Update for Australian API and IMP manufacturers exporting to the EU

The impact of recent changes to the “Internationally harmonised requirements for Batch Certification”?

The European Union (EU) has reformed the rules for importing active pharmaceutical ingredients into the EU for medicinal products for human use.

As of 2 January 2013, all imported active substances must have been manufactured in compliance with standards of good manufacturing practices (GMP) at least equivalent to the GMP of the EU.

The manufacturing standards in the EU for active substances are those of the ‘International Conference for Harmonisation’ – ICH Q7.

As of 2nd July 2013, this batch certificate must be confirmed in writing by the competent authority of the exporting country. This could have meant the TGA in an Australian context.

This certificate must confirm that the plant where the active substance was manufactured is subject to control and enforcement of good manufacturing practices at least equivalent to that in the EU.

An objective of this legislation is to reduce falsified medicines in the EU.

It has been a requirement for many years that exporters to the EU follow the “internationally harmonised requirements for batch certificate of a medicinal product”.

The template for such written confirmation can be found here. This must accompany the active substance being imported into the EU.

This certificate may also be used for active pharmaceutical ingredients and investigational medicinal products used in clinical trial authorisations which were included from 1st May 2004.

So what is new?

On the 23rd of January 2013, the EU adopted the decision, which means as from the 2nd of July 2013 any active substance imported into the EU from that date is subject to the rules on the written confirmation. This applies to Active Pharmaceutical Ingredients (APIs) and Investigational Medical Products (IMPs) intended for human use.

The good news?

On the 24th April 2013 the Australian TGA was successful in their application to be exempted from this rule and joined Switzerland not needing this Batch Certification. The latest list of countries can be found here.

This means Australian API and IMP manufacturers will have a slightly lower regulatory burden, thanks for the TGA.

Other news?

Need more info?

There is a great Q & A article available here.

To read more about EU and EMA related topics, click here and here.