Medicine containing narcotic drugs

All activities involving narcotic drugs and psychotropic substances requires, as a starting point, a company authorisation from the Danish Medicines Agency.

A company authorisation describes which activities the holder may carry out. This refers to, for example, receipt, possession, importation, exportation, trade, repackaging and production. The authorisation is valid for a limited amount of time and is followed up by inspections, where the holder's procedures and accounts of narcotic drugs and psychotropic substances are controlled.

If you wish to import or export these substances, you must have, in addition to the company authorisation, a special authorisation (certificate) for each trade. The Danish Medicines Agency issues import and export certificates on the basis of a written application. The certificates are valid for four months from the date they are issued, and may only be used for one dispatch or receipt and only in one single consignment. The Danish Medicines Agency collects a fee for issuing import certificates.

In January each year, all holders of authorisations have to make an account, covering activities from the previous calendar year. Depending on those substances that are traded, the account must contain information on, for example, the amount held in stock, import, export, purchase and retail in Denmark and quantity destroyed. The account must be sent to the Danish Medicines Agency before 1 February.