Category Variations

MHRA guidance on operational information sharing for relevant regulatory applications

The UK MHRA has developed a process to share operational information with health system partners across the UK. This applies to medicines applications submitted via National and International Recognition regulatory routes. For the purposes of operational information sharing, what is…

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TGA update on the registration or variation of Category 1 and COR report-based prescription medicines

The TGA, Australia has published an update on the registration or variation of Category 1 and Comparable Overseas Regulator (COR) report-based prescription medicines. Module 1.2.1: Application form This application form must be used for the following Category 1 and COR…

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MHRA updates guidance on applying for a variation to your marketing authorisation

The MHRA has updated its guidance on applying for a variation to your marketing authorisation. The original guidance was published in December 2014. Following the end of the transition period on 31 December 2020, the guidance has been updated with…

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