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Commission Implementing Regulation (EU) 2022/1646 of 23 September 2022 on uniform practical arrangements for the performance of official controls as regards the use of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically active substances and residues thereof, on specific content of multi-annual national control plans and specific arrangements for their preparation (Text with EEA relevance)

Commission Implementing Regulation (EU) 2022/1646 of 23 September 2022 on uniform practical arrangements for the performance of official controls as regards the use of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically active substances and residues thereof, on specific content of multi-annual national control plans and specific arrangements for their preparation (Text with EEA relevance)

CHAPTER I SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1 Subject matter

For the purpose of official controls on the use of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically active substances and residues thereof, this Regulation lays down the following:

  1. the annual uniform minimum sampling frequency as part of official controls, having regard to the hazards and risks related to the substances concerned;

  2. specific additional arrangements and specific additional content for the Member States’ multi-annual national control plan (‘MANCP’), in addition to those provided for in Article 110 of Regulation (EU) 2017/625.

Article 2 Definitions

For the purposes of this Regulation, the definitions in Regulation (EC) No 178/2002, Commission Delegated Regulation (EU) 2019/2090(1), Implementing Regulation (EU) 2021/808 and Delegated Regulation (EU) 2022/1644 apply.

CHAPTER II SPECIFIC ADDITIONAL CONTENT OF THE MANCP

Article 3 General provisions

Member States shall ensure that the part of the MANCP concerning the performance of official controls on the use of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically active substances and residues thereof in live animals and products of animal origin contains the following:

  1. a ‘national risk-based control plan for production in the Member States’, as set out in Article 4;

  2. a ‘national randomised surveillance plan for production in the Member States’ as set out in Article 5;

  3. a ‘national risk-based control plan for third-country imports’ as set out in Article 6.

Article 4 National risk-based control plan for production in the Member States

Article 5 National randomised surveillance plan for production in the Member States

Article 6 National risk-based control plan for third-country imports

Article 7 Additional content of the national risk-based control plans and the national randomised surveillance plan

CHAPTER III SUBMISSION AND EVALUATION OF THE PLANS AND SUBMISSION OF DATA BY THE MEMBER STATES

Article 8 Submission and evaluation of the national risk-based control plans and the national randomised surveillance plan

Article 9 Submission of data by the Member State

CHAPTER IV GENERAL PROVISIONS

Article 10 Repeal of Decision 97/747/EC

Article 11 References

Article 12 Entry into force and application

ANNEX I

ANNEX II

ANNEX III