Article 3, Paragraph 3. · Commission Delegated Regulation (EU) 2022/139

Contents

3.The contracts referred to in paragraph 1 shall cover at least the following matters:

(a)conditions for the supply of various quantities and types of antigens, vaccines or diagnostic reagents to the Union antigen, vaccine and diagnostic reagent banks;

(b)conditions for the secure storage and replacement of antigens, vaccines or diagnostic reagents;

(c)in the case of Union antigen banks, guarantees and conditions for:

(i)the rapid formulation of the antigens into vaccines;

(ii)the production, bottling and labelling of vaccines reconstituted from the antigens;

(d)conditions for the release, shipment and delivery of vaccines or diagnostic reagents;

(e)conditions for the destruction and safe disposal of the antigens, vaccines or diagnostic reagents, or for the buy-back of antigens, for which the validity period has expired.

Defined terms · 10

Show every defined term

bovine animal
means an animal of the species of ungulates belonging to the genera Bison, Bos (including the subgenera Bos, Bibos, Novibos, Poephagus) and Bubalus (including the subgenus Anoa) and the offspring of crossings of those species;
caprine animal
means an animal of the species of ungulates belonging to the genus Capra and the offspring of crossings of those species;
category A disease
means a listed disease that does not normally occur in the Union and for which immediate eradication measures must be taken as soon as it is detected, as referred to in Article 9(1), point (a), of Regulation (EU) 2016/429;
contracted manufacturer
means a selected manufacturer with whom the Commission has concluded a contract referred to in Articles 3(1) and 4(1);
European Union reference laboratories
means laboratories designated in accordance with Article 93(1) of Regulation (EU) 2017/625;
ovine animal
means an animal of the species of ungulates belonging to the genus Ovis and the offspring of crossings of those species;
porcine animal
means an animal of the species of ungulates of family Suidae listed in Annex III to Regulation (EU) 2016/429.
Union antigen bank
means a Commission-managed reserve of antigenic components that can be rapidly formulated into the final product for emergency use or other vaccination campaigns in Member States or third countries or territories granted access by the Union;
Union diagnostic reagent bank
means a Commission-managed reserve of diagnostic reagents or components thereof for the rapid diagnosis of category A diseases in Member States or third countries or territories granted access by the Union;
Union vaccine bank
means a Commission-managed reserve of ready-to-use vaccines for emergency use or other vaccination campaigns in Member States or third countries or territories granted access by the Union;