Commission Implementing Regulation (EU) 2021/17 of 8 January 2021 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance)

As per EDQM standard terms the system of names and terms published by the EDQM for marketing authorisation applications.

In cases where a given pharmaceutical form or strength has received an individual marketing authorisation which is separate to the marketing authorisation for other pharmaceutical forms or strengths of the same product, the deletion of the former will not be a variation but the withdrawal of the marketing authorisation.

In cases where a given pack size has received an individual marketing authorisation which is separate to the marketing authorisation for other pack sizes of the same product, the change of the former will not be a variation according to Article 61, but a variation according to Article 62 of Regulation (EU) 2019/6.

There is no need to notify the competent authorities of an updated monograph of the European pharmacopoeia or a national pharmacopoeia of a Member State in the case that reference is made to the ‘current edition’ in the dossier of an authorised medicinal product. Applicants are reminded that compliance with the updated monograph should be implemented within six months. If implementation does not occur within 6 months from the publication date, this variation applies.

Commission Implementing Regulation (EU) 2024/875 of 21 March 2024 adopting a list of abbreviations and pictograms common throughout the Union to be used on the packaging of veterinary medicinal products for the purposes of Article 10(2) and Article 11(3) of Regulation (EU) 2019/6 of the European Parliament and of the Council (OJ L, 2024/875, 22.3.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/875/oj).

Commission Delegated Regulation (EU) 2024/1159 of 7 February 2024 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council by laying 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 (OJ L, 2024/1159, 19.4.2024, ELI: http://data.europa.eu/eli/reg_del/2024/1159/oj).

The reference to a change in the administrative information of the distributor(s) applies only in those cases where the competent authority has allowed, in accordance with Regulation (EU) 2019/6, the inclusion of the information on the distributor(s).