Renewals of marketing authorisations
- Published: May 26, 2020
- Last updated: October 16, 2023
A marketing authorisation for human 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 applies for renewal applications.
According to the Veterinary Medicinal Products Regulation (EU) 2019/6, marketing authorisations for veterinary medicinal products are granted with unlimited validity, with the exception of marketing authorisations granted under the legal basis “limited markets” and “exceptional circumstances”. The follow-up of veterinary marketing authorisations granted under the legal basis “limited markets” and “exceptional circumstances” is however conducted via other procedure types than renewal procedures. Renewal applications are therefore not applicable for veterinary medicinal products.
Date for submitting an application
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.
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 Swedish Medical Products Agency. A request for bringing forward the renewal date must be received by the Swedish Medical Products Agency by post or email and must specify the reasons why the applicant wishes to bring forward the renewal date.
Email: RIC@lakemedelsverket.se
Documentation that must be included
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".
The principles and documentation requirements detailed in the abovementioned CMDh Best Practice Guide are also applied for national marketing authorisations.
Information regarding document requirements and renewal applications for centrally authorised marketing authorisations is available on the EMA website. Queries regarding renewal applications for centrally authorised marketing authorisations should be sent directly to the EMA.
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.