Drugs

Resolution - RDC nº 140 of 29 May 2003
Besides the definitions established in items I, II, III, IV, V and VII of Article 4 of Law nº 5.991 dated 17 December 1973, of Article 3 of Law nº 6.360 dated 23 September 1976 and of Law nº 9.787 dated 10 February 1999, the definitions described below shall be adopted in this resolution.

Resolution - RDC nº 139 of 29 May 2003
This resolution encompasses the registration of industrialized homeopathic drug products, the exemption of registration of industrialized homeopathic drug products, their dispensation and their classification in the sales category of homeopathic drug products.

Resolution - RDC nº 138 of 29 May 2003
All drug products that have their therapeutic groups and indications described in the Annex: List of Specified Therapeutic Groups and Indications (GITE), respecting textual restrictions and other pertinent legal norms and regulations, shall be sold over the counter, except for those administered parenterally, that shall be sold with prescription only.

Resolution - RDC nº 137 of 29 May 2003
Approve the attached Technical Regulation for the registration of Similar Drugs. Whereas the information contained in the package inserts and packaging of drug products is extremely important for professional prescribers and users giving details of the active ingredients and usage warnings;

Resolution - RDC nº 136 of 29 May, 2003
Approve the attached Technical Regulation for New Drugs with Synthetic or Semi-Synthetic Active Ingredients

Resolution - RDC nº 135 of 29 May, 2003
Approve the attached Technical Regulation for Generic Drugs.

Resolution - RDC nº 134 of 29 May, 2003
Upon the first registration renewal after the publication of this resolution, all holders of drug product registrations shall submit production and quality control reports as described in specific legislation.

Resolution - RDC nº 133 of 29 May, 2003
Approve the attached Technical Regulation for the registration of Similar Drugs.

Resolution - RE nº 896 of 29 May, 2003
To determine the publication for the attached “GUIDE FOR RELATIVE BIOAVAILABILITY/BIOEQUIVALENCE TESTS".

Food

Resolution n º 40 of March 21, 2001
To approve the Technical Regulation for OBLIGATORY NUTRITIONAL LABELING OF PACKAGED FOODS AND BEVERAGES, attached to this Resolution.

Resolution n º 39 of March 21, 2001
To approve the Packaged Food and Beverage Serving Size for Food Labeling Reference Table attached to this Resolution.

Resolution n º 23 of March 15, 2000
(Federal Official Gazette - DOU 16/03/2000)
Approve the Technical Regulation on the Manual of Basic Procedures for Registration and Exemption from Obligatory Registration of Food Products in the Annex of this Resolution

Resolution n º 22 of March 15, 2000
(Federal Official Gazette - DOU 16/03/2000)
Deals with the Basic Procedures to be followed for the Registration of Imported Products in the Area of Foodstuffs and the Exemption of the Same from the Compulsory Requirement

Resolution nº 19, of April 30, 1999 (*)
(republished on 10/12/1999)
Approve the TECHNICAL REGULATION ON PROCEDURES FOR REGISTRATION OF FOODS WITH FUNCTIONAL AND OR HEALTH CLAIMS ON THEIR LABELS.

Resolution nº 18, of April 30, 1999 (*)
(republished on 03/12/1999)
To approve the TECHNICAL REGULATION ESTABLISHING THE BASIC GUIDELINES FOR ANALYSIS AND PROOF OF FUNCTIONAL AND OR HEALTH CLAIMS ON FOOD LABELS, included in the annex of this Administrative Order.

Resolution nº 17, of April 30, 1999 (*)
(republished on 03/12/1999)
To approve the TECHNICAL REGULATION ESTABLISHING THE BASIC GUIDELINES FOR EVALUATION OF RISK AND SAFETY OF FOODS, included in the annex of this Administrative Order.

Resolution nº 16, of April 30, 1999 (*)
(republished on 03/12/1999)
To approve the TECHNICAL REGULATION ON PROCEDURES FOR REGISTRATION OF FOODS AND OR NEW INGREDIENTS, included in the annex of this Administrative Order.

Generic Drugs (legislation from hotsite)

Law nº 9.787, of February 10, 1999
Alters Law nº 6.360, of September 23, 1976, concerning sanitary surveillance, establishes the generic drug, decides upon the use of generic names in pharmaceutical products, among other procedures.

Law nº 6.360, of September 23, 1976
Deals with sanitary surveillance, to which medicines, drugs, pharmaceutical inputs and related products, and others are henceforth subject and enacts other provisions.

Provisional Remedy nº 2.039-20, of August 25, 2000
Alters provisions of Law nº 9.782, of January 26, 1999, which Defines the National Sanitary Surveillance System, establishes the National Sanitary Surveillance Agency and sets out other provisions.

Decree nº 4.204, of April 23, 2002
The provisions of Article 1 of Decree n.3.675, of November 28, 2000, shall henceforth be in force with the following changes:

Decree nº 3.841, of June 11, 2001
Alters the dispositions stated on Decree nº 3.675, of November 28, 2000, concerning special measures in relation to the registration of generic medicine, under art. 4th of Law nº 9.787, of February 10, 1999.

Decree nº 3.718, of January 3, 2001
Alters the dispositions stated on Decree nº 3.675, of November 28, 2000, concerning special measures in relation to the registration of generic medicine, under art. 4th of Law nº 9.787, of February 10, 1999.

Decree nº 3.675, of November 28, 2000
Which establishes special measures to provide the filing of generic medicines, regarding the item 4 of the Law nº 9,787 of February 2, 1999.

Decree nº 3.181, of September 23, 1999
Regulates Law nº 9.787, of February 10, 1999, concerning Sanitary Surveillance, establishes the generic medicine, and decides upon the use of generic names in pharmaceutical products, among other procedures.

Administrative Order nº 185, of March 8, 1999
The importation of pharmaceutical products subject to the Sanitary Surveillance Regimen shall only be made by companies which are legally authorized to function as importers by the Sanitary Surveillance Secretary / Ministry of Health.

Administrative Order nº 911, of November 12, 1998
To approve the list, annexed to this Administrative Order, of documents needed for the instruction of authorization requests to carry out Clinical Research with Pharmaceutical Substances, Medicaments, Vaccines and New Diagnosis Tests.

Administrative Order nº 772, of October 2, 1998
To approve the Procedures to be adopted in the importation of products and raw materials subject to sanitary control as provisioned for in Annex 1 of this Administrative Order.

Administrative Order nº 331, of May 6, 1998
To authorize the clearance, by the Sanitary Surveillance Office of the Ministry of Health, of products imported directly or by third party means, for institutions or agencies interested in carrying out researches or scientific investigations.

Administrative Order nº 110, of March 10, 1997
To establish guidelines for the text of the "direction for use" of medicines, whose items must be strictly followed, as to order and content.

Administrative Order nº 19, of February 16, 1996
To approve the list of documents needed to open processes requesting registration of imported medicines.

Resolution - RDC nº 84, of March 19, 2002
Approve the attached Technical Regulations for Generic Drugs.

Resolution - RDC nº 92, of October 23, 2000
Resolution ANVS nº 510, of October 1, 1999, published in the Official Journal of the Union, enters into force with the language given by this Resolution.

Resolution - RDC nº 78, of August 17, 2000
Regulates the presentation of monthly information referring to the production and trade of generic products.

Resolution nº 41, of April 28, 2000
The entities or companies that intend to register vis-à-vis ANVS/MS in order to qualify for carrying out the trials of pharmaceutical equivalence, bioavailability and/or bioequivalence must proceed to the completion of the specific form available on the Internet, at the following electronic address: http://anvs.saude.gov.br, section of the Rede Brasileira de Laboratórios, registration item.

Imported Merchandise

Resolution - RDC 01, of January 6, 2003
To approve, as in attachments, the Technical Regulation for the purposes of sanitary surveillance of imported merchandise.

Pharmacovigilance

Resolution RDC nº 68, 28 March 2003
For the enforcement of article 2 of RDC nº 305, dated 2002, the presentation of information will be mandatory as disposed in ANNEX of this Resolution, concerning the entry, trade and exposure to consumption of goods (finished, semi-finished or in bulk) for use in human beings that contain raw materials obtained from the tissues/fluids of ruminant animals as well as the documents already foreseen in the legislation in force.

Resolution - RDC nº 305, dated 14 November 2002
While conditions that present health risks persist, the following remains forbidden in the national territory: the entry and trade of raw materials and finished, semi-elaborated or bulk products made of the tissues/fluids of ruminant animals for use in human beings including medicines, cosmetics and health products, as specified below:

Resolution - RE nº 356, dated 28 February 2002
Determine as a measure of sanitary interest the seizure in the national territory of any pharmaceutical product containing Kava-Kava (Piper methysticum L.) that does not have a red strip with the warning “Prescription Only”.

Resolution RE nº 530, dated 17 April 2001*
Cancel the licenses of CISAPRIDE-based medicines according to the annexed list.

Resolution RE nº 528, dated 17 April 2001
Forbid the use of mercury compounds in medication

Resolution - RDC nº 67, dated 14 July 2000
To suspend as of this date, as a measure of sanitary interest, the fabrication, distribution, trade/sale and dispensation of products that contain the substance TERFENADINE and its salts in their formula, be it in isolation or in association to other substances

Ports, Airports and Borders

Resolution - RDC 71, of April 3, 2003 (PDF)
Change lines "b" and "c" of article 28, caput of article 41, clause VIII of article 76, item A – LIST OF MEDICINES and item B – LIST OF HEALTH PRODUCTS of annex 1 from RDC nº 2, January 8th, 2003, published in the Official Daily Government Newspaper of January 13th, 2003, that are in force with the following text

Resolution - RDC 2, of January 8, 2003 (PDF)
Approve the Technical regulation, for sanitary inspection and control in airports and aircraft, attached to this Resolution.

Resolution - RDC 217, of November 21, 2001 (PDF)
To approve the Technical Regulation attached herewith, for the promotion of the sanitary surveillance at Sanitary Control Ports established in the national territory, of cargo and passengers transportation vessels in such locations and aiming at the promotion of the epidemiological surveillance and the control of vectors in such areas and the transport vehicles circulating therein

Tobacco Products

Resolution - RDC 346, of December 2, 2003 (*)
The present Resolution revokes RDC nº 105, dated 31 May 2001, and provides new norms for the listing of tobacco products.

Resolution - RDC 335, of November 21, 2003 (*)
Revokes RDC nº 104 date 31 May 2001 and RDC nº 14 dated 17 January 2003.

Resolution - RDC 15, of January 15, 2003 (*)
The following definitions shall be adopted for compliance with Article 3 of Law nº 9294 dated 15 July 1996, with the changes introduced by Law nº 10167 dated 27 December 2000

Resolution - RDC 14, of January 17, 2003 (*)
Changes provisions of RDC number 46, of March 28, 2001 and of RDC number 104, of May 31, 2001.
Revoked for Resolution - RDC nº 335, dated 21 November 2003

Resolution - RDC 105, of May 31, 2001 (*)
Has adopted the following Resolution, applicable to tobacco leaves and tobacco products which are processed, manufactured, transported, marketed and/or stored throughout  the  territory of Brazil , and whether imported or for purposes of export.
Revoked for Resolution - RDC nº 346, dated 02 December 2003

Resolution - RDC 104, of May 31, 2001 (*)
Has hereby adopted the following Resolution of the Collegiate Board of Directors, applicable to smoking products derived from tobacco and marketed in Brazilian national territory, whether the products are produced domestically or imported, and I, Director- Chairman hereby determine that it should be republished
Revoked for Resolution - RDC nº 335, dated 21 November 2003

Resolution - RDC n. 46, of March 28, 2001
Establish the maximum levels allowed of tar, nicotine and carbon monoxide present in the mainstream smoke of cigarettes commercialized in Brazil.

Law 10.167, of 27 December 2000
(Federal Official Gazette - DOU of 28/12/2000)
The present Law alters the provisions contained in Law 9.294, of July 15, 1996, which provides for restrictions to the use of - and publicity referring to - smoking products, alcoholic beverages, medicines, therapeutic treatments and pesticides

Law 9.294 of July 2, 1996
Federal Official Gazette - DOU of 16/07/1996
Sets forth restrictions on the use and advertising of smoking products, alcoholic beverages, medicines, therapeutic remedies and pesticides, in accordance with the terms of Paragraph 4 of Article 220 of the Federal Constitution.

Inspect drug manufacturing establisments

Resolution - RDC nº 25. december 9, 1.999 (*)
To approve, in a form of an APPENDIX, , the Technical Regulation - Rules for Inspections applicable to inspect drug manufacturing establisments, which are installed in countries other than those comprised by the MERCOSUL.