Derogation extension will cover veterinary medicines in the short-term

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For veterinary medicinal products, an exemption is extended in the short term to ensure the long-term supply of medicinal products from Great Britain to Northern Ireland and to resolve delivery problems in Ireland, Cyprus and Malta.

This month the European Commission tabled a number of proposals to address these issues.

While the Commission’s proposals apply to medicinal products for human use, in the short term mainly veterinary medicinal products will fall under the exemption.

According to the Health Products Regulatory Authority (HPRA):

“The existing exemptions for human and veterinary medicinal products affected by Brexit will be extended until the end of 2022 or until a legislative proposal is presented.”

Historically, many drugs in Ireland, Cyprus and Malta have been shipped via or from the UK, according to the HPRA. The UK’s exit from the EU has made it difficult for operators in these Member States to fully comply with EU law.

“To address this situation, prevent drug shortages and ensure a high level of public health protection, Cyprus, Ireland and Malta will benefit from certain derogations for three years,” the HPRA said.

In these three countries, UK drug importers will not be required to obtain a manufacturing license during this period, nor will these drugs have to be re-batch tested if they have already been tested in the UK.

In addition, Cyprus and Malta may, under certain conditions and for public health reasons, authorize the placing on their national market of a medicine authorized in the United Kingdom.

This gives operators more time to adjust.

A long-term permanent solution is being worked on within the framework of the EU pharmaceutical strategy.

As mentioned above, while the Commission’s proposals do not apply to veterinary medicinal products, they will benefit from the exemption in the short term.

The HPRA explains:

“Discussions on veterinary medicines will continue over the next few months in order to gather information, identify any outstanding implementation issues and find the most appropriate way to ensure long-term continuity of veterinary supply to Northern Ireland, as well as Cyprus, Ireland and Malta.

“In the short term, however, the expansion of the Commission’s interpretative communication includes veterinary medicinal products. The existing regulations in this area will be continued until the end of 2022. ”

More information can be found here