EU Commission – Further Updates on the Importation of Active Substances for Medicinal Products

The European Commission have recently published an Implementing Decision specifying the framework for assessment of the GMP standards in place in countries from where active substances are exported to the EU for use in medicinal products for human use.

These are aspects introduced in Article 111b(1) of Directive 2011/62/EU, the ‘falsified medicines directive’ that amends Directive 2001/83/EC.

The implementing decision can be accessed at the following location:

https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/dec_2013_51/dec_2013_51_en.pdf

Also published is an updated Q&A document (version 3.0) regarding the importation of active substances for medicinal products for human use. Together with an updated template for the ‘written confirmation’ required from the competent authority of the exporting third country when such active substances are imported to the EU.

These documents can be viewed using the following links:

https://ec.europa.eu/health//sites/health/files/files/gmp/2013_01_28_qa_en.pdf

https://ec.europa.eu/health//sites/health/files/files/gmp/2013_01_28_template.pdf

Both of these updates are described on the following page of the EC website: https://ec.europa.eu/health/human-use/quality/developements_en