Sweden Raises New Product Application Fees 9%

In Sweden, the government has announced new fees for the Medical Products Agency, which approves new drug marketing applications, which equate to an average rise of around 9%.

The new fees are as follows: application fee for new substances, new combination and biotechnology products 76,000 Swedish kroner ($10,868); additional dosage form or strength 45,000 kroner; application fee for generic products 45,000 kroner; new indication 45,000 kroner; annual fee for products younger than five years at January 1, 1996, per product 63,000 kroner; additional dosage form or strength for such products 14,000 kroner; annual fee for products older than five years at January 1, 1996, 32,000 kroner; and additional dosage form or strength for such products 14,000 kroner.

MPA Provisions And Guidelines The MPA has also issued new provisions and guidelines for parallel importing, manufacturing, wholesale distribution, permission for selling unapproved medicinal products, approval of medicinal products, products which should be considered as medicinal products, prescriptions for medicinal products and samples. In addition, the agency has released provisions and guidelines for comments on pharmacovigilence, analytical pharmacotoxicological and clinical standards and protocols in respect of testing of human and veterinary medicines.