A registration of a homeopathic medicinal product is valid for 5 years. A registration may be renewed after 5 years on the basis of a re-evaluation. A renewal application shall be received by the MPA at the latest 6 months before the end of the 5 year period.
There will be a temporary procedure for the renewal application of homeopathic medicinal products registered before May 1, 2007.
According to the Swedish Medicines Act [1992:859] 8 e § in comparison to 2 b § of the same act, a registration of a homeopathic medicinal product is valid for 5 years. Registration holders must submit a renewal application at least 6 months before the end of the 5 year registration period, for the application to be valid.
For homeopathic medicinal products registered before May 1, 2006, the renewal application shall be received by the MPA no later than November 1, 2010. For homeopathic medicinal products registered after May 1, 2006, the renewal application shall be received by the MPA no later than 6 months before the end of 5-year registration period.
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.
Each registered homeopathic medicinal product requires a separate renewal application.
Temporary procedure for products registered before May 1, 2007
Due to heavy work load for registration holders with homeopathic medicinal products registered before May 1, 2007, and ongoing assessments of homeopathic products subject to transitional rules (so called free-listed homeopathic products), there will be a temporary procedure for the renewal application of homeopathic medicinal products registered before May 1, 2007.
The temporary procedure for renewal applications will be divided into two phases:
Phase 1. No later than 6 months before the end of the 5-year registration period, the registration holder must submit a list of their homeopathic medicinal products in question. The list should include the product names and dosage forms.
Phase 2. No later than November 1, 2011, each registered homeopathic medicinal product requires a separate renewal application. The application form can be found on the right hand side under the heading Application form.
If a product is not in the list described in phase 1 (above), 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 temporary procedure for the renewal application described above is not mandatory. The possibility to submit a renewal application for each registered homeopathic medicinal product remains. The application form can be found on the right hand side under the heading Application form.
Procedure for products registered after May 1, 2007
Each registered homeopathic medicinal product requires a separate renewal application. The application form can be found on the right hand side under the heading Application form.