New Batch of MHRA No-Deal Brexit Guidance for Drugs, Devices

Regulatory NewsRegulatory News | 19 March 2019 |  By 

With a little more than a week left before the UK could depart from the EU without a deal, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday and Tuesday released 16 new and updated guidance documents, mostly related to marketing authorizations, variations and licensing.

A couple of the guidance documents deal with how MHRA will authorize new medicines in the event of a no-deal Brexit, including guidance on how the agency will handle centralized applications that are still pending on exit day, approaches for products approved or pending in the decentralized procedure (DCP) or mutual recognition procedures (MRP), converting centrally authorized products to UK marketing authorizations and certain new routes of assessment for MHRA’s evaluation of marketing authorization applications (MAAs). Such new assessment routes would include targeted assessments, accelerated assessments and rolling reviews.

The targeted assessment means MHRA will evaluate MAAs alongside the European Medicines Agency’s Committee for Medicinal products for Human Use (CHMP) assessment reports submitted by the applicants. The guidance says MHRA will reach its opinion on approvability within 67 days of submission of a valid application to the MHRA.

Under the accelerated assessment, MHRA will evaluate MAAs and reach its opinion on approvability within 150 days of submission of a valid application. And the rolling review assessment offers “on-going regulatory input and feedback enabling the applicants to ‘get it right first time’ and reduce attrition due to avoidable regulatory pitfalls.”

Other recently released guidance documents discuss the licensing of biological products, reference medicinal products, MAAs submitted to the UK that have been referred under Article 29, converting parallel distribution notices to UK parallel import licenses, the handling of active substance master files and certificates of suitability and new provisions for traditional herbal medicinal products and homeopathic products.

Another guidance on orphan or rare disease drugs explains how in the event of a no-deal scenario, the UK will offer incentives in the form of market exclusivity and full or partial refunds for marketing authorization fees to encourage their development. 

An updated guidance on medical devices also features more information about how to register medical devices in a no-deal scenario. An updated guidance on pharmacovigilance also builds upon previous guidance published in January. “More detailed guidance regarding the mechanisms for submission of pharmacovigilance data will be issued shortly,” MHRA said.

MHRA guidance and publications on a possible no deal scenario


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