News about GMP/cGMP

22.02.2019

MHRA: Guidances on No-Deal-Brexit

The British MHRA (Medicines and Healthcare Products Regulatory Agency) has launched a new website containing all guidances and documents released for a no-Brexit-deal.

Furthermore, the NIBSC (National Institute for Biological Standards and Control) has published a guidance document on GMP for biological medicinal products. In the event of a no deal scenario, the UK would no longer be subject to EU Directive 2001/83/EC (Article 114(1)). From 29 March 2019, NIBSC would be a stand-alone National Control Laboratory and the UK would require national certification by NIBSC before batches of biological medicines could be placed onto the UK market.