Under the new section 60 (2) 2nd sentence of the Medicines Act, the Danish Medicines Agency may lay down rules on the sale of OTC drugs from shop areas both in and outside pharmacies, including rules as to which drugs may be available for self-selection and how to place these drugs.
The new rules therefore make it possible for retailers of OTC drugs to make them available for self-selection (in shop areas) instead of at the counter or in locked cupboards, which they were obligated to under the rules previously in force. The purpose of the rules is to support the citizens’ access to medicinal products so that they can assess themselves which OTC drug to buy.
The Danish Medicines Agency’s guidelines interpret the conditions for the location of OTC drugs in shop areas when the drugs are available for self-selection. The guidelines are aimed at pharmacies, branches of pharmacies, OTC drug stores, retail outlets and distributors of veterinary products which sell OTC drugs which are available for self-selection (distributors).
The Danish Medicines Agency decides which medicines may be available for self-selection. This list differs as to whether it concerns sale from pharmacies or retail distribution. The Danish Medicines Agency’s list appears from the Agency’s website.
If you wish to sell OTC drugs available for self-selection, the below requirements must be met:
- The drugs must be under the supervision of the staff;
- The drugs must be placed out of a child's reach (generally 140 cm above the floor);
- The drugs must be placed so that there is a clear separation between OTC drugs and other products; and
- The drugs must be clearly marked as medicinal products (for instance by writing “”Medicinal products”, "OTC medicines”, “Medicines” or “OTC drugs”.
- The requirements are elaborated in the guidelines.
The guidelines came into force on 1 January 2018.