In accordance with Article 24 of Directive 2001/83/EC as amended by 2004/27/EC (human code), Article 28 of Directive 2001/82/EC as amended by Directive 2004/28/EC (veterinary code) and Article 14 (1-3) of Regulation (EC) No. 726/2004 a marketing authorisation is valid for five years.
The marketing authorisation may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance by the competent authority. Once renewed, the marketing authorisation shall be valid for an unlimited period unless the competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal.
The renewal dossier should contain a consolidated version of the file in respect of quality, safety and efficacy including all variations introduced since the marketing authorisation was granted or since the last renewal.
Note: The fee for an application for renewal is included in the annual fee for the marketing authorisation.
Timelines for submission of renewal applications
A renewal application shall 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 there is no possibility for the MPA to extend the approval. This means that the approval automatically ceases to be valid when the renewal date has passed and that further sale is forbidden. The MPA has no legal possibilities to give a respite for submission of a renewal application.
The renewal application can also be submitted earlier than six months in advance of the renewal date after agreement with the MPA. A request should be submitted to the MPA by mail or email (using the address sok.central@mpa.se) and should include a justification of why the renewal application should be submitted in advance.
National, mutual recognition and decentralised procedures
The documentation included in the application should be in accordance with the renewal guidelines, ”Guideline on the processing of renewals in the mutual recognition and decentralised procedure” for human medicinal products or ”Guideline on the processing of renewals in the mutual recognition procedure for veterinary medicinal products” for veterinary medicinal products. The guidelines can be found on the right hand side under the heading External links.
Applications for renewal for products authorised via the national procedure:
The first application for renewal should always be complete and follow the renewal guidelines as mentioned above. For a product authorised via the national procedure which has already been renewed at least once, but where an additional renewal has been requested, 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 authority upon request. A special application form for this kind of application can be found on the right hand side under the heading External links.
If an application for renewal is under evaluation at the MPA when the next application for renewal is due according to the five-year period, it is not necessary to submit another application for renewal as long as the previously submitted application is pending.
Additional information, guidelines and application forms can be found on the right hand side under the heading External links.