European Commission releases outsourcing guidelines

Pharmaceutical companies have been asked to comment on revised European Union (EU) guidelines on good practice regarding the outsourcing of medicine manufacturing.

Pharmaceutical companies have been asked to comment on revised European Union (EU) guidelines on good practice regarding the outsourcing of medicine manufacturing. This covers contracts by EU companies for work carried out both within and outside the EU.

The European Commission’s directorate general for health and consumers (DG SANCO) has released the changed guidelines and wants comments by 28 February 2011.

The new guidelines aim to ensure that there is clarity in any outsourcing agreement and say that the ‘outsourced activities must be correctly defined, agreed and controlled in order to avoid misunderstandings which could result in a product or operation of unsatisfactory quality’.

They also outline two distinct legal roles: a written contract between a ‘Contract Giver’ (the main pharmaceutical company) and the ‘Contract Acceptor’, and this contract ‘clearly establishes the duties of each party’.

These duties must be integrated into the