An EU Regulation laying down specific rules for medicinal products for human use for Northern Ireland has been published in the Official Journal of the EU. It mainly concerns importation into NI and safety features.
The MHRA has announced a "long-term solution" of the Windsor Framework for the supply of medicines into Northern Ireland, effective from January 1, 2025. One key issue concerns the packaging and labelling of medicinal products.
The Mutual Recognition Agreement (MRA) between the EU and the US will be extended to veterinary medicines. This was announced by the EU Commission in a press release.
If you are a non-EU based company exporting drug products into the EU, it is essential to understand the role of a QP. It's also helpful to understand all other EU-GMP requirements to be better prepared for inspections.
The EMA has published a Guidance for Industry on "Good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact". It provides ten recommendations for various stakeholders.
EMA has published a new version of the "3-year work plan for the Quality domain". This also includes partly renewed timeframes for the revision of GMP specifications.
Swissmedic has specified the conditions for the submission of an audit report by the Responsible Person as proof of GMP compliance of foreign manufacturers.
The EU Commission has published the proposal for the revision of the EU pharmaceutical legislation. The changes are to be regulated in a directive and a regulation. There are also GMP-relevant changes.
The EU Commission and the UK government have reached an agreement on special arrangements for Northern Ireland (the so-called "Windsor Framework"). Part of it is also a possible solution for medicines.
