Synthon, Escitalopram & Memantine: legal consequences of the RMS/CMS-position

1. Synthon, Escitalopram & Memantine: legal consequences of the RMS/CMS-position Court Cases about Procedures with NL as RMS/CMS head of Policy and Legal Affairs

2. Synthon case • ECJ 2008: Is it possible to refuse application for mutual recognition on the ground that the medicinal product in question is not essentially similar to the reference product referred to in that marketing authorisation? • The existence of a risk to public health constitutes the only ground that a Member State is entitled to rely on to object to the recognition of a marketing authorisation granted by another Member State.

3. Lessons • Member States cannot call into question, on grounds other than those relating to the risk to public health, the assessments carried out by the reference Member State. • Recognition subject to a second assessment of all or part of the application for authorisation would deprive the mutual recognition procedure of all meaning and seriously compromise the objectives of community law such as the free movement of medicinal products.

4. Escitalopram • The Court of Haarlem considered that the MEB should have investigated, whether Lexapro should have been considered as New Active Substance (NAS). Moreover, the Marketing Authorisation should have been withdrawn and not suspended. • The court ruled that the MEB was never able to judge, whether Lexapro could be considered as a NAS, nor did itself investigate it.

5. Relevant facts • In Annex 3 of the Notice to Applicants is stipulated that a single enantiomer could be considered as a new active substance if it differs in properties with regard to safety and/or efficacy. • The MEB deemed in its decision of 25 February 2010 that the data, which was submitted for Lexapro, that the differences between the products Cipramil and Lexapro were not clinically relevant.

6. Lessons to be learned? • In Annex 3 of the notice to applicants is stipulated that a single enantiomer could be considered as a new active substance if it differs in properties with regard to safety and/or efficacy. • The MEB deemed in its decision of 25 February 2010 that the data, which was submitted for Lexapro, that the differences between the products Ciprimil and Lexapro were not clinically relevant.

7. Memantine • The court ruled that article 28, paragraph 5 Directive 2001/83/EC nor the protection of legitimate expectations and legal certainty, does not rule out that the Reference Member State can revise its Assessment Report on the basis of new information. • The court ruled that the reference member state should make a judgement on the legality of the MA and that its judgement can be based on information provided by the competent authority.

8. Lessons to be learned? This case contains two important elements: • The MEB is allowed to revise its assessment report after finalisation of the DCP. • A MA not granted according to the provisions of Directive 65/65/EC or Directive 2001/83/EC can not be used as a reference product.

9. Conclusion We have to trust each other as competent authorities, unless we have information we are not allowed to do so

10. Thanks for your attention! d.slijkerman@cbg-meb.nl