Commission Delegated Regulation (EU) 2022/139 of 16 November 2021 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards the management, storage and replacement of stocks of the Union antigen, vaccine and diagnostic reagent banks and the biosecurity, biosafety and bio-containment requirements for the operation of those banks (Text with EEA relevance)

• CELEX: Delegated Regulation (EU) 2022/139
• Articles: 14

Article 1 Subject matter and scope

1.   This Regulation supplements the rules laid down in Article 48 of Regulation (EU) 2016/429 as regards the Union antigen, vaccine and diagnostic reagent banks for category A diseases.

2.   This Regulation lays down:

(a)

the rules on the management, storage and replacement of stocks of antigens, vaccines and diagnostic reagents in the Union antigen, vaccine and diagnostic reagent banks, and in particular on:

(i)

rules on the contracts and grants for the supply and storage of antigens, vaccines and diagnostic reagents;

(ii)

the conditions for the supply and storage of antigens, vaccines and diagnostic reagents;

(iii)

the principles of selecting strains and variations of antigens, vaccines and diagnostic reagents;

(iv)

the destruction and safe disposal of antigens, vaccines and diagnostic reagents which have reached the end of their validity period;

(v)

the possibilities of buy-back of the antigens for which the validity period has expired;

(b)

the biosecurity, biosafety and bio-containment requirements for the operation of the Union antigen, vaccine and diagnostic reagent banks;

(c)

transitional provisions for the Union antigen and vaccine banks established and maintained prior to the date of application of this Regulation.

Article 2 Definitions

For the purposes of this Regulation, the following definitions shall apply:

1.

‘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;

2.

‘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;

3.

‘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;

4.

‘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;

5.

‘European Union reference laboratories’ means laboratories designated in accordance with Article 93(1) of Regulation (EU) 2017/625;

6.

‘contracted manufacturer’ means a selected manufacturer with whom the Commission has concluded a contract referred to in Articles 3(1) and 4(1);

7.

‘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;

8.

‘ovine animal’ means an animal of the species of ungulates belonging to the genus Ovis and the offspring of crossings of those species;

9.

‘caprine animal’ means an animal of the species of ungulates belonging to the genus Capra and the offspring of crossings of those species;

10.

‘porcine animal’ means an animal of the species of ungulates of family Suidae listed in Annex III to Regulation (EU) 2016/429.

Article 3 Rules on the contracts with manufacturers required for the management of the Union antigen, vaccine and diagnostic reagent banks

1.   The Commission shall conclude contracts with selected manufacturers in order to manage, for category A diseases as referred to in Article 3 of Commission Implementing Regulation (EU) 2022/140, the following banks:

(a)

Union antigen banks;

(b)

Union vaccine banks;

(c)

Union diagnostic reagent banks.

2.   The Commission shall implement a public procurement procedure, in accordance with the rules laid down in Regulation (EU, Euratom) 2018/1046, for the selection of the manufacturers for the contracts referred to in paragraph 1.

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.

Article 4 Framework supply contracts for the vaccines and diagnostic reagents

1.   The Commission may conclude the contracts referred to in Article 3(1) in the form of framework supply contracts with selected manufacturers (‘framework supply contracts’).

2.   By way of derogation from Article 3(3), framework supply contracts shall be required to cover at least the release, shipment and delivery of vaccines or diagnostic reagents upon the request of the Commission.

3.   Framework supply contracts may cover leasing costs.

Article 5 The management of the Union diagnostic reagent banks through grants awarded to European Union reference laboratories

1.   The Commission may establish and maintain Union diagnostic reagent banks for category A diseases as referred to in Article 3 of Implementing Regulation (EU) 2022/140 at the European Union reference laboratories.

2.   The Commission shall include the management and maintenance of the Union diagnostic reagent banks referred to in paragraph 1 of this Article in the annual or multiannual work programmes of the European Union reference laboratories referred to in Article 94(2) of Regulation (EU) 2017/625 for which grants have been awarded in accordance with Article 180 of Regulation (EU, Euratom) 2018/1046.

3.   The annual or multiannual work programmes, referred to in paragraph 2, for the purpose of the Union diagnostic reagent banks shall cover at least the following:

(a)

the supply of various quantities and types of diagnostic reagents to the Union diagnostic reagent banks;

(b)

the secure storage and replacement of diagnostic reagents;

(c)

the release, shipment and delivery of diagnostic reagents;

(d)

the destruction and safe disposal of the diagnostic reagents for which the validity period has expired.

Article 6 Conditions for the supply and storage of antigens, vaccines and diagnostic reagents

1.   The Commission shall ensure that the contracts, referred to in Articles 3(1) and 4(1), and the annual or multiannual work programmes of the European Union reference laboratories for the Union diagnostic reagent banks, referred to in Article 5(2), guarantee conditions for the supply and storage of the antigens, vaccines or diagnostic reagents that are at least equivalent to those laid down in Annex I.

2.   In addition to the requirements laid down in paragraph 1 of this Article, the contracts referred to in Articles 3(1) and 4(1) for the purchase, supply, storage and replacement of the concentrated inactivated antigens of the foot and mouth disease virus for the production of foot and mouth disease vaccines shall guarantee conditions for the supply and storage of concentrated inactivated antigens of the foot and mouth disease virus that are at least equivalent to those laid down in Annex II.

Article 7 Principles of selecting strains and variations of antigens, vaccines and diagnostic reagents

The Commission, in consultation with experts from scientific and reference institutions, including the European Union reference laboratories, and international standard setting bodies, shall select the vaccine strains and decide the characteristics of the antigens, vaccines and diagnostic reagents held in the Union antigen, vaccine and diagnostic reagent banks.

Article 8 Destruction and safe disposal of antigens, vaccines and diagnostic reagents

The Commission shall ensure that the contracts, referred to in Article 3(1), or the annual or multiannual work programmes of the European Union reference laboratories, referred to in Article 5(2), guarantee appropriate conditions for the destruction and safe disposal of any unused antigen, vaccine or diagnostic reagent after the expiry of its validity period.

Article 9 Buy-back of the antigens for which the validity period has expired

By way of derogation from Article 8, the Commission may agree with contracted manufacturers on the buy-back of the antigen supplied to a Union antigen bank and remaining in that bank after the expiry of its validity period.

Article 10 Biosecurity, biosafety and bio-containment requirements for the operation of the Union antigen, vaccine and diagnostic reagent banks

The Union antigen, vaccine and diagnostic reagent banks shall operate at least in accordance with the following biosecurity, biosafety and biocontainment requirements:

(a)

the facilities where the antigens, vaccines and diagnostic reagents are stored shall:

(i)

comply with the recognised quality standards provided for in international standards referred to in point 3 of Annex I and in point 4 of Annex II;

(ii)

be subjected to controls by the Commission to ensure continuous compliance with the recognised quality standards referred to in point (i), in addition to regular and risk-based controls by the competent authorities;

(iii)

be secure and protected from accidental or intentional damage, including microbial contamination;

(b)

where a Union antigen, vaccine or diagnostic reagent bank is co-located with a laboratory or other facility where pathogens are handled, the storage facilities referred to in point (a) shall be effectively protected from contamination by physical separation and biosafety procedures for the personnel;

(c)

the personnel shall, where they have had possible exposure to relevant pathogens of the category A diseases referred to in Article 3(1) or 5(1), comply with a quarantine procedure before entering the Union antigen, vaccine and diagnostic reagent banks.

Article 11 Transitional measures

The Union banks established before the date of application of this Regulation shall be maintained until the date of expiry of the relevant contracts under which those Union banks were established for the following commodities:

(a)

antigens of foot-and-mouth disease virus, established in accordance with Decision 91/666/EEC and with Article 80(1) of Directive 2003/85/EC;

(b)

vaccines against classical swine fever, established in accordance with Article 18(2) of Directive 2001/89/EC and with Decision 2007/682/EC;

(c)

vaccines against lumpy skin disease, established in accordance with Article 6(5) of Regulation (EU) No 652/2014;

(d)

vaccines against peste des petits ruminants, established in accordance with Article 6(5) of Regulation (EU) No 652/2014;

(e)

vaccines against sheep pox and goat pox, established in accordance with Article 6(5) of Regulation (EU) No 652/2014.

Article 12 Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

It shall apply from 1 May 2022.

Schedules & Appendices

ANNEX I CONDITIONS FOR THE SUPPLY AND STORAGE OF ANTIGENS, VACCINES AND DIAGNOSTIC REAGENTS AS REFERRED TO IN ARTICLE 6(1)

ANNEX I

CONDITIONS FOR THE SUPPLY AND STORAGE OF ANTIGENS, VACCINES AND DIAGNOSTIC REAGENTS AS REFERRED TO IN ARTICLE 6(1)

1.

Antigens, vaccines or diagnostic reagents shall be stored at the site and under the responsibility of the selected manufacturers referred to in Article 3(1) or Article 4(1) or the European Union reference laboratories referred to in Article 5.

2.

In the case of vaccines produced and stored in the Union, the principles and guidelines of good manufacturing practice shall be maintained throughout the production process, as referred to in:

(a)

Commission Directive 91/412/EEC  ( 1 ) , or

(b)

as of the date of their application, the implementing acts adopted pursuant to Article 93(2) of Regulation (EU) 2019/6 of the European Parliament and of the Council  ( 2 ) .

The principles and guidelines of good manufacting practice shall also be maintained during the storage and finishing, namely filling of vials with vaccine and finishing the process of packaging for distribution, of the vaccine reconstituted from the antigens in store.

3.

The antigen or vaccine shall be produced and stored at least in accordance with the principles of the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for Animal Health (OIE), Edition 2021.

4.

The vaccine must have a marketing authorisation granted by the Commission or by a competent authority in at least one Member State, as applicable, in accordance with:

(a)

either Chapters 3 and 4 of Title III of Directive 2001/82/EC, or Chapter 1 of Title III of Regulation (EC) No 726/2004 of the European Parliament and of the Council  ( 3 ) , respectively, or,

(b)

as of 28 January 2022, Chapter III of Regulation (EU) 2019/6.

However, in the event of a serious epidemic, particularly caused by an emerging disease, where a marketing authorisation has not been granted for a vaccine in the Union, a marketing authorisation or other equivalent document granted in the country of production of that vaccine shall be made available by the manufacturer to the Commission.

( 1 )   Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products ( OJ L 228, 17.8.1991, p. 70 ).

( 2 )   Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC ( OJ L 4, 7.1.2019, p. 43 ).

( 3 )   Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency ( OJ L 136, 30.4.2004, p. 1 ).

ANNEX II ADDITIONAL CONDITIONS FOR THE SUPPLY AND STORAGE OF CONCENTRATED INACTIVATED ANTIGENS OF THE FOOT AND MOUTH DISEASE VIRUS AS REFFERED TO IN ARTICLE 6(2)

ANNEX II

ADDITIONAL CONDITIONS FOR THE SUPPLY AND STORAGE OF CONCENTRATED INACTIVATED ANTIGENS OF THE FOOT AND MOUTH DISEASE VIRUS AS REFFERED TO IN ARTICLE 6(2)

1.

Each antigen shall consist of a single homogeneous batch.

2.

Each batch shall be split in order to permit its storage in separate storage capacities to prevent, in the case of technical problems, the deterioration or loss of the entire batch.

3.

The vaccine produced from the antigens to be supplied shall comply with the position paper on requirements for vaccines against foot-and-mouth disease of the Committee for Medicinal Products for Veterinary use of the European Medicines Agency)  ( 1 ) .

4.

The antigens shall meet at least the requirements of the European Pharmacopoeia  ( 2 ) and the relevant provisions of Chapter 3.1.8 ‘Foot and mouth disease (infection with foot and mouth disease virus)’ of the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for Animal Health (OIE), Edition 2021.

5.

If not otherwise specified in the documents referred to in point 4, the antigen shall be purified to remove non-structural proteins of the foot and mouth disease virus. The purification shall at least ensure that the residual content of non-structural proteins in vaccines reconstituted from such antigen does not induce detectable levels of antibodies against non-structural proteins in animals which had received one initial and one subsequent booster vaccination.

6.

The vaccine reconstituted from the antigens stored in the Union antigen bank must have a marketing authorisation granted by the Commission or by a competent authority in at least one Member State, as applicable, in accordance with:

(a)

either Chapters 3 and 4 of Title III of Directive 2001/82/EC, or Chapter 1 of Title III of Regulation (EC) No 726/2004, respectively, or,

(b)

as of 28 January 2022, Chapter III of Regulation (EU) 2019/6.

In the absence of suitable vaccines against emerging strains of foot and mouth disease virus, a marketing authorisation may not be required for vaccines reconstituted from high and medium priority or new antigens produced under the same conditions and to the same quality standards as antigens that have a marketing authorisation.

7.

Each dose of vaccine produced from antigens stored in the Union antigen bank shall have a potency of at least 6 PD 50 in cattle, and shall be suitable for the emergency vaccination of bovine, ovine, caprine and porcine animals , depending on the request by the Commission.

( 1 )   European Medicines Agency (2004). Position paper on requirements for vaccines against foot-and-mouth disease, EMEA/CVMP/775/02-FINAL 01/12/2004.

( 2 )   https://www.edqm.eu/en