Written Confirmation for API imports into the EU

The Falsified Medicines Directive requirement

Under Directive 2011/62/EU (Falsified Medicines Directive, FMD), since 2 July 2013 every batch of an active substance imported into the EU for medicinal use must be accompanied by a Written Confirmation (WC) issued by the competent authority of the exporting third country.

What the Written Confirmation states

The WC confirms that, for the specific API and manufacturing site:

• GMP standards at least equivalent to the EU's apply;
• the site is subject to regular GMP inspections;
• in case of findings, the authority will inform the EU.

Equivalence (white-list) countries

The EU maintains a list of third countries recognised as having equivalent regulatory frameworks (e.g. Switzerland, Japan, USA, and others). APIs from these countries are exempt from the WC requirement. China is not on the equivalence list, so a Written Confirmation is required.

What this means for Chinese API exports

For an API shipped from China into the EU, the exporter must obtain the WC from the Chinese competent authority (NMPA) for each shipment/site. As an experienced exporter to the EU, we handle the WC process for our EU-bound products and support customers with the required documentation.

Requirements and country lists change. Always confirm the current FMD/WC status with the importing EU authority.

Información exclusivamente general; no constituye asesoramiento jurídico ni regulatorio. Los requisitos cambian; confirme siempre con la autoridad competente.