An extension to a derogation to ensure the long-term supply of medicines from Great Britain to Northern Ireland, and to address supply concerns in Ireland, Cyprus and Malta, will apply to veterinary medicines, in the short term.
This month, the European Commission put forward a number of proposals to address these issues.
While the Commission’s proposals apply to human medicinal products, in the main, veterinary medicines will, in the short-term, come under the derogation.
According to the Health Products Regulatory Authority (HPRA):
“The existing derogations for human and veterinary medicinal products impacted by Brexit will be extended until the end of 2022, or until a legislative proposal is put in place.”
Historically, according to the HPRA, many medicines in Ireland, Cyprus and Malta have been supplied through, or from, Great Britain. The UK’s withdrawal from the EU has made it challenging for operators in these member states to comply fully with EU law.
“In order to address this situation, prevent shortages of medicine, and ensure a high level of public health protection, Cyprus, Ireland and Malta will benefit from certain derogations for a three-year period,” the HPRA said.
During this period, in these three countries, importers of medicines from the UK will not need to hold manufacturing authorisations, nor will these medicines need to be batch tested again if they have already been tested in the UK.
In addition, Cyprus and Malta will be able, under certain conditions, and for justified public health reasons, to authorise the placing on their national market of a medicine authorised in the UK.
This will give operators more time to adapt.
Work on a long-term permanent solution is ongoing in the context of the EU’s Pharmaceutical Strategy.
As mentioned, although the Commission’s proposals do not cover veterinary medicines, these medicines will benefit, in the short-term, from the derogation.
The HPRA explains:
“Discussions on veterinary medicines will continue over the next months in order to gather information, identify any outstanding implementation issues and find the most appropriate way forward to ensure long-term continuity of veterinary medicines supply to Northern Ireland, as well as Cyprus, Ireland and Malta.
“For the short term, however, the extension of the Commission’s interpretive notice includes veterinary medicines. Existing arrangements in this area will continue until the end of 2022.”
Additional information is available here