Approximately 230 veterinary anti-parasitic and anti-coccidial medicines will be impacted by changes to veterinary medicines regulations in 2022 when new new EU rules (Regulation (EU) 2019/6) come into effect.
The Health Products Regulatory Authority (HPRA) has confirmed to Agriland that the prescription status of approximately 230 medicines will change, meaning that they will require a prescription after January 2022.
But the HPRA added that that ‘only anti-coccidial veterinary medicinal products are affected’ – feed additives are not.
“Anti-coccidial feed additives that are regulated under feed legislation by the Department of Agriculture, Food and the Marine (DAFM) are not within the scope of the new regulations,” the HPRA said.
The HPRA said that the changeover process of products concerned has commenced and the prescription-only medicine (POM) route of supply will become obvious on the labelling of these products over the coming months.
“However, in agreement with the DAFM, a veterinary prescription will only be required after January 28, 2022,” the HPRA said.
One exception
The only exception to the prescription-status change relates to anti-parasitics for bees, the HPRA has confirmed.
These medicines will continue to be available over the counter from licensed merchants.
This exception is based on a recommendation by the HPRA’s Advisory Committee for Veterinary Medicines (ACVM), which recommended that special status be given to anti-parasitic products for bees, given their important role in pollination.
“Such products will not be subject to prescription control,” said the HPRA.
According to the HPRA, the various anti-parasitic products can be downloaded from the HPRA website by selecting the category of medicine (e.g. ectoparasiticide, endectoparastiticide) and the species involved (e.g. poultry, sheep, cattle).
Generic veterinary medicines
In relation to the availability of generic medicines, the HPRA said that “it is recognised that the availability of generic medicines can lead to greater choice and will increase competition in the marketplace”.
“However, generic medicines, whether for use in human or veterinary settings, must meet the same quality standards as other medicines and be shown to be bioequivalent (i.e. that their safety and efficacy is the same as the non-generic equivalent) before they can be placed on the market,” said the HPRA.
So the prescription status change (resulting from Regulation (EU) 2019/6) will apply to generic anti-parasitic medicines as well as non-generic, or branded, medicines.
“All medicines which fall under the remit of Regulation (EU) 2019/6 and are intended for the treatment of parasites in food animals will be subject to prescription control,” said the HPRA.