We have unpacked how the Windsor Framework (WF) affects Regulatory activities through several of our Fusion webinars and articles, so I thought it only fair that we now explore how Pharmacovigilance (PV) activities will be impacted! You can revisit our webinars on the WF here.
A quick reminder of the Windsor Framework measures:
- Implementation 1st Jan 2025.
- All new medicines for the UK market will be authorised by the MHRA.
- All outer packaging must state ‘UK Only’ and can only be distributed/sold within UK.
How will licences be affected?
To understand how PV will be impacted, we need to first appreciate how the licence types will be changing after the deadline. Up until 31st Dec 2024, the following UK licence types will exist:
Following the implementation of the Windsor Framework, from 1st Jan 2025 the UK will only have the following licence types:
What are Category 1 and Category 2 products?
For PV considerations the Windsor Framework changes covers only those products which fall under the mandatory scope* of the Centralised Procedure (CP), therefore the MHRA have split products into two categories, Category 1 and Category 2, detailed below.
The MHRA will publish a list of existing Category 1 products before the end of 2024, it is expected therefore that if a product is not listed, it will be considered Category 2.
All new products submitted from 1st Jan 2025 will be requested to select the appropriate category within the MHRA submissions portal, this will be confirmed by the MHRA within the grant letter.
How will PV activities be affected from 1st Jan 2025?
There are differences between your PV responsibilities depending on whether your product falls into Category 1 or Category 2. The areas that are impacted include:
- Individual Case Safety Report (ICSR) reporting
- Safety referrals
- Period Safety Update Reports (PSURs)
- Post Authorisation Safety Studies (PASS)
- Implementation of EU outcomes
- UK Qualified Person for Pharmacovigilance (QPPV)
- UK PSMF
- Notification of QPPV and PSMF to Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
- UK-specific issues, as required
We will write another article delving into the impact from a regulatory perspective on the above PV activities shortly!
Sources:
*Mandatory scope of CP includes:
- HIV or AIDS
- cancer
- diabetes
- neurodegenerative diseases
- auto-immune and other immune dysfunctions
- viral diseases
- biotech medicines
- advanced-therapy medicines e.g. gene-therapy etc.
- orphan medicines (rare diseases)
- veterinary medicines for use as growth or yield enhancers
Optional scope of CP includes products that:
- contain new active substances for indications other than those stated above
- are a significant therapeutic, scientific or technical innovation
- would be in the interest of public or animal health
