European API

Update on European API legislation

Essential changes in the API market requirements are currently being enforced by the health authorities of the European Union:

1. GMP certification of 3rd country API manufacturers through EMEA or similiar national authority (Ministry of Health)

2. Import-licence for 3rd country APIs

3. GMP conformity of all trading and handling activities regarding APIs, intermediates and pharmaceuticals

4. Registration of handling and trading activities of APIs, pharmaceuticals and intermediates

5. CTD-Format for API drug master files (DMF) used in EC

Legal Basis

• Arzneimittelgesetz/ German Medicines Law: AMG (curr.ed.)

• "Basic requirements for active substances as starting materials": EU GMP Part II (curr. ed.) of the EU guidelines to good manufacturing practice for medicinal products for human and veterinary use (directive 2004/27/EC and 2004/28/EC); to be implemented by all European Union member states!

• Arzneimittel- und Wirkstoffherstellungsverordnung/ decree for manufacturing of medicinal products and active ingredients: AMWHV (curr. ed., amendet 26.03.08) in force since Nov 10th, 2006 and amendment in force since 4th April 08

• ICH-principles and guidelines of good manufacturing practice for medicinal products for human use (directive 2004/27/EC and 2004/28/EC)

Consequences
The whole supply chain of medicinal products, including APIs and intermediates has to comply with the current ICH-GMP guidelines and principles as well as with the medicinal laws of the EC countries.

Therefore the import, sampling, packing and handling of such products is only allowed by authorized companies.