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Guidance on Qualified Person Responsible for Pharmacovigilance (QPPV) Including Pharmacovigilance System Master Files (PSMF) from 1 January 2021

From 1 January 2021, the following legal obligations will apply to UK marketing authorisations (MAs). These include those that cover the whole of the UK, or are specific to Northern Ireland or to Great Britain (England, Wales and Scotland). Where the QPPV is not in the UK, there will be a need for a national contact person for pharmacovigilance.

There will be no temporary exemption as to the requirement to have a QPPV who resides and operates in the EU or the UK. If you choose to establish a QPPV who resides and operates in the EU, you must nominate a national contact person for pharmacovigilance who resides and operates in the UK. The individual should be able to facilitate responses to pharmacovigilance queries raised by the MHRA.

The PSMF describes the pharmacovigilance system for UK authorised products. 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. The PSMF must be accessible electronically at the same point in the UK from which the reports of suspected adverse reactions are accessible.

Statutory guidance concerning the PSMF for UK authorised products is described in GVP Module II. The PSMF must describe the global pharmacovigilance system and reflect the global availability of safety information for UK authorised products. A UK PSMF number can be requested via the MHRA Submissions Portal from 1 January 2021.

You are encouraged not to request the UK PSMF number until you are applying for a new UK marketing authorisation or notifying the MHRA of a change in the details of the QPPV for UK authorised products from the baseline information held by the MHRA.

Guidance for applicants for UK marketing authorisations from 1 January 2021. The material to accompany an application for a UK marketing authorisation includes a summary of the applicant's pharmacovigilance system (SPS). This must include the elements, such as, proof that the applicant has at their disposal an appropriately qualified person responsible for pharmacovigilance.

From 1 January 2021, we are expecting a large volume of Regulatory submissions. You should submit your SPS updates as single changes. You should submit no more than two collections in a single package.

Changes made after 13 December 2020 will not be included in the baseline dataset. The submission of SPS details for licences that were authorised via the EU centralised procedure should be handled differently to UK national licences.

Licences authorised via the EU centralised procedure will automatically be converted into UK MAs. These MAs will be issued with a UK MA number before the end of the transition period. You will have a period of one year, starting on 1 January 2021, to submit the baseline initiating sequence data.

From 1 January 2021, for products in respect of Northern Ireland (UK-wide and Northern Ireland-only MAs), you must also continue to submit this information to the Article 57 database in accordance with Regulation (EC) No 726/2004 Article 57(2).

Source: MHRA guideline on Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) from 1 January 2021

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