The Health Products Regulatory Authority (HPRA) of Ireland is geared up and ready to support MA holders as they prepare for Brexit.
What happens if UK leaves the EU with no deal?
The implications of Brexit with regard to the UK’s role in the licensing of medicines will be determined by the terms of the ongoing exit negotiations. However, in accordance with Directives 2001/82/EC and 2001/83/EC:
- For marketing authorisations issued through the mutual recognition procedure (MRP) or decentralised procedure (DCP), the Reference Member State (RMS) must be based in the EU/EEA.
- The marketing authorisation holder (MAH) must be located within the EU/EEA.
- MAHs will need to ensure that their EU qualified person responsible for pharmacovigilance (QPPV) and their pharmacovigilance system master file (PSMF) are located within the EU/EEA.
- The batch release/testing site must be located within the EU/EEA.
HPRA are working “extraordinarily” hard on preparing for all scenarios
HPRA are Brexit ready
– Willing to act as RMS for all products where Ireland (IE) is currently CMS and a change of RMS is required. No fees will apply to the process for changing RMS to IE. The HPRA commits to an efficient and simple process for handling these requests (for example allowing the inclusion of multiple products in one request where applicable).
– To encourage the use of multilingual labelling the HPRA will proactively work with other European regulators to help optimise opportunities for multilingual labelling. The HPRA ‘Guide to labels and leaflets of Human Medicines’ has been updated (Oct 2018) to give specific guidance on the development of multilingual labelling
– HPRA MAH transfer procedures have recently been changed to allow MAHs up to 6 months to implement packaging changes following issue of the transferred authorisation, for Brexit related transfers. In addition the HPRA no longer requires stock to be recalled from wholesaler level six months following the issue of the transferred authorisation/ licence/registration.
Timeline for changing RMS
Can be completed within a matter of days. The critical issue will be the timing of when the change in RMS should occur as it is required to occur when there are no open regulatory activities for a product.
Procedures for MAHs to transfer MAH to EU/EEA based MAH
The transfer procedure must be used where the legal entity of an authorisation/licence holder is changed as marketing authorisations are transferred to a new company number. It is possible to transfer the MAH while there are ongoing/open variations. If the transfer is processed/issued, the new MA holder details will transfer onto the open/ongoing variations
- Bulk transfers are accepted by the HPRA for Brexit and reduced fees apply.
- New PA number is provided in advance of application.
- Word version of an updated package leaflet is acceptable.
If the only changes proposed relate to MAH details and a new PA number, an Article 61(3) application is not required. However, if there are additional changes to the labels and package leaflet an Article 61(3) application must be submitted. This can be submitted in parallel to the transfer.
Medical devices containing an ancillary medicinal substance
Transfers of medical devices containing a medicinal ancillary substance with a valid CE certificate are considered administrative only. Transfers typically take less than 30 days from validation of the submission to be completed. No fees will apply to this transfer process.
Parallel Product Authorisations
If the UK is listed as one of a number of source countries on a PPA, this will need to be removed by way of a type IA variation (category 4).
Where the holder of PPA is located within the UK, the authorisation will need to be transferred to holder located within the EEA.
Qualified person certification of repackaging activity must take place within the EEA. Variations to change the site of batch certification can be submitted using the PPA variation category No 9a and 9b.
Variations to Marketing Authorisations to change Qualified Person Responsible for Pharmacovigilance (QPPV), manufacturing site or/and batch release sites.
Any variations required for a marketing authorisation (MA), e.g change in location of QPPV or site of batch release, should be completed prior to the date of the UK’s departure from the EU (prior to the 29 March 2019).
Changes in the QPPV, including contact details (telephone, and fax numbers, postal address and email address) may, for medicinal products for human use, be updated through the Article 57 database only (without the need for a variation)
Changes to the location of the PSMF (street, city, postcode, country) may be updated through the Article 57 database only (without the need for a variation)
Are you in search of advice and support on Brexit?
Please contact us, Ivowen are available to offer advice and support on HPRA compliance.
Written by Nanda Naik