Argentina

Policy

One of the main mission to carry out the Health Policy in Argentina, the Argentinean Ministry of Health in coordination with the relevant ministries conduct regular supervisions on all matters pertaining to the manufacture, distribution and marketing of medicinal products which include biological, drugs and herbs. This obligation was also reemphazised in the Bioethics Document no. 367 which was passed on 2010. In the same year of 2010, the Act on Plants with therapeutic effects for the Protection and Promotion of Health was gazetted which is aimed at regulating the process of selection of plant varieties, the cultivation, harvesting, packing, processing, bottling, packaging, storage and marketing of drug preparations, herbal preparations, herbal medicines, animal health and phytocosmetic preparation and people and legal entities involved in such activities.

Contact 

Ministerio de Salud, Av. 9 de Julio 1925 (C1073ABA) 
Buenos Aires República Argentina 
Tel.: 54-11-4379-9000 
Website: http://www.msal.gov.ar

 

Laws & Regulations

All health supplements much be registered with the Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (National Administration of Drugs, Foods and Medical Devices, ANMAT).  ANMAT insures compliance for manufacturing and safety.  There are no regulations that are specific to health claims for nutritional products.

Herbs are regulated as prescription medicines, over the counter medicines and dietary supplements under the National Administration of Drugs, Food and Medical Technology and the National Institute of Medicines (INAME) of the Ministry of Health. Herbal regulation has been introduced in 1998 which differs from conventional medicine. Botanicals are regulated under Resolution 144/98 which allows for legal claims to be made.  Herbal preparations are directed by guidance from various pharmacopoeias and this guidance is legally binding in all cases. Claims may be made on herbal supplements. However, homeopathic medicines must be prepared immediately before dispensing, and may only be sold in pharmacies.  Pre-manufactured homeopathic products are illegal.

A post-market surveillance program was established in 1993 and tracks all adverse events.

There are specific laws about certain forms of TM/CAM. According to the National Ministry of Health, acupuncture may be practised only by allopathic physicians. 

Contact 

National Administration of Drugs, Foods and Medical Devices.  
http://www.msal.gov.ar.                                                        
Conmutador: 54-11-4379-9000                     
Av. 9 de Julio 1925 (C1073ABA) Buenos Aires República Argentina

 

Standards & Guidelines

In the year of 2010, the Act on Plants with therapeutic effects for the Protection and Promotion of Health was gazetted which is aimed at regulating the process of selection of plant varieties, the cultivation, harvesting, packing, processing, bottling, packaging, storage and marketing of drug preparations, herbal preparations, herbal medicines, animal health and phytocosmetic preparation, also includes people and legal entities involved in such activities.

The National Administration of Drugs, Foods and Medical Devices (ANMAT) is an organization from the National Public Administration that was created by Decree 1490/92 in August 1992. It protects the human health by assuring the quality of the products it regulates which includes drugs, foodstuff, medicinal products, diagnosis reagents, cosmetic products, dietary supplements and household cleaning products. The professionals and technicians use modern technology in order to efficiently fulfil the process of authorization, registration, standardization, vigilance and monitoring of the products used in the medicine, food and cosmetic fields. ANMAT's main objective is to guarantee that drugs, foodstuff, medical devices available to the public must be compliant in terms of efficacy (fulfilment of the therapeutic, nutritional or diagnostic objective), safety (high benefit/risk ratio) and quality (by meeting the citizens´ needs and expectations).

Argentina is an OECD member country which adheres to the OECD. In order to encourage the use of high quality of seed in terms of agriculture purpose in Argentina and other OECD member countries, a scheme called OECD Seed Schemes is introduced. The scheme authorizes the use of labels and certificates for seed production and processing for international trade according the agreed principle.

Contact

Ministerio de Salud y Acción Social. Postal Address: Av de Julio 1925 (C1073ABA) - CABA – Argentina
Website: http://www.msal.gov.ar/
National Administration of Drugs, Foods and Medical Devices (ANMAT) 
Avenida de Mayo 869 (C1084AAD) - City of Buenos Aires - Argentina
Telephone: 54-11-4340-0800 / 54-11-5252-8200
Website: http://www.anmat.gov.ar/principal_en.asp