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28 March 2007

UK MHRA Publishes Guidance for Qualified Persons

The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued detailed guidance on the content and presentation of the QP declaration in respect of the GMP status of active substance manufacturers. This guidance is also applicable to the QP declaration of compliance required for new applications and renewals.

In this context, the government agency has also published Frequently asked questions in the Variations section.

Although only applicable in the U.K., the guidance and the answers to the FAQs give indications and advice for any European QP being faced with the confirmation of compliance for applications for new marketing authorisations, renewals and variations in which a change is proposed to the manufacturer of the active substance, finished product or site of batch release.

For more information please see the MHRA news.

The detailed duties and responsibilities of a Qualified Person will be covered in the European QP Association’s

Qualified Person Education Course – Understand the Implications of Working as a QP
Prague, Czech Republic, 13/14 June 2007