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Regulation (EU) 2016/429 Article 50

Regulation (EU) 2016/429 Article 50

Implementing powers concerning the Union antigen, vaccine and diagnostic reagent banks

Article 50

1.   The Commission shall, by means of implementing acts, lay down rules for Union antigen, vaccine and diagnostic reagent banks, specifying for the biological products referred to in Article 48(1): (a) which of those biological products are to be included in the Union antigen, vaccine and diagnostic reagent banks and for which of the listed diseases referred to in point (a) of Article 9(1); (b) the types of those biological products that are to be included in the Union antigen, vaccine and diagnostic reagent banks and in what quantities for each specific listed disease referred to in point (a) of Article 9(1) for which the bank in question exists; (c) the requirements concerning the supply, storage and replacement of those biological products; (d) the delivery of those biological products from the Union antigen, vaccine and diagnostic reagent banks to the Member States and to third countries and territories; (e) procedural and technical requirements for the inclusion of those biological products in the Union antigen, vaccine and diagnostic reagent banks and for requesting access to them. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2). 2.   On duly justified imperative grounds of urgency relating to a listed disease referred to in point (a) of Article 9(1) representing a risk of a highly significant impact, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure provided for in Article 266(3).

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Other provisions in CHAPTER 3 — Antigen, vaccine and diagnostic reagent banks

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 50 of Regulation (EU) 2016/429 (LawPlayer, data as of 2026-07-04)

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

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