Assessment of new names of authorised veterinary medicines under the new veterinary regulation
The assessment of names for already authorised veterinary medicines must be approved by the Danish Medicines Agency before the submission of a variation application. This follows from the new veterinary regulation which entered into to force on 28 January 2022. Because this is different from the previous practice for medicines authorised under the national procedure, mutual recognition procedure (MRP) or decentralised procedure (DCP), the Danish Medicines Agency introduces a new separate national administrative procedure whereby marketing authorisation holders can submit their proposals for new medicine names for Denmark directly to the Danish Medicines Agency.
Name changes for veterinary medicines are classified as an administrative variation requiring no assessment (A.2).
For the assessment and authorisation of names for medicines authorised under the NP, MRP, DCP or SRP (subsequently MRP) procedure, the marketing authorisation holder must complete a request form (Word). This form is to be sent to the Danish Medicines Agency with the text “Name proposal for a veterinary medicinal product in DK” in the subject field.
Please note that only two name proposals can be given in the request form.
The Danish Medicines Agency will return the completed form with its decision after which the name is reserved for a period of 30 days. If a variation is not submitted within 30 days thereafter, the reservation is cancelled automatically, cf. CMDv Best Practice Guide for “Variations not requiring assessment”. This means that a new request must be submitted.
The Danish Medicines Agency's assigns a case identification number (caseID) to its decision. We encourage applicants to provide this number in the “submission comment field” in UPD when submitting the variation.
Please note that the practice for naming new medicinal products has changed. Read more in the “Questions and answers about the naming of medicines”, question 5 concerning when the Danish Medicines Agency comments on medicinal product names.