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GMP for API's Concept Paper

Wednesday the 8th February 2012

Dear All,

In late January 2012 the Commission published a Concept Paper on extending the scope of the current GMP Directive 2003/94/EC to cover APIs. The reason for this is proposal is given as the implementation of Directive 2011/62/EU and the need to bring a coherent approach across the EU. This proposal is thus being made to ensure that there is a ‘level playing field’ in the legal provisions relating to API GMP across the EU.

The Concept Paper proposes the following:

• “… all provisions in that Directive which currently address the manufacturing or manufacturer of medicinal products would also apply to the manufacturing and manufacturer of active substances.”
• However, some provisions will not apply to APIs:
o Marketing Authorisations
o Qualified Persons
o Manufacturing Authorisations

Adoption of the new Directive is planned for 2013. It is proposed that Member States will have just 6 months after the publication of a revised GMP Directive to transpose it into national law and it will have to be implemented just 3 months later.

Comments on the Concept Paper should be submitted by 20 April 2012.

Best regards,

Peter Gough, Partner

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