The Danish Pharmacopoeia Commission

In questions relating to requirements for the quality of medicinal products, the Danish Medicines Agency consults the Danish Pharmacopoeia Commission.

The Commission advises in connection with the work on the European Pharmacopoeia and preparation of guidelines for the quality of medicinal products in the EU and in the harmonisation collaboration (the ICH collaboration) between the EU, the USA and Japan.

The Danish Pharmacopoeia Commission consists of no more than 6 members, who are appointed by the Minister for the Interior and Health for a period of 4 years at a time.

Three committees are appointed within the Pharmacopoeia Commission:

• the pharmacy committee
• the chemistry committee
• the pharmacognosy committee

Within the three fields, the committees advise about quality requirements for medicinal products and the raw materials used in the production of medicinal products, e.g. in connection with the draft standards published in the Pharmeuropa.

On the recommendation of the Danish Pharmacopoeia Commission, the European Pharmacopoeia enters into force as a legal base in Denmark with Danish Medicinal Standards three times a year.