The Medicines and Healthcare products Regulatory Agency (MHRA) on Monday released six new guidelines related to a no-deal Brexit scenario.
The guidance documents are on importing and exporting medicines and active substances.
According to the documents related to the export of active substances, UK will be recognised as a third country for the export of active substances for human use to the European Economic Area (EEA) and written communication will be required for each shipment manufactured in the UK.
The guidance on air freight of medicines advises on Good Distribution Practice (GDP requirements for air freight to ensure that product quality and security is protected.
Existing wholesale dealers who import medicines into the UK from an EEA state will need to review their existing wholesale dealer’s licence.
The Human Medicines Regulations 2012 will refer to the list of approved countries for importation of medicines under a wholesale dealer’s licence, batch testing of medicines and manufacturing of active substances with regulatory standards equivalent to the UK. The guidance on this list provides a summary of the circumstances under which it can be used.
The purpose of the guidance on the importation of investigational medicinal products from approval countries is to describe the principles for the management and oversight of the import of investigational medicinal products (IMPs) to the UK from the listed countries. To implement this guidance, there will be a one-year transition period following the date of the UK’s exit from the EU.
The document on completed paediatric studies gives guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs) in the event of a no deal scenario.