Keywords

Summary



Keywords

1. Approximation of laws — Proprietary medicinal products — Marketing authorisation — Abridged procedure — Essentially similar products — Waiver of the obligation to provide the results of pharmacological and toxicological tests or of clinical trials — Application for a marketing authorisation for a generic medicinal product — Reference medicinal product — Product marketed — Assessment criterion — (Council Directive 65/65, Art. 4, third para., point 8, second indent, (a)(iii))

2. Approximation of laws — Proprietary medicinal products — Marketing authorisation — Abridged procedure — Essentially similar products — Waiver of the obligation to provide the results of pharmacological and toxicological tests or of clinical trials — Application for a marketing authorisation for a generic medicinal product — Reference medicinal product — Necessary for marketing authorisation for that product to be in force at the date of the application — (Council Directive 65/65, Art. 4, third para., point 8, second indent, (a)(iii))

Summary

1. Point 8, second indent, (a)(iii) of the third paragraph of Article 4 of Directive 65/65, relating to proprietary medicinal products, as amended by Directive 93/39, which permits recourse to an abridged procedure for the issue of authorisation to place medicinal products on the market where the product for which such authorisation is sought is essentially similar to a product which has been authorised within the Community, in accordance with the Community provisions in force, for not less than 6 or 10 years and is marketed in the Member State for which the application is made must be interpreted as meaning that "product ... marketed" refers to a medicinal product which has been granted a marketing authorisation in the Member State concerned. In order to be able to grant a marketing authorisation for a generic medicinal product on the basis of the abridged procedure laid down in the provision at issue, what matters is that all the particulars and documents relating to the reference medicinal product remain available to the competent authority for the Member State where the application for the marketing authorisation is made and not that the reference medicinal product has in fact been placed on the market.

see paras 27, 29, operative part 1

2. Point 8, second indent, (a)(iii) of the third paragraph of Article 4 of Directive 65/65, relating to medicinal products, as amended by Directive 93/39, which permits recourse to an abridged procedure for the issue of authorisation to place medicinal products on the market where the product for which such authorisation is sought is essentially similar to a product which has been authorised within the Community, in accordance with the Community provisions in force, for not less than 6 or 10 years and is marketed in the Member State for which the application is made must be interpreted as meaning that in order to be able to grant a marketing authorisation for a generic medicinal product on the basis of the abridged procedure laid down in that provision, it is necessary and sufficient that the marketing authorisation of the reference medicinal product be in force in the Member State concerned on the date of that application.

see para. 58, operative part 2