Written Confirmation of Active Substances used in medicinal products marketed in the EEA will become effective in July 2013 in accordance with Directive 2001/83/EC.
This means that all active substances used in medicinal products marketed in the EEA must be manufactured in accordance with the EU Good Manufacturing Practice (GMP) or, if imported, with equivalent rules.
From 2nd July 2013 the importation in the EEA of active substances is only possible if:
- Option 1: the consignment is accompanied by a ‘written confirmation’ by the competent authority of the exporting third country that the plant manufacturing active substances operates in compliance with EU GMP or with equivalent rules, and is subject to equivalent rules for control and inspections; or…
- Option 2: the country has been listed by the European Commission as a country with an equivalent system of supervision and inspection as in the EU; or…
- Option 3: exceptionally and only where necessary to ensure the availability of medicinal products, the need for the written confirmation can be waived if the specific manufacturing plant has been inspected by the competent authority of a Member State.