OTC

Submissions for application for switch of OTC status:

  • A clear rationale for the OTC application is needed for all medicinal products.
  • A clinical overview, including a critical analysis of the suitability and safety for self medication of the medicinal product, should be submitted by the applicant. The proposed OTC indication, dosage and pack-size, should reflect the target population and must be in line with other similar products available as OTC, or otherwise justified.
  • The proposed PL, labelling and mock up should be included in the application.
  • It is recommended that the supporting documents are submitted also in an electronic format to allow an expedite process.

OTC substance reports

An OTC substance report is the result of an overview of a substance, concerning all over the counter (OTC) products  approved in Sweden, regarding strength, pharmaceutical form, pack size, sales outside pharmacies, indication and dosage.
The information in an OTC substance report has been standardized and harmonized for substances in the same therapeutic group. The OTC substance report gives an overview over the wording in product information (package leaflet and labelling) of approved OTC products in Sweden.

When submitting an application for OTC status, the OTC substance report, should be followed.

Even if the application is within the range with already approved OTC product or not, the application has to be in line with current regulations and ”A guideline on changing the classification for the supply of a medicinal product for human use” (see link in the right margin).

The OTC substance reports will be continuously updated if/when new information is available.

 Approved OTC substance reports (Swedish)

 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information