Posted by Michael Wonder on 28 Nov 2017
Guidance to help pharma companies prepare for Brexit
28 November 2017 - Additional guidance relates to medicines for human and veterinary use.
The EMA has published additional guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU).
The guidance document outlines the practical and simplified requirements that companies should follow when they apply for changes to their marketing authorisation to allow for the continued marketing of their medicine in the European Economic Area after the UK withdraws from the EU. The guidance has been prepared on the basis that the UK will become a third country as of 30 March 2019. It should be read in conjunction with the Questions and answers related to the United Kingdom's withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the framework of the centralised procedure published in May 2017.
