Implementation of new QRD templates

The new versions of the QRD templates taking into account the requirements of the Veterinary Medicinal Products Regulation (EU) 2019/6 are available here: www.ema.europa.eu/en/veterinary-regulatory/marketing-authorisation/product-information/veterinary-product-information-templates. The BASG has updated the accessible versions, which are available for download at https://www.basg.gv.at/en/companies/marketing-authorisation-life-cycle/marketing-authorisation-procedure/accessible-patient-information-leaflet.

On 28.01.2022, clarification was provided by the Commission regarding Article 152(2) of the Regulation (regarding transitional provisions): https://ec.europa.eu/food/animals/animal-health/vet-meds-med-feed/statement_en, furthermore the following document was published: Register of Commission Documents - COM(2022)76 (europa.eu).


Further information:
https://www.hma.eu/veterinary-medicines/cmdv

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Further inquiry note