Categoría: medicamentos veterinarios
Referencia: MVET, 01/2024
- The AEMPS enables RAEVET for the submission of this information. This system makes access to this service easier for applicants and speeds up the process
- The AEMPS will allow such inclusion only if it is considered useful information, if it is compatible with the summary of the product characteristics and if it is not considered an advertisement of a veterinary medicinal product
The AEMPS has enabled RAEVET to manage requests for additional information on the packaging of veterinary medicinal products, based on article 13 of Regulation (EU) 2019/6 of the European Parliament and of the Council, of December 11, 2019, on veterinary medicinal products and repealing Directive 2001/18/EC. This system makes access to this service easier for applicants and speeds up the process.
According to this article, the AEMPS may allow the inclusion of additional information on the labeling of the immediate or the outer packaging of a veterinary medicinal product, on request of the applicant. The inclusion of the additional information can be accepted whenever it is useful, compatible with the summary of the product characteristics and is not an advertisement for a veterinary medicinal product.
These requests can be submitted through RAEVET, attaching the necessary documentation to justify them. The AEMPS may request additional information if necessary. In any case, this service does not require payment of fee.
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.