Why is this required?
In line with the new European Falsified Medicines Directive, all active substances imported into the EU must now be accompanied by a written confirmation from the competent authority of the exporting country which confirms that the standards of GMP and control of the manufacturing plant are equivalent to those in the EU.
What is required?
The written confirmation is required per manufacturing site and per active substance, and should show that standards of GMP applicable at the plant are at least equivalent to those in force in the EU. It should also detail that the plant is subject to regular and strict controls and effective enforcement of GMP, including inspections. Also, non-compliance information should supplied by the exporting third country without delay to the authorities in the importing country in the EU. The duration of validity of the written confirmation is established by the exporting non-EU country. Marketing authorisation holders and applicants should always bear this in mind when selecting active substance suppliers to avoid future supply problems.
What countries are exempt?
The directive foresees that exporting countries with a regulatory framework equivalent to that of the EU will not need to issue written confirmations. Following a request from a non-EU country, the European Commission, together with GMP experts from Member States and with the support of the EMA, will assess the regulatory framework of the requesters and if the assessment if positive, the county will be listed as an ‘equivalent country’.
Four countries have been listed so far by the European Commission an ‘equivalent country’ and therefore will not need to issue written confirmations. These currently include Australia, Japan, Switzerland and the United States.
For further information:
This information was obtained from the EMA website on 03 July 2013 here.