Medicines Healthcare Products Regulatory Agency
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Get ready for Brexit on 31 October 2019. This page tells you how to prepare for Brexit. It will be updated if anything changes, including if a deal is agreed.
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The following legal obligations will apply to marketing authorisation holders (MAH) in the UK, in a no deal scenario:
- To operate a pharmacovigilance system for UK authorised products.
- To have an appropriately qualified person responsible for pharmacovigilance (QPPV) that resides and operates in the UK and is responsible for the establishment and maintenance of the pharmacovigilance system for UK authorised products (the UK QPPV).
- To maintain and make available upon request a pharmacovigilance system master file (PSMF) that describes the pharmacovigilance system for UK authorised products (the UK PSMF). The UK PSMF must be located in, or accessible electronically from, the UK at the same site at which adverse reaction reports may be accessed.
The purpose of this guidance is to provide practical information and instructions to UK MAHs on:
- the role and responsibilities of the UK QPPV
- the development and registration of the UK PSMF and
- the notification of the summary of pharmacovigilance system to the Medicines and Healthcare products Regulatory Agency (MHRA).
Guidance on the UK QPPV
Role and responsibilities of the UK QPPV
The role and responsibilities of the UK QPPV are equivalent to that of the EU/EEA QPPV. In accordance with The Human Medicines Regulations (HMR) regulation 182(2) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (the EU Exit Regulations)), the holder must:
(a) have permanently and continuously at its disposal an appropriately qualified person responsible for pharmacovigilance who is ordinarily resident, and operates, in the United Kingdom and is responsible for the establishment and maintenance of the pharmacovigilance system.
Furthermore, HMR Schedule 12A (inserted by the EU Exit Regulations) paragraph 10(4) states:
The holder must ensure that the qualified person responsible for pharmacovigilance has sufficient authority to influence the performance of the quality system and the pharmacovigilance activities of the holder.
Further guidance on the qualifications and role of the EU/EEA QPPV is described in Good Pharmacovigilance Practice (GVP) Module I Pharmacovigilance systems and their quality systems.
Temporary exemption as to the location of the UK QPPV
There is a temporary exemption in place which allows you until 21 months after exit day to appoint a UK QPPV that resides and operates in the UK. This is stated in section 1.9 of the further guidance from January 2019.
This temporary exemption will allow the EU/EEA QPPV who, immediately before exit day, resided and operated in an EEA state, to assume responsibility for UK authorised products until a QPPV who resides and operates in the UK can be established.
Guidance on the UK PSMF
UK PSMF location
You need to ensure that the UK PSMF is located at the same point in the UK from which the reports of suspected adverse reactions referred to in HMR regulation 187(4) are accessible (electronically or physically). This differs from the EU concept where the EU PSMF shall be located either at the site where the main pharmacovigilance activities are performed or at the site where the EU/EEA QPPV operates.
The UK PSMF needs to be permanently and immediately available for inspection at the stated location in the UK.
UK PSMF format, content and representation of PV systems
The requirements for the format and content of the UK PSMF are equivalent to that of the EU PSMF. The minimum requirements for the content and maintenance of the UK PSMF are laid out in HMR Schedule 12A and further guidance on the format and content of the EU PSMF is described in GVP Module II Pharmacovigilance system master file.
The UK PSMF must describe the global pharmacovigilance system and reflect the global availability of safety information for UK authorised products. The annex content should be specific to UK authorised products.As per GVP Module II, there are different approaches to establishing a pharmacovigilance system. For example:
- MAHs can establish more than one pharmacovigilance system.
- A pharmacovigilance system can be shared by several MAHs.
You must make sure that every pharmacovigilance system covering UK authorised products is identified by a unique number.
How to request a UK PSMF number
All UK PSMFs must be registered with the MHRA. You should request a unique UK PSMF number from the MHRA for each pharmacovigilance system that you are operating for UK authorised products. Where the pharmacovigilance system is shared by several MAHs, a single request for a UK PSMF number should be submitted to the MHRA.
A UK PSMF number request form will be