Over-the-Counter Medicines

To be allowed to sell certain over-the-counter (OTC) medicines in retail, the operation must first notify the trade to the Swedish Medical Products Agency. Only certain approved OTC medicines may be sold outside pharmacies. There is a search service on the Swedish Medical Products Agency's website where one can check which medicines are approved for sale in places other than pharmacies.

Before sales can begin, the operation must ensure that it complies with all requirements in the legislation. This includes, among other things, a self-inspection program, correct purchasing and labeling, 18-year age limit, appropriate display and storage, and monthly/quarterly reporting to the eHealth Agency. The municipality exercises supervision over the operation.

Requirements for Sale

  • Self-inspection program: Written procedures for handling and sales must exist before sales begin
  • Purchasing and labeling: Medicines must be purchased from supplier with wholesale permit, have Swedish labeling and be approved for sale outside pharmacies
  • 18-year age limit: Only sale to customers over 18 years, procedures for age verification and signs required
  • Display and storage: Medicines must be stored locked or under direct supervision, separated from other products
  • Reporting: Monthly/quarterly reporting of sales to the eHealth Agency

Notification and Fees

  • Notification: Via e-service at the Swedish Medical Products Agency before sales begin
  • Annual fee: 2,700 SEK per sales outlet to the Swedish Medical Products Agency, regardless of assortment size or when during the year notification is made
  • Municipal fee: The municipality may charge a fee for inspections
  • Supervision: The municipality checks compliance and reports deficiencies to the Swedish Medical Products Agency