Committee Reports::Report No. 25 - Studies of Veterinary Medicinal Products::08 November, 1978::Report



1. The Joint Committee has examined the Commission’s proposals [R/1238/76 (ECO 105)] for Council Directives on the approximation of the laws of Member States relating to—

Veterinary medicinal products,

Analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products.

2. A Council Working Party, after several meetings, has completed its examination of the proposed Directives. They will now go to COREPER for submission to the Council. A decision by the latter is expected within three or four months.

Outline of Commission’s Proposals

3. The first draft Directive, which defines the products to which both Directives would apply, prohibits the marketing or administration of these products unless authorised by a competent national authority. Specific authorisation would also be required for the manufacture of these products or their import from third countries. Other provisions deal with labelling and package insert, the obligations of Member States regarding enforcement and the establishment of a Committee for Veterinary Medicinal Products to supervise the operation of the Directive. According to the latest draft of the proposals, Member States would be required to adopt the provisions within two years but a phasing-in period of ten years would be allowed during which these provisions would be progressively applied to products already on the market.

4. The second draft Directive specifies the requirements to be met for obtaining the required authorisation. In particular, it contains detailed provisions regarding the tests to be carried out.

General Views of the Joint Committee

5. The Joint Committee accepts that the functioning of the common market necessitates the approximation of national laws relating to veterinary medicinal products. In view of the importance of the agricultural industry in the Irish economy, it considers that whatever Community legislation is adopted should conform to the highest practicable standards. In light of these considerations the Committee readily accepts the principles on which the Commission’s proposals are based.

6. The system of control proposed in the first draft Directive seems unusually elaborate and appears designed for more advanced and sophisticated facilities for the manufacture of veterinary preparations than obtain in Ireland. The Joint Committee would have preferred if the phasing-in period of 15 years originally proposed by the Commission were allowed so as to enable smaller firms to adapt to the system. However, it understands that a 10 year phasing-in period is the maximum likely to command general acceptance.

7. The Joint Committee has also been concerned by the possible effect on farming costs. It is advised that national systems of control either existing or contemplated in the United Kingdom and Holland, which are the main sources of our imports, would have been likely to affect prices in any event and that the adoption of the Directive is unlikely in itself to influence costs substantially.

8. In general, therefore, the proposed Directive is acceptable to the Joint Committee but it wishes to comment specifically on a number of its provisions.

Products Covered by Draft Directive

9. The first draft Directive would prohibit the administration to animals of a veterinary preparation for which an authorisation has not been issued by the competent authority. This prohibition is apparently intended to apply to preparations specially compounded for the occasion by a veterinary surgeon if intended for more than one animal. The Committee believes that this provision would extend bureaucratic control to quite an unreasonable degree and it is totally opposed to it. If a veterinary surgeon, called in to treat a number of animals, decided to use a preparation compounded by himself, the Committee believes that his professional and contractual obligations should be sufficient safeguard against abuse.

10. The draft Directive would also seem to prohibit the administration to animals of medicine acceptable for the treatment of humans unless specifically authorised for the purpose. The Joint Committee understands that an amendment may be adopted to ensure that this prohibition would not apply in the case of animals not intended ultimately for human consumption. The result of its own enquiries would suggest to the Joint Committee that even with this amendment the provision is difficult to justify.

Tests, Labelling and National Control

11. The Pharmaceutical, Chemical and Allied Industries Association raised with the Joint Committee (i) the need for furnishing particulars of special tests in seeking authorisations, (ii) the requirement that particulars of tracer substances be included on labels and (iii) the possible exclusion of well known substances the safety of which has been demonstrated from the obligations of part 2 of the Annex to the second draft Directive. The Committee’s enquiries in relation to these points reveal that (a) reference to special tests is included by way of explanation only and does not impose a binding obligation, (b) the requirement regarding tracer substances is not mandatory but one within the discretion of the national authority and (c) amendments to the second draft Directive may go some way at least to meet the Association’s point of view.

12. The Irish Farmers’ Association suggested to the Joint Committee that there should be “no antibiotic residues in milk or meat designated for human consumption”. The Joint Committee understands that it is proposed to include in the first draft Directive by way of amendment a provision that “pending Community rules, the competent authorities may refuse to grant authorisation for a veterinary medicinal product where this is necessary for the protection of public health, consumers or animal health”. If this is accepted, the matter raised by the Association would appear to fall within the competence of the national authorities to control.


14. The Joint Committee when considering these proposals received considerable help from the Pharmaceutical, Chemical and Allied Industries Association, Irish Farmers’ Association, the Veterinary Council and the Irish Veterinary Association. It wishes to express its sincere thanks to those bodies.


Chairman of the Joint Committee.

8th November, 1978.