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Basic Legislation for importation, according to category of product


Foods

Resolution 22 of March 15, 2000
Approves technical regulations regarding the basic procedures for registration and exemption of registration concerning imported food related products

Resolution 23 of March 15, 2000
Approves technical regulations regarding the manual for registration of , as well as exemption from, compulsory registration concerning imported food related products

Administrative Rule SVS 42 of January 16, 1998
Institutes norms for food labeling

Medicines

Administrative Rule SVS 344 of May 12, 1998
Approves technical regulation concerning the substances and medicines subject to special controls, and sets out the types of documents needed, as well as setting out other provisions.

Administrative Rule 6 of January 29, 1999
Approves the Normative Order of Administrative Rule 344 of 12/5/98 dealing with the technical regulation of substances and medicines subject to special controls.

Resolution (RDC) 98 of November 20, 2000
Approves updating of the lists of psychotropic and narcotic substances .
Health Products

Administrative Rule SVS/MS 996 of December 10, 1998
Dispenses with the need to present the operation permit issued by ANVS to import radiotherapeutic drugs and associated items, and medicines for image diagnosis purposes by hospital and health establishments.

Administrative Rule SVS/MS 54 of October 29, 1997
Approves list of medical devices exempted from registration, while remaining subject to other sanitary inspection requirements.
Cosmetics

Administrative Rule SVS/MS 71 of May 29, 1996
Regulates norms and procedures regarding operating licenses for and registration of personal hygiene products, cosmetics and perfumes and other items in this category, and sets out other provisions.

Resolution 335 of July 22, 1999
Regulates control activities regarding health inspection of cosmetics, hygiene products and perfumes, according to the level of risk involved.

Resolution 10 of October 21, 1999
Exemption from registration for feeding bottles, baby dummies, biters and rubber nozzles, disposable diapers and sanitary napkins, tooth brushes and flexible bottle-cleaning brushes.

Sanitizing and home cleaning products

Resolution 336 of July 22, 1999
Regulates sanitary control activities concerned with sanitizing and home cleaning products, according to the level of risk to health.
Blood and blood products

Resolution - RDC 46 of May 2000
Sets forth norms for production, quality control, procurement and distribution of blood products for human use.
Organs, tissues and human body parts

Decree 2268 of June 30, 1997
Regulates Law 9434 of February 4, 1997 which deals with organ removals, tissue and human body parts for transplant and treatment purposes, as well as other provisions.

Law 9434 of February 4, 1997
Deals with organ removals, tissue and human body parts for transplant and treatment purposes, and other related provisions.

Administrative Rule 937 of July 22, 1999
Import of human corneas.
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