Good Distribution Practices News

Several European pharmaceutical associations are calling on the EU to give priority to access to medicines in the ongoing Brexit negotiations. Specifically, they are calling for an MRA.

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the second revision of the common document "Questions And Answers On Regulatory Expectations For Medicinal Products For Human Use During The Covid-19 Pandemic". The update includes several new questions and answers from the GDP area, for example on the adaptations to the work of the Responsible Person (RP) and the use of equipment or newly authorised premises for storage and distribution with limited prospective qualification.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has recently published a post on temporary changes in Good Distribution Practice (GDP) in the MHRA Inspectorate Blog.

During the current Sars-CoV-2 outbreak, there are sometimes delivery problems with medicines, medical devices and protective equipment. Unfortunately, this also brings up many fraudsters, as a case revealed by Interpol shows.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a list of temporary regulatory flexibilities on good distribution practices (GDP) that will be allowed to address the current exceptional circumstances during the coronavirus (COVID-19) outbreak.

The Medicines and Healthcare products Regulatory Agency (MHRA) is currently investigating an incident where several medicines appear to have left the legal supply chain.

Annex 21 to the EU-GMP Guidelines (Importation of medicinal Products) has been published as a draft. It summarises the GMP requirements for importers of medicinal products.