Overview:

The MHRA – Medicines and Health care Regulatory Agency is the regulatory body in the United Kingdom. The Division responsible for Pharmacovigilance is Vigilance Risk Management of Medicines Division (VRMMM). MHRA works with collaborating with the EU until the full transition of Brexit.

Yellow Card Scheme:

Adverse events are reported under “yellow card scheme” where the MHRA decides on the severity of the events taking necessary actions.

Drug safety monitoring is done by PSUR, annual reporting and risk management plan submitted to VRMMM while for device safety monitoring any serious events should be submitted within 15 days of the event and non-serious events within 90 days of the event to UK and WHO database.

A new schedule regulation for the UK, (12A) to Regulation 205A, which provides “further provision as to the performance of pharmacovigilance activities”, there is the requirement to have in place one or more PSMFs (Pharmacovigilance System Master File) by the MAH, covering all the products licensed by the MAH. The format mirrors to that of the EEA PSMF as specified under the EMA’s Guideline on Good Pharmacovigilance Practices (GVP) Module II: Pharmacovigilance System Master File.

Regarding the location of this PSMF, the draft legislation states that the PSMF must be in, or accessible electronically from, the United Kingdom and permanently accessible to the UK QPPV. This implies a PSMF fulfilling EU requirements and located in the EEA may be acceptable so long as it is electronically accessible from the UK; is at the permanent disposal of the UK QPPV; and covers the products licensed in the UK, but this may need further clarification from the MHRA. However, it is important to note that a change in QPPV details or PSMF location would now require a minor (Type IA) variation to the UK Marketing Authorization (MA).

Black Triangle Products:

Another pharmacovigilance practices that MHRA has is the Black Triangle Products which means:

  • the product is subject to intensive monitoring
  • it contains a new active substance; new medicines or vaccines authorized on or after January 2011 are assigned a Black Triangle
  • it is a biological medicine (e.g., a vaccine or a medicine derived from plasma)
  • it has been given a ‘conditional approval’ (enabling medicines to reach patients with unmet medical needs earlier than might otherwise be the case while ensuring that additional data on a product are generated, submitted, assessed, and acted on)
  • it contains a new active substance; new medicines or vaccines authorized on or it is approved ‘under exceptional circumstances’ (where the company is unable to provide comprehensive data for safety and efficacy under normal conditions of use because, for example, the indication is so rare)
  • the company that markets the medicine is required to carry out additional studies (e.g., to obtain data on long-term use or a rare side effect seen in clinical trials)

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com

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