OTC medicines and release for sale outside pharmacies

The Danish Medicines Agency has the following practice describing when an over-the-counter (OTC) medicine is released for sale outside pharmacies.

All new OTC medicines and medicines which change classification from prescription-only to OTC will by definition be restricted to pharmacy sale (dispensing status HA) for a period limited to two years. When the OTC medicines have been on the market for two years, they will be released for sale outside pharmacies (dispensing status HF), unless exceptional circumstances go against it. New generic versions of OTC medicines that are already sold outside pharmacies will naturally be released for sale outside pharmacies immediately.

Under section 60(2) of the Danish Medicines Act, the Danish Medicines Agency may, "where it is justifiable in terms of health, decide that a non-prescription medicinal product... may be sold to users outside pharmacies."

Annual review of pharmacy-only OTC medicines

In practice, the Medicinal Products Committee will conduct two annual reviews to assess if some of the OTC medicines that have been pharmacy-only for two years, and thus ready to be released for sale outside pharmacies, ought to remain pharmacy-only products.

On the basis of the Medicinal Products Committee's recommendation, the Danish Medicines Agency then decides which OTC medicines should be released for sale outside pharmacies.

In assessing the dispensing status of medicinal products, the Medicinal Products Committee and the Danish Medicines Agency will especially give weight to the following aspects, in compliance with section 60(2) of the Danish Medicines Act:

• The need for professional expertise and guidance
• Side effects
• Interactions with other medicines
• Risk of overdoses
• Risk of abuse
• Consumption patterns