Pharmaceuticals

Consequences of Brexit on the sufficiency of pharmaceutical products in Cyprus

 

The Pharmaceutical Services of the Ministry of Health have identified in a timely manner the medicinal products that will possibly be affected by the withdrawal of the UK from the EU and have made all the necessary communications to the Marketing Authorisation Holders who are responsible for the marketing of the medicinal products so they can take all the necessary steps to ensure their market continuity.  It is noted in particular, that all the actions taken by the Pharmaceutical Services were taking into consideration the possibility of a hard Brexit.  The Pharmaceutical Services are in continuous communication with all stakeholders and the European Commission and are closely monitoring the developments in order to meet the challenges that may lie ahead, with a view to mitigating the impact of the withdrawal of the UK from the EU.

 

 

Medical devices

In case where the UK withdraws from the European Union with a ratified withdrawal agreement, there will be a transitional period until 2020 with the possibility of extension until 2022.

 

In case where the UK exits European Union without a ratified withdrawal agreement, the UK will become a third country as of the exit day.

 

Being that our general approach, CyMDA may, by invoking Article 11(13) of Directive 93/42/EEC, authorize, on duly justified request, the placing on the market and putting into service, within our territory, of individual devices for which the conformity assessment procedures have not been carried out and the use of which is in the interest of protection of health. Any derogation request that we receive will be evaluated individually by assessing the effects in our market.

 

 

 

Relevant documents: