Import of active substances from third countries
Import after 2 July 2013
According to section 11 of the Danish executive order no. 1360 of 18 December 2012 on manufacture, import and distribution of active substances for manufacturing of medicinal products, which implements the Directive on falsified medicines (2011/62/EU), active substances (API) for use in human medicines with a marketing authorisation must only be imported into Denmark from third countries if either of the following criteria is fulfilled:
- The active pharmaceutical manufacturer is from a third country on the list of countries approved by the European Commission. Countries on this list have been approved based on inspections establishing that the country has a regulatory system for active substances which corresponds to EU standards. The updated list is available at the website of the European Commission: Quality of medicines and Good Manufacturing Practices (GMP)
- The imported consignment of active substances is accompanied by a "written confirmation" from the competent authority of the third country where the manufacturer is based. This document confirms that the manufacturer is subject to GMP standards and control of the plant equivalent to those in the EU.
If these criteria cannot be fulfilled, the Danish Medicines Agency may, in special circumstances, waive the requirement for a written confirmation in order to ensure the supply of medicines.
The requirement for a written confirmation may only be waived if the active pharmaceutical manufacturer holds a valid GMP certificate for the concerned active substance issued by an authority within the EU/EEA.
Please be advised that the Danish Medicines Agency generally only waives this requirement in the case of active pharmaceutical manufacturers in countries where the authorities do not issue written confirmations.
You can find further information about the requirements for using imported APIs on the website of the European Union. Quality of medicines and Good Manufacturing Practices (GMP)
Companies seeking a waiver from the requirement for a written confirmation must apply to the Danish Medicines Agency using the below application form, which is in Danish only.