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Internal Market: Norway given final warning for delays in authorising medicinal products

6.7.2011

PR(11)49
Today, the EFTA Surveillance Authority delivered a reasoned opinion, a final warning, to Norway concerning its consistent failure to issue authorisations for medicinal products within the deadlines required under EEA law.[1]


At the beginning of the Authority's proceedings in this case, the delays in the authorisation amounted up to eight months. At present they are lowered to approximately two months depending on the type of procedure. Norway has explained that the relevant Norwegian Medicines Agency is understaffed and cannot deal with the applications in time.

As a basic principle, medicinal products have to be authorised before introduced in an EEA State. The consequences of the delays of authorisations are that the producers of medicinal products cannot predict the launching of their products on the Norwegian market. This makes it impossible to participate e.g. in public tenders of hospitals and leads in general to high financial losses. Furthermore, patients do not have access to the new medication during these times of delays.

The reasoned opinion constitutes a final warning to Norway. Norway has been given two months to organise its working procedures in a way to be generally able to issue authorisations within the set deadlines. If this problem cannot be solved by Norway, the Authority may bring the matter before the EFTA Court.

 

For further information, please contact:

 

Mr.Xavier Lewis
Director, Legal & Executive Affairs Directorate
tel. (+32)(0)2 286 18 30

 

 



[1] See Directive 2001/83 on the Community code relating to medicinal products for human use and Regulation 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products.




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