30.4.2004   

EN

Official Journal of the European Union

C 118/7

1.

Products cannot be regarded as essentially similar for the purposes of the application of Article 4.8(a)(i) or (iii) of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products, as amended by Council Directives 87/21/EEC of 22 December 1986, 89/341/EEC of 3 May 1989, and 93/39/EEC of 14 June 1993, where they are not bioequivalent.

2.

For the purposes of the procedure laid down by Article 4.8(a)(i) and (iii) of Directive 65/65, as amended, in determining the pharmaceutical form of a medicinal product, account must be taken of the form in which it is presented and the form in which it is administered, including the physical form. In that context, medicinal products such as those at issue in the main proceedings, which are presented in the form of a solution to be mixed in a drink for administration to the patient and which, after mixing, form, respectively, a macroemulsion, a microemulsion and a nanodispersion, are to be treated as having the same pharmaceutical form, provided that the differences in the form of administration are not significant in scientific terms.

3.

The proviso, that is, the hybrid abridged procedure laid down by the final subparagraph of Article 4.8(a) of Directive 65/65, as amended, applies to applications for marketing authorisation based on Article 4.8(a)(i) or (iii).

An application for marketing authorisation for a medicinal product may be made under the proviso, that is, by the abridged hybrid procedure provided for in the final subparagraph of Article 4.8(a) of Directive 65/65, as amended, with reference to an authorised medicinal product provided that the medicinal product in respect of which marketing authorisation is sought is essentially similar to the authorised medicinal product, unless one or more of the differences set out in the proviso apply, as the case may be.

4.

In considering an application for marketing authorisation for a new product C under Article 4.8(a)(iii) of Directive 65/65, as amended, with reference to a product A authorised for more than six or 10 years, the competent authority of a Member State is entitled, with a view to granting marketing authorisation, to refer without the consent of the person responsible for marketing to data submitted in support of a product B which was authorised within the previous six or 10 years under the hybrid abridged procedure laid down by Article 4.8(a) of Directive 65/65, as amended, with reference to product A, where those data consist of clinical trials provided in order to demonstrate that product B, though suprabioavailable to product A when administered in the same dose, is safe.

5.

In considering two hybrid applications for marketing authorisation for products B and C brought under the final subparagraph of Article 4.8(a) of Directive 65/65, as amended, and referring to product A, the competent authority of a Member State does not infringe the principle of non-discrimination where, as a precondition for the grant of marketing authorisation, it requires full clinical data on the bioavailability of product B, but, having examined the data filed in support of product B, does not require the same data for product C.