Given that the regulations applicable to medicines and medical devices are subject to harmonised EU-wide rules, the United Kingdom’s withdrawal could have major consequences in this area.
For example, medicines authorised under the centralised procedure managed by the EMA (European Medicines Agency) will no longer be marketed within the UK based on this authorisation, and the UK will be obliged to carry out another assessment and make unilateral decisions. Conversely, authorisations that have been granted by the UK will no longer be deemed to be authorisations granted by a Member State of the EU, as from 30 March, if the UK Parliament does not approve the draft agreement.
EU law also lays down specific rules for packaging and labelling that will most certainly have to be complied with by UK manufacturers that wish to export their goods to Member States. On the other hand, these rules will be less restrictive for British companies that do not export their goods to the European Economic Area (EEA). The issue of trade flows of pharmaceutical products to and from British territory will be brought sharply into focus if there is a hard Brexit, which will directly result in the reintroduction of checks at the EU borders with the UK.
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