Qualifications and Duties of the Argentine Registration Holder

1. Key takeaways

An Argentine local registration holder must simultaneously satisfy 4 hard qualifications: ① a legally established Argentine legal person; ② operating qualification under Disposición ANMAT 2319/2002 (manufacturing and/or import); ③ a Good Manufacturing Practice compliance certificate (Certificado de Cumplimiento de BPF) issued by ANMAT under Disposición 3266/2013; ④ a technically qualified Director Técnico registered with ANMAT (who must be a licensed university-level professional with the corresponding technical competence).

The holder also bears 6 statutory duties: local legal liability for product quality, safety and effectiveness; custody of the technical dossier for inspection; handling all import matters as the importer; fulfilling post-market vigilance obligations; managing renewals and changes; and answering for the truthfulness of all submitted information. All registration documents must be signed jointly by the legal representative and the Director Técnico — a requirement that distributes responsibility across two named individuals rather than leaving it with the company alone.

Taken together, the four qualifications and six duties describe a holder that is operationally live in Argentina, not a passive name on a certificate. Each qualification is verifiable in original documents, and each duty produces observable conduct — signatures on filings, custody of dossiers, import transactions, vigilance reports, renewals, and accurate submissions. A manufacturer should therefore audit a prospective holder on both dimensions, paper qualifications and demonstrated performance, since a lapse on either side ultimately lands on the product’s market position.

2. Legal basis

The instruments below establish the four qualifications, the GMP certificate requirement, and the vigilance duties of the holder.

3. Expert insights

Insight 1: the BPF compliance certificate is the local layer in a two-layer GMP structure. The foreign manufacturer provides an ISO 13485:2016 certificate, while the local registration holder must separately hold a BPF compliance certificate issued by ANMAT under 3266/2013. Neither layer can be missing, and the application procedure for the latter is governed by 7425/2013 and 2096/2022 and requires its own scheduling. Companies that plan only for the ISO 13485 layer discover late that the local GMP certificate runs on a separate clock.

Insight 2: the Director Técnico is a signing responsible person. This position must be held by a licensed university-level professional registered with ANMAT. Because registration documents are signed jointly by the legal representative and the Director Técnico, the Director Técnico bears personal responsibility for the technical truthfulness of the filings — it is not a ceremonial title. Losing or changing this person can freeze a company’s entire regulatory operations until a replacement is registered.

Insight 3: liability for false sworn declarations can extend to the criminal level. Article 110 of Decreto 1759/72 is the legal basis for this liability. As 8799/2025 converts enterprise qualification into a sworn declaration regime and 236/2026 converts import and commercialization into a sworn notification regime, the weight of responsibility at the signing stage has risen substantially — the more streamlined the procedure, the heavier the signer’s responsibility.

Most failures observed in holder relationships are failures of allocation rather than of qualification: the holder is validly qualified, but no one inside the organization knows who executes which duty or by when. The recommendations below therefore pair document verification with contractual precision, so that every statutory duty has a named owner, a deadline and a consequence for non-performance that the manufacturer can actually invoke.

4. Practical recommendations

1. Verify the original documents of all four qualifications before signing. The legal person registration documents, the 2319/02 operating qualification certificate, the 3266/13 BPF compliance certificate and the Director Técnico registration record must each be examined in original form and checked for validity periods.
2. Implement each of the six duties point by point in the holder agreement. Fix a specific executor and response deadline for every duty — especially vigilance reporting and renewal handling — to avoid duties that are nominally assumed but never actually performed.
3. Agree on a commitment for deficiency-response timing. The speed of deficiency responses directly determines the review timeline; agree in the contract on the number of internal days to respond after receiving an ANMAT notification.
4. Build an early-warning mechanism for Director Técnico changes. A change of Director Técnico must be reported to ANMAT, and the holder should inform the manufacturer in advance whenever key personnel change.

5. Verification checklist

Confirm each item below when selecting and auditing a registration holder.

• □ The holder is a legally established Argentine legal person, and registration documents have been verified
• □ The 2319/2002 operating qualification certificate and its scope of coverage have been verified
• □ The 3266/2013 BPF compliance certificate and its validity period have been verified
• □ The Director Técnico is registered with ANMAT and meets the qualification requirements
• □ The holder agreement assigns executors and deadlines for each of the six statutory duties
• □ An internal deadline commitment for deficiency responses has been agreed

Run this checklist at onboarding and repeat it periodically, since qualifications expire, personnel change, and coverage gaps can emerge whenever a holder takes on new product lines. A periodic audit costs a fraction of what it saves, particularly compared with discovering a lapsed certificate in the middle of a deficiency response or an ANMAT inspection.

Regulatory information verified as of October 29, 2026.

In Argentina, GRZAN operates a wholly-owned subsidiary that can act as the registration holder and importer for foreign manufacturers, directly handling classification assessment, pathway selection, GMP and CFS documentation chains, Spanish-language technical documentation and labeling localization, HELENA submissions and deficiency responses, as well as BONITA import notifications, ARGOS vigilance system operation, change maintenance and 5-year renewal planning.

The GRZAN regulatory team consists of professionals with many years of hands-on international registration experience and tracks the developments of regulatory authorities worldwide. All published content follows the drafting standard of conclusions first, traceable legal basis, and verifiable figures. For an Argentina or MERCOSUR market-access plan tailored to a specific product, contact the GRZAN regulatory team at info@grzanglobal.com.