Information on the implementation of labelling and packaging requirements for medicinal products for human use under the Windsor Framework. Read the news from Medicines and Healthcare products Regulatory Agency published on 13 September 2024.
Submission and approval enabled of the first application for In Vitro Diagnostic devices under the EU IVDR in Northern Ireland due to recent implementation of a submission route for manufacturers for performance studies. Read the news...
Information on the implementation of changes to pharmacovigilance for medicines authorised in the UK following the agreement of the Windsor Framework. Read the news from Medicines and Healthcare products Regulatory Agency published on 30 August 2024.
Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework. Read the update from Medicines and Healthcare products Regulatory Agency published...
The Directive 2022/642/EC requires the competent authority of the United Kingdom to publish on their website a list of medicinal products making use derogations under the European Commission Directive 2022/642. Read the updated list from Medicines...
The EMA issued a Practical guidance on the applicable rules to centrally authorised medicinal products for human use intended to be placed on the market in Northern Ireland before and after the application of Regulation...
Guidance for key stakeholders in the medicines supply chain to facilitate their use of the NIMAR regulatory route for the continued supply of GB licensed medicines to NI. Read the press release from Medicines and Healthcare...
The European Commission and the United Kingdom have today reached a political agreement on the UK’s participation in Horizon Europe, the EU’s research, and innovation programme, and Copernicus, the EU’s world-leading Earth observation programme. Read the press release...
The Medicines and Healthcare Regulatory Agency has released a statement on CE marking recognition for medical devices and in vitro diagnostics. Read the press release from Medicines and Healthcare products Regulatory Agency published on 1st August...
Consultation on a statutory instrument to amend the Human Medicines Regulations 2012 to remove the provision which provides the legal basis to the European Commission Decision Reliance Procedure. Read the press release from Medicines and Healthcare...
