On-line help for clinical compliance

Penn Pharmaceutical Services has launched an on-line advice service to help pharmaceutical companies comply with Directive 2001/20/EC.

The directive has implications for investigational medicinal products, says Penn, and will be incorporated into national law by all member states within three years.

'It requires that, to import materials for clinical supply, a manufacturing authorisation is held by the importer and that they have access to the continuous services of a Qualified Person (QP) for conducting and supervising release of products into the EU,' explains Penn director Keren Winmill.

'This means that clinical trial supplies which are manufactured outside the EU must be QP released. For many companies this will need to be outsourced.'

Penn's website (www.pennpharm.co.uk) has pages explaining the directive, and an enquiry form to contact the company's clinical trials specialists.