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.
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