Category: Veterinary medicines
Reference: MVET, 02/2023
- The publication of Commission Execution Decision C(2023) 2311 final implies modifications on the marketing authorizations for these veterinary medicinal products (VMPs)
- The marketing authorization holders (MAHs) of the VMPs affected must contact with the AEMPS before submitting their variations through the Union Database (UPD) if they are not included in annex I of the decision
- The Agency will notify each holder individually and will urge him, where appropriate, to submit the pertinent variation
On March 28, Commission Implementing Decision C(2023) 2311 final was published, concerning, the marketing authorisations for veterinary medicinal products containing N-methyl pyrrolidone as an excipient., in the framework under Article 83 of Regulation (EU) 2019/6 of the European Parliament and of the Council.
Accordingly, the Spanish Agency for Medicines and Health Products (AEMPS), as the competent authority in Spain, informs the MAHs involved that they must initiate the procedure of modification of their marketing authorizations.
In accordance with the provisions of the aforementioned Implementing Decision, the affected Member States will maintain the national authorizations of the VMPs listed in its Annex IA on the basis of the scientific conclusions that appear in its Annex II, and will modify the national authorizations of marketing of veterinary medicinal products listed in annexes IB, IC and ID on the basis of the scientific conclusions listed in its Annex II.
These modifications of the summary of the characteristics of the product, the labelling and the leaflet that appear in its Annex III, are variations not requiring assessment (VNRA) classified as C2 in the Implementing Regulation (EU) 2021/17 of the Commission.
Likewise, the Member States shall take into account the scientific conclusions listed in the Annex II for the assessment of the efficacy and safety of veterinary medicinal products containing N-methylpyrrolidone as an excipient and which are not included in Annex I.
For all VMPs not identified at the start of the referral, and therefore not included in Annex I, their MAHs may request the corresponding modification classified as C2, even if they do not meet the condition that the product must be included in the scope of the procedure. The MAHs of these VMPs must contact with the AEMPS before the submission of variations by the UPD.
This variation cannot be grouped or submitted simultaneously with the G.I.18 modification. In any case, the holders of the affected products will be notified individually and urged to present the corresponding variation, in accordance with the provisions of article 84.5 of Regulation (EU) 2019/6.
For more information, please contact to gestionvet@aemps.es and/or mresvet@aemps.es, available mailboxes of the Department of Veterinary Medicines of the AEMPS, where they can ask questions necessary to carry out this procedure.