Quote from VigiServe Admin on January 29, 2026, 2:13 PM

In Andorra, the pharmacovigilance system is hospital-based and collaborative, relying heavily on the Ministry of Health (Ministeri de Salut) and the Servei Andorrà d'Atenció Sanitària (SAAS). While independent, it maintains close ties with Spain's AEMPS for regulatory alignment.

1. Clinical Safety (Clinical Trials)

Clinical trials are limited and mostly hospital-based.

• Expedited Reporting: Sponsors follow international/WHO norms for SUSARs (Suspected Unexpected Serious Adverse Reactions).

  • Fatal or Life-Threatening: Typically within 7 calendar days.

  • Other Serious Unexpected: Typically within 15 calendar days.

• Submission: Reports go directly to the Ministry of Health or SAAS.

2. Post-Marketing Pharmacovigilance

There are no strict local obligations for Marketing Authorization Holders regarding local personnel or system master files.

• Personnel & Infrastructure:

  • No Local QPPV: Not required.

  • No PSMF Mandate: Not required.

• Incident Reporting (ICSRs):

  • Enforcement: Voluntary/Hospital-driven.

  • Timelines: "Prompt" reporting is expected for serious cases (aligned with WHO expectations).

• Risk & Periodic Reporting:

  • PSURs: Not routinely mandatory; may be requested (often accepting Spanish/EU formats).

  • RMPs: Reactive; not a standard requirement.

Summary of Requirements

Component	Requirement in Andorra
Regulatory Authority	MoH (Ministeri de Salut) / SAAS
Framework	WHO / Spain (AEMPS) Alignment
Local QPPV / PSMF	Not required
Safety Reporting	Spontaneous; "Prompt" reporting
Clinical Reporting	SUSARs (7/15 days - International practice)
Submission Language	Catalan / Spanish