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UK MHRA Guidance: Marketing Authorisation Variations and Renewals for Medicines
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published two guidance documents covering important aspects of medicines regulatory lifecycle management: variations to marketing authorisations and renewal of marketing authorisations. The first explains how marketing authorisation holders can submit changes to authorised medicines, including minor variations, major variations, and extensions. The second outlines renewal requirements for products authorise
Sharan Murugan
1 hour ago4 min read