Delayed implementation of EU's new pharmaceutical legislation in the EEA EFTA states

The European Union has passed considerable changes in its pharmaceutical legislation, and its member states will implement this legislation in national law at the latest October 30th 2005.

Before these changes can be implemented into Norwegian law, the changes have to be made part of the EEA-agreement. The process of admitting these changes in the EEA-agreement has taken longer than expected, and it is probable that these changes will not be implemented in our legislation until the second half of 2006.

The Norwegian Medicines Agency will do our best to ensure that the existing situation will create as few problems as possible for the participants in the industry. We will do our best to come up with practical solutions to ensure Norwegian participation in the procedures after October 30th 2005. The Medicines Agency will in that respect work to ensure that our legislation regarding data protection will be harmonized as far as possible with the EU’s new legislation from October 30th 2005. This will be done within the limits that follow of Directive 2001/83/EC, which is part of the EEA-agreement.

The Norwegian Medicines Agency is aware of the fact that the participants in the industry may have the need to clarify questions that as a consequence follow the fact that the pharmaceutical legislation in Norway will not be changed at the time earlier presumed after all. Therefore, we will in the best way possible try to answer questions of current interest, in connection with the “profession day” arranged by the Norwegian industry association (the LMI) and the Norwegian Medicines Agency on October 12th 2005. A summary of the answers will be published at our website www.legemiddelverket.no after the “profession day”. As later clarifications follows, these answers will also be published on our websites.

Sist gjennomgått: 28.10.2005
Første gang publisert: 27.09.2005