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UK MHRA Publishes Guidance for Qualified Persons
UK MHRA Publishes Guidance for QualifiedPersons
In this context, the government agency hasalso publishedFrequently 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 theMHRA news.
|The detailed duties and responsibilities of aQualified Person will be covered in the European QP Association’s|
Prague, Czech Republic, 13/14 June 2007