Variation, renewal and withdrawal

The parallel importer/wholesale distributor must stay up to date with variations that may have an impact on the licence to sell a medicinal product, and continuously inform the Swedish Medical Products Agency of this. This applies both to variations in the source Member State and variations regarding the medicinal product already authorised in Sweden.

For variations, an application is sent to the Swedish Medical Products Agency. The application consists of the form “Application for variation of a parallel imported human medicinal product or a parallel traded veterinary medicinal product” (link below), a cover letter and documentation concerning the application. If the application regards multiple variations, all variations must be valid for all ASP numbers in the application. Attach the required information for the Swedish Medical Products Agency to assess the application.

Applications for variations are sent by e-mail or by regular mail. The application is not sent to individual case workers.

Before applying the Swedish Medical Products Agency recommends that the applicant goes through the application form, which provides guidance. The information in the assessment report which is attached to the approval of the licence to sell the product can also be used to receive guidance on which types of variations that are essential and must be submitted to the Swedish Medical Products Agency. In addition, see the checklist under “Electronic application for parallel importation/trade”.

Please note that if the intended variation leads to further variations, these must also be stated in the variation form. For example, a variation in the package leaflet may lead to variations in the labelling.

Application for variations

Email: RIC@lakemedelsverket.se
Regular mail:
Läkemedelsverket
Box 26
751 03 Uppsala

Withdrawal of the licence for medicinal products already authorised in Sweden

If the direct imported medicinal product or the veterinary medicinal product already authorised in Sweden is withdrawn for reasons other than quality, safety or effect, the parallel imported/traded medicinal product may keep its licence to be sold. As the product information for the direct imported medicinal product or the veterinary medicinal product already authorised in Sweden will no longer be updated, an application must be submitted to the Swedish Medical Products Agency.

Form for an application for change of reference SmPC for parallel imported/parallel traded medicinal product

Renewals

A licence to sell a parallel imported medicinal product for human use is valid for five years. After that, the parallel importer can renew the licence by submitting an application to the Swedish Medical Products Agency. A renewal of the licence is valid until further notice unless the Swedish Medical Products Agency states otherwise.

An application for a renewal of the licence must be sent to the Swedish Medical Products Agency no later than nine months before the renewal date for human medicinal products.

Withdrawal of the licence for parallel imported human medicine or parallel traded veterinary medicine

To withdraw the licence to sell a medicinal product, an application must be submitted to the Swedish Medical Products Agency.