Categoría: medicamentos veterinarios
Referencia: MVET, 02/2024
- Regulation (EU) 2019/6 sets January 29 2027 as the deadline for veterinary medicinal products (VMPs) authorized in accordance with the former legislation to be in compliance with the aforementioned regulation
- For this reason, it is necessary to adapt the summary of product characteristics (SPC), package leaflet (PL) and labelling of these VMPs to version 9.0 of the QRD
- The AEMPS will start a revocation procedure for the marketing authorization of all VMPs that on that date are not adapted
- The AEMPS provides new information to applicants in order to facilitate the submissions and assessment of these variations
Article 152 of the Regulation (EU) 2019/6 has set a period of five years for those VMPs authorized under the former legislation to comply with this regulation. Consequently, the VMPs authorized in accordance with such legislation can be placed on the market until 29 January 2027. For this reason, it is necessary to adapt the SPC, PL, and labelling to version 9.0 of the Quality Review of Documents (QRD) guideline, through the ad hoc variation G.I.18 One-off alignment of the product information with version 9.0 (or the latest) of the QRD templates i.e. major update of the QRD templates, in accordance with Regulation (EU) 2019/6, for veterinary medicinal products placed on the market in accordance with Directive 2001/82/EC or Regulation (EC) No 726/2004
Additionally to the information notes published on October 21, 2022 and March 6, 2023, and in accordance with what has been agreed in the Coordination Group of Mutual and Decentralized Recognition Procedures (CMDv) in December 2023, the AEMPS reports the following:
- According to the data available in the CMDv, the current percentage of VMPs that have already been adapted to version 9.0 of the QRD is not enough to guarantee that all products will be updated before the deadline.
- Likewise, the percentage of G.I.18 variations already submitted, that are under validation or under assessment is also notoriously low.
- Marketing authorization holders (MAHs) are therefore strongly requested to plan and communicate as soon as possible the submissions of the aforementioned G.I.18 variations to the AEMPS or the reference Member State, as appropriate.
In order to speed up this procedure as much as possible, the AEMPS recommends the following:
- Submit the G.I.18 variations as single applications as a general rule. Grouping with other variations is not excluded, but will be considered on a case-by-case basis.
- Agree with the AEMPS, or inform it, to the extent possible, a schedule for these submissions to guarantee their updating before the deadline. This is especially important for MAHs with numerous marketing authorizations pending updating.
- The documentation attached to the applications must be submitted with the correct structure and content. The quality of the documents (SPC, PL and labelling) is decisive for the duration of the procedure.
The AEMPS has foreseen internal procedures to make these variations more efficient and thus be able to achieve the intended objective.
References
- Regulation (EU) 2019/6, of the European Parliament and the Council, of 11 December 2018, on veterinary medicinal products and repealing Directive 2002/82/EC.
- Real Decreto Legislativo 1/2015, de 24 de julio, por el que se aprueba el texto refundido de la Ley de garantías y uso racional de los medicamentos y productos sanitarios.