EU Wants ‘Written Guarantees’ From UK On New Medicine Rules
Executive Summary
Numerous political and legislative procedures will be needed before new rules on the UK-wide approval of new medicines and their marketing in Northern Ireland can be implemented.
You may also be interested in...
EU Parliament OKs Law Ending Validity Of Centralized Drug Approvals In Northern Ireland
Giving the UK regulator the power to issue UK-wide marketing authorizations for products that fall within the scope of the EU centralized procedure will reduce the regulatory burden on companies marketing medicines in Northern Ireland.
UK-EU Northern Ireland Deal Reinstates ‘Single UK Market For Medicines’
Under the landmark “Windsor Framework” agreed by the UK and the EU, medicines will take the “green lane” from Great Britain to Northern Ireland, while the UK regulator will have UK-wide responsibility for all drug approvals. In addition, the provisions of the EU Falsified Medicines Directive will no longer apply in Northern Ireland.
Austria & Germany Call For ‘Competitiveness Check’ On EU Pharma Revision Package
The two countries want the European Commission’s proposals to be more closely examined for their possible negative effect on pharmaceutical investment decisions. The industry federation EFPIA says it is surprised more EU member states aren’t taking the same stance.