Decision documents for new products, parallel imports, variations and renewals

Certain approval decisions are no longer signed by the MPA. This applies to both new products including parallel imports, as well as variations and renewals.

Transition to electronic formats. Approval decisions may be sent electronically by the MPA. The paper version of the decision will in these cases be replaced by an electronic document.

Approval decisions not to be signed. Decisions regarding new products including parallel imports, variations and renewals which are in compliance with the request of the applicant will not be signed by the MPA. In order to avoid the questioning of the validity of such a decision, the following information will be stated on all decisions: “The Swedish Medical Products Agency does not sign approval decisions. This does not affect the decision’s validity”.

Rejection decisions (complete or partial rejection of an application) will henceforth be submitted in paper versions and signed by the MPA.

A weekly list of decisions are published here (in Swedish):

 Beslut om nya godkännanden 


 

 
 
 
 

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