Resolution - RDC nº 68, of March 28, 2003
DOU 03/31/2003

Establishes the conditions for the import, trade and exposure to consumption of the products included in the Resolution of the Collegiate Directorate - RDC nº 305, dated 14 November 2002.

The Collegiate Directorate of the Brazilian Sanitary Surveillance Agency, in the use of the attributions vested in it by article 11, item IV of the ANVISA Regulation, approved by Decree nº 3.029, dated 16 April 1999, c/c § 1 of article 111 of the Internal Regulation approved by Administrative Order nº 593, dated 25 August 2000, republished on 22 December 2000, in meeting held on 27 March 2003,

WHEREAS the recommendations of the World Health Organization (WHO) on the prevention of transmissible spongiform encephalopathies (TSEs);

WHEREAS the need to standardize data on raw materials defined in Decree nº 3.961, dated 10 October 2001;

WHEREAS the need for information on the components of products for use in human beings;

WHEREAS also that disposed in Resolution RDC nº 305, dated 14 November 2002;

WHEREAS the need to promote the sanitary inspection of the import of goods dealt with in RDC nº 305, dated 2002;

WHEREAS the need to ensure the introduction in the national territory of imported goods that meet the identification and quality standards of the in force sanitary legislation;

WHEREAS the need to establish procedures to be respected by importers concerning the import of goods dealt with in RDC nº 305, dated 2002;

WHEREAS the need to standardize sanitary inspection procedures concerning the internalization of imported goods in the national territory,
Adopted the following Resolution of the Collegiate Directorate and I, Substitute Director-Chairman, determine its publication:

Art. 1 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.

Sole paragraph. The information referred to in this article is a pre-requisite to demand a permit for the loading of goods in foreign country.

Art. 2 The external packaging of the goods must have a similar notice to that of table Q2 of the ANNEX of this Resolution in a visible place that can be easily accessed and read by the sanitary inspection.

Art. 3 the information of tables Q1 and Q2 and a copy of the supporting documentation referring to table Q3 must be presented on each importSole paragraph. The information of table Q3 shall only be accepted when presented in Portuguese, English or Spanish.

Art. 4 In Order to import products made of tissues/fluids of categories I, II and III described in ANNEX 4 of RDC nº 305, dated 2002 , the documentation referring to table Q3 must be submitted for analysis and authorization by the competent technical area of ANVISA, Brasilia, prior to loading in foreign country.

Art. 5 In Order to import products made of tissues/fluids of category IV only as described in ANNEX 4 of RDC nº 305, dated 2002 , the documentation referring to table Q3 must be submitted for analysis and authorization by the sanitary authority of ANVISA in exercise at the site of unloading of the goods, prior to loading in foreign country.

Art .6 In Order to import products made of tissues/fluids not foreseen in ANNEX 4 of RDC nº 305, dated 2002 , the products must be submitted for analysis and authorization by the competent sanitary authority of ANVISA, Brasilia

Art.7 The introduction of new tissues/fluids in ANNEX 4 of RDC nº 305, dated 2002, shall take place through the RDC.

Art. 8 Any person or legal entity that imports goods through the Foreign Trade Integrated System – SISCOMEX will receive from the competent technical area of ANVISA the result of the analysis of the “on line” import request, by means of the authorization or not of the previous consent of the Import License – LI or through a Simplified Import License - LSI.Sole paragraph. A SISCOMEX import permit shall be granted by the ANVISA sanitary authority in exercise at the point of unloading of the imported goods, through the presentation of the documents specified in the ANNEX of this Resolution and by means of a satisfactory physical inspection.

Art. 9 Any person or legal entity that imports goods by mail or courier will also be subject to the demands of this Resolution.

Art. 10 The imported goods dealt with in this Resolution shall enter the national territory packaged, identified, with valid expiration date that is within the consumption expectation of the national territory and that complies with the identification and quality standards established by the sanitary legislation in force.

Art. 11 The following documents shall be presented to the sanitary authority in force at the place of unloading by the importer upon the arrival of the merchandise in national territory:
a) commercial invoice;
b) bill of lading;
c) identification of lot or batch;
d) quality control analytical report emitted by manufacturer.

Art.12 Besides the requirements foreseen in this Resolution, the importer shall also present the quality control analytical report of the raw material supplying the information contained in table Q1 as well as the documents that compose table Q3 in the occurrence of the following situations:

1. at the moment of requesting a new license or the revalidation or exemption of a license for products at ANVISA;
2. whenever changes are made in the composition of a product, in the geographical origin of a product or its components or in the process used to obtain the components of a formula;
3. in routine inspections, including inspections for the certification of good manufacturing and control practices (CBPFC).
4. at any moment judged pertinent by the federal sanitary authority.

§ 1-A consularized copy of the documents described in Table Q3 must be presented together with their certified translations to the Portuguese language.

§ 2 Information concerning the production and manufacturing method of the raw material that is the object of this Resolution can be requested additionally.

Art 13 Additional information can be requested by the regulatory organization at any moment.

Art 14. The situations foreseen in this Resolution shall be analyzed by the technical areas of ANVISA, in Brasília.

Art. 15 The Resolution RDC nº 306, dated 14 November 2002 of the Collegiate Directorate is hereby revoked.

Art. 16 This Resolution enters into force on the date of its publication.

CLÁUDIO MAIEROVITCH PESSANHA HENRIQUES

ANNEX
MANDATORY DOCUMENTS FOR COMPLIANCE WITH RDC Nº 305, DATED 14 NOVEMBER 2002TABLE Q1

One table must be filled in per physical/pharmaceutical entity:

* Information regarding the environmental conditions needed to ensure the integrity and quality of the imported merchandise (temperature, humidity, luminosity and considered necessary).
a) Such ingredients such as softgel capsules, coatings and other mixtures must also have their ingredients discriminated.

TABLE Q2

OBS: The information in this table must be presented in Portuguese, English or Spanish.

TABLE Q3

| | | | | V	<-------------------------------------
	Geographic Risk Tissue / Fluid Category I II III IV 1 GMP*+IVC or CEP GMP*+IVC or CEP GMP*+IVC or CEP B 2 FORBIDDEN GMP*+IVC or CEP GMP*+IVC or CEP B 3 FORBIDDEN FORBIDDEN FORBIDDEN** D 4 FORBIDDEN FORBIDDEN FORBIDDEN** D 5 FORBIDDEN FORBIDDEN FORBIDDEN** D

GMP – Certificate of Good Manufacturing Practice of the Manufacturer or Quality Control Analytic Report of Finished Product emitted by manufacturer
IVC – International Veterinary Certificate
CEP – Conformity Certificate - European Pharmacopoeia
B – IVC or CFE (State Supplier’s Certificate) or official document of the local sanitary authority attesting to the origin of the raw material
D – Conformity Certificate – European Pharmacopoeia + GMP

* - Required for finished or bulk products / Obs: the presentation of the GMP or of the Quality Control Analytic Report emitted by manufacturer will be required for each component of semi-finished products
** - Excepting pulmonary surfactants, as long as they present CFE
--> Indicates a growing degree of infectivity (tissue/fluid) or risk (country)