ANMAT
Argentina's National Administration of Drugs, Foods and Medical Devices.
Short answer
ANMAT is Argentina's regulator for medicines, biologics, food, and medical devices. All submissions are in Argentine Spanish. Clinical research filings follow Disposición 6677/10, which sets the good clinical practice framework, consent content, and the documentation ANMAT expects alongside provincial ethics committee approvals. Foreign public documents require apostille plus a traductor público translation legalized by the Colegio de Traductores Públicos.
What it means
ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) regulates clinical trials, medicines, biologics, food, and medical devices in Argentina. It reviews submissions in Spanish and expects alignment with Disposición 6677/10 and related eCTD requirements.
Why it matters for LATAM submissions
Argentina maintains a strong investigator base and clinical trial volume. ANMAT's review can be delayed by Spanish inconsistencies or incomplete documentation of provincial ethics committee materials.
Submission language rules
Spanish is the only accepted submission language, and Argentina applies a stricter certification chain than most of the region for documents originating abroad.
- Protocol, investigator brochure, and consent: Argentine Spanish, with the voseo-neutral register ethics committees expect in patient-facing text.
- Foreign public documents: apostille on the original, then translation by a traductor público matriculado, then legalization of the translator's signature by the Colegio de Traductores Públicos.
- Consent documents must satisfy Disposición 6677/10 content requirements plus any additional wording required by the provincial ethics committee reviewing the site.
- Multi-province studies often carry province-specific consent annexes; each annex is a separate translated and version-controlled document.
- Safety reporting (SAE, SUSAR) narratives are submitted in Spanish and must use the same terminology as the protocol.
Where Argentine submissions lose time
ANMAT delays attributed to language are usually chain-of-certification problems rather than translation quality problems: a correct translation without Colegio legalization is rejected the same way an incorrect one is.
- Translation done by a qualified but unmatriculated translator.
- Apostille obtained after translation instead of before.
- Provincial ethics committee consent versions drifting out of sync with the ANMAT-filed master consent.
Document checklist
| Document | Language / certification requirement |
|---|---|
| Clinical trial protocol and amendments | Argentine Spanish, aligned with Disposición 6677/10 structure |
| Investigator brochure | Argentine Spanish; version-locked with the protocol |
| Informed consent form (master and provincial annexes) | Argentine Spanish, 6677/10 content elements, per-committee versions tracked |
| Foreign certificates (GMP, free sale, incorporation) | Apostille, then traductor público translation, then Colegio legalization |
| Power of attorney / local representative appointment | Notarized, apostilled, traductor público translation with legalization |
| Insurance certificate for trial participants | Spanish; coverage terms consistent with consent wording |
| SAE / SUSAR narratives | Spanish, terminology consistent with the protocol and IB |
Frequently asked questions
What is Disposición 6677/10?
ANMAT's regulation on good clinical practice for pharmacological studies in humans. It sets trial conduct standards, informed consent content, sponsor and investigator responsibilities, and the documentation ANMAT reviews for authorization.
Who is allowed to translate documents for an ANMAT filing?
Public documents require a traductor público matriculado — a translator registered with a provincial Colegio de Traductores Públicos — whose signature is then legalized by that Colegio. Scientific dossier text does not require a traductor público but must be consistent and reviewer-ready.
Does ANMAT accept documents in English?
No. Spanish is required. Original English documents accompany, but never replace, the Spanish version.
Do provincial ethics committees add translation work?
Frequently. Committees can require specific consent wording for their jurisdiction, producing annexes that must be translated, versioned, and kept synchronized with the master consent filed at ANMAT.
Is Argentina part of the Hague Apostille Convention?
Yes. Foreign public documents are apostilled in the issuing country; there is no consular legalization step for documents from other member states.
Primary sources
- ANMAT Disposición 6677/10 — Good clinical practice regime for pharmacological studies in Argentina.
- Ley 20.305 (traductores públicos) — Establishes the traductor público profession and Colegio legalization requirement.
- Hague Apostille Convention (Argentina, in force since 1988) — Governs legalization of foreign public documents used in Argentine filings.
Next step
Disposición 6677/10 in detail, the traductor público and Colegio legalization chain, and provincial ethics committee handling.
Read the full ANMAT translation requirements guideKeep going on this topic
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