UK MHRA Publishes Guidance for Qualified Persons

UK MHRA Publishes Guidance for Qualified Persons

GMP News
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 (Type I Notification and Type II variations).

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

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

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