FantasticSearch

Scroll to: TopResults

Explore European Union Legislation by Asking a Legal Question

assisted-checkbox

filter-instruction-1
positive-filters
negative-filters
act-filter tabs-all

parameters-title

query

assisted-checkbox:

result-title

total 4

Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU (Text with EEA relevance)

article  15

CELEX:  32022R2371

EU reference laboratories
1. In the area of public health or for specific areas of public health relevant for the implementation of this Regulation or of the national prevention, preparedness and response plans, the Commission may, by means of implementing acts, designate EU reference laboratories to provide support to national reference laboratories to promote good practice and alignment by Member States on a voluntary basis on diagnostics, testing methods, use of certain tests for the uniform surveillance, notification and reporting of diseases by Member States. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 29(2).
Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU (Text with EEA relevance)

article  15

CELEX:  32022R2371

2. The EU reference laboratories shall be responsible for coordinating the network of national reference laboratories, in particular, in the following areas:
(a) reference diagnostics, including test protocols;
(b) reference material resources;
(c) external quality assessments;
(d) scientific advice and technical assistance;
(e) collaboration and research;
(f) monitoring, alert notifications and support in outbreak response, including to emerging communicable diseases and pathogenic bacteria and viruses; and (g) training.
3. The network of EU reference laboratories shall be operated and coordinated by the ECDC, in cooperation with the WHO reference laboratories. The governance structure of that network shall cover cooperation and coordination with existing national and regional reference laboratories and networks.
4. The designations provided for in paragraph 1 shall follow a public selection process, be limited in time, with a minimum period for designation of four years, and be reviewed regularly. Such designations shall establish the responsibilities and tasks of the designated EU reference laboratories.
Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU (Text with EEA relevance)

article  15

CELEX:  32022R2371

5. The EU reference laboratories referred to in paragraph 1 shall:
(a) be impartial, free from any conflict of interest, and, in particular, not be in a situation which may, directly or indirectly, affect the impartiality of their professional conduct as regards the exercise of their tasks as EU reference laboratories;
(b) have, or have contractual access to, suitably qualified staff with adequate training in their area of competence;
(c) possess, or have access to, the infrastructure, equipment and products necessary to carry out the tasks assigned to them;
(d) ensure that their staff and any contractually engaged staff have good knowledge of international standards and practices, and that the latest developments in research at national, Union and international levels are taken into account in their work;
(e) be equipped, or have access to, the necessary equipment to perform their tasks in emergency situations; and (f) where relevant, be equipped to comply with relevant biosecurity standards. In addition to the requirements laid down in the first subparagraph of this paragraph, the EU reference laboratories shall also be accredited in accordance with Regulation (EC) No 765/2008 of the European Parliament and of the Council .
Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU (Text with EEA relevance)

article  15

CELEX:  32022R2371

6. Grants may be awarded to the EU reference laboratories referred to in paragraph 1 for the costs that they incur in implementing annual or multiannual work programmes that have been established in conformity with the objectives and priorities of the work programmes adopted by the Commission in accordance with the EU4Health Programme.