After a 15-month prison sentence, the owner of Immuno Biotech is now threatened with the seizure of GBP 1.4 million in connection with the manufacture, sale and supply of an unlicensed drug.
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.
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the first 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 a question on GDP certificates and wholesale authorisations.
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 European Commission has published Version 17 of the "Questions & Answers regarding the implementation of the rule on safety features for medicinal products for human use".
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 European Medicines Agency (EMA) is urging the general public not to buy medicines from unauthorized websites and other vendors aiming to exploit fears and concerns during the ongoing pandemic.
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.
The EMA and its partners are closely monitoring the potential impact of the outbreak of the novel coronavirus disease (COVID-19) on pharmaceutical supply chains into the EU.
