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Timeline to be compliant with QRD Version 9.0 template
The European Medicines Agency (EMA) has developed a new template for product information to be used by the Marketing Authorization Holder (MAH). The QRD Template Version 9.0 supports the requirements of the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6), which has been applied since 28 January 2022. The Regulation (EU) 2022/839 requires that all the authorized Veterinary Medicinal Products, beginning January 2027, must be compliant with the updated template. The MAH must submit variations to the marketing authorization coded G.I.18 to ensure compliance prior to the scheduled date.
Leaflets and SPC sections alignment
Version 9.0 has a new structure for the Statistical Process Control (SPC). Labelling and the package leaflet, with sections ordered properly in the package leaflet, are now aligned with the SPC. Required information now must only be included in the package leaflet, to simplify the front page of the leaflet and immediate labelling and to emphasize the importance of reading the package leaflet.
Antimicrobials dedicated section
In order to promote the prudent use of antimicrobials and limit the risk of the development of antimicrobial resistance, a new section on any restrictions on the use of antimicrobial and antiparasitic veterinary medicines is now present. This includes restrictions on conditions of use that are not in accordance with the terms of the marketing authorization.
Environmental impact of the Veterinary Medical Product (VMP) section
The importance of environmental impact on packaging materials and unused or waste of veterinary medicines was given with a reference to national collection systems for the disposal of waste veterinary medicines to reflect legal requirements under Regulation (EU) 2019/6.
Pharmacovigilance updates
With respect to the new pharmacovigilance obligation, the contact information for the Local Representative responsible for receiving suspected Adverse Event (AE) Reports is now required. EMA has also simplified the AE section of the SPC, which now appears in a Table that lists, in order, from the most to the least common AEs based on the AE incidence/frequency calculation.
Bibliography
REGULATION (EU) 2022/839 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 May 2022 laying down transitional rules for the packaging and labelling of veterinary medicinal products authorized or registered in accordance with Directive 2001/82/EC or Regulation (EC) No 726/2004
COMMISSION IMPLEMENTING REGULATION (EU) 2021/1281 of 2 August 2021 laying down rules for the application of Regulation (EU) 2019/6 of the European Parliament and of the Council as regards good pharmacovigilance practice and on the format, content and summ. (2021). Bruxelles: Official Journal of the European Union.
REGULATION (EU) 2019/6 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC. (2019). Bruxelles: Official Journal of the European Union.
Veterinary product information templates [Version 9, 03/2022] corr. 11/2022
