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Change in method of supply of antiparasitic veterinary medicines that are used in food-producing animals

Notice type: Advisory

Date: 18/05/2021

 The Health Products Regulatory Authority (HPRA) wishes to advise that the method of supply on the labelling of antiparasitic veterinary medicines that are used in food-producing animals is being changed to comply with legislative requirements

Product name or type:
Antiparasitic veterinary medicines that are used in food-producing animal, including wormers, flukicides, anti-coccidial medicines and ectoparasitic drugs

Active Substance:
Several

Product Classification:
The concerned products are being changed to supply under the ‘Prescription Only Medicine’ (POM) category.

Authorisation Holder:
Numerous

Prescription Required:
Yes

Target Audience:
Veterinary practitioners, pharmacists, farmers.

Problem Or Issue:
In accordance with the outcome of the HPRA report on compliance of antiparasitic veterinary medicinal products for food-producing animals against the criteria in Regulation (EU) 2019/6 for exempting from the normal requirement of a veterinary prescription, the changeover process of the products concerned has commenced. The POM route of supply will become increasingly manifest on the labelling of the products concerned over the period coming up to the date of application of regulation on 28 January 2022. However, in agreement with the DAFM, a veterinary prescription will only be required from that date.

Background Information Or Related Documents:
Further information can be found here. Although the HPRA has incentivised applicant companies to comply with the change of supply route within the period April to July 2021, the implementation of the change on the product labelling may take some months to feed through for all the products concerned. This is expected, and in accordance with the HPRA Guide to Implementation of Packaging Changes.

Actions To Be Taken:
Farmers and users should note that a veterinary prescription will be required for purchase of antiparasitic veterinary medicines that are used in food-producing animals from 28 January 2022, in accordance with Regulation 2019/6.

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