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.
The European QP Association published a new version 9.0 its "Code of Practice for QPs". It now also comprises a new chapter "Ethics for the Qualified Person - A Professional Code of Conduct" in addition to general revisions and a revised Annex 1 with the national requirements.
The UK government consulted stakeholders on an important decision regarding batch testing and certification. The result is that it should remain as it is.
Following the entry into application of the CTR at the beginning of last year, the final version of the "Guideline on the responsibilities of the sponsor with regard to handling and shipping of IMPs" has been published. IMPs may not be used in a clinical trial in a member state of the European Union until the completion of the two-step procedure referred to in this guideline.
The Danish Medicines Agency has revised its guidelines on the requirements and expectations of the QP. In places, these deviate from the requirements of Directive 2001/83/EC, especially with regard to education and experience.
The EU Commission has published a document on a "Structured Dialogue on the security of medicines supply". This document presents the most important results of the analysis of the security of supply and possible measures.
