Masterstudiengang "Drug Regulatory Affairs"


Development of the Counterfeit Directive - More confidence in the legal supply chain? (Focussed on "Basic Requirements for Active Substances used as Starting Materials": ICH Q7, GMP) ***

Silke Dorothea Kilzer (Abschlußjahr: 2011)

Language: English

At EU level, on 10 December 2008 the European Commission published a legislative proposal to amend Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use. The aim of this initiative is to address, in particular, the risk of falsified medicines entering the legal supply chain of medicines in the EU.

The Commission's proposal on the prevention of falsified medicines entering the supply chain highlights a concern which is getting higher and higher on the agenda of the European citizens: the quality and safety of the medicines they are consuming. The use of falsified medicines can result in therapeutic failure and can put lives at risk, therefore, combating counterfeit medicines is an obligation of all stakeholders, especially governments, in order to develop and maintain a concerted effort to ensure the quality and safety of medicines and a decrease in the number of counterfeits.

The European Commission is proposing a number of legislative actions to address the problem of the increase of medicines detected in the EU which are falsified in relation to their identity, history or source.
Particularly, the manufacture and placing on the market of active substances should fulfil the following obligations:

  • Notification of manufacture and import of active substances
  • Obligation to perform audits
  • Obligation to apply fingerprint technologies for testing
  • Legally binding principles for GMP
  • Mandatory inspections in third countries without equivalent GMP and inspection standards GMP certificates for all active substances.

The proposed Counterfeit Directive forms part of three proposals introduced in the European Commissions update of the "Pharmaceutical Package". It seeks to ensure a harmonised European response to deal with pharmaceutical crime and the severe threat it poses to public health.

Manufacturers and operators of the API supply chain are expected to establish a quality assurance/ quality management system. In addition, all parties should work together to fulfill their obligations in the fight against counterfeit medicines.
Pages: 39