ANMAT market placement notice (Disp. 236/2026) for products sold in reference countries
The market placement notice is a sworn statement filed as prior notification that registers an imported product with ANMAT before it is sold, without local testing. It was created by ANMAT Disp. 236/2026, under Decree 892/2025. It is used by licensed establishments importing cosmetics, perfumes, personal and oral hygiene products and disposable and intravaginal hygiene products authorized in a reference country. It also covers Class I and II medical devices and IVD A and B that do not require a cold chain.
- Required by
- Disp. (ANMAT) 236/2026
- Agency
- ANMAT
- Estimated timing
- The statement is filed before the product is placed on the market (prior notification, Disp. 236/2026). ANMAT response time: [COMPLETAR].
- Official fee
- $ 1.501.800
- Our fee
- Tailored quote
Why it is mandatory
Disp. 236/2026 (art. 2) states that these products may only be imported and sold if they are authorized and registered with ANMAT, and that registration is made through this sworn statement. It does not replace the importer's license: it replaces traditional product registration when it is proven that the product is already sold in a reference market.
Because it is a prior notification, ANMAT does not evaluate beforehand: it inspects afterwards. With the declared information it can control, verify, recall and sanction (art. 6). The declaration and its backing must support the product for as long as it remains on the market.
What the regulation says
«Establécese que los productos alcanzados por la presente disposición sólo podrán ser importados y comercializados en el territorio nacional por empresas que cuenten con la correspondiente habilitación sanitaria, y siempre que dichos productos se encuentren debidamente autorizados e inscriptos ante esta Administración Nacional. A tales efectos, el proceso de inscripción y autorización de los productos se instrumentará mediante un sistema de declaración jurada con carácter de notificación previa (…)»Unofficial translation: “The products covered by this disposition may only be imported and marketed in Argentina by companies holding the corresponding health license, and provided that such products are duly authorized and registered with this National Administration. To that end, product registration and authorization will be carried out through a sworn-statement system serving as prior notification (…)”
«El incumplimiento de la presente disposición dará lugar a la iniciación del sumario pertinente y a la aplicación de las sanciones que pudieran corresponder en virtud de la Ley N° 16.463, la Ley N° 18.284 y las normas dictadas en su consecuencia, sin perjuicio de la aplicación de las medidas preventivas que correspondan según las leyes mencionadas, el Decreto N° 341/92 y/o sus normas complementarias y/o modificatorias.»Unofficial translation: “Failure to comply with this disposition will lead to the opening of the relevant administrative proceedings and to the sanctions that may apply under Law No. 16,463, Law No. 18,284 and their implementing rules, without prejudice to the preventive measures applicable under those laws, Decree No. 341/92 and/or its complementary and/or amending rules.”
Rules that require it
- Disp. (ANMAT) 236/2026: Registration by sworn statement as prior notification of imported products authorized in reference countries; exemption from local testing. Official Gazette 06/02/2026.
- Dec. 892/2025: Recognizes approvals and certifications from reference countries (Annex I) for low and moderate risk products under ANMAT oversight. Official Gazette 17/12/2025, in force after 60 days.
- Ficha oficial del trámite (ANMAT): Requirements, documents and transitional 'DDJJ HERA' filing. Updated 28/04/2026.
- Disp. (ANMAT) 2978/2026 y 5461/2026: Fees for the market placement notice and for notification of medical devices and IVD.
Products covered
Foreign products that comply with Argentine law on formulation, labeling, quality and safety (art. 1):
- Cosmetics, personal hygiene products and perfumes, grade I and grade II.
- Oral hygiene products for dental use.
- Disposable hygiene products for external use and hygiene products for intravaginal use.
- Class I and II medical devices and Class A and B IVD that do not require a cold chain: details in ANMAT medical device registration.
Requirements and documents
How it works, according to Disp. 236/2026 and the official procedure sheet:
- A licensed company in Argentina authorized by ANMAT for the category (prior registration in THEMIS).
- One sworn statement per product, including its variants.
- Route 1, no local testing (art. 3): certificate of free sale from the health authority of Australia, EFTA countries, the EU, the US, Israel, Japan or the UK, no older than 24 months unless it states another validity.
- Route 2 (art. 4): certifications and test reports from recognized certification bodies or OAA-accredited laboratories.
- Foreign documents legalized or apostilled, with certified Spanish translation.
- Transitional filing at ANMAT's front desk as 'DDJJ HERA' until the digital platform runs. Without either route, traditional registration applies (art. 5).
Official fees and timing
| Concept | Amount | Valid | Source |
|---|---|---|---|
| Market placement notice - imported grade I cosmetics, personal hygiene products and perfumes | $ 1.501.800 | 2026 | Disp. ANMAT 2978/2026, Anexo III, punto F (vigente desde 01/06/2026) |
| Market placement notice - imported grade II cosmetics, personal hygiene products and perfumes | $ 2.511.000 | 2026 | Disp. ANMAT 2978/2026, Anexo III, punto F (vigente desde 01/06/2026) |
| Market placement notice - imported oral hygiene products for dental use | $ 1.255.800 | 2026 | Disp. ANMAT 2978/2026, Anexo III, punto F (vigente desde 01/06/2026) |
| Market placement notice - imported disposable hygiene products for external use / for intravaginal use | $ 1.501.800 / $ 2.511.000 | 2026 | Disp. ANMAT 2978/2026, Anexo III, punto F (vigente desde 01/06/2026) |
| Modification of declared data - grade I or II cosmetics and disposable hygiene products / oral hygiene products for dental use | $ 275.400 / $ 271.800 | 2026 | Disp. ANMAT 2978/2026, Anexo III, punto F (vigente desde 01/06/2026) |
| Notification by sworn statement - Class I-II medical device / IVD A-B | $ 476.400 / $ 424.500 | 2026 | Disp. ANMAT 5461/2026, Anexo II (vigente desde 01/09/2026) |
Official ANMAT fees per product, paid through the agency's electronic payment system. Legalization, apostille, certified translation and private laboratory reports are not official fees and are quoted separately.
Estimated timing
The statement is filed before the product is placed on the market (prior notification, Disp. 236/2026). ANMAT response time: [COMPLETAR].
Depends on: Validity and legalization of the certificate of free sale, compliance of formula and label with the Argentine rules for the category, and the front-desk workload while transitional filing applies.
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How we handle it remotely
Product eligibility
We review origin, category and your certificate of free sale, and confirm the sworn statement or traditional registration.
What you provide
Certificate of free sale, formula and label artwork; we check dates and variant coverage.
Adaptation to Argentine rules
We compare formula and label with national rules and flag changes before declaring.
Preparing and filing
One statement per product, with legalizations and translations, filed with ANMAT.
Post-market control
Each product's file stays ready for inspection, and we flag modifications to declare.
Risks of not having it
- Selling without a filed statement: the product is not registered and is exposed to proceedings and preventive measures (art. 6).
- A certificate of free sale that is expired, from an unlisted country or not covering all variants: the statement has no backing.
- A formula or label that does not meet Argentine rules, even if the product is sold in the country of origin: the sworn statement does not validate it.
15+ years with Argentine agencies
ANMAT's prior-notification route under Disposition 236/2026 is recent, but our 15-plus years of ANMAT filings taught us the logic: what you declare today gets audited later, once the product is on shelves. So we never treat it as a form. Before signing, we confirm the free sale certificate comes from an Annex I country of Decree 892/2025, is under 24 months old, covers every variant, and that formula and label meet Argentine rules.
Frequently asked questions
Is the market placement notice filed within 48 hours of clearance?
No. That is a different obligation: the import notice of Disp. 4033/2025, filed for each shipment within 48 hours of clearance. The market placement notice of Disp. 236/2026 is a prior notification per product, filed before it is sold. The full path is in selling cosmetics in Argentina.
Which countries' certificates of free sale are accepted?
Those in Annex I of Decree 892/2025 according to ANMAT's official sheet: Australia, EFTA countries, the European Union, the United States, Israel, Japan and the United Kingdom. The certificate is issued by that country's competent health authority, must prove the product is authorized and sold there, and cannot be older than 24 months unless it states another validity.
My product is made in China or Brazil. Can it use this route?
Not through the certificate of free sale, unless the same product is authorized in one of the listed countries. Route 2 remains: certifications and test reports from recognized certification bodies or OAA-accredited laboratories. If neither can be proven, the product goes through traditional registration with ANMAT.
Is one statement needed per color or fragrance?
The official sheet requires one sworn statement per product, including its variants. The key point is that the certificate of free sale covers the same variants that will be shipped. If variants are added or changed later, a modification must be declared, which has its own fee in ANMAT's schedule.
Does this statement license the importer?
No. It registers the product, not the company. Disp. 236/2026 requires whoever imports and sells to hold a valid ANMAT sanitary license for the category. If your buyer is not yet licensed, the establishment is registered first and the products are declared afterwards. Both can be run in parallel to save time.
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