Argentina Manufacturer Authorization Statement: Required Elements and Validity Management

1. Key takeaways

The manufacturer’s authorization statement is one of the basic documents listed in Part III, Article 6 of GMC 25/21, and its 4 required elements must all be present:

1. Valid for 2 years from the date of issue;
2. Expressly authorizing that Argentine importer to represent the manufacturer and market its products in Argentina;
3. Stating the full legal names and complete addresses of both parties;
4. Legalized or apostilled, with a certified Spanish translation attached.

The document defines the boundary of the rights that the foreign manufacturer grants to the local registration holder, and it is the foundational instrument on which later changes, holder transfers and enforcement actions all rest. Because every subsequent regulatory step, from deficiency-letter responses to transfer applications, presupposes a valid authorization, the quality of this single document echoes through the entire lifecycle of the registration.

Because the authorization statement is issued by the manufacturer, its preparation sits with a party that is often distant from the Argentine project team, and in a different time zone and language. The practical consequence is that this document is the one most frequently delayed: legal departments need templates reviewed, notaries need appointments, and the legalized translation needs a sworn translator. Building these dependencies into the project plan with explicit owners and dates, rather than assuming the statement will arrive on request, is what keeps the dossier assembly on schedule.

2. Legal basis

The regulatory layering matters here. GMC 25/21 fixes the content requirements of the authorization statement itself, Disposición ANMAT 64/2025 embeds them in the domestic document checklist, and Disposición ANMAT 2319/2002 (T.O. 2004) governs who may act as an authorized establishment for manufacture or import, which is what makes the counterparty of the authorization statement legally meaningful in the first place.

One further consequence of this layering deserves attention: because the holder’s own establishment authorization and the manufacturer’s product-level authorization are separate instruments, they can expire on different dates and be amended by different procedures. A company managing several products under one holder therefore needs to track two families of documents, each with its own renewal rhythm, and to reconcile them before any submission or transfer so that the authorization chain is intact at the moment ANMAT examines it.

3. Expert insights

Insight 1: an authorization drafted too narrowly constrains every later step. The text only requires authorization to represent and market, but in practice it is advisable to state at the same time whether the holder may submit changes and renewals on the manufacturer’s behalf, whether it may receive official correspondence from ANMAT, and whether it may handle vigilance reports and recalls. Without these extended authorizations, the holder lacks a legal basis in later proceedings, and each gap tends to surface at the worst possible moment, when an urgent regulatory action is needed.

Insight 2: the 2-year validity is in structural tension with the registration cycle. The practical cycle for Class III/IV often reaches 12–15 months, so if the authorization statement was issued more than a year before submission it may well expire inside the review period. The clean fix is to re-issue the statement shortly before submission, or to renew it proactively during the review, rather than waiting for a deficiency letter to point out the lapse.

Insight 3: changing the registration holder always requires a new authorization statement. Certificate transfer (transferencia) involves re-notarizing the authorization, which is precisely this requirement in action. The authorization statement is bound to the holder entity, so any change of holder necessarily triggers an update of the authorization paperwork; there is no mechanism under which an existing statement simply carries over to a new holder.

4. Practical recommendations

1. Draft from a template of the 4 statutory elements plus 3 extended authorizations. Beyond the four mandatory elements, add authority to act as agent for changes and renewals, authority to receive official correspondence, and authority to handle vigilance and recalls, so the document is fit for the full lifecycle from day one.
2. Check the issue date before submission. If the statement was issued more than 12 months earlier, re-issue it to avoid expiry during the review period, and record the chosen timing rule in the project plan so the same judgment is applied consistently across products.
3. Handle legalization and translation in the same batch as the CFS. Consular legalization or apostille plus a certified Spanish translation can be processed together with the CFS paperwork, saving calendar time and aligning all legalized documents to the same freshness window.
4. Archive originals with both the manufacturer and the holder. Keep duplicate originals on each side so they can be produced quickly for a later transfer or dispute, without depending on a single party’s document management.

5. Verification checklist

• □ Authorization statement issued less than 2 years ago and still within its validity
• □ Express authorization granted for the Argentine importer to represent the manufacturer and market the products
• □ Full legal names and complete addresses of both parties stated in full
• □ Legalization or apostille completed with a certified Spanish translation attached
• □ The three extended authorizations added: changes and renewals, official correspondence, vigilance and recalls
• □ Originals retained separately by the manufacturer and the holder

Regulatory information verified as of October 29, 2026.

In Argentina, GRZAN operates a wholly owned subsidiary that can serve as the registration holder and importer of record for foreign manufacturers, directly handling classification assessment, pathway selection, building the GMP and CFS documentation chain, Spanish-language localization of technical documentation and labeling, HELENA submissions and responses to deficiency letters, as well as BONITA import notifications, operation of the ARGOS vigilance system, change maintenance and planning for the 5-year renewal. For support with registration dossiers and conformity documentation for the Argentine market, contact the GRZAN regulatory team at info@grzanglobal.com.

The GRZAN regulatory team consists of professionals with many years of hands-on experience in international registrations, tracks the activity of regulatory authorities across markets on an ongoing basis, and applies a writing standard of conclusions first, traceable sources and verifiable figures to everything it publishes. For a market access plan tailored to a specific product in Argentina or the wider MERCOSUR region, the GRZAN regulatory team welcomes your enquiry at info@grzanglobal.com.