The European Medicines Agency (EMA) and the European Commission have published a first update of the initial questions-and-answers document that was published at the end of May 2017. The updated guidance, which was published on 1 December, includes additional information on how the UK’s withdrawal from the EU will affect marketing applications and authorisations for different types of medicinal products, for instance, generic, hybrid and biosimilar medicines. This updated Q&A should be read in conjunction with EMA’s first version of its procedural guidance published on 28 November. Please see previous post here.
The EMA’s updated Q&A can be found here: