- Legal Basis
- ICSRs submission
1. Legal Basis
Starting from the 1st of January 2021 the MHRA will have full responsibility for the UK MA, including Northern Ireland or to Great Britain (England, Wales and Scotland). MAH with product registered there should maintain following responsibilities according to the recently published guidance (updated 06 Jan 2020):
- To operate a pharmacovigilance system for UK authorised products
- To have an appropriate QPPV that resides and operates in the EU or the UK
- To maintain and make available upon request a PSMF that describes the pharmacovigilance system for UK authorised products
- The PSMF must be accessible electronically from the UK at the same site at which reports of suspected adverse reaction may be accessed
This is provided for by regulation 182 of the Human Medicines Regulations 2012 (as amended) (HMR).
The Good Vigilance Practices (GVP) modules will remain in force but a guidance note on the exceptions and modifications to the EU guidance on good vigilance practices has been published.
Summary of brief changes and requirements you could find below:
- MAH shall make PSMF available upon request of the MHRA
- PSMF must be located in the EU or UK where the main activities are performed or at the site of EU QPPV
- PSMF must be accessible from the UK by UK NCP
- A single PSMF can be used for all UK authorized product for one MAH
- PSMF number shall be requested from the MHRA portal
- Change in the details of the QPPV for the UK should be notified to the MHRA first before requesting UK PSMF number
- PSP changes should be notified as a variation type IAIN C.i.8
- The format and content of the UK PSMF are equivalent to that of the EU PSMF
Note: For MAs that cover the whole of the UK or are specific to Northern Ireland, 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 MAH must have permanent and continuous QPPVat its disposal
- The QPPV for UK national authorised products can reside and operate anywhere in the UK or the EU/EEA
- Where the QPPV does not reside and operate in the UK, there will be a need for a national contact person (NCP) for pharmacovigilance who resides and operates in the UK
- A UK located QPPV will not be accepted in the EU Member States
Note: There is no temporary exemption as to the requirement to have a QPPV who resides and operates in the EU or the UK and is responsible for the pharmacovigilance system for UK authorised products.
4. National Contact Person for Pharmacovigilance
- UK NCP should be located in the UK
- Reporting line to QPPV
- Access to PSMF and ADRs
- MHRA Submissions Portal notification
- No specific requirement (‘The individual should be able to facilitate responses to pharmacovigilance queries raised by the MHRA, including via inspections. They should have knowledge of pharmacovigilance requirements in the UK)
- The national contact person does not necessarily have to be directly employed by the MAH
Note: There is a temporary exemption in place of which allows you 12 months from 1 January 2021 to appoint an NCP that resides and operates in the UK.
5. ISCR Submission
- Submission of all the UK (including Northern Ireland) ICSRs (serious and non-serious) and serious ICSRs from other countries
- Submission via new MHRA gateway or/ICSR Submissions portal
- For products placed on the market in Northern Ireland you will need to continue to submit ICSRs according to theEU requirements to the Eudravigilance database including all serious reports from the UK and other countries and non-serious reports that occur in the EEA or in Northern Ireland
- In general, submission of historical data will not be required but the MHRA may request this where it is needed for assessment purposes
6. Signal/PSA and Outcomes Implementation
- MAH is obliged to notify the MHRA of signals arising from any data source. This also includes standalone signal notifications submitted by you to the EMA that are relevant to your products as well as signals raised by the EMA.
- The MHRA will not require you to conduct signal detection against their own database
- You are obliged to notify the MHRA of emerging safety issues within 3 working days after establishing that a signal or a safety issue from any source meets the definition of an emerging safety issue
7. PSA and Outcomes Implementation
- Post-authorisation obligations - including specific obligations, Annex II conditions, additional pharmacovigilance activities in the RMP (MEA), legally binding measures (LEG) or recommendations - in place on 1 January 2021 will remain in place.
- For converted EU MAs you can use the current application forms for PAMs and submit the information to the MHRA as a post-authorisation commitment, following the same principles for submission as for variations in the CAPs conversion guidance.
- Where data relating to a PAM was submitted before 1 January 2021, but the assessment was not concluded MHRA will conclude the assessment where appropriate.
- The MHRA will continue to accept EU versions of the PSUR, but where the MHRA has made a specific request for information or where there is UK-specific information relevant to the benefit/ risk assessment this should be included in a specific annex.
- PSURs for actives authorised via a EU MA (CAP) which will apply directly in Northern Ireland need only be submitted to the EU PSUR repository.
- Where the product is authorised for sale and supply in Northern Ireland, you should additionally submit your PSUR in line with EU requirements to the EMA via the EU PSUR repository.
- MHRA may develop our own submission requirements and develop a list of UK reference dates, but until this happens the EU reference date (EURD) list should be followed and PSURs
- PSUR should be submitted to the MHRA system.
- There is a fee of £890 payable for the assessment of PSURs for actives/ combinations currently listed on the EURD and reduced £445 for each PSUR where more than one PSUR is involved in the procedure.
- The MHRA will continue to accept EU versions of the RMP
- Additionally, requested information should be added in a specific annex
- For CAPs, the currently approved version of the RMP should be included in the initiating sequence as part of the conversion process.
- For PASS, where the study is a condition of the UK MA, prior to the start of the study the draft protocol should be submitted to the MHRA and will be assessed in line with usual practices.
- Where the MA applies in Northern Ireland the draft study protocol should also be submitted to the Pharmacovigilance Risk Assessment Committee (unless the study is only to be conducted in the UK at the request of the MHRA).
- You should submit the final study report (and abstract of study results) to the MHRA
- Where the MA applies in Northern Ireland the study report should also be submitted to the Pharmacovigilance Risk Assessment Committee (unless the study was only conducted in the UK).
Hope provided above summary was beneficial for you in an understanding of all changes applicable to the UK MA after Brexit. In case you miss the MHRA webinars on the same topic, you could easily find a recorded version on YouTube.