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.
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
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;
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;
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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