Time is ticking for Indian APIs Exporters to Europe …

 One of the key elements is the requirement given  in Article 46(b) stating that active substances shall only be imported into the EU if :-

1. They have been “manufactured in accordance with standards of good manufacturing practice at least equivalent to” those of the EU.
2. And they are accompanied by a written confirmation from the competent authority of the exporting country stating:

• That product is manufactured under the GMP standards equivalent to the EU GMPs
• The manufacturing plant concerned is subject to regulator, strict and transparent controls and to effective enforcement of GMP including repeated and unannounced inspections and
• Information on non-compliance is communicated by the exporting country to the EU “without delay”

On July 10, 2012, the European Commission issued the template form for “written confirmation” required by Article 46(b). The EMA published a 32-question Q &A document on July 11, 2012 that clarifies the expectations associated with the confirmation requirement. This confirmation does not apply to active substances contained in imported finished product, nor does it apply to partially manufactured finished product (active plus excipients) imported into the EU.