Pöördumine

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË – Tel. +32 22991111

[email protected]

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Public Health, Cancer and Health security

The Director (acting)

Luxembourg SANTE.B.2/RF/tm (2024)2488112

NOTE FOR THE ATTENTION OF THE PERMANENT REPRESENTATIONS OF THE MEMBER

STATES OF THE EUROPEAN UNION

Subject: Invitation to nominate Member State competent authorities in the scope

of the calls for applications for EU reference laboratories for public

health (Article 15 of Regulation (EU) 2022/2371)

Regulation (EU) 2022/2371 on serious cross-border threats to health and repealing

Decision No 1082/2013/EU ("SCBTH Regulation") entered into force on 26 December

2022.

According to Article 15, the European Commission is empowered to designate EU

reference laboratories (EURLs) for public health “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”.

On 2 October 2023, the first calls for applications for EURLs were published by the

Commission (1). Laboratories in EU/EEA countries were invited to submit applications to

be designated as EURL in one of six areas of public health. As part of their application,

national laboratories had to seek endorsement by a national competent authority. The

competent authorities endorsing applicants were asked to confirm that each candidate

laboratory met the eligibility criteria of the call. Importantly, this included the confirmation

that they already played an active role in the national public health microbiology system.

The applications were evaluated in January 2024 and selected laboratories are about to be

designated as EURLs, via an implementing regulation, expected to be adopted before the

end of March 2024.

The Commission is currently working on the next set of calls for applications to designate

further EURLs. The topics are being defined at the moment and calls for applications will

be launched in the very near future (Q2 2024). Competent public health authorities will be

asked again to endorse the national laboratories wishing to apply.

(1) https://health.ec.europa.eu/health-security-and-infectious-diseases/surveillance-and-early-warning/eu-

reference-laboratories-public-health-calls-application_en

2

In a change to last year’s procedure, aimed at streamlining the application process further

and as a result of feedback received from the Member States, this time each EU/EEA

country is asked to formally nominate one national competent authority in public

health ahead of the calls for application being launched. Only that authority will be

responsible for the endorsement of national applicants.

This information will be made public at the time of the launch of the calls and applicants

will be invited to contact the nominated authority via pre-defined contact channels. For

that, we ask countries to submit the following information:

- name of national competent authority;

- contact information (email address and telephone number and, where relevant,

name of responsible person).

We would be grateful to receive your nominations by Monday 22 April 2024. Please send

your nominations to [email protected].

Philippe ROUX

c.c.: KEYS Rosalyn (SANTE.B), KELLER Ingrid (SANTE.B.2), FIGUEIRA Rita

(SANTE.B.2), MACÉ Tamara (SANTE.B.2)

Electronically signed on 25/03/2024 11:59 (UTC+01) in accordance with Article 11 of Commission Decision (EU) 2021/2121