UK MHRA Publishes Guidance for Qualified Persons

UK MHRA Publishes Guidance for Qualified Persons

GMP News
28 March 2007

UK MHRA Publishes Guidance for QualifiedPersons

The Medicines and Healthcare Products Regulatory Agency (MHRA) has issueddetailed guidance on the content and presentation of the QP declaration inrespect of the GMP status of active substance manufacturers. This guidanceis also applicable to the QP declaration of compliance required for newapplications and renewals.

In this context, the government agency hasalso published

Frequently asked questionsin the Variations section (Type I Notification and Type II variations).

Although only applicable in the U.K., theguidance and the answers to the FAQs give indications and advice for anyEuropean QP being faced with the confirmation of compliance forapplications for new marketing authorisations, renewals and variations inwhich 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 aQualified 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

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)


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