UK Law and Practice Contributed by: Jackie Mulryne, Ewan Townsend, Adela Williams and Libby Amos-Stone, Arnold & Porter
• record and report all suspected adverse reac- tions occurring in relation to their products; and • submit periodic risk-benefit evaluation reports for their products. The MHRA may grant an MA subject to one or more conditions, including post-marketing obligations such as the requirement to conduct post-authorisation safety and efficacy studies. The MA holder must incorporate any such con- dition into the risk management system for the product. Once a medical device has been placed on the UK market, the MHRA requires the manufacturer to monitor and report to it any serious adverse incidents associated with the product. The manufacturer must also take appropriate safety action when required. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices Requests for information about MAs and pend- ing MAs for medicinal products may be submit- ted to the MHRA under the Freedom of Informa- tion Act 2000 (FOIA). The MHRA releases very little information in rela- tion to pending applications. Following the grant or refusal of an MA, the MHRA generally releases detailed informa- tion about the application and authorisation, both proactively via disclosures on its website and also in response to third-party informa- tion requests. The FOIA provides mechanisms whereby personal data, confidential information and commercially sensitive information may be withheld or redacted from documents requested by third parties, and the MHRA typically allows
MA holders to comment on any proposed redac- tions prior to their release. For medical devices, Approved Bodies are private entities. Therefore, access to information provi- sions that apply to public bodies do not apply. As such, both before and after UKCA marking, the information pertaining to the device remains the property of the manufacturer. Once regis- tered with the MHRA, a manufacturer’s details will be added to the Public Access Database for Medical Device Registration. Other information held by the MHRA could be requested under the FOIA, but will only be provided where no excep- tions under the FOIA apply. 4. Regulatory Reliance and Fast Track Registration Routes 4.1 Fast Track Registration Routes The UK operates a national accelerated proce- dure for medicinal products, which took effect in January 2021. Under this route, the MHRA evaluates all high quality UK MA applications and reaches an opinion within 150 days of appli- cation validation, with the aim of accelerating market access. The assessment period is split into two phases. Phase I involves an 80-day period, during which the MHRA will consult with the Commission on Human Medicines (CHM) and/or therapy area experts. Any concerns arising after this initial assessment will be raised in a request for further information letter to the applicant. The applicant has 60 days (a clock-stop period) to address and respond to the concerns (an extension is avail- able in exceptional circumstances only). Phase II begins following MHRA’s receipt of the appli- cant’s responses, following which the MHRA will provide an opinion on approvability. If the MHRA
367 CHAMBERS.COM
Powered by FlippingBook