New Europe-wide approach for the classification of commercially confidential information and personal data in MAAs

The Heads of Medicines Agencies(HMA) and the European Medicines Agency (EMA) have adopted a joint guidance document, providing a consistent Europe-wide approach regarding the classification of commercially confidential information and personal data in marketing authorisation applications (MAAs) for human medicinal products. This should provide applicants with clarity on the kind of information that will be protected from public disclosure and the information that is likely to be accessible in the interests of transparency.  At Wainwright Associates, we will be pleased to advise clients how their data may be regarded following authorisation. 

To understand how these new harmonised principles may apply to you, please contact us on enquiries@wainwrightassociates.co.uk or telephone +44 (0)1628 530554.

www.wainwrightassociates.co.uk