No-deal Brexit technical notices and reference products

In response to the subject of reference products following the publication of the Government’s technical notices on a no-deal Brexit, Warwick Smith, Director General of the British Generic Manufacturers Association (BGMA) and the British Biosimilars Association (BBA) said: “The technical notice makes clear that the details of the conversion of Centralised Procedure Marketing Authorisations into UK MAs on 29 March will be subject to consultation. But we infer that these products will then legally become reference products that have been authorised in the UK. We therefore expect that it will be possible for generic UK MA applications to be made based on these reference products. We shall, however, take this up with the MHRA as part of the consultation to confirm the position. It is clearly in no-one’s interests for the supply of new generics to be barred or delayed.