Introduction:

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced significant updates to its Good Pharmacovigilance Practices (GVP), effective from 1 January 2025. These updates highlight the UK’s distinct regulatory framework post-Brexit and introduce critical changes for Marketing Authorisation Holders (MAHs) in the UK.

Summary of Guidance:

This revised guidance impacts multiple pharmacovigilance areas, including periodic safety update reports (PSURs/PBRERs), risk management plans (RMPs), adverse drug reaction (ADR) reporting, the pharmacovigilance system master file (PSMF), and signal detection processes. Below, we explore the key changes and their implications.

View full guidance here

Act Now to Secure Compliance for 2025!

As your trusted partner in navigating regulatory change and driving drug safety excellence, whether you need support meeting UK standards or ensuring global pharmacovigilance compliance, PharSafer delivers compliant safety solutions not only in the UK but worldwide.

For any questions or assistance for how to best navigate these updates and their implications for your safety operations, please do not hesitate to contact our team.

Key Updates in MHRA GVP Guidance:

Periodic Safety Update Reports (PSURs/PBRERs):

1. Product Categorisation:

Category 1 Products: Products which fall under the mandatory or optional scope of the EU Centrally Authorised Procedure. Where a license is changed to a PLGB (authorised in Great Britain only) by the MHRA, pharmacovigilance requirements will be in line with Category 1 products. Category 1 products fall under UK PV requirements and so a PSUR/PBRER needs to be submitted.

Category 2 Products: Products which do not fall within the scope of Category 1. Pharmacovigilance requirements for Northern Ireland only MAs (PLNI) will be in line with those for Category 2 products. Category 2 products fall under EU PV requirements and so a PSUR does not need to be submitted to the MHRA unless:

1. The product is not authorised in the EU and is not included in the EURD list.

2. The product is imported under a parallel import.

2. Submission and Assessment:

PSURs/PBRERs must align with EU structures but include UK-specific content (e.g. proposed UK product information in the regional appendices).

Generic, well-established-use, and herbal products are exempt from the requirement to submit PSURs/PBRERs.

3. Data Lock Points (DLPs):

UK-specific DLP schedules may be issued by the MHRA. If none are provided, the EURD list applies.

Products not listed in EURD follow a default MHRA schedule (6 months until 2 years on the market, 1 year for the next 2 years, then every 3 years).

Risk Management Plans (RMPs):

1. UK-Specific Focus:

RMPs must address risk minimisation measures specific to the UK and templates must reflect UK regulatory needs.

2. Continuous Updates:

The MHRA may request ongoing RMP updates as new safety data emerges.

3. Operational Adjustments:

MAHs must implement robust processes to meet these evolving requirements effectively.

*The impact of this approach could mean that products authorised both in the UK and Europe have differing RMPs for the same product with the same indications. This has to be considered for all deliberations for safety and risk minimisation activities.

Adverse Drug Reaction (ADR) Processing and Reporting:

1. Medical Literature Monitoring (MLM):

The MLM service undertaken by the European Medicines Agency (EMA) continues to apply to UK MAHs for products authorised as Category 2. In order to avoid the submission of duplicate ICSRs, MAH’s must only submit ICSRs described in medical literature which is not reviewed by the EMA for Category 2 products containing active substances which are not included in the list monitored by the EMA.

2. ICSR Submission:

ADRs must continue to be submitted via the MHRA in standardised electronic formats e.g. ICH E2B R2/R3.

MHRA ICSR Submission Requirements:

All UK authorised products:

Serious: MAH to submit all serious ICSRs that occur within or outside the UK, including ICSRs received from competent authorities outside the UK within 15 calendar days.

Non-serious: MAH to submit all non-serious ICSRs that occur within the UK within 90 calendar days:

EMA ICSR Submission Requirements:

Category 1 products:

Serious: MAH to submit all serious ICSRs that occur within or outside the UK, including ICSRs received from competent authorities outside the EU to the EudraVigilance database where an equivalent licence was granted in the EU/EEA within 15 calendar days.

Non-serious: MAH to submit all non-serious ICSRs that occur within an EEA state or Northern Ireland to the EudraVigilance database where an equivalent licence was granted in the EU/EEA within 90 calendar days:

Category 2 products:

Serious: MAH to submit all serious ICSRs that occur within or outside the UK, including ICSRs received from competent authorities outside the EU to the EudraVigilance database within 15 calendar days.

Non-serious: MAH to submit all non-serious ICSRs that occur within an EEA state or Northern Ireland to the EudraVigilance database within 90 calendar days:

Pharmacovigilance System Master File (PSMF):

1. UK Accessibility:

PSMFs must be electronically accessible from a single UK-based point.

2. Enhanced Inspections:

The MHRA will increase focus on compliance, including UK-specific pharmacovigilance activities, which will focus upon UK law (Statutory Instruments) as well as the implemented and unchanged EU GVP Modules not amended by the UK.

3. Routine Updates:

Regular updates are mandatory to maintain alignment with UK standards.

4. QPPV/NCP:

Any changes to the contact details for this nominated contact person should be notified to the licensing authority immediately and no later than 14 calendar days from the change.

Description of responsibilities of the NCP is required: responsibilities of the contact person for pharmacovigilance where such a person has been nominated at national level in accordance with HMR regulation 182(2A), including contact details.

5. Annexes:

Annex A: A list of tasks that have been delegated by the qualified person for pharmacovigilance shall also be included in the Annexes (II.B.4.8). This should outline the activities that are delegated and to whom, and include the access to a medically qualified person is applicable (GVP Module I) and HMR schedule 12A paragraph 10(2)(b) for Category 1 products or [IR Art 10(1)] for category 2 products.

Annex B, C and H of the UK PSMF should continue to include all global authorisations and information as applicable to all UK authorised products.

Annex F: For Category 2 products, the MAH should include reporting metrics to the EMA as well as to the MHRA. Only reporting metrics to the MHRA are required for Category 1 products. If the MAH has Category 1 and Category 2 products, for which ICSR submission is required to the EMA, the MHRA will accept EMA metrics for both types of products to be displayed within the PSMF.

Annex H: Should include the categorisation of the product – i.e., Category 1 or 2.

Signal Detection and Risk Minimisation:

1. UK-Specific Signal Management:

Signal detection must incorporate MHRA-defined parameters and prioritise UK-focused risks.

2. Transparent Risk Communication:

Risk information may be published on the national medicines web portal, supporting public awareness.

3. Proactive MHRA Engagement:

MAHs are encouraged to collaborate with the MHRA on emerging signals to ensure timely interventions.

What These Changes Mean for MAHs:

These updates from the MHRA signify a robust, independent UK pharmacovigilance framework, requiring MAHs to:

Adapt systems, processes and training for UK-specific reporting and documentation.

Prioritise electronic accessibility for PSMFs.

Align RMPs and ADR reporting processes with MHRA requirements.

The changes demand meticulous preparation, operational updates, and clear differentiation between UK and EU compliance responsibilities.

Is Your Organisation Ready for the 2025 GVP Updates?

With the MHRA’s updated Good Pharmacovigilance Practices (GVP) taking effect in January 2025, now is the time to act. Staying compliant is essential to maintaining smooth operations, avoiding costly penalties, and protecting your organisation’s reputation.

PharSafer’s global team of regulatory experts is ready to guide you through every step of compliance. We offer tailored solutions to help you:

Implement and maintain UK-specific Risk Management Plans (RMPs).

Provide experienced EU, local, and UK QPPVs and Pharmacovigilance contact persons.

Conduct comprehensive audits to prepare for UK regulatory inspections.

Ensure seamless electronic PSMF accessibility, including writing and maintenance.

Streamline Adverse Drug Reaction (ADR) reporting protocols.

Implement robust electronic data systems for direct MHRA reporting.

Prepare and submit PBRERs in full compliance with MHRA requirements.