The Agency is publishing a series of guidance documents for industry and other stakeholders covering our proposed arrangements for the regulation of medicines, medical devices and clinical trials, if there is a no-deal Brexit.
Added new guidance 'Comparator products in Bioequivalence/Therapeutic Equivalence studies after Brexit' under the 'Marketing authorisations, variations and licensing guidance' heading.
Added new Guideline on Paediatric Investigation Plans, waivers, deferrals and compliance check under the 'Medicines for children' heading.
Added a new publication 'Exceptions and modifications to the EU guidance on good pharmacovigilance practices that will apply in a no-deal Brexit', in the section 'Regulatory submissions and vigilance activities'
Added a link to the guidance on Applying for a Certificate of Pharmaceutical Product in a no deal scenario.
New Group on Vaccines and Blood Products added to the document collection, with a link to the page on 'how to apply to release a vaccine or a blood product to market'. This page includes an updated section with guidance for the OCABR Release and Marketing Information Form processes, if the UK leaves the EU without a deal.
New guidance page on substantial amendments to a clinical trial if the UK leaves the EU with no deal has been added to the page.
New guidance about Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice in a no deal scenario added to the page.
New guidance has been added to the page. This guidance explains the steps companies will need to take to register new artwork for medicines packaging as a result of new marketing authorisations being issued in the event the UK leaves the EU without a deal.
New no deal guidance has been added to the page on procedures for UK-PIPs in the event the UK leaves the EU without a deal
New guidance on registration of clinical trials for investigational medicinal products and publication of summary results if the UK leaves the EU without a deal.
Added a link to a new guidance page on licensing of biological products: biosimilars, ATMPs and PMFs in a no deal scenario.
Added links to new guidance covering marketing authorisations, centrally authorised products and other information about medicines and medicinal products licensing.
Added new guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) if the UK leaves the EU without a deal.
Added a new section on importing and exporting in a no deal scenario.
New section on Vigilance and Risk Management added to the page in addition to a new guidance document which addresses Completed Paediatric Studies - submission, processing and assessment in the event of a no deal scenario.
Added links to two new statements from NIBSC, covering information for customers of biological reference materials and information for collaborators.
Added link to guidance on making submissions to the MHRA in a no deal scenario.
New guidance on regulating medical devices in the event of a no deal scenario added to the page.
We have added a link to updated guidance for manufacturers of biological medicines on NIBSC.org. The guidance addresses independent batch release in the United Kingdom following the UKs departure from the EU without a deal.