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
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