Argentina, Colombia, and Chile peptide regulation

Argentina (ANMAT), Colombia (INVIMA), and Chile (ISP) each regulate peptides independently. No unified regional regime exists, although the Pacific Alliance (incorporating Mexico, Colombia, Chile, Peru) facilitates regulatory cooperation. All three require marketing authorisation for peptide medicines. Compounding is permitted within defined boundaries. No general consumer-market pathway for unauthorised research peptides was identified in the sources reviewed; national exceptions require current country-specific analysis.

Authorities and legal categories

• ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica): drug registration, enforcement, import control.

Key instruments:

• Ley 16.463 and Ley 17.565.

• Disposición series.

Approved medicines

Approved peptide medicines include GLP-1 receptor agonists (semaglutida/Ozempic, liraglutida, tirzepatida/Mounjaro), insulin analogues, teriparatida (Forteo), leuprorelina, octreotida, desmopresina, calcitonina.

Source: ANMAT medicines register, https://www.argentina.gob.ar/anmat

Compounding

The materials reviewed for this snapshot do not support importing the US section 503A “essentially a copy” test—or a shared three-condition substitute— into Argentine law. Whether a particular active and patient-specific formula is eligible must be traced to the current ANMAT rule, pharmacopoeia, pharmacy law, and an exact licensed-establishment authorization; this page does not establish that research-market peptide material is eligible.

Import

• Disposición 5842/2025: ANMAT issued a criminal referral for falsified Ozempic identified in the supply chain.

• Disposición 3752/2025: introduced a two-stage Effective Commercialisation Authorisation process for new drug registrations.

• This review did not verify a general consumer personal-import pathway for unapproved peptide medicines. Case-specific advice must come from ANMAT and customs under the current instrument, not from Disposición 2847/2026.

Enforcement

ANMAT issued multiple alerts in 2025–2026 regarding falsified and unapproved peptide products. ELEA (domestic manufacturer) received approval for generic semaglutide, expanding patient access.

Authorities and legal categories

• INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos): sanitary registration, pharmacovigilance, enforcement.

Key instruments:

• Decreto 677/1995.

• Decreto 2200/2005.

• Resolución 444/2008 (Buenas Prácticas de Elaboración — BPE).

Approved medicines

Approved peptide medicines include semaglutida, liraglutida, tirzepatida, insulin analogues, teriparatida, leuprorelina, and octreotida.

Compounding

Resolución 444/2008 governs pharmacy compounding practice, but it does not create the US section 503A “registered API / prescription / essentially a copy” test. This snapshot therefore makes no categorical eligibility claim for a research- market peptide without an exact INVIMA/ministry provision and product-specific assessment.

Import

• INVIMA's Resolución 2025010547 addressed a backlog of 14,000 pending sanitary registration applications with a contingency plan.

• Personal import is limited to approved medicines for personal use with appropriate documentation.

Enforcement

• Alerta INVIMA 95-2026: specifically warned against aesthetic (cosmetic) use of tirzepatida — unauthorised product presentations.

• J.E. Laboratorios case: INVIMA enforcement action against unauthorised manufacturing and supply.

Authorities and legal categories

• ISP (Instituto de Salud Pública): drug registration, enforcement.

• Ministerio de Salud: policy direction.

Key instruments:

• Código Sanitario.

• Decreto 3/2010 (Reglamento del Sistema Nacional de Control de Productos Farmacéuticos).

Approved medicines

Approved peptide medicines include semaglutida/Ozempic, liraglutida, insulin analogues, teriparatida, leuprorelina, and octreotida.

Unique classification

The reviewed Chilean source classifies semaglutide as a biological product; no worldwide uniqueness claim is made. This means generic semaglutide cannot follow a chemical generic pathway; a biosimilar pathway applies. The Selfix (biosimilar semaglutide) application was filed December 2025 and remains under ISP evaluation.

Compounding

ISP uses a "use-destined" criterion: whether a product is intended for therapeutic use determines its regulatory status. "Research use only" labelling is not a defence.

Import

Personal import is limited to approved medicines for personal use. No structured pathway exists for unauthorised peptide import.

Enforcement

• ISP active enforcement against online peptide vendors making therapeutic claims.

• Generic pathway for semaglutide blocked by biological classification, creating market uncertainty.

This is general regulatory research, not legal advice. Classification can turn on composition, claims, intended use, route, supplier role, and facts not captured by a product name.

Related atlas pages: Latin America overview, Brazil, Mexico, and cross-border supply.

1. ANMAT. https://www.argentina.gob.ar/anmat

2. INVIMA. https://www.invima.gov.co

3. ISP Chile. https://www.ispch.cl

4. Disposición 5842/2025 (ANMAT). https://www.argentina.gob.ar/anmat (disposiciones).

5. Resolución 2025010547 (INVIMA). https://www.invima.gov.co (normatividad).

6. Decreto 677/1995 (Colombia). https://www.funcionpublica.gov.co/eva/gestornormativo/

7. Alerta INVIMA 95-2026. https://www.invima.gov.co (alertas).