A new role was announced at the MHRA GDP Symposia in London, yesterday.
Cheryl Blake’s presentation “Preparing for a Changing World” included information and potential scenarios post Brexit.
Within this presentation was information on the new role… the “RPI”
The RPI (Responsible Person – Import) will come into being in the coming weeks and months, but there is no formalised job description/role profile although we will share how the MHRA see the role might work further down in the post.
A by-product of the Brexit situation, this new role will be pivotal for the import of medicines from EU member states under certain conditions.
At present most WDAs include the category “1. Medicinal Products, 1.1 With a Marketing Authorisation in EEA member state(s).” This allows people to purchase products, under specific conditions, from any member state.
Cheryl explained further, that in the unlikely event of a no deal scenario the UK will continue until further notice to use EU GMP and GDP under article 47 and 84 of EU directive 2001/83/EC
A technical notice on how medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal was posted on the UK .Gov website on 23 August 2018.
So – What would the “No Deal” supply chain look like?
It was explained that there will continue to be sourcing of finished certified product (EEA imported or manufactured) into UK wholesale supply chain.
EU directives require products be only allowed on the market with a Marketing Authorisation (MA).
Product within the EU network must be QP certified.
On 29 Mar 2019 the UK becomes a 3rd country to the EU and vice versa
There is a plan for the introduction of a system for further checks under a new type of WDA or WDA classification, and the aforementioned new type of Responsible Person
Supply from EU/EEA will become importation (products must be made and released by a QP in Europe, via new WDA(H).
If the product has been introduced (brought in from or made in a third country) will be under an MIA as a WDA cannot be utilised to bring in introduced medicines that have travelled through the EEA in this circumstance.
There is no obligation on EU/EEA countries to perform a QC test and QP certification of medicines imported from a third country for onward supply to UK (Unlicensed under special clinical need, notices of intent to import and medical need proven).
It was not mentioned, but likely to remain the same, that introduced products may be brought into the UK on the basis that they are exported to third countries, as it stands with the use of a WDA.
Sourcing from EEA under no deal
Sourcing will be under the concept of introduced medicines.
UK no deal legislation must protect patients against introduced product while enabling the minimum possible burden to the supply chain.
New Responsible Person Role – RPI (RP Import)
The RPI will;
– Hold relevant qualifications (TBC)
– Have enhanced experience, including importation
– Be a member of recognised body
– Be named of RPI on central register (Like QP register)
The RPI must provide evidence of EEA QP batch certification and evidence that it came in from, and remained within, one of the 27 states during and after manufacture, and shipping.
What will a “good” RPI look like?
From the look of the information above someone with heavy import and industry experience, likely with a background that includes a site working with MS/MIA/MIA (IMP) or potentially a suitably experienced QP.
Whilst the MHRA fully define the role, possibly in a similar way to http://www.paradigmshiftconsulting.co.uk/gold-standard-rp/ the RP Gold Standard, we cannot categorically say.
The MHRA Process Licensing Team (PCL) will focus on variations, and more information will be released in time on any potential changes.
The MHRA request that you do NOT add export “just in case” as this will cause issues for you if they arrive at an inspection (as they recently have) where this is the situation.
Finally, this leads us into other relevant information – Questions you may be asked by your inspectors in the coming weeks/months;
How are you preparing for Brexit?
What does Brexit mean to you?
Show me your change controls relating to Brexit
What risk assessments have you carried out relating to Brexit?
All of the above questions could be asked of your FMD preparations, which we will blog on separately.
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Welcome to a changing world… and a new Paradigm!
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