Last year, the UK Department of Health & Social Care issued a statement emphasizing their continued support for the acceptance of batch testing and certification by a Qualified Person (QP) performed in the EU. This statement came after a public consultation seeking opinions on four potential options for a batch testing policy in the UK
The GMP/GDP Inspectors Working Group has put up and approved a list of frequently asked questions (FAQs) on Good manufacturing practice (GMP) and Good distribution practice (GDP) that the European Medicines Agency (EMA) posts on its website. The list was revised on January 2023. There were three more GDP-related questions added. Maintaining an eye on
In accordance with the "Guideline on the responsibilities of the sponsor with regard to handling and shipping of IMPs for human use in accordance with GCP and GMP," investigational medicinal products (IMPs) cannot be used in a clinical trial in a member state of the European Union until the two-step process has been completed. The
Wholesalers must ensure that their suppliers are permitted to supply pharmaceuticals. Legal History The following is applicable in accordance with chapter 5.2 of the EU GDP Guidelines (Guidelines on Good Distribution Practice of Medicinal Products for Human Use, 5 November 2013 - 2013/C 343/01): Only individuals who themselves have a wholesale distribution authorization or who
The EU Commission has published a document on a "Structured Dialogue on the security of medicines supply". The document is based on a mandate for a dialogue of different actors in the value chain of medicines from manufacturing, authorities, non-governmental organisations as well as from research. The aim was to gain a better understanding of
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the 2022-2026 workplan of the initiative Accelerating Clinical Trials in the EU (ACT EU). ACT EU, launched in January 2022, seeks to transform how clinical trials are initiated, designed and run. The aim is to further develop the EU as a focal
FDA Proposed Rule "National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers" In February 2022, the FDA has announced the availability of the proposed rule "National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs)". The proposed rule sets national licensing standards for both federal and
The COVID19 pandemic presents an unprecedented challenge to healthcare, the pharmaceutical industry’s supply chain and personnel movement. MHRA understands the impact of its work on industry, NHS and patients. This is not just in terms of our regulatory support to bring new technologies and products quickly and safely to market, but also the personnel and
The European Commission has published a Communication to prepare for the end of the transition period. The document is appropriately entitled "Getting ready for changes - Communication on readiness at the end of the transition period between the European Union and the United Kingdom". Far-reaching changes and consequences are therefore to be expected after 1
In an ever changing and complex industry the role of the Responsible Person has developed and grown over the past 10 years as the focus of regulatory bodies have placed a higher level of scrutiny on how GDP principals are implemented and applied for Wholesale Distributors. Initially the main areas of compliance for
