COMMISSION IMPLEMENTING REGULATION (EU) 2021/1280 of 2 August 2021 as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council
1. Article 95(8) of the European Union Regulation on veterinary medicines (Regulation (EU) 2019/6) makes provision for the adoption of measures on good distribution practice (GDP) for active substances used as starting materials in veterinary medicines. These measures are set out in the Commission Implementing Regulation (EU) 2021/1280 which is the subject of this Explanatory Memorandum.
2. Regulation (EU) 2019/6 will apply in the EU and in Northern Ireland (due to the Northern Ireland Protocol) from 28 January 2022; Regulation (EU) 2021/1280 entered into force on 23 August 2021.
3. Article 93(1)(j) of Regulation (EU) 2019/6 requires that Marketing Authorisation Holders (MAHs) only use active substances as starting materials which have been distributed in accordance with GDP for active substances.
4. Article 95(1) of Regulation (EU) 2019/6 requires that importers, manufacturers and distributors of active substances used as starting materials in veterinary medicines, that are established in the Union, register their activity with their national competent authority and comply with good manufacturing practice or GDP, as applicable.