BAKGRUNN (fra kommisjonsforordningen)

(1) On 8 January 2021 the Commission, as required under Article 60(1) of Regulation (EU) 2019/6 and taking into account the criteria listed in Article 60(2) of that Regulation, adopted Commission Implementing Regulation (EU) 2021/172 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6. 

(2) The European Medicines Agency and the Coordination Group on Veterinary Medicinal Products advised the Commission to update the Annex to Regulation (EU) 2021/17, based upon experience gained and evolving scientifical and technical knowledge. 

(3) Commission Delegated Regulation (EU) 2024/11593 lays down rules on appropriate measures to ensure the effective and safe use of veterinary medicinal products authorised and prescribed for oral administration via routes other than medicated feed and administered by the animal keeper to food-producing animals. The product information on veterinary medicinal products authorised before the date of application of that Delegated Regulation are to be adapted if necessary with the requirements of Article 9, paragraphs 1 and 2of that Delegated Regulation, and therefore a change to the terms of the marketing authorisation may be required. Changes, resulting from the necessity to ensure compliance with Delegated Regulation (EU) 2024/1159 that do not require a scientific assessment, should be included in the Annex to Implementing Regulation (EU) 2021/17. 

(4) The Commission has assessed against the conditions established in Article 60(2) of Regulation (EU) 2019/6 changes that are required in terms of marketing authorisation for the implementation of Article 9 of Regulation (EU) 2024/1159 to determine which of these changes do not require an assessment and what the documentation shall be submitted with the application for the variation not requiring assessment. 

(5) Implementing Regulation (EU) 2021/17 should therefore be amended accordingly. 

(6) The entry into application of this Regulation should be deferred in order to allow the European Medicines Agency to make the necessary adaptions in the database used for the submission of the variations not requiring assessment. 

(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,