In the event of no deal, the MHRA have released new guidance yesterday. A wholesale dealer may import QP certified medicines from the EEA if certain checks are made by the Responsible Person (import) (RPi). Here’s a summary of what the guidance says on how to become a RPi and how to complete these checks:
How to Become a Responsible Person (Import)
To demonstrate that you are eligible to act as an RPi, you must have evidence of formal qualifications, experience and membership of professional bodies. Of course, if you are already a person named on the Qualified Persons register you will also be eligible to act as a RPi; however, you must still apply to be named on the RPi register.
In addition to eligibility, the MHRA will confirm your suitability to be named on a specific WDA(H) licence. The example they provide is an eligible RPi without prior experience in parallel importation might not be considered suitable to be named on a WDA(H) where the company is importing licensed products for parallel trade.
RPi application may be submitted through the MHRA Portal after the UK leaves the EU.
How to Complete Checks for QP Certification
The RPi is responsible for implementing a system that confirms the required QP certification has taken place for products imported into the UK from the EEA. Acceptable written evidence that confirms QP certification has taken place for the batch in question could be one of the following:
- Batch certificate
- A copy of the ‘control report’
- Statement of certification
- Reference to company internal systems
- Confirmation of the final manufacturing step (other than batch certification)
- Confirmation of purchase from an authorised wholesaler after it has been ‘placed on the market’ in the listed country
To read the guidance in full, please click here.
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