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

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