| Author (Corporate) | Council of the European Union, European Parliament |
|---|---|
| Series Title | Official Journal of the European Union |
| Series Details | L 148, Pages 6-7 |
| Publication Date | 31/05/2022 |
| Content Type | Legislation, Policy-making |
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Summary: Regulation (EU) 2022/839 - formally signed by the co-legislators on 30 May 2022 -Â laying down transitional rules for the packaging and labelling of veterinary medicinal products authorised or registered in accordance with Directive 2001/82/EC or Regulation (EC) No 726/2004. This is a text with EEA relevance. Further information: Directive 2001/82/EC set out rules on the authorisation, manufacturing, supervision, sale, distribution and use of veterinary medicinal products (VMPs). It was repealed and replaced by Regulation (EU) 2019/6 as of January 2022. Regulation (EC) No 726/2004 sets out procedures for authorising and supervising medicinal products for human and veterinary use. This Regulation allows medicinal products which were authorised or registered in accordance with those legal acts, and which comply with Articles 58 to 64 of Directive 2001/82/EC (in the version applicable in January 2022), to be placed on the markets until 29 January 2027, even if their labelling and package leaflet are not compliant with Articles 10 to 16 of Regulation (EU) 2019/6. The draft law was tabled by the European Commission on 2 March 2022 to address concerns raised by competent authorities and stakeholders in the Member States of the European Union (EU) in relation to the practical application of Article 152(2) of Regulation (EU) 2019/6 and the need to ensure continued supply of VMPs authorised under the preceding legislation on the EU market. The proposal aimed to avoid the risk of shortages of VMPs, and provided for transitional rules. Following a number of informal contacts between the co-legislators, the European Parliament endorsed the compromise on 5 May 2022, followed by the Council of the European Union on 16 May. The Act was signed on 30 May 2022 and published in the Official Journal on the following day. |
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| Source Link | http://data.europa.eu/eli/reg/2022/839/oj |
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| Subject Categories | Business and Industry, Internal Markets |
| Subject Tags | Consumer Rights | Protection, Medicines | Medical Devices, Pharmaceuticals |
| Keywords | Animal Health | Welfare, Labelling |
| International Organisations | European Union [EU] |
