Quality & complianceOfficial

Estonian Medicines Agency laboratory attested within European OMCL network after joint audit

🇪🇪 Ravimiamet · Mon 26 Oct 2026

Ravimiamet's laboratory has been formally attested by the European OMCL network following an international Mutual Joint Audit assessing its quality system against ISO/IEC 17025 and network requirements.

The laboratory of the Estonian State Agency of Medicines (Ravimiamet) has received attestation from the European network of Official Medicines Control Laboratories (OMCL), the agency announced on 26 October 2026. The attestation takes effect from that day.

It followed an international Mutual Joint Audit (MJA) carried out by experts from the OMCL network. The auditors assessed whether the laboratory's quality management system complies with the ISO/IEC 17025 standard, the relevant requirements of the European Pharmacopoeia and the network's own quality guidelines.

According to Ravimiamet, the attestation confirms that the laboratory meets the common quality requirements set for official medicines control laboratories in Europe, and that its work and analytical results are reliable. The agency stressed that cooperation within the OMCL network rests on mutual trust and on members recognising one another's test results.

The agency added that the international assessment also helps identify opportunities to improve the laboratory's work organisation and quality management system, and supports collaboration with other European control laboratories.

The laboratory also holds accreditation from the Estonian Accreditation Centre, which demonstrates its competence through the national accreditation system. Ravimiamet said the OMCL attestation complements this by confirming conformity with the shared requirements of the European network.

What it means for your team

  • Test results from Ravimiamet's laboratory are now backed by OMCL network attestation, which rests on mutual recognition of results between member laboratories.
  • Quality teams can read the attestation as separate from, and additional to, the laboratory's national accreditation from the Estonian Accreditation Centre.
  • The MJA covered ISO/IEC 17025 conformity, European Pharmacopoeia requirements and OMCL quality guidelines, which indicates the benchmarks used in peer audits of official control laboratories.

Official source: Ravimiamet ↗

Article written by VigiEye from the official source (Ravimiamet). AI-assisted; check the source before acting.

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