EU legislation and Danish legislation define falsified medicines as any medicinal product with a false representation of its:
- identity (its packaging, labelling, name and composition)
- source (its marketing authorisation holder, its manufacturer or its country of origin) or
- history (the records and documents relating to the distribution channels used).
The concept of falsified medicine does not cover issues regarding the violation of patents and copyrights.
Examples of falsified medicines:
- medicines that have been illegally repackaged
- stolen medicines that are subsequently sold illegally in the legal chain
Medicines must be distributed via the legal supply chain between companies authorised to distribute medicines.
Our efforts to prevent the entry of falsified medicines into Denmark
We supervise medicines and companies manufacturing and distributing medicines in the legal supply chain. Moreover, pharmaceutical companies are obliged to inform the authorities if they suspect that their products have been falsified.
Cooperation with other authorities
We cooperate with drug regulatory authorities both in and outside the EU/EEA to prevent the distribution of falsified medicines in the legal chain. In the EU/EEA, the authorities are obliged to inform the other EU/EEA countries in the case of any suspicion of falsified medicines in the legal chain.
Denmark has acceded to the Medicrime Convention, which is a voluntary international convention adopted by the Council of Europe with the purpose of combating falsified medicines.
New efforts in the EU to prevent falsified medicines
Due to an increasing risk that falsified medicines may reach European consumers, an EU directive on falsified medicines was adopted in 2011. Among other things, the directive introduces:
- generally stricter rules for the distribution of medicines in the EU/EEA to increase consumer safety
- generally stricter rules for the import and distribution of active substances used in marketed medicinal products for human use
- a requirement that all medicine packages of certain products are labelled with a unique code
- an obligation that all websites in the EU/EEA with an authorisation to sell medicinal products display a common logo on the website. This will allow consumers to identify whether they are buying medicinal products from a company holding an authorisation in the EU/EEA.
These requirements are being implemented.