Keywords

Summary



Keywords

1 Approximation of laws - Proprietary medicinal products - Marketing authorisation - Revocation of authorisation - Discretion of the national authorities - Judicial review - Limits

(Council Directive 65/65)

2 Approximation of laws - Proprietary medicinal products - Marketing authorisation - Revocation of authorisation - Discretion of the national authorities - Judicial review - Obligation to take into account scientific material coming to light after the adoption of the revocation decision - No such obligation

(Council Directive 65/65)

3 Approximation of laws - Proprietary medicinal products - Marketing authorisation - Revocation of authorisation - Committee for Proprietary Medicinal Products - Opinion not issued within the prescribed time-limit - No effect on the power of national authorities to adopt a revocation decision

(Council Directives 65/65 and 75/319, as amended by Directive 83/570)

Summary

1 Neither Directive 65/65 relating to proprietary medicinal products nor, more generally, Community law requires Member States to establish a procedure for judicial review of national decisions revoking authorisations to market proprietary medicinal products, empowering the competent national courts and tribunals to substitute their assessment of the facts and, in particular, of the scientific evidence relied on in support of the revocation decision for the assessment made by the national authorities competent to revoke such authorisations.

Directive 65/65 does not lay down detailed rules for the exercise of the right of recourse against national decisions revoking marketing authorisations for proprietary medicinal products; it thus leaves to the Member States the task of organising their own systems of judicial review of such decisions. In the case of these decisions, which are taken by the competent national authorities following complex assessments in the medico-pharmacological field, it does not appear that the only appropriate means of preventing the exercise of rights conferred by Community law from being rendered virtually impossible or excessively difficult would be a procedure for judicial review empowering the competent national courts and tribunals to substitute their assessment of the facts - and, in particular, of the scientific evidence relied on in support of the revocation decision - for the assessment made by the competent national authorities. Where a Community authority is called upon, in the performance of its duties, to make complex assessments, it enjoys a wide measure of discretion, the exercise of which is subject to a limited judicial review in the course of which the Community judicature may not substitute its assessment of the facts for the assessment made by the authority concerned.

Consequently, Community law does not require the Member States to establish a procedure for judicial review of national decisions revoking marketing authorisations - taken pursuant to Directive 65/65 and in the exercise of complex assessments - which involves a more extensive review than that carried out by the Court in similar cases.

2 Community law does not require a national court or tribunal which is seised of an application for annulment of a decision revoking a marketing authorisation for a particular proprietary medicinal product to take into account, when determining that application, any relevant scientific material coming to light after the adoption of that decision.

A system of judicial review whereby the national courts are to determine applications for annulment of such decisions without taking into account relevant scientific material coming to light after the adoption of the contested decision is not such as to render virtually impossible or excessively difficult the exercise of the rights conferred by Directive 65/65 relating to proprietary medicinal products, since, in the event of new material coming to light following the adoption of a decision revoking a marketing authorisation, the person concerned will still be able to make a fresh application for authorisation.

6 Directives 65/65 and 75/319 relating to proprietary medicinal products, as amended by Directive 83/570, are to be construed as meaning that, where the matter has been referred by various Member States to the Committee for Proprietary Medicinal Products following the adoption by the competent national authority of a decision revoking a marketing authorisation and where the time-limit for the issue by that Committee of its opinion has expired, those directives do not preclude that authority from deciding to revoke the marketing authorisation in question without awaiting the opinion of the Committee for Proprietary Medicinal Products.

The opinion of the Committee is in no way binding. Moreover, since the issue is one of public health, Member States cannot be required to await the Committee's opinion, even after the period allowed for its production has expired, before deciding to withdraw a medicinal product that may prove to be harmful to public health, the protection of which constitutes the primary objective of Directive 65/65.