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News about GMP/cGMP

EC: Active Substances in Medicinal Products

The European Commission (EC) released a concept paper for public consultation concerning the principles and guidelines of good manufacturing practice for active substances in medicinal products for human use.

 

Directive 2011/62/EU places an obligation on Member States to take appropriate measures to ensure that manufacturers of active substances on their territory comply with good manufacturing practice ('GMP') for active substances. It also places an obligation on the Commission to adopt, by means of delegated acts, the principles and guidelines of good manufacturing practice for active substances. This concept paper is being released for public consultation with a view to preparing the delegated act on principles and guidelines of good manufacturing practice for active substances in medicinal products for human use.

Outcome:

Public consultation is open until April 20, 2012. For contact details see page two of the draft document. The adoption of the delegated act is scheduled for 2013.

Source:

EC - Medicinal Products

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