Advisor 469

CLINICAL RESEARCH • CLINICAL QUALITY ASSURANCE

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All the documents are available on the MHRA website and are dated 1 September 2020. They will be updated as necessary over the coming months and are categorised under the following headings. Clinical trials • Registration of clinical trials for investigational medicinal products (IMPs) and publication of summary results • Guidance on substantial amendments to a clinical trial Pharmacovigilance • Guidance on pharmacovigilance procedures • Guidance on Qualified Person responsible for pharmacovigilance including pharmacovigilance system master files Paediatrics • Procedures for UK Paediatric Investigation Plan • Completed paediatric studies – submission, processing and assessment • Format and content of applications for agreement or modification of a PIP and requests for waivers or deferrals and concerning the operation of the compliance check Licensing • Conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice • Registering new packaging information for medicines • Guidance on the handling of applications for centrally authorised products (CAPs) pending on 1 January 2021 • How marketing authorisation applications referred under Article 29 will be handled • Converting parallel distribution notices to UK parallel import licences Devices • Regulating medical devices

• Handling of active substance master files and certificates of suitability • Reference medicinal products • Converting CAPs to UK marketing authorisations, ‘grandfathering’ and managing lifecycle changes • Renewing marketing authorisations for medicines • Guidance on new provisions for traditional herbal medicinal products and homoeopathic medicinal products • Guidance on licensing biosimilars, advanced therapy medicinal products and plasma master files • Comparator products in bioequivalence/ therapeutic equivalence studies Importing and exporting • Importing medicines on an approved country for import list • Exporting active substances manufactured in Great Britain for use in European Economic Area and Northern Ireland • Importing IMPs into Great Britain from approved countries • List of approved countries for authorised human medicines • Acting as a Responsible Person (import) • Applying for a Certificate of Pharmaceutical Product IT systems • Registering to make submissions to the MHRA • Webinars: preparing to make submissions to the MHRA ABPI response On 1 September 2020, the Association of the British Pharmaceutical Industry (ABPI) indicated that UK companies will welcome the important detail included in the guidance, which will support them in planning for the end of the transition period. However, the ABPI noted that the latest u page 7

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Issue 469, 2020

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