Brexit update: Time-limited exemption to continue batch control testing in the UK after the UK’s withdrawal from the European Union

News Category: Regulatory news

Date: 06/03/2019

The European Commission recently published a communication which indicated that competent authorities may allow marketing authorisation holders, for a limited period of time subject to certain conditions, to rely on quality control testing performed in the United Kingdom (hereafter ‘the exemption’).

Human Medicines 

The HPRA would like to outline some key points relating to the process for applying for this exemption for human medicines:

• All requests for an exemption must be submitted without undue delay and no later than 29^th March 2019.
• Requests for centralised products must be sent to EMA and details of the process are available on the EMA website.
• Requests for products in MRP/DCP must be sent to the RMS (and also copying the CMSs in the procedure).
• Requests for purely nationally authorised products must be sent to the national competent authorities.
• The request template published on the CMDh website must be used for products in MRP/DCP and for purely nationally authorised products.
• The email heading must state ‘Brexit batch control testing exemption’ and include the ‘MR/DCP procedure number xxxx’ for MRP/DCP requests and the ‘PA number xxxx’ for national requests.
• Any applications to the HPRA should be submitted via email to article50changes@HPRA.ie
• The MAH requesting the exemption will receive a notification of the outcome from the relevant competent authority. The MAH is responsible for communicating the outcome of their request to the QP of the batch release site, to the EU27/EEA competent authority that granted the manufacturing authorisation for the batch release site, and also to any other MAH in an MRP/DCP procedure.
• As the exemption is only valid in a member state where the MAH has been transferred to an MAH in the EU27/EEA, such transfers should be carried out promptly and prior to 29^th March.

For products in MRP/DCP and purely national products further detail, including a link to the required template, in available in Q32 of the CMDh practical guidance for procedures related to Brexit.

The full list of member state contact points is also available on the CMDh website.

Information in relation to the process for veterinary medicines will be published in the coming days.

Veterinary Medicines

The HPRA would like to outline some key points relating to the process for applying for this exemption for veterinary medicines:

• All requests for an exemption must be submitted without undue delay and no later than 29^th March 2019.
• Requests for centralised products must be sent to EMA and details of the process are available on the EMA website.
• Requests for products in MRP/DCP must be sent to the RMS (and also copying the CMSs in the procedure).
• Requests for purely nationally authorised products must be sent to the national competent authorities.
• The request template published on the CMDv website must be used for products in MRP/DCP and for purely nationally authorised products.
• The email heading must state ‘Brexit batch control testing exemption’ and include the ‘MR/DCP procedure number xx/V/xxxx/xxx’ for MRP/DCP requests and the ‘VPA number VPAxxxx/xxx/xxx’ for national requests.
• Any applications to the HPRA should be submitted via email to vetinfo@hpra.ie
• The MAH requesting the exemption will receive a notification of the outcome from the relevant competent authority. The MAH is responsible for communicating the outcome of their request to the QP of the batch release site, to the EU27/EEA competent authority that granted the manufacturing authorisation for the batch release site, and also to any other MAH in an MRP/DCP procedure.
• As the exemption is only valid in a member state where the MAH has been transferred to an MAH in the EU27/EEA, such transfers should be carried out promptly and prior to 29^th March.

For products in MRP/DCP and purely national products, further details, including a link to the required template, are available in Q24 of the  CMDv practical guidance for procedures related to Brexit.

Brexit update from 26 February