To the attention of interested persons
In order to deal with the consequences described in the opinion issued by the European Commission together with the European Medicines Agency, marketing authorisation holders, manufacturing authorisation holders and wholesale distributors of medicinal products are strongly advised:
− To take all measures in order to take account of the fact that, after the end of the transitional period, the United Kingdom will, in all respects, no longer observe the EU regulatory system for medicinal products (marketing authorisation procedures, import requirements, (co)labelling, medicinal product supply, etc.];
– To take into account, in all trade-related decisions, that after the end of the transitional period all goods, medicinal products included, shipped from the United Kingdom to the EU will be subject to procedures / controls regarding fiscal (customs duties, origin, VAT) and non-fiscal requirements (batch release).