Regulatory Changes

National Reference Laboratories 2026: Call for Arboviruses, Measles and Tuberculosis

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Equipo Editorial CambiosLegales
08 Aug 2026 6 min 12 views

Key data

RegulationOrder SND/845/2026, of 27 July
Publication8 August 2026
Entry into force8 August 2026
Affected partiesPublic and private laboratories in the healthcare-microbiological field with registered office in Spain
CategoryRegulatory Changes
Enabling legal frameworkRoyal Decree 568/2024
Duration of designation4 years (initial)
Selection modalityCompetitive procedure
Body receiving applicationsCCAES (Coordination Centre for Health Alerts and Emergencies)
FundingNot automatic — regulated by separate mechanisms
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Spanish public and private healthcare and microbiological laboratories have a concrete window of opportunity: the Ministry of Health convenes, under the Royal Decree 568/2024, the designation of National Reference Laboratories in Public Health (LNR-SP) in three priority areas of epidemiological surveillance. The Order SND/845/2026, published on 8 August 2026, activates the procedure under competitive procedure.

Being designated LNR-SP implies assuming functions of high strategic value: advanced diagnosis, technique validation, training, international representation and preparation of annual reports. However, the designation does not carry automatic funding, which requires candidates to assess the operational and reputational return against the cost of compliance.

3
Areas called: arboviruses, measles/rubella and tuberculosis
1
Laboratory or maximum consortium designated per area
Up to 3
Entities that can form a consortium per area
4 years
Initial duration of designation

What does this regulation establish?

Order SND/845/2026 convenes the procedure to designate LNR-SP in the following areas:

AreaMaximum designatedModality
Arboviruses1 laboratory or consortium (max. 3 entities)Competitive procedure
Measles and rubella1 laboratory or consortium (max. 3 entities)Competitive procedure
Tuberculosis1 laboratory or consortium (max. 3 entities)Competitive procedure

The functions assigned to each designated LNR-SP include:

  • Advanced diagnosis in its area of specialization
  • Validation of diagnostic techniques
  • Training for other laboratories and system professionals
  • International representation in reference bodies and networks
  • Preparation of annual activity reports

Access requirements demand that candidates are authorized as healthcare centres and accredit compliance with specific technical criteria for each area. Both public and private entities with registered office in Spain can apply. Applications are submitted exclusively electronically to the CCAES.

Economic and operational impact

The most relevant aspect for decision-making is clear: the designation does not carry automatic funding. Access to economic resources will be regulated through separate mechanisms, which means that being designated LNR-SP does not by itself guarantee immediate additional income.

This has direct implications for any laboratory considering applying:

  • Cost of preparing the candidacy: technical accreditation, documentation, possible consortium formation.
  • Operational cost of functions: advanced diagnosis, training, annual reports and international representation require sustained human and material resources over 4 years.
  • Return not guaranteed in the short term: funding will come through separate channels, whose specifics are not defined in this order.
  • Strategic and reputational value: the designation positions the laboratory as a national and international reference in its area, with access to European and global epidemiological surveillance networks.

For laboratories already performing these functions de facto, the designation may represent formal recognition of existing activity. For those that do not, it implies a real investment without guaranteed immediate economic return.

Who does it affect?

  • Public microbiology and public health laboratories (university hospitals, regional public health institutes, national centres)
  • Private laboratories authorized as healthcare centres with advanced diagnostic capacity in virology, bacteriology or parasitology
  • Consortiums of up to three entities (public, private or mixed) wishing to apply jointly
  • Directors and managers of healthcare centres evaluating the strategic impact of designation
  • CFOs and financial managers of laboratories who must assess the cost-benefit of the candidacy

Practical example

A university hospital with a consolidated microbiology service in tuberculosis diagnosis decides to evaluate its candidacy as LNR-SP in the tuberculosis area. The management team must consider the following before submitting an application:

  1. Verification of healthcare authorization: the centre must be authorized as a healthcare centre, a prerequisite and essential requirement.
  2. Accreditation of technical criteria: must demonstrate capacity for advanced diagnosis, technique validation and training experience.
  3. Decision on consortium: if the hospital does not cover all required capacities, it can form a consortium with up to two additional laboratories to submit a stronger candidacy.
  4. 4-year financial planning: given that funding is not automatic, the hospital must budget the operational costs of LNR-SP functions (annual reports, international representation, training) without assuming guaranteed income from day one.
  5. Electronic submission to CCAES: all documentation is processed exclusively electronically.

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What should companies do now?

  1. Verify current healthcare authorization: check that the laboratory is authorized as a healthcare centre, a sine qua non condition to be able to apply.
  2. Evaluate compliance with specific technical criteria for the area or areas of interest (arboviruses, measles/rubella or tuberculosis).
  3. Assess consortium formation: if individual candidacy is weak, explore alliances with up to two complementary laboratories to submit a more competitive proposal.
  4. Analyze financial impact over 4 years: quantify the operational cost of assuming LNR-SP functions without automatic guaranteed funding from the start.
  5. Prepare documentation and submit the application electronically to the CCAES within the deadline set by the call.
  6. Consult Royal Decree 568/2024, the enabling legal framework that defines in detail the technical criteria and designation procedure.

Frequently asked questions

How many laboratories will be designated per area in this call?

A single laboratory or consortium per area will be designated. Each consortium can consist of a maximum of three entities. The three areas called are: arboviruses, measles and rubella, and tuberculosis.

Does LNR-SP designation include automatic funding?

No. Order SND/845/2026 expressly establishes that the designation does not carry automatic funding. Access to economic resources will be regulated through separate mechanisms, whose specifics are not defined in this order.

Can private laboratories apply for this call?

Yes. Both public and private laboratories can submit applications, provided they have registered office in Spain and are authorized as healthcare centres, in addition to meeting the specific technical criteria for each area.

How long does the designation as National Reference Laboratory in Public Health last?

The initial designation has a duration of 4 years, as established in Order SND/845/2026 under Royal Decree 568/2024.

Where and how are applications submitted to become LNR-SP?

Applications are submitted exclusively electronically to the CCAES (Coordination Centre for Health Alerts and Emergencies). Paper applications or submissions through other channels are not accepted.

Official source

Consult complete regulation in official source

Notice: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://www.boe.es/diario_boe/txt.php?id=BOE-A-2026-17370



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