Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The Global Marketing Authorisation according to Article 6 of Directive 2001/83/EC, as amended ***

Sabine Wägele (Abschlußjahr: 2007)

Language: English

With coming into force of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use as amended a new regulatory concept has been introduced into the European legislation the global marketing authorisation according to Article 6 (1).

When a medicinal product has been granted a marketing authorisation in accordance with the first subparagraph, any additional strengths, pharmaceutical forms, administration routes, presentations, as well as any variations and extensions shall also be granted an authorisation in accordance with the first subparagraph or be included in the initial marketing authorisation. All these marketing authorisations shall be considered as belonging to the same global marketing authorisation, in particular for the purpose of the application of Article 10 (1).

The object of this Master Thesis is to examine this new concept of global marketing authorisation according Article 6 (1) of Directive 2001/83/EC, as amended, from two different perspectives: on the one hand with regard to the legislation previous to Directive 2001/83/EC, as amended and several judgements from the European Court of Justice, based on that legal basis, on the other hand its impact on miscellaneous Articles within the current regulatory environment as laid down in Directive 2001/83/EC, as amended.

When adopting Directive 2001/83/EC, the European Parliament and the Council followed several decisions from the European Court of Justice that have been issued on the basis of the legislation into force at the time of the ruling. There are four judgements that had a significant influence leading to the current wording of Articles 6, 10 (1), 10 (2) and 10 (3) of Directive 2001/83/EC, as amended, and a common understanding of regulatory aspects such as essential similarity, data protection, or the abridged application procedure for medicinal products. These judgements are the Generics Case, C-368/96, the Novartis Case, C-106/01, the Eli Lilly Case, C-36/03 and the SmithKline Beecham Case, C-74/03.

For the purpose to reach a common understanding about the regulation of the above mentioned regulatory aspects, the incorporation of the concept of global marketing authorisation according Article 6 (1) into pharmaceutical legislation, in connection with the adoption of Article 10 (1), Article 10 (2) and Article 10 (3), seems to be obvious.

Nevertheless, it implicates basis for discussion, since the impact on the regulatory environment has to be considered. This means, it has to be seen in context with all other regulatory requirements being relevant for a marketing authorisation as defined before coming into force of Article 6 (1) of Directive 2001/83/EC, as amended and not restricted to Article 10 (1).
The meaning of miscellaneous Articles within Directive 2001/83/EC, such as Articles 8 (1) in connection with Article 25 of the German Drug Law, Article 17, Article 18, Article 28 and Article 35 is currently not precise enough. The concept of marketing authorisation mentioned in these Articles can be interpreted both, as ′'global marketing authorisation′' or as ′'marketing authorisation in the conventional meaning′'. But since there is a difference between marketing authorisations in the context of proceeding applications including their life-cycle management and a marketing authorisation in the context of data protection and market exclusivity periods according Article 10 (1), this induces space for interpretation of these Articles.

Even more relevant issues touched by introducing the concept of global marketing authorisation are the ones of Articles 10 (1), 10 (3), 10 (5), 10a, 23a and 24, 104, as well as Annex II of Regulation (EC) No 1084/2003 and the issue of transfer of marketing authorisation. When reading and interpreting Articles 10 (1), 10 (3), 10 (5) and 10a before the background of the new concept of global marketing authorisation the main question arising is, how to apply the provisions for data protection and market exclusivity for these different application procedures. With regard to Articles 23a, 24 and 104 the question is, how to apply the different requirements and time lines of the Sunset Clause, for Renewals and for PSUR-submissions.

There is no doubt that there is a need for clarification of these issues either by the CMD(h), the EMEA or, when not addressed in time, the European Court of Justice. Maybe, at the end, pharmaceutical legislation, respectively Directive 2001/83/EC, will have to be amended once more due to the experiences made.

Pages: 58