Sustainment of sales permit or registration
- Permit or other obligation
- Nationwide
- Public service
A variation must be submitted in case of changes to a granted sales permit or registration documentation. Sales permit or registration must be renewed in accordance with the permit decision.
Do the following
The holder of a sales permit or a company authorized by the holder submits a variation or renewal and supporting documentation to Fimea or to European Medicines Agency (EMA) that will evaluate it and either accept or reject it. The variations can be implemented after the application is accepted. Certain small variations can be submitted within a year from their implementation.
The current holder of a permit can apply for a transfer to a new holder. The transfer comes into force on the day of the decision or as separately agreed with the applicant.
More information available on the website of Fimea
To whom and on what terms
Variations are regulated under the variation regulation (EC) No 1234/2008 and (EC) No 712/2012 and in the directives 2001/83/EC (medicinal products for human use) and 2001/82/EC (veterinary drugs).
Renewal of sales permit is regulated in the directives 2001/83/EC (medical products for human use) and 2001/82/EC (veterinary drugs), in the order of the Finnish Medicines Agency Fimea “Applying for and sustaining a sales permit and registration of a pharmaceutical preparation” and in the European Commission’s “Notice To Applicants”.
More information available on the website of Fimea
Deadline
Variation must be submitted before its implementation. Certain small variations can be submitted within a year from their implementation. Renewal must be applied for not later than 9 months before the expiration date on the sales permit decision. Sales permit will expire if it has not been properly renewed.
Processing time
Depending on the procedure and type of the application, the processing time is between 30 and 120 days and the time required for the decision making process of the European Commission in centralized procedure must also be taken into account.
Period of validity
The renewal of a sales permit prolongates its validity for the period mentioned on the decision or until further notice.