In more detail
Regulation (EU) 2019/6, of 11 December 2018, on veterinary medicinal products (hereinafter, "Regulation") gives a period of five years to adapt veterinary medicinal products authorised under the previous Directive 2001/82/EC to the current Regulation. For this purpose, the Quality Review of Documents (hereinafter, "QRD") has to be adapted to version 9.0, which includes the summaries of product characteristics of veterinary medicinal products, the package leaflet and the labelling of veterinary medicinal products. It is also worth mentioning that in October 2022, the Spanish Agency of Medicines and Health Products (hereinafter, "AEMPS") already issued an information note on the fees for the variation procedure, which can be consulted via this link.
It is worth mentioning that version 9 of the QRD model is already adapted to the requirements established in the Regulation, and its content includes, among other features, a new order structure of the labelling and package leaflet of the veterinary medicinal product, in addition to a simplification of the external labelling, as well as a new section on restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products, and a greater flexibility on the content of various sections. Detailed information on the current QRD model is available via this link.
In this regard, the AEMPS has adopted a series of measures with the aim of facilitating the development and harmonisation of these new procedures, applicable both at national level and in centralised procedures. The different actions include the following:
- Flexibility in the implementation time of the change
A period of up to twelve months has been established for the implementation of changes to the packaging material of those medicinal products that have been authorised on a national basis, irrespective of the procedure used for such approval. This requires that the variation is only an individual modification of type G.I.18, i.e., not applied for as a grouping. In case the modification is applied for as a group, the implementation date shall be the one set out in the authorisation resolution of the relevant group. Likewise, if further variations concerning the texts of the medicinal product are authorised within the twelve-month period, the dates to be taken into account for their implementation will be those set out in their resolutions, and version 9 of the QRD must also be used.
It is also necessary for the holder of the medicinal product to use the electronic G.I.18 variation application form to indicate that all changes will be implemented before the end of the twelve-month period.
- Reduction of the administrative burden
Applicants requesting the amendments should check that the template of the new QRD version has been correctly used to adapt all the texts attached to the application and those submitted in response to the assessment carried out by the AEMPS.
In short, this new development is particularly relevant for all those companies whose activity is focused on the marketing of veterinary medicinal products and who intend to carry out their activity in Spain. In this regard, please contact our team of experts at Baker McKenzie for further advice on all the procedures related to this new AEMPS development.
