Council of Europe / EDQM

In close collaboration with the Strasbourg-based European Directorate for the Quality of Medicines (EDQM) of the Council of Europe, Swissmedic prepares, on the basis of contractual state commitments, internationally binding quality regulations for medicines, verifies them in its laboratories and publishes them in the pharmacopoeia. The Agency ensures that the European Pharmacopoeia is enacted in Switzerland, and issues the Swiss Pharmacopoeia. Furthermore, Swissmedic is a member of the Official Medicines Control Laboratories (OMCL) network.

Swissmedic is also involved in the expert groups that drafted the text of the Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health, also known as the MEDICRIME Convention. The agency also helps to organise and run conferences on this subject.

The Council of Europe's MEDICRIME Convention is the first international convention that aims to prevent threats to public health as a result of counterfeit medical products (medicinal products and medical devices). Signatory states are required, among other things, to criminalise the manufacture, supply, offering to supply and trafficking of counterfeit medical products. It also provides a framework for national and international co-operation between the relevant authorities. The Convention will enter into force as soon as it has been ratified by five states, three of which must be members of the Council of Europe.

Switzerland signed the Convention on 28 October 2011. To satisfy the requirements of the convention, certain provisions of the Therapeutic Products Act (TPA) and the Criminal Procedure Code (CrimPC) were modified.

Swissmedic is represented on the EDQM's European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH), which it supports in various activities. The agency also participates in expert meetings, training sessions and conferences in the three associated Committees of Experts:

• Committee of Experts on the classification of medicines as regards their supply (CD-P-PH/PHO)
• Committee of Experts on quality and safety standards in pharmaceutical practices and pharmaceutical care (CD-P-PH/PC)
• Committee of Experts on minimising the public health risks posed by counterfeiting of medical products and related crimes (CD-P-PH/CMED); Swissmedic has chaired this Committee since 2013.