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Estonia · Law · SE

544

Act to amend the Medicines Act and the Veterinary Act

avaldatud riigiteatajasEstonia· Riigikogu· ET

Introduced

7 March 2022

Last action

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Status

AVALDATUD_RIIGITEATAJAS

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Discovery layer

Source updated

1 June 2022

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Summary

As of January 28, the corresponding EU regulation applies to veterinary drugs, which is binding in its entirety and directly applicable in all member states of the European Union. In order to achieve the goals of the regulation and to better implement it, the Medicines Act must be amended and, in addition, the provisions related to medicines in the Veterinary Act must be specified. As of January 28, licenses for wholesalers of veterinary medicinal products will be valid throughout the EU. As a result, the bill is planned to provide veterinarians, general and veterinary pharmacies the right to import veterinary medicines from EU veterinary medicine wholesalers into Estonia. So far, veterinarians have been able to buy medicines from an Estonian wholesaler of veterinary medicines. Also, according to the draft, veterinarians no longer have to apply for a separate permit from the Medicines Board to use a veterinary drug without a marketing authorization. When using medicines with a marketing authorization in veterinary medicine, the veterinarian must follow the mentioned regulation of the stipulated requirements. However, as a first choice, the licensed veterinary medicinal product must continue to be used in accordance with the conditions of the marketing authorization. The bill clarifies the tasks of the competent authorities in the field of veterinary medicines, the Medicines Board and the Agriculture and Food Board, modernizes the regulation of the Medicines Board's fees, and gives the Medicines Board the right to allow exceptions regarding the packaging requirements of veterinary medicines.

Machine translation from Estonian. The official text remains authoritative.

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26 official files

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