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.
Directive 2011/62/EU introduces obligatory 'safety features' to allow, inter alia, verification of the authenticity of medicinal products for human use ('unique identifier'). The Directive places the Commission under an obligation to adopt delegated acts setting out the details relating to inter alia the unique identifier. This concept paper is being rolled out for public consultation with a view to preparing both the impact assessment and the delegated act.
The European Commission is planning to put forward, a limited and targeted amendment to Commission Regulation (EC) No 658/2007 concerning financial penalties for certain obligations in connection with centrally authorised medicinal products in the human and in the veterinary sector. The purpose of this amendment is two-fold. Firstly, to fulfil the mandate given by the legislator in the Paediatric Regulation (EC) No 1901/2006 and secondly, to adapt Commission Regulation (EC) No 658/2007 to the modifications introduced by the new pharmacovigilance legislation in the human sector.