In order to maintain the surveillance system, the Medical Products Agency keeps a register of cosmetics and hygiene products put on the market in Sweden.
All manufacturers of cosmetics and hygiene products and importers who import from countries outside the EU/EES are obliged to notify their products to the Medical Products Agency. Manufacturing also means reformulation and reworking as well as amendments to the labelling (the product´s designation, trademark or area of use). The products are obliged to be notified, no later than one month after the products have been put on the market. If a product is imported by more than one company, each company is obliged to notify the Agency separately. The products are classified into 21 product categories at the notification.
The company/business responsible is also to be notified to the Agency. Information on the Product Information holder within EU/EEA must be included in the notification.
Further details on the requirements of the notification(s) are available in Sections 5 to 13 of LVFS 2004:12 (English translation). Application forms to be used are supplied in English.
Fees
To cover the costs of the Medical Products Agency’s surveillance of cosmetics and hygiene products, fees must be paid to the Agency at the notifications of products and company/business. Annual fee per manufacturer or importer (who brings cosmetics and hygiene products into Sweden) is SEK 2 100 and annual fee per product is SEK 300. Detailed information on annual fees is available in LVFS 2006:17 (English translation).