3.1 When should an application for renewal be submitted to the Medical Products Agency (MPA)?
A renewal application shall be received by the MPA six months before the end of the five year period (i.e. the renewal date) at the latest. If an application is received too late there is no legal possibility for the MPA to grant renewal of the marketing authorisation. This means that the marketing authorisation will automatically cease to be valid when the renewal date has passed, and that further sale is forbidden. The MPA has no legal possibilities to grant postponement for submission of a renewal application.
The process for renewal applications is about to be changed (see article 24.2 of EU Directive 2001/83/EG to be amended by Directive 2010/84/EU). The new rules, expected to be effective 21 July 2012, require applications to be submitted no later than nine months prior to the renewal date.
Further information about the new procedure will be communicated at a later date.
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.
For nationally authorised products already renewed once before it is sufficient if the marketing authorisation holder ensures that the documentation according to the renewal guideline is available and can be submitted to the MPA upon request. A special application form for this kind of application is available.
The application forms are available via our website:
Renewals
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.