3. Renewal

3.1 When should an application for renewal be submitted to the Swedish Medical Products Agency (MPA)?

A renewal application must be received by the Swedish Medical Products Agency (Läkemedelsverket) no later than nine months before the renewal date for medicinal products for human use, and six months before the renewal date for veterinary medicinal products. The Swedish Medical Products Agency cannot extend the validity of an authorisation if the renewal application is received too late. This means that the authorisation expires automatically when the renewal date has passed and continued sale is prohibited. The Swedish Medical Products Agency has no legal possibility to extend the deadline for submitting a renewal application.

3.2 Is it possible to request an earlier renewal date?

The renewal date might be changed if this is agreed upon with the MPA. A request should be submitted to the MPA by post or email (using the address RIC@mpa.se) and should include a justification of why the renewal application should be made earlier than the original renewal date.

3.3 Which application form should be used for a renewal of a nationally authorised product?

The same renewal application form is used as for products authorised via the Mutual recognition/Decentralised procedure or the Centralised procedure.

3.4 What is the fee for an application for renewal?

There is no separate fee for an application for renewal. It is included in the annual fee.

 
 

Contact us

Adam Andersson
adam.andersson@mpa.se

 

   
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information