European Commission releases aide-memoire to help medicine manufacturers comply with GMP inspections related to falsified medicines delegated regulation

In order to help medicine manufacturers comply with the 2015 European Union (EU) delegated regulation protecting against falsified medicines, which came into force in February 2019, the European Commission has released an aide-memoire for good manufacturing practice (GMP) inspections of manufacturers. Read more “European Commission releases aide-memoire to help medicine manufacturers comply with GMP inspections related to falsified medicines delegated regulation”

Netherlands and Luxembourg to benefit from EU-US mutual recognition agreement for GMP inspections

The Netherlands and Luxembourg have been added to the mutual recognition agreement for good manufacturing practice (GMP) inspections between the United States (US) Food and Drug Administration (FDA) and the European Union (EU) member states. The FDA can now recognise inspections carried out by regulators from the Netherlands and Luxembourg. Read more “Netherlands and Luxembourg to benefit from EU-US mutual recognition agreement for GMP inspections”

Bulgaria and Cyprus to benefit from EU-US mutual recognition agreement for GMP inspections

Bulgaria and Cyprus have been added to the mutual recognition agreement for good manufacturing practice (GMP) inspections between the United States (US) Food and Drug Administration (FDA) and the European Union (EU) member states. The FDA can now recognise inspections carried out by regulators from Bulgaria and Cyprus. Read more “Bulgaria and Cyprus to benefit from EU-US mutual recognition agreement for GMP inspections”

Implementing the Falsified Medicines Directive: Safety Features

European Union (EU) member states had until 9th February to implement the final part of the Falsified Medicines Directive (FMD). Member states are required to implement the new falsified medicinal products for the majority of prescription-only medicines, which aims to prevent falsified medicinal products from entering the pharmaceutical supply chain. Read more “Implementing the Falsified Medicines Directive: Safety Features”

MHRA releases final consultation response for the Falsified Medicines Directive

A public consultation was launched by the Government in July 2018 regarding actions that need to be taken to ensure that the United Kingdom (UK) meets its obligations to apply the provisions of the Falsified Medicines Directive (FMD). The FMD requires ‘safety features’ to be applied to the packaging of specified medicinal products. The consultation closed on 23rd September 2018, and the final consultation response has been published with the Medicines and Healthcare Products Regulatory Agency’s response to over 50 replies that were received from a variety of stakeholders. Read more “MHRA releases final consultation response for the Falsified Medicines Directive”