Renewal application

A renewal application for a medicinal product for human use must be received by the MPA at the latest nine months before the end of the five year period (i.e. the renewal date). A renewal application for a veterinary medicinal product must be received by the MPA at the latest six months before the end of the five year period (i.e. the renewal date).

If an application is received too late the approval ceases to be valid and the medicinal product cannot be marketed in Sweden. There is no legal possibility for the MPA to grant a deferral.

The MPA recommends that the documentation included in the application are in accordance with the renewal guideline ”CMDh BEST PRACTICE GUIDE ON THE PROCESSING OF RENEWALS IN THE MUTUAL RECOGNITION AND DECENTRALISED PROCEDURES” for human medicinal products. The guideline can be found on the CMDh:s webpage.

The application form “Application for Renewal of a Marketing Authorisation” from the European Commission can be used. The application form can be found on the MPAs webpage MPAs webpage or the Commissions webpage.

Additional information can be found on the MPAs webpage Medicinal-products/Renewals.

 
 
 

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