What you need to know to submit Study Data to FDA
The HPRA published guidance in April on batch testing rules in the event of the potential legal impact of an exit by the UK from the EU.
It is important to note that, the advice recently provided may require update as the Brexit negotiation process continues. In the event that a transition period is agreed, this guidance will be updated to reflect the terms of the transition.
Finished product coming from the UK; Importation Controls
Any Irish company that physically receives finished medicinal product from the UK (originating from a UK manufacturer or wholesaler or transiting the UK without the use of the customs transit code), will be required to hold a manufacturer’s/importer’s authorisation (MIA) with the activity ‘Physical Importation’ listed on it. Medicines coming from a third country must be first physically received at the site that holds an MIA which includes the activity ‘Site of Physical Importation’.
In addition, the product imported for the Irish market requires QP certification. (this can happen at any EU site of batch release that is registered on the marketing authorisation for that product).
Where the batch release certificate checks performed by a WDA holder may highlight a batch that is potentially non-compliant post Brexit, the HPRA would recommend that the WDA holder reverts to the relevant MAH for clarification.
Currently legislation requires that the sourcing of exempt/unlicensed medicines from a third country is carried out under an MIA, however, legislative amendments are currently under review to permit a wholesaler to do so.
The HPRA is open to accepting requests for exemptions for Batch Testing in line with the Commission’s position of 25th Feb 2019: “Withdrawal of the United Kingdom and EU rules for batch testing of medicinal products”. Further details on the process to apply for this exemption are available on the HPRA website.
The expanded detail on the above information can be found by visiting the the link to HPRA Brexit Guidance – Human and Veterinary Medicines – Update 26 April 2019:
PharmaLex can support your organisation in many ways. If you would like our Brexit Taskforce Team to examine your Brexit-preparedness strategy and tactical action plan, please connect with us to discuss +353 1 846 4742 or contactirl@pharmalex.com
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