Keywords

Summary



Keywords

Approximation of laws - Proprietary medicinal products - Directive 65/65 - Marketing authorisation - Medicinal product that has been authorised in several Member States - Withdrawal of authorisation in a Member State following grant of authorisation for a new version of the medicinal product containing the same active ingredients and having the same therapeutic effects - Importation into that Member State of the previous version of the medicinal product under a simplified procedure as compared with the procedure provided for by the directive and applicable to parallel imports - Whether permissible - Conditions

(Council Directive 65/65)

Summary

$$Where it is sought to import medicinal product X from Member State A into Member State B, it is permissible for the person who proposes to place the imported product upon the market in Member State B to seek and obtain a parallel import licence from the competent authority in Member State B, without complying with all the requirements of Directive 65/65 relating to medicinal products, under a simplified procedure provided for in Member State B under which the applicant needs to provide less information than is required for an application for a marketing authorisation made in accordance with Directive 65/65 if:

- medicinal product X is the subject of a marketing authorisation granted in Member State A and was the subject of a marketing authorisation which has ceased to have effect in Member State B;

- medicinal product Y is the subject of a marketing authorisation granted in Member State B, but is not the subject of a marketing authorisation granted in Member State A;

- medicinal product X has the same active ingredients and therapeutic effect as medicinal product Y, but does not use the same excipients and is manufactured by a different manufacturing process, where the competent authority in Member State B is in a position to verify that medicinal product X complies with the requirements relating to quality, efficacy and safety in normal conditions of use and is in a position to ensure normal pharmacovigilance;

- the marketing authorisations referred to above were granted to different members of the same group of companies and the manufacturers of medicinal products X and Y are also members of that group of companies; and

- companies within the same group as the holder of the marketing authorisation for product X which has been withdrawn in Member State B continue to manufacture and market product X in Member States other than Member State B.

In such a situation, the competent authority is not required to take into consideration the fact that medicinal product Y was developed and introduced in order to provide a particular benefit to public health which medicinal product X does not provide and/or that that particular benefit to public health would not be achieved if product X and product Y were both on the market in Member State B at the same time.

National authorities must not obstruct parallel imports by requiring parallel importers to satisfy the same requirements as those which are applicable to undertakings applying for the first time for a marketing authorisation for a medicinal product, provided that an exception of that kind to the rules normally applicable to marketing authorisations for medicinal products does not undermine the protection of public health.