The United Kingdom (UK) formally left the European Union (EU) on 31 January 2020, since then, there has been a transitionary arrangement in place maintaining the status quo regarding EU regulations on goods and services including the regulation of medicines and pharmacovigilance requirements. The transition period after Brexit will come to an end this year and from 1 January 2021, new legal obligations will apply to holders of UK marketing authorisations (MA). These new requirements take into account certain regional considerations for products available to Northern Ireland market versus the rest of the UK.
This guidance provides a summary of the updated UK Government requirements effective from 01-Jan-2021 regarding the following topics:
- Guidance on the Qualified Person for Pharmacovigilance (QPPV)
- Guidance on the UK National Contact Person for Pharmacovigilance
- Guidance on the UK Pharmacovigilance System Master File (PSMF)
Further guidance regarding the notification of QPPV and PSMF details to the MHRA for new and existing holders of UK marketing authorisations will be published in due course.
Qualified Person for Pharmacovigilance
- The QPPV‘s roles and responsibilities for products licensed in the UK will be equivalent to that of the EU/EEA QPPV. Further guidance on the role and qualifications of the EU/EEA QPPV is outlined in GVP Module I – Pharmacovigilance systems and their quality management systems. This guidance is supplemented by the ‘Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders’.
- The QPPV must be appropriately qualified, resident and operational in the EU or the UK according to regulation 182 of the Human Medicines Regulations 2012 (as amended (HMR), the UK QPPV is responsible for the establishment and maintenance of the PV system for UK authorised products.
- From 01 January 2021, there will be no temporary exemption as to the requirement to have a QPPV who resides and operates in the EU or the UK and is responsible for the pharmacovigilance system for UK authorised products.
- For MAs that cover the whole of the UK or are specific to Northern Ireland, the legal requirements concerning the qualifications and responsibilities of the QPPV that are outlined in Article 10 of the Commission Implementing Regulation (EU) No 520/2012 (CIR) will remain unchanged.
- For MAs that are specific to Great Britain, legal requirements concerning the qualifications and responsibilities of the QPPV are outlined in paragraph 10 of HMR Schedule 12A (inserted by the EU Exit Regulations 2019), which mirrors Article 10 of CIR.
National Contact Person for Pharmacovigilance
- If choice is made to establish a QPPV who resides and operates in the EU, then a national contact person for pharmacovigilance who resides and operates in the UK and reports to the QPPV must be nominated, who will have access to the reports of suspected adverse reactions referred to in regulation 187 of the HMRs and the PSMF for UK authorised products.
- There will be a temporary exemption in place for 12 months from 1 January 2021 to appoint a national contact person for pharmacovigilance who resides and operates in the UK. Further guidance on the process for notifying the details of the national contact person for pharmacovigilance to the MHRA will be published in due course.
Pharmacovigilance System Master File
- For MAs that cover the whole of the UK or are specific to Northern Ireland, the PSMF must be located either at the site in the European Union where the main pharmacovigilance activities are performed or at the site where the QPPV operates, in accordance with Article 7(1) of the CIR. The PSMF must be accessible electronically at the same point in the UK from which the reports of suspected adverse reactions referred to in regulation 187 of the HMRs are accessible.
- For MAs that are specific to Great Britain, the PSMF must be accessible electronically at the same point in the UK from which the reports of suspected adverse reactions referred to in regulation 187 of the HMRs are accessible.
- The UK PSMF must be permanently and immediately available for inspection at the stated location in the UK.
- The format and content of the UK PSMF will remain equivalent to that of the EU/EEA PSMF. Further guidance of the format and content is outlined in GVP Module II – Pharmacovigilance System Master File.
- The UK PSMF must describe the global PV system and the global availability of safety information for UK authorised products.
- The MAH can have more than one PV system or a PV system can be shared by several MAHs, however, they must ensure that each PV system for UK authorised products is identified by a unique PSMF number.
- All UK PSMFs must be registered with the MHRA and the MAH should request a unique PSMF number for each PV system via the MHRA submission portal from 1 January 2021.
- The MAH should not request the UK PSMF number until they are notifying the MHRA of a change in the details of the QPPV for UK authorised products from the baseline information held by the MHRA. The baseline information includes be the QPPV details that were registered in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) on 31 December 2020.
QVigilance is well placed to support our customers with implementing these new requirements and ensuring full compliance with both UK and EU requirements following the end of the transition period. Our experienced UK-based team of pharmacovigilance experts can support with MHRA Submission Portal registration arrangements, creation and maintenance of your UK specific PSMF, and fulfilling the role of the UK National Contact Person for Pharmacovigilance.
Please contact us for further information.