From 2013 on, APIs from Third Countries will be allowed for importation into the European Union when - in addition to the GMP certificate - an enclosed document from the regulatory authority in the exporting countries confirms that:
- The GMP standards in the exporting country are equivalent to those in the EU
- The manufacturing plant is regularly and rigorously controlled. These controls should be unannounced. Measures should be taken in case of GMP deviations.
- The EU must be immediately notified about GMP deviations (by the members states' authorities).
This will enforce the Anti-Counterfeiting Directive 2011/62/EU (see also our News from 14 December 2011). On 16 April 2012, the EU Commission aligned on the WHO's model GMP certificate and created a template for comment. The deadline for comment is 1 June 2012.
Please also see the Commission consultation paper incl. the template.
Note: You will get first hand information about the newest developments regarding manufacture, distribution, and safety of APIs at the "15th APIC/CEFIC European Conference on Acitve Pharmaceutical Ingredients" in Budapest, Hungary, from 7-9 November 2012.
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)