TOPRA In Ireland - NI Protocol Webinar - follow up discussion

Dear TOPRA Members,
On Thursday 04 March, Janet Fitzgerald from Acorn Regulatory presented on the NI Protocol, a consultancy approach. Please find the link to the recording and slides.

TOPRA NI Protocol Final.pdf (211.6 KB)

The webinar generated so many questions that we ran out of time to answer them all so we will posting them here and we welcome you to continue the discussions through this forum.


Q: If we submit NI via DCP/MRP. Do we need to submit nationally to GB via MHRA Portal?

Presenter answer: According to recent communication with MHRA it is not necessary to duplicate submissions to DCP and MHRA, they will approve based on DCP

Question: Can you briefly explain the Unfettered Access Route?

Presenter answer: NI Authorised product can be supplied to GB if conditions are met, see guidance:

Q: Do you know if any EU RMS rejected any variation submissions where the UK are CMS?

Presenter answer: No, you must select UK (Nothern Ireland) as CMS on the form, MHRA will consider DCP approval for all of UK

Q:Where is it stated that the UK wide PL number MA will not be acceptable after the end of this year?

Presenter answer: Only not acceptable if EU requirements for NI are not met i.e. if MAH is a UK entity this is not acceptable for NI. Either need to transfer UK MA to EU entity or split GB from NI

Q: what are company’s experiences in removing NI as the CMS and having a GB only licence?[Sobhey Nassar

Presenter answer: Currently not possible to split GB and NI, but may be possible to change UK PL to GB PL is MAH is UK entity. Many delays in getting responses form MHRA, may be better to approach about need for an actual submission. E.g. request a GB PL number to submit a baseline and it may speed up response

Q: Could you explain me more on potential impact on the national licences that are currently UK-wide ones. Also for CAPs which are currently pending and we will submit baseline submission to NI and there is no need for GB, what would be submitted with sequence 0000? (e.g. module 1 only). There will also be a chance for discrepancy as we might not submit all submissions to the GB which we will submit for NI.

Presenter Answer: UK national MAs may not be impacted if they meet EU requirements for NI e.g. have EU MAH & QP release site

CAP – NI is automatically included in centralised procedure. GB will approve base din EMA assessment:

MAA Submission

On receipt of the positive CHMP opinion, or as soon as possible after this date, the ECDRP MAA should be submitted to the MHRA as one electronic Common Technical Document sequence through MHRA Submissions.

The submission should include the entire dossier as reviewed by the CHMP (and approved by the EC if the EC decision has already been received), including the full responses to CHMP questions. If the entire dossier has already been submitted to the MHRA as Northern Ireland, and no changes are required for the ECDRP MAA dossier, the dossier need not be submitted for the ECDRP MAA.

The Working Documents Folder should include:

all iterations of the CHMP assessment reports and the CHMP opinion for the initial MAA and any subsequent variations,

the proposed product information in Microsoft Word format.

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Q: : We have followed your approach regarding our XEVMPD/ Article 57 registration as a UK (GB) MAH for NI. This had seemed acceptable but EMA came back this week requesting an EU MAH.

Presenter answer: I expect we will also get the same communication. Decision to be made on whether or to transfer NI only after PLs can be split, or transfer entire UK to an EU entity

Q: Can NI act as an RMS in a future MRP?

Presenter answer: No

Q: For UK wide national licences only, I presume it is still acceptable to have an MA holder based in England? There have been some questions from EMA because of MAH location in the Article 57 database

Presenter answer: It is only acceptable to have an English MAH in GB, NI must have an EU MAH. Option to transfer entire UK to EU Entity or split GB and NI

Q: I wonder if you have had any experience of possible challenges with Wholesale Distribution Authorisations for the sites located in NI and whether they will still be issued by MHRA?

Presenter answer: MHRA still has full responsibility for NI, they should audit & issue WDA for NI base don UK & EU requirements. There may be delays at the moment due to Brexit updates e.g. adding RP for importation, adding import/export activities not required prior to Brexit

Q:For DCP products if a decision is made to have a joint IE-NI pack and transfer the MAH to IE, what is the MHRA role? Will the IE MAH be subject to MHRA requirements and inspection?

Presenter answer: MHRA will asses on behalf of NI, HPRA assess on behalf on IE, 2 separaet MAs but a joining label, both MA numbers will be needed on pack.

Q: A general Brexit query, do PLGB MAs still require a UK MAH by 2023 or is this requirement now removed?

Presenter answer: MHRA will accept UK or EU MAH for GB, but for NI only an EU MAH will be accepted

Q: Any experience on eAF for UK national variations? How to select UK in the country list? As i believe only UK (NI) is now available in the eAF

Presenter answer: You can only accept UK (NI) from communication with MHRA I have been informed this will be considered applicable to entire UK. Recent type 1A submission validated and MHRA acceptance listed ‘UK’ as market

Q: Will we be forced by the EU to remove our UK testing and release sites from the UK product licences if we don’t split our GB licences?

Presenter answer: I think so, Recent AIFA guidance says UK QC/Release sites should be removed within 1 month. We actively removed during an ongoing variation as we anticipate the request, the current sites MIA is no longer applicable to EU markets.

Q: : If a UK MAH wants to market a product in NI must the MA be part of an EU procedure?[Lorraine Marsh

Presenter answer: No, it can still be a UK national if all EU requirements for NI are met e.g EU MAH/QC testing & Release. There is also an option for NI only national procedure

Q: Do you think companies will be able to keep their current PL numbers when they are able to split to GB PLs? or will we have new numbers issued?

Presenter answer: We were issued with a completely new number. We have expected to keep existing numbers just with GB/NI appended but this was not the case.