Keywords

Summary



Keywords

1 Approximation of laws - Veterinary medicinal products - Application for marketing authorisation - Information and documents to be provided by the applicant - Right of the competent authority to impose requirements other than those imposed by Directives 81/851 and 81/852 - None - Request for further information - Suspension of the time-limit for granting authorisation - No obligation to state reasons for the request

(Council Directive 81/851, Arts 5, second para., 8, 9, point 3, and 40, and Council Directive 81/852, Annex, Part 1(C))

2 Approximation of laws - Veterinary medicinal products - Application for marketing authorisation - Information and documents to be provided by the applicant - Right of the competent authority to exempt the applicant from compliance with the requirements of Directive 81/851 - None

(Council Directive 81/851, Art. 5)

3 Approximation of laws - Veterinary medicinal products - Application for marketing authorisation - Information and documents to be provided by the applicant - Requirements imposed by Directives 81/851 and 81/852 - Breach of the principle of proportionality - None - Compatible with Articles 30 to 36 of the Treaty

(EC Treaty, Arts 30 to 36; Council Directive 81/851, Article 5, second para., points 3, 4 and 9, and Council Directive 81/852, Annex, Part I(A), (B) and (C))

4 Approximation of laws - Veterinary medicinal products - Application for marketing authorisation - Information and documents to be provided by the applicant - Rules laid down by Directives 81/851 and 81/852 - Infringement by a Member State - Obligation to make reparation for damage caused to individuals - Conditions - Manner of ensuring reparation - Application of national law - Limits

(Council Directives 81/851 and 81/852)

Summary

5 The second paragraph of Article 5 of Directive 81/851 relating to veterinary medicinal products, read in conjunction with the other provisions of that directive and Directive 81/852 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, must be interpreted as not authorising the competent authority to require particulars and documents other than those expressly listed in that provision, as set out in detail in the Annex to Directive 81/852. More particularly, the competent authority is not authorised to require an applicant for marketing authorisation

- to disclose the name(s) and address(es) of the manufacturer(s) of the substance used in the manufacture of one of the active ingredients of the veterinary medicinal product concerned and information concerning the manufacturing site(s), unless disclosure of that information constitutes the only reliable means of obtaining a particular required by Directives 81/851 and 81/852;

- to disclose the results of tests carried out on each batch of the substance with a view to approval thereof; or

- to purchase the active ingredient from a specified third party.

Part 1(C) of the Annex to Directive 81/852 does, however, allow particulars to be required of the manufacturing process and control testing methods used by the manufacturer of a starting material. In that regard, it is for the national court to determine whether the substance in question is a starting material within the meaning of the first paragraph of that provision. If it is not, such particulars may nevertheless be required in so far as the features of the process by which the starting material is manufactured from the substance are such that no other means of assessing the purity of the starting material is available.

Moreover, where, under Article 9, point 3, of Directive 81/851, the competent authority requires an applicant for a marketing authorisation to provide further information on the matters referred to in Article 5 of that directive, the time-limits for granting the authorisation laid down in Article 8 of the directive are suspended until that information has been provided. Furthermore, such a request need not state the reasons on which it is based, given that Article 40 of the directive, concerning the obligation to state reasons, applies only to decisions to withhold, withdraw or suspend marketing authorisation.

Finally, the fact that the process by which a medicinal product is manufactured is continuous or other than continuous does not affect the foregoing findings.

6 An application for marketing authorisation for a veterinary medicinal product must fulfil all the conditions laid down in Article 5 of Directive 81/851 for the issue of an authorisation. Consequently, the competent authority is not authorised to exempt an applicant for marketing authorisation from providing a particular or document required under Article 5 of Directive 81/851 even if it appears practically impossible, in a given case, to obtain that information.

7 The Council did not manifestly exceed the limits of its discretion by adopting the provisions in points 3, 4 and 9 of the second paragraph of Article 5 of Directive 81/151 and Part I(A), (B) and (C) of the Annex to Directive 81/852 in so far as they require an applicant for a marketing authorisation for a veterinary medicinal product to provide particulars of the manufacturing process and the control testing methods employed by the manufacturer of a substance used in the manufacture of one of the active ingredients of the medicinal product concerned. There is thus nothing to indicate that those provisions infringe the principle of proportionality.

Directives 81/851 and 81/852 are also, as regards the information and documents required in relation to an application for authorisation, compatible with Articles 30 to 36 of the Treaty. First, the harmonisation of national procedures for the issue of marketing authorisations is designed to eliminate hindrances to the free movement of veterinary medicinal products. Second, even if the stringent requirements imposed by those directives in themselves constitute restrictions, there is nothing to indicate that they are not justified by the safeguarding of public health, which is the essential objective of both directives.

8 A Member State is required to make good loss and damage caused to an applicant for marketing authorisation for a veterinary medicinal product as a result of requests for information and requirements which infringe Directives 81/851 and 81/852 where the rule of Community law infringed is intended to confer rights on individuals, the breach is sufficiently serious and there is a direct causal link between that breach and the damage sustained by the individuals concerned. Subject to that reservation, it is on the basis of rules of national law on liability that the State must make reparation for the consequences of the loss and damage caused by a breach of Community law for which it can be held responsible, with the proviso that the conditions laid down by the applicable national legislation must not be less favourable than those relating to similar domestic claims and must not be so framed as to make it in practice impossible or excessively difficult to obtain reparation.