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Internal Market

Medical products: Iceland fails to implement rules



The EFTA Surveillance Authority today delivered two reasoned opinions to Iceland for failure to implement two directives on medical products. The Directives should have been implemented into national law, respectively, by 1 March 2010 and 23 December 2009.

Directive 2005/28/EC applies to clinical trials of “investigational medicinal products”, i.e. medicines which are being developed for human use. The Directive lays down the principles of good clinical practice, the requirements for authorisation of the manufacture or importation of investigational medicinal products and the documentation relating to clinical trials, archiving, qualifications of inspectors and inspection procedures.

Directive 2004/24/EC lays down a regulatory approval process for traditional herbal medicines within the EEA. It provides for a special simplified registration procedure for traditional herbal medicinal products provided that they comply with the Directive.

The purpose of a reasoned opinion is to give the State in question a last chance to take corrective measures before the Authority decides whether to bring the matter before the EFTA Court. Iceland has been given two months to take the measures necessary to comply with the three reasoned opinions. 


For further information, please contact:


Ms Tuula Nieminen
Deputy Director, Internal Market Affairs Directorate
Tel. (+32)(0)2 286 1867

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