 becomes Article 42(1) and the following 
paragraphs are added: 
'2. The person responsible for the marketing of a 
veterinary medicinal product shall be obliged to 
notify the Member States forthwith of any action 
taken by him to suspend the marketing of a product 
or to withdraw a product from the market, together 
with the reasons for such action. Member States 
shall ensure that this information is brought to the 
attention of the Committee forthwith. 
3. Member States shall ensure that appropriate 
information about actions taken pursuant to para­
graphs 1 and 2 which may effect the protection of 
health in third countries is forthwith brought to the 
attention of the relevant international organizations, 
with a copy to the Committee.' 
20. In the first paragraph of Article 43, points 2, 7 and 8 
are replaced by the following, and the following 
point 9a is inserted: 
'2. A statement of the active ingredients expressed 
qualitatively and quantitatively per dosage unit 
or according to the form of administration for a 
particular volume or weight, using the interna­
tional non-proprietary names recommended by 
the World Health Organization, where such 
names exist, or where no such names exist, the 
usual common names. 7. The withdrawal period, even if this is nil, in the 
case of veterinary medicinal products admin­
istered to food-producing animals. 
8. Expiry date, in plain language. 
9a. Special precautions for disposal of unused 
product or waste material, if any.' 
21. In Article 48, the first paragraph is replaced by the 
following: 
'The inclusion of a package insert in the packaging 
of veterinary medicinal products shall be obligatory 
unless all the information required by this Article can 
be conveyed on the packaging itself. Member States 
shall take all appropriate measures to ensure that the 
information included on a package insert of a 
veterinary medicinal product relates solely to the 
veterinary medicinal product concerned.' 
22. In the second paragraph of Article 48, point (e) is 
replaced by the following and the following point 
(h) is added: 
'(e) the withdrawal period, even if this is nil, in the 
case of veterinary medicinal products admin­
istered to food-producing animals: 
(h) special precautions for the disposal of unused 
product or waste materials, if any.' 
23. The final paragraph of Article 48 is deleted. 
24. The following Chapter VIII is inserted: 
'CHAPTER VIII 
Distribution of veterinary medicinal products 
Article 51 
1. Member States shall take all appropriate 
measures to ensure that wholesale dealing in 
veterinary medicinal products is subject to the 
holding of an authorization and to ensure that the 
time taken for the procedure for granting this auth­
orization does not exceed 90 days from the date on 
which the competent authority receives the 
application. 
2. In order to obtain the authorization referred to 
in paragraph 1, the applicant shall have at his 
disposal suitable and sufficient premises complying 
with the legal requirements laid down in the 
Member State concerned as regards the storage and 
handling of products. 
10. 3. 89 Official Journal of the European Communities No C 61/19 
3. The holder of the authorization referred to in 
paragraph 1 shall be required to maintain detailed 
records. The following information shall be recorded 
in respect of each incoming or outgoing transaction: 
(a) date; 
(b) name of the veterinary medicinal product; 
(c) name of the manufacturer; 
(d) manufacturers batch number, expiry date; 
(e) quantity received or supplied; 
(f) name and address of the supplier or recipient. 
At least once a year, a detailed audit shall be carried 
out, and incoming and outgoing supplies shall be 
reconciled with supplies currently held in stock and 
any discrepancies recorded. 
These records shall be available for inspection by the 
competent authorities for a period of three years. 
4. Member States shall take all appropriate 
measures to ensure that wholesalers supply 
veterinary medicinal products only to persons 
permitted to carry out retail activities in accordance 
with the provisions of Article 52, or to other persons 
who are lawfully permitted to receive veterinary 
medicinal products from wholesalers. 
Article 52 
1. Member States shall take all appropriate 
measures to ensure that the retail supply of 
veterinary medicinal products is conducted only by 
persons who are expressly permitted to carry out 
such operations by the legislation of the Member 
State concerned. 
2. Any retailer of veterinary medicinal products 
shall be required to maintain detailed records. The 
following information shall be recorded in respect of 
each incoming or outgoing transaction: 
(a) date; 
(b) name of the veterinary medicinal product; 
(c) name of the manufacturer; 
(d) manufacturers batch number, expiry date; 
(e) quantity received or supplied; 
(f) name and address of the supplier or recipient; 
(g) name and address of the prescribing veterinarian 
if any, date of prescription. At least one a year, a detailed audit shall be carried 
out, and incoming and outgoing supplies shall be 
reconciled with supplies currently held in stock and 
any discrepancies recorded. 
These records shall be available for inspection by the 
competent authorities for a period of three years. 
However, Member States may dispense retailers of 
veterinary medicinal products from the obligation to 
maintain detailed records in respect of products 
supplied by them in small transactions for the 
treatment of companion animals such as cats, dogs, 
aquarium fish, cage birds, homing pigeons, terrarium 
animals and small rodents provided that such 
products do not contain substances the use of which 
requires veterinary control and all possible measures 
have been taken to prevent the unauthorized use of 
the products for other animals. 
Article 53 
Where, in accordance with the legislation of a 
Member State, a person responsible for marketing a 
veterinary medicinal product is permitted to supply 
samples of the product directly to a veterinarian or 
other authorized person, the veterinarian or other 
authorized person shall be required to maintain the 
records referred to in Article 52 (2) in respect of 
medicines received and subsequently supplied by 
him, whether or not such supply is made for 
payment.' 
25. Chapter VIII becomes Chapter IX and Articles 51, 
52 and 53 become Articles 54, 55 and 56 
respectively. 
Article 2 
1. Member States shall take the necessary measures to 
comply with this Directive not later than 1 January 1992. 
They shall forthwith inform the Commission thereof. 
2. Requests for marketing authorization lodged from 
the date set out in paragraph 1 must comply with the 
provisions of this Directive. 
3. Within four years of the date set out in paragraph 
1, Article 1 where relevant, shall be progressively 
extended to existing veterinary medicinal products. 
Article 3 
This Directive is addressed to the Member States.