SPC harmonisation 2023 - end of procedure for products Catosal and Domosedan
Harmonised product information texts (EN version) for reference veterinary medicinal products Catosal and Domosedan available on CMDV homepage.
Action for marketing authorisation holders of the respective generic or hybrid veterinary medicinal products for alignment of the SPC: Application for the respective variation requiring assessment.
Date: 14.06.2024
The results of the SPC harmonisation procedure for Catosal and Domosedan are published on the CMDV website and English harmonised product information texts can be downloaded from the respective page.
Marketing authorisation holders of generic or hybrid veterinary medicinal products which refer to the above mentioned reference veterinary medicinal products should apply for the respective variation requiring assessment (VRA) within 60 days after the decision of the national competent authority has been issued. For the national competent authority BVL the respective information is available on the BVL website (SPC harmonisation).
According to article 71 of the Regulation (EU) 2019/6, marketing authorisation holders of generic or hybrid veterinary medicinal products shall apply within 60 days for a variation requiring assessment in order to align the SPC (concerning target species, clinical information referred to in point (c) of article 35(1) and withdrawal period) of their veterinary medicinal products. In case of hybrid marketing authorisations, whereby parts of the SPC have been supported by product-own data (for example additional target species or a withdrawal period based on product-own data), the information in the SPC, based on product-own data will not be harmonised.
Marketing authorisation holders are advised to consult the CMDv Best Practice Guide.
Further Information:
CMDV:
SPC harmonisation
BVL:
SPC harmonisation
Year of issue
2024
Date
14.06.2024
Pressekontakt
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)
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• Fax: 030 18444 -89999
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presse@bvl.bund.de