Pharmacovigilance in a No-Deal Brexit Scenario

The uncertainty of Brexit and the possibility of a no-deal resolution has left the life sciences industry in a precarious position. A no-deal Brexit would result in adjustments to the laws, regulations, and specifications in almost all of the facets of business and production.

With so much going on, our aim is to keep you up to date on the possible changes and requirements if there is a no-deal Brexit. In this blog post, we highlight the most important changes to be wary of in the case of a no-deal Brexit, according to the UK government.

Who Is Affected?

In the case of a no-deal Brexit, certain legal obligations will apply to all marketing authorization holders in the UK. This means that any pharmaceutical company that has the right to market its products will have to abide by the requirements that follow.

The qualified person responsible for pharmacovigilance (UK QPPV) for each of these companies needs to reside and operate within the UK and will have to maintain and make available upon request a pharmacovigilance system master file (PSMF) that describes the pharmacovigilance system for UK-authorized products. This master file must be located in or accessible electronically from the UK at the same site at which adverse reaction reports may be accessed.

Let’s take a closer look at these aspects.

The UK QPPV

The UK QPPV has the same roles and responsibilities as the pre-Brexit EU QPPV and is responsible for the establishment and maintenance of the pharmacovigilance system.

Here are some important takeaways from the official Brexit UK guide.

The QPPV must reside and operate in the UK

The UK QPPV must be an appropriately qualified person responsible for pharmacovigilance which is

• ordinarily resident, and
• operates within the United Kingdom. 

21-Month Exemption for Current EU QPPVs

• There is a temporary exemption in place that allows companies up to 21 months after exit day to appoint a UK QPPV that resides and operates within the UK.
• This exemption will allow the EU QPPV who, before exit day, resided in an EU state to assume responsibility for UK products.

The UK PSMF

The UK PSMF describes the global pharmacovigilance system and reflects the global availability of safety information for UK-authorized products, whereas the content of the annexes should be specific to products authorized in the UK. The format and content of the UK PSMF are the same as the content of the EU PSMF. These minimum requirements are laid out in HMR Schedule 12A.

Here are a few of the important takeaways and differences.

The UK PSMF must be located in the UK at the same point from which reports of suspected adverse reactions are accessible

• This differs from the previous concept, where the file was located either at the site where the main pharmacovigilance activities were performed or at the site where the EU QPPV operates.
• The file can be accessed either physically or electronically as long as it is permanently and immediately available for inspection at the stated location in the UK.

Every pharmacovigilance system must be identified by a unique number

• All UK PSMFs must be registered with the MHRA. Companies that wish to apply must fill in a number request form immediately after exit day in a no-deal Brexit scenario.
• Do not request a UK PSMF number until the summary of the pharmacovigilance system is updated.

Once the form is completed, applicants must submit it to UKPSMFadmin@mhra.gov.uk.

Applicants will receive a unique UK PSMF number via email within ten working days.

The Process to Notify MHRA by Existing holders of UK Marketing Authorizations

Companies that already have a UK marketing authorization (MA) must follow the procedure below in order to notify the MHRA of the changes to their pharmacovigilance system, including the UK PSMF number. All companies must notify the MHRA of any changes within two weeks of the change.

How to make a submission

• Submit a Type IAIN - C.I.8.a variation via the MHRA submissions portal.
• SPS updates must be submitted as single changes.
• Only submit in collections of no more than 25 PLs.

Documentation needed for a submission

• A summary of the pharmacovigilance system including:
• Proof of a qualified UK QPPV.
• Contact details of the UK QPPV.
• A reference to the location of the PSMF, physical or electronic.
•  UK PSMF number

The Process to Apply for a UK MA

Companies that wish to apply for the new UK MA follow a similar procedure as set out above. The material to accompany an application for a UK marketing authorization includes a summary of the applicant’s pharmacovigilance system, which must include the following elements:

• Proof of a qualified UK QPPV.
• Contact details of the UK QPPV.
• A reference to the location of the PSMF, physical or electronic.
• A statement signed by the applicant to the effect that the applicant has the necessary means to fulfill their role as an MA.
• A UK PSMF number.

Further Assistance

General queries relating to the UK QPPV, UK PSMF, and establishment of pharmacovigilance systems for UK-authorized products should be sent to: gpvpinspectors@mhra.gov.uk

Queries relating to the UK PSMF number should be sent to: UKPSMFadmin@mhra.gov.uk

Queries relating to the submission of Type IA variations should be sent to: variationqueries@mhra.gov.uk