UK Law and Practice Contributed by: Adela Williams, Ewan Townsend, Libby Amos-Stone and Eleri Abreo, Arnold & Porter
and operate in the UK, there will be a need for a national contact person for pharmacovigilance who resides and operates in the UK); • maintain a pharmacovigilance master file; • operate, monitor and update a risk management system for the product; • record and report all suspected adverse reactions 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 incor- porate any such condition 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 moni- tor and report to it any serious adverse incidents asso- ciated with the product. The manufacturer must also take appropriate safety action when required. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations Requests for information about MAs and pending MAs for medicinal products may be submitted to the MHRA under the Freedom of Information Act 2000 (FOIA). The MHRA releases very little information in relation to pending applications. Following the grant or refusal of an MA, the MHRA generally releases detailed information about the application and authorisation, both proactively via dis- closures on its website and also in response to third- party information requests. The FOIA provides mecha- nisms whereby personal data, confidential information and commercially sensitive information may be with- held or redacted from documents requested by third parties, and the MHRA typically allows MA holders to comment on any proposed redactions prior to their release. For medical devices, Approved Bodies are private entities. Therefore, access to information provisions 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 registered with the MHRA, a man- ufacturer’s details will be added to the Public Access Database for Medical Device Registration. Other infor- mation 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 Medicinal Products The UK operates a national assessment procedure for both innovative and established medicinal products. For innovative medicines, the MHRA aims to issue an opinion within 150 “clock-on” days following applica- tion validation where all issues are resolved following one round of questions, or to reach a final decision within 210 days if issues remain beyond 150 days. Under the fixed timetable for innovative medicines, the first Request for Further Information (RFI) is issued at Day 90 of the assessment period, following MHRA consultation with the Commission on Human Medi- cines (CHM) or its expert advisory groups (EAGs). The applicant has six months (a clock-stop period) to address and respond to the concerns (an extension is available in exceptional circumstances). Follow- ing receipt of the applicant’s responses, the MHRA will assess the responses by Day 150 (60 days after the procedure has restarted). If minor issues remain a second RFI will be issued, or if major issues remain a letter from the CHM will be provided. Otherwise, final compliance checks will be made before the appli- cation is granted. The applicant has three months (a clock-stop period) to respond to the further RFI, and if all issues are resolved the application will be granted by Day 210. Otherwise, a third RFI may be issued, fol- lowing a similar process to the second RFI. Where a letter from the CHM is received indicating major con- cerns, written or oral representations can be made. The UK is also part of the Access Consortium work- sharing procedure. This allows for simultaneous sub-
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