Masterstudiengang "Drug Regulatory Affairs"


The Special Role of Norway and Iceland in Regulatory Affairs as EEA but not EU Members (To be or not to be "a full member" - that is the question) ***

Dr. Svenja Johannsen (Abschlußjahr: 2013)

Language: English

The European Economic Area (EEA) is a single market with one legal framework established by the EEA Agreement which came into force on 1 January 1994. In May 2013 the EEA comprises the 27 European Union (EU) Member States and the three European Free Trade Association (EFTA) Member States Norway, Iceland and Liechtenstein. By signing the EEA Agreement, Norway and Iceland consented to implement the crucial European legislation, the Community aquis, into national law in order to gain access to the European market and European programmes. Detailed information on medicinal products is contained in Chapter XIII of Annex II to the EEA Agreement.

For different steps during the life cycle of a medicinal product - from conducting clinical studies to obtaining and maintaining a marketing authorisation - information found in European legislation and guidance documents, in the EEA Agreement and on the Norwegian Medicines Agency’s (NoMA) and Icelandic Medicines Agency’s (IMA) homepages, has been evaluated in order to investigate, whether Norway and Iceland participate in procedures and have the same obligations and rights as EU Member States.

It was found that Norway and Iceland participate in all different types of procedures, Committees and the Co-ordination Group for Mutual Recognition and Decentralised Procedures   human (CMDh). They contribute e.g. as Rapporteur and Co Rapporteur in the Centralised Procedure (CP) and for Paediatric Investigation Plans (PIP), as Reference Member State (RMS) in the Decentralised Procedure (DCP) and the Mutual Recognition Procedure (MRP) and as Rapporteur and RMS in renewal and variation procedures. Both countries have the same obligations as EU Member States regarding e.g. the granting and maintaining of marketing authorisations.

Nevertheless, there are important differences in comparison with EU Member States as Norway and Iceland do not have the right to start an arbitration procedure as Concerned Member State (CMS) nor are their representatives allowed to vote and thus influence the opinion and recommendation of the respective Committee and CMDh directly. New EU legislation needs to be incorporated into the EEA Agreement prior to the implementation into Norwegian and Icelandic law which results in a timeshift in the implementation which leads to regulatory insecurities in the interim.

Therefore, it could be demonstrated that the obligations of Norway and Iceland are equal while their rights are unequal to those of the EU Member States with regard to regulatory affairs. Compared with EU Member States, Norway and Iceland can thus not be considered as “full members”.

Total Pages: 86