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dossier	COM(2022)76 - Transitional rules for the packaging and labelling of veterinary medicinal products authorised in accordance with Directive ...
source	COM(2022)76
date	02-03-2022

1. CONTEXT OF THE PROPOSAL

• Reasons for and objectives of the proposal

This proposal addresses the serious concerns raised by Member State competent authorities and stakeholders in relation to the practical application of Article 152(2) of Regulation (EU) 2019/6 on veterinary medicinal products and the need to ensure continued supply of veterinary medicinal products (VMPs) authorised under the preceding legislation on the EU market. It is necessary to take urgent steps to address the interpretation problems raised, to remove any legal uncertainty and avoid any disruption in the supply of VMPs, as Regulation (EU) 2019/6 entered into application on 28 January 2022. The proposal aims to avoid the risk of shortages of VMPs, which would have led to a serious impact on animal health and welfare, both in farm and companion animals. It therefore provides for transitional rules allowing marketing authorisation holders to place VMPs complying with the packaging and labelling requirements of Directive 2001/82/EC or Regulation (EC) No 726/2004 on the market until 29 January 2027, even if they do not comply with the relevant requirements of Regulation (EU) 2019/6.

2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

• Legal basis

The legal bases of this proposal are, Articles 114 and 168 i, point (b) of the Treaty on the Functioning of the European Union.

• Subsidiarity (for non-exclusive competence)

The authorisation of veterinary medicinal products, including requirements concerning packaging and labelling, have been comprehensively regulated at Union level. Therefore, it would not be possible to address the issue at national level.

• Proportionality

Laying down transitional rules for the packaging and labelling of veterinary medicinal products authorised in accordance with Directive 2001/82/EC or Regulation (EC) No 726/2004 is indispensable in order to ensure the continued availability of veterinary medicinal products and to establish legal certainty.

3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS

From a Better Regulation perspective, a roadmap, stakeholder consultation or impact assessment are not necessary, as the proposal sets out transitional rules that are necessary for the entry into application of Regulation (EU) 2019/6, which already started to apply on 28 January 2022. It is therefore required as a matter of urgency. The proposal does not introduce any burden on economic operators or on Member States. DG SANTE’s statement issued on 28 January 2022, indicating its intention to prepare this proposal, responded to concerns raised by both industry and Member State competent authorities.

4. BUDGETARY IMPLICATIONS

The proposal has no implications on the Union budget.

5. OTHER ELEMENTS

• Detailed explanation of the specific provisions of the proposal

The transitional rules in the proposal allow marketing authorisation holders to continue to place VMPs complying with the packaging and labelling requirements of Directive 2001/82/EC or Regulation (EC) No 726/2004 on the market until 29 January 2027, even if they do not comply with the relevant requirements of Regulation 2019/6.