Renewals of marketing authorisations

A marketing authorisation for medicinal products is valid for five years. Thereafter the authorisation holder can apply for renewal of the marketing authorisation by means of a renewal application.

In most cases, one renewal after five years is sufficient and the authorisation will then be valid until further notice. The authority may however, due to safety reasons, decide that a further renewal is required.
No fee apply for renewal applications.

Date for submitting an application

A renewal application must be received by the 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 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 Medical Products Agency has no legal possibility to extend the deadline for submitting a renewal application.

The date for submitting a renewal application may be brought forward on agreement with the Medical Products Agency. A request for bringing forward the renewal date must be received by the Medical Products Agency by post or e-mail (via the address RIC@mpa.se) and must specify the reasons why the applicant wishes to bring forward the renewal date.

Documentation that must be included in the application

An application must contain documentation regarding the efficacy, safety and quality (including detailed pharmacovigilance data) as well as a list of all changes made since the first authorisation or last renewal.

The documentation that must be included in the application is specified in the guideline for renewals of medicinal products for human use, ”Guideline on the processing of renewals in the mutual recognition and decentralised procedure”, and in the guideline for renewals of veterinary medicinal products, ”Guideline on the processing of renewals in the mutual recognition procedure for veterinary medicinal products”. The guidelines are available to the right under the heading Guidelines.

Other information

If a renewal application for a product is still under investigation at the Medical Products Agency when it is time to submit a new renewal application in accordance with the five year period, such a new renewal application is not required, unless the Medical Products Agency decides otherwise during the course of the ongoing investigation.

Further information, guidelines and application forms for renewal applications are available to the right.

 
 
 

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