Regulations and requirements for licences
- Published: November 27, 2019
- Last updated: September 25, 2024
The licence to sell a parallel imported medicinal product for human use is regulated by the Swedish Medical Products Agency’s Provisions (HSLF 2022:8). The parallel importer must also hold a wholesale distribution authorisation and the repackager must hold a manufacturing authorisation.
The licence to sell a parallel traded medicinal product for veterinary use is regulated by the Swedish Medical Products Agency’s Provisions (HSLF 2022:9). The wholesale distributor must also hold a wholesale distribution authorisation and the repackager must hold a manufacturing authorisation.
Provisions
Requirements for parallel importation of medicinal products
The Swedish Medical Products Agency's Provisions on parallel imported medicinal products (HSLF 2022:8) (in Swedish):
Guide to the Swedish Medical Products Agency's Provisions on parallel imported medicinal products (HSLF 2022:8) (in Swedish):
Requirements for labelling and package leaflet
The Swedish Medical Products Agency's provisions on labelling and package leaflet (HSLF-FS 2021:96 and HSLF-FS 2021:97) (in Swedish)
Wholesale distribution authorisation
In order to trade with medicinal products a wholesale distribution authorisation is needed. Swedish companies apply for this at the Swedish Medical Products Agency. For companies in other EU/EEA countries, a corresponding authorisation is needed from that country’s competent authority. The authorisation is submitted with the company’s first application for a licence to sell a parallel imported or traded medicinal product.
More information on wholesale distribution authorisation:
Manufacturing authorisation and technical agreement
To repackage and relabel parallel imported medicinal products for human use and parallel traded veterinary medicinal products, a manufacturing authorisation is needed. Swedish companies apply for this at the Swedish Medical Products Agency. For companies in other EU/EEA countries, a corresponding authorisation is needed from that country’s competent authority. The authorisation is submitted with the company’s first application for a licence to sell a medicinal product, and also with an application to change the repackager.
When repackaging and relabelling is carried out by a company other than from the parallel importer’s/wholesale distributor’s corporation, a technical agreement must be established. This entails an agreement that regulates how the responsibility is distributed between the contract giver and the contract acceptor.
More information about the manufacturing authorisation and GMP:
Parallel importation/trade of medicinal products classified as narcotics
When parallel imported/traded medicinal products are classified as narcotics, the parallel importer/wholesale distributor must hold a licence to import narcotics to Sweden. If someone else than the parallel importer/wholesale distributor imports the medicinal products to Sweden, for example a stockist, the parallel importer/wholesale distributor must hold a licence to trade with medicinal products classified as narcotics. The repackager must hold a manufacturing authorisation for narcotics.
Read more about the application for a licence to import medicinal products classified as narcotics: