Resolution - RDC nº 01, of January 6, 2003
DOU 09/01/2003

Adjustment

The Collegiate Board of Directors of the Brazilian Sanitary Surveillance Agency, ANVISA, in the use of the attributions vested in it, in compliance with article 11, numeral IV, of the Regulation of this Agency, approved by Decree n. 3.029, of April 16, 1999, combined with article 111, paragraph 1, of the Bylaws of ANVISA, approved by Administrative Order n. 593 of August 25, 2000, republished in the Official Journal of December 22, 2000, at the meeting held on December 18, 2002.

whereas provided for in Laws n. 6.360, of September 23, 1976, n. 6.368; of October 21, 1976, n. 8.078; of September 11, 1990, n. 8.080; of September 19, 1990; n. 9.434, of February 4, 1997; n. 9.782, of January 26, 1999; n. 9.787, of February 10, l999; in Decree n. 986, of October 21, 1969; in Decree n. 79.094, of January 5, 1977; n. 87, of April 15, 1991; n. 2.268 of June 30, 1997; and in the Resolutions of the Common Market Group (GMC) already internalized in Brazil; and

whereas the need to promote, on custom-bonded premises, the sanitary control of merchandise imported under sanitary surveillance.

whereas the need to establish the required documentation to be presented to the sanitary authority, relating to applications for authorization for shipment form abroad, inspection and sanitary clearance of imported merchandise;

whereas the need to establish sanitary control procedures related to importation of merchandise under sanitary surveillance;

whereas the need to define duties and obligations of individuals, or public or private companies, involved with importation of merchandise under sanitary surveillance,

has adopted the following Resolution of the Collegiate Board of Directors and I, Substitute Director-Chairman, determine its publication:

Article1. To approve, as in attachments, the Technical Regulation for the purposes of sanitary surveillance of imported merchandise.

Article2. Failure to comply with the provisions contained in this Regulation and its Annexes, shall constitute sanitary infraction, subjecting the offenders to the penalties provided for in Law n. 6.437, of August 20, 1977, and its alterations, without damage to other appropriate civil or criminal sanctions.

Article3. This Resolution shall enter into force on February 1,f 2003, when Administrative SVS/MS n. 772, of October 2, 1998; Resolution RDC/ANVISA n. 19, of January 18, 2002; Normative Instruction SVS, n. 1, of December 16, 1996; Administrative Order MS/SVS n. 331, of May 6, 1998 and Administrative Order MS/SVS n. 996, of December 10, 1998 shall be revoked.

CLAUDIO MAIEROVITCH PESSANHA HENRIQUES

ANNEX

TECHNICAL REGULATION FOR THE PURPOSES OF SANITARY SURVEILLANCE OF IMPORTED MERCHANDISE

TITLE I
BASIC TERMINOLOGY

Article1. For the purpose of the provisions contained in this Regulation, the following definitions apply:

I - Sample: represented by amount, fragments or parts of any raw material, product or other merchandise pursuant to this Regulation, strictly as needed to reveal its nature, type and quality;

II - Fiscal analysis: routine analysis of the merchandise pursuant to this Regulation, for verification of infraction or conformity with the standards established in the applicable sanitary legislation;

III - Control analysis: analysis carried out, before delivery for consumption or beginning of manufacturing process, of raw materials and products pursuant to this Regulation, meant to prove their conformity with their standard of identity and quality, in compliance with the effective legal devices or with their respective registration at ANVISA;

IV - Authorization for shipment: authorization for importation of merchandise to be granted by ANVISA, subject to previous consent abroad for its shipment;

V - Sanitary authority: authority that is directly responsible, within its territory, for the application of appropriate sanitary measures in compliance with the Laws and Regulations in force in the national territory, as well as with treaties and other international acts to which Brazil is signatory;

VI - Luggage: for the purposes of this Regulation, the set of belongings of travelers that, in view of amount and frequency, does not reveal a commercial destination;

VII - Bioequivalence: demonstration of pharmaceutical equivalence between products presented under the same pharmaceutical form, containing identical qualitative and quantitative composition of active principle or active principles, and that have comparable bioavailability, when studied under the same experiment design;

VIII - Bioavailability: indicates the speed and the extension of absorption of an active principle in a dosage form, on the basis of its concentration/time curve in systemic circulation or its excretion in urine;

IX - Shipment Notice: Document issued by the transporter or consolidator, as part of the contract for international transport and proof of property of the merchandise for the importer (aerial transportation: Air Waybill (AWB), maritime transportation: Bill of Landing (BL) and road transportation: International Transportation Manifesto (CRT);

X - Quality control: set of procedures to check the quality of each batch of merchandise under sanitary surveillance, with a view to verifying their compliance with norms relating to activity, purity, effectiveness and security;

XI - Customs importation clearance: the final act of customs dispatch;

XII - Customs importation dispatch: fiscal procedure where the accuracy of the data stated by the importer regarding the imported merchandise is verified definitely or provisionally, as well as in relation to the documents presented and the pertinent legislation, with a view to customs clearance;

XIII - Advance dispatch: modality of customs dispatch of merchandise in which the importation declaration ID can be registered with the dispatch unit before the arrival of the merchandise;

XIV- Holder of the document of product regularization at ANVISA: designation of the holder of the registration, the file, the model authorization, or the notification of the product at ANVISA;

XV - Package: pack, container or any form of packing, removable or non-removable, intended to cover, to pack, to contain, to protect or to keep, specifically or not, the imported merchandise;

XVI - External Package: packaging used exclusively for protection of the merchandise during movement and storage operations;

XVII - Primary package: package that is in direct contact with the product and that may be a container, wrap or any another form of protection, removable or non-removable, that is intended to contain or to keep, to cover or to pack raw materials, semi-prepared products or finished products;

XVIII - Courier company: the company whose main activity is to render services of express door to door international transport of express dispatch to third parties, in at least three distinct continents, on a regular and continuous basis, both in importation and exportation.

XIX - International aerial order: merchandise subject to sanitary control in the form of order transported by airlines;

XX - Fractioned delivery: importation carried out by a single importer who, due to its volume or weight, cannot be transported in a single transporting vehicle or that, for commercial or technical reasons, cannot be transported in a single shipment;

XXI - Sanitary inspection -set of procedures focusing on analysis of administrative and technical documents and physical inspection of imported merchandise, in order to eliminate or prevent risks to human health, as well as intervening in sanitary problems derived from the environment, and the production and circulation of merchandise that directly or indirectly relate to public health;

XXII - Importation: introduction in a country of merchandise originating from another country;

XXIII - Importer: the natural person or legal entity responsible for the entry of merchandise from abroad into the national territory;

XXIV - Physical inspection - one of the instruments of sanitary inspection used to verify compliance with the requirements provided for in the sanitary legislation in force;

XXV - Importation licensing: required for merchandise subject to non-automatic licensing and applied for on-line by the importer or the importer's legal representative, through SISCOMEX (Importation Module);

XXVI - Place of entry: the port, airport or customs unit that has jurisdiction over the point of custom-bonded border arrival of the merchandise under sanitary surveillance in the Country;

XXVII - Place of clearance: custom-bonded premises where customs dispatch and clearance are carried out;

XXVIII - Free shop: store located in the primary zone of a port or airport, with the purpose of selling national or foreign merchandise to passengers on international trips, against payment in exchangeable foreign currency;

XXIX - Batch: amount of a product obtained in a production cycle with continuous stages and characterized by its homogeneity;

XXX - Diplomatic or consular mail: volume that contains:

a) diplomatic or consular documents, in any physical means;

b) material for official use by the representation of the accredited State, notably crested stationery, envelopes, stamps, seals, passport, decoration insignias;

c) objects and equipments for official use by the representation of the accredited State, notably communication and computer equipment, under secrecy protection or whose shipment and customs dispatch under the common importation or exportation regime may compromise security.

XXXI - Merchandise imported under sanitary surveillance: raw materials, inputs, finished products, products in bulk, semi-prepared products and in natura products, and the other merchandise under the sanitary surveillance regime pursuant to Law n. 9.782, of January 26, 1999, including, amongst others, the following classes of products and merchandise:

a) food: any substance or combination of substances, in solid, liquid, creamy state or any other appropriate form, intended to supply to the human organism the normal, essential elements for its formation, maintenance and development;

b) cosmetic: product used externally, intended to protect or beautify different parts of the body such as face powders, talcum, beauty creams, hand creams and similar products, face masks, beauty lotions, milky, creamy and astringent solutions, hand lotions, make-up foundation and cosmetic oils, rouges, blushes, lipsticks, lip liners, sun-blocking preparations, tanning preparations and suntan simulators, mascaras, eye shades and liners, hair dyes, hair bleaches, hair fixers, hair sprays, brilliantine and similar products, hair tonics, depilatories or epilatories, nail preparations and others;

c) perfume: product with aromatic composition containing natural or synthetic substances that, in appropriate concentration and media, have the main purpose of odorizing people or environments, including extracts, perfumed waters, creamy perfumes, bath preparations and environment odorizers, presented in liquid, gel, cream or solid form;

d) toiletries: external use products, with or without antiseptic properties, intended for grooming or body disinfection, including soaps, shampoos, tooth pastes, mouth washers, antiperspirants, deodorants, shaving and after-shave products , styptics and others;

e) home sanitizing product: substance or preparation intended for cleaning, disinfestation or disinfection of households, collective or public premises, in common use places and in water treatment, including: insecticide, pesticide, disinfectant, detergent and similar products and others;

f) product for diagnosis: reagents, standards, calipers, controls and materials, as well as instructions for their use, that contribute to qualitative or semi-quantitative determination of a biological sample and that are not intended to fulfill an anatomical, physical or therapeutic function, that is not to be ingested, injected or inoculated in human beings and that are used solely to provide information on samples obtained from the human organism.

g) health products: devices, instruments and accessories used in medical, odontologic and related activities, as well as in physical education, beautifying and esthetic correction.

h) used health product: a product that after being used, was not submitted to any process of reform or revision to restore it to the technical and operational conditions provided for when it was regularized at ANVISA;

i) refurbished health product: product that has already been used and has been submitted to a reform or revision process that may include substitution of components, parts and pieces, calibration, quality tests, re-sterilization or labeling, among other services necessary to restore the product to the technical and operational conditions provided for when it was regularized at ANVISA, under the express responsibility of the company that holds its registration;

j) medicine: any pharmaceutical product, technically obtained or prepared, with prophylactic, curative, palliative purpose or for diagnosis purposes;

l) garments: clothes and footwear for personal use, imported by means of international donation;

m) hospital garments: health products, such as clothes and other cotton or synthetic garments, to be used by patients and in medical-hospital premises;

n) artifacts made of textile and synthetic materials: curtains, blankets, sheets, pillow cases, cushions, etc., imported by means of international donation;

o) raw material: the active or inactive substance employed in the manufacture of medicines and other products pursuant to Law n. 6.360, of September 23, 1976;

p) alimentary raw material: any vegetal or animal substance, in raw state, that, in order to be used as food, undergoes treatment and or transformation of a physical, chemical or biological nature;

q) food product: any food derived from alimentary raw material or in natura food with or without the addition of other allowed substances, obtained through appropriate technological process;

r) ingredient: any substance, including food additives, used in the manufacture or preparation of a food and that remains in the final product, even if it is modified;

s) input: drug or ingredient of any nature, used in the manufacture of products and their recipients;

t) organs and tissues: of a human nature, including blood from umbilical cord, bone marrow, placenta blood, hair and nails.

XXXII- Movement of merchandise under sanitary surveillance: the practices of loading, unloading, transfer, transport and storage of imported merchandise in patios, buildings and other facilities of waterway terminals, organized ports, airports and custom-bonded premises;

XXXIII - Country of manufacture: the country where the product was produced or, in case it was developed in more than one country, the country where it received its last substantial transformation process;

XXXIV - Native country: the native country of the raw material(s) that compose the imported merchandise;

XXXV - Country of origin: the country where the imported merchandise are located at the moment of their acquisition and from whence they leave for Brazil, regardless of the native country and the place of final shipment;

XXXVI- Gross weight: the weight of the merchandise with all its containers, packings and other wraps;

XXXVII- Net weight: the weight of the merchandise free of any wrap or packing;

XXXVIII - Clinical research: individual or collective research involving human beings directly or indirectly, wholly or partially, including the handling of information and materials;

XXXIX- Scientific research: scientific research or inquiry that does use human beings as subjects;

XL -Finished product: product that undergoes all the phases of production and packing, ready for sale or delivery for consumption;

XLI - Bulk product: processed material in its final form, and that is only waiting to be packed or wrapped before becoming a final product, including injectables in their primary package, considered bulk products;

XLII - Product in natura : any food of vegetal or animal origin, whose immediate consumption requires only the removal of inedible parts and the treatments recommended for its perfect cleaning and conservation;

XLIII -Semi-prepared product: substance or combination of substances that requires later processes of production in establishments qualified by the sanitary authority, prior to its commercialization;

XLIV - Custom-bonded premises: are the following:

a) primary zone: free shops, patios, warehouses, terminals and other places meant for movement and storage of imported merchandise for merchandise for exportation that are to be moved and remain under customs control, as well as the areas reserved for verification of luggage going abroad or coming from abroad;

b) secondary zone: the warehouses, depots, terminals or other units meant for storage of merchandise under the conditions of the previous item, as well as the premises meant for deposit of international mail and express mail.

XLV - Special Customs Regimes: are the following:

a) Temporary Admission: allows the importation of merchandise that must remain in the Country for a fixed period of time, with suspension of taxes, in the form and conditions set forth by Decree n. 91.030/85 (Customs Regulation);

b) Drawback: allows the importation of merchandise(s) by a company that, through a commitment undertaken in specific documentation (Concessionary Drawback Deed), proves or comes to prove the exportation of product (s) that has undergone, in the Country, some type of industrial improvement or aggregation of value, with suspension, exemption or restitution of taxes, provided the criteria established in proper legislation are fulfilled, allowed and controlled by the Federal Revenue Secretariat/Ministry of Finance and by the Foreign Trade Secretariat/MDIC.

c) Customs Warehouse in importation: allows the storage of merchandise, in a designated place, with suspension of taxes and under fiscal control of the Federal Revenue Secretariat/MF, provided the criteria established in proper legislation are fulfilled.

XLVI - International Mail Shipment: merchandise under sanitary surveillance transported by means of international order by the Brazilian Mail and Telegraph Company- ECT;

XLVII - Express shipment: document or international order aerially transported by courier company, requiring speed in the transfer and immediate delivery to the addressee;

XLVIII - Person in charge: legally qualified professional, with registration at professional entity, responsible for the activities described in article 2 of Law n. 6.360, of September 23, 1976 and article 45 of Decree n. 986, of October 21, 1969, or for the technology of the final product.

XLIX - Label: printed or lithographed identification, as well as words painted or imprinted by fire fire, pressure, tag or copy, applied directly on containers, packings, packs, wraps, cartridges or any another protector of internal or external package;

L - Public custom-bonded terminals: facilities intended for rendering public services of movement and storage of merchandise that is under customs control, not located in port or airport areas.

a) Border Customs Stations (BCS): situated in primary zone of custom-bonded border point or adjacent area.

1. adjacent area is that located in the municipality where the border point is located.

b) Retroportuary Custom-bonded Terminals (RCT): located in zones adjacent to organized port or port installation, custom-bonded.

2. adjacent area is located in the perimeter of five kilometers of the limits of the primary zones marked out by the local customs authority.

c) Inland Customs Stations (ICS) or Dry Ports: located in secondary zone.

LI - Customs transit: the regime that allows the transport of merchandise, under customs control, from one point to another of the customs territory, that is, from the place of entry of the merchandise to the place of clearance.

LII - Sanitary surveillance: the set of actions capable of eliminating, diminishing or preventing risks to health and intervening in the sanitary problems resulting from the environment, the production and circulation of goods and the rendering of services of interest to health, including:

a) control of consumption goods that are directly or indirectly related to health, including all the stages and processes, from production to consumption; and

b) control of the rendering of services related directly or indirectly to health;

TITLE II

PETITION FOR SANITARY INSPECTION AND SANITARY CLEARANCE OF MERCHANDISE IMPORTED UNDER SANITARY SURVEILLANCE

Article2. The petitions of companies involved with sanitary inspection and clearance of imported merchandise pursuant to this Regulation shall be made through on-line petitioning or petitioning not regulated by ANVISA.

TITLE III
IMPORTATION OF MERCHANDISE UNDER SANITARY SURVEILLANCE

CHAPTER I
GENERAL PROVISIONS

Article3. The imported merchandise subject to sanitary surveillance pursuant to this Regulation shall only be cleared for its intended purpose as well as for display or delivery for human consumption in the national territory after meeting the sanitary requirements set forth in this technical norm and in other sanitary legislations in force, involved with sanitary prevention and control of inputs, raw materials and classes and categories of products.

Only paragraph. The merchandise, upon arrival in the national territory, submitted to control or fiscal analysis, shall only be cleared for display or human consumption after satisfactory laboratory evaluation.

Article 4. It is forbidden the importation and entry in the national territory of products belonging to the classes of medicines, foods, cosmetics, toiletries, perfumes, home sanitizing products and products for diagnosis, n the form of finished product, ready for consumption, in bulk and semi-prepared, meant for trade or industry, that is not regularized at the National Sanitary Surveillance System regarding, when fitting, obligatory registration, notification, file, authorization of model, registration exemption, or any another form of control regulated by the Brazilian Sanitary Surveillance Agency.

Only paragraph. The situations provided for in this Regulation are excluded from the provision above.

Article 5. Merchandise imported under sanitary surveillance belonging to the classes medicines, foods, perfumes, cosmetics, toiletries, home sanitizing products, health products and products for diagnosis, shall be presented, upon arrival in the national territory:

I- in compliance with the standards of identity and quality required by the pertinent sanitary legislation;

II- within the period of validity and the expectation of consumption in the national territory;

III- with identified external package.

Paragraph1. Imported raw materials and inputs that are used in the manufacturing of these classes of products are subject to the provisions of this article.

Article 6. The following information must be displayed on the external package of each volume of merchandise imported under sanitary surveillance:

I- corporate name, when the product in question is a finished product or in bulk, and in the case of importation of product, belonging to the class of medicine, the name of the base active principle of the formula must be displayed;

II- common, technical or chemical name of the merchandise, when the product in question is an input or substance intended for the industry of medicines, cosmetics, perfumes, foods, toiletries, home sanitizing products and products for diagnosis;

III- name of the alimentary raw material, in the case of foods;

IV- number or code of the batch(s) or batch(es) of production of the packaged merchandise(s);

V- name of the manufacturer;

VI- special procedures for storage (temperature, humidity, luminosity and others), when appropriate.

Paragraph 1. The following are excluded from the requirements set forth in this article:

I- imported merchandise, belonging to the class of health products, that must be presented for sanitary inspection with the information of the label and marking on the product provided for in the pertinent sanitary legislation and in compliance with the information approved upon the product's registration or filing at ANVISA;

II- the imported merchandise whose requirement of inscription of obligatory information on the external package shall be regulated in specific sanitary legislation;

Paragraph 2. The external package of products imported under semi-prepared form must display the trade name of the product to which the imported merchandise will give origin.

Paragraph 3. The importing companies shall be granted a period of sixty days as from the date that this Regulation enters into force to fulfill the requirements pursuant to this article, set forth in numerals IV, V and VI, as well as in paragraph 2.

Article 7. The garments, artifacts made of textile or synthetic materials and hospital clothes, imported by means of donations to public or private legal entities, must, upon arrival in the national territory, be protected by identified external package.

Paragraph 1. The external package of the merchandise pursuant to this article shall display information referring to:

I- nature of the garments of personal use or hospital use;
II-identification of the native country,
III country and city of origin;
IV identification of the addressee;
V-condition of the merchandise, specifying whether it is new, used or refurbished, in the case of health products.

Paragraph 2. The importing companies shall be granted a period of ninety days as from the date that this Regulation enters into force to fulfill the requirements set forth in this article.

Article 8. Authorization shall not be granted to the entry in the national territory of finished products, raw materials, inputs, semi-prepared products or products under sanitary surveillance, imported products with industrial or commercial purpose, or intended for distribution in fairs and events, market research and international donation, whose validity is to expire within thirty days after its sanitary clearance.

Paragraph1. Merchandise whose validity period is inferior to thirty days, as defined upon regularization at the competent organ of ANVISA, is excluded from the provisions set forth in this paragraph;

Paragraph2. Exceptions to the provisions set forth in this article shall be analyzed by the competent technical areas of ANVISA, in Brasilia.

CHAPTER II
TYPES OF IMPORTATION

Section I
INTEGRATED FOREIGN TRADE SYSTEM / SISCOMEX -IMPORTATION MODULE

Article 9. Registration with the Integrated Foreign Trade System / SISCOMEX -Importation Module, is required for importations of merchandise under sanitary surveillance pursuant to this Regulation, intended for:

I- industry or trade of products submitted to the sanitary surveillance regime;

II- display, demonstration or distribution in fairs and or events;

III- clinical research;

IV- scientific research, when appropriate;

V- laboratory assays, diagnosis or experiments;

VI- approval of registration at ANVISA, qualification tests of equipment, market research or laboratory assay for quality control;

VII- donation of products under sanitary surveillance, garments, hospital clothes and artifacts made of textile or synthetic materials, imported by legal entity;

VII- natural person or legal entity, with a view to rendering services to third parties;

IX- individual use by natural person when its amount and or frequency do not indicate commercial destination, when appropriate;

X- replacement of infirmary, pharmacy or medical onboard set or rendering of services in Brazilian flag vessels or foreign flag vessels, provided they are chartered or leased to a Brazilian company;

XI- replacement of pharmacy or medical onboard set or rendering of services on aircrafts and land vehicles that undertake collective transport of passengers linked to a Brazilian company.

Only paragraph. Any importation purpose not provided for in this article must comply with the provisions set forth in paragraph1 of article 10 of this Regulation.

Article 10. The importation of merchandise under sanitary surveillance pursuant to this Regulation, subject to SISCOMEX non-automatic licensing, intended for public or private legal entity is forbidden, without the previous and express favorable manifestation of ANVISA.

Paragraph 1. The importation of merchandise subject to SISCOMEX non-automatic licensing pursuant to this article, arranged in Common MERCOSUL Nomenclature - NCM in Table I, of Annex I, of this Regulation, must comply with the administrative procedures and the document requirements of the aforementioned Annex.

Paragraph 2. The procedures of this Regulation related to importations by means of international donation and the ones intended for laboratory clinical diagnosis and scientific research are excluded from the provisions set forth in the previous paragraph.

Paragraph 3. The importer of merchandise under sanitary surveillance pursuant to this Section is obliged to register, in the fields of the SISCOMEX Supplier's Form, the information related to the manufacturer and the exporter.

Paragraph 4. The importer of health product is obliged to register in the fields of the SISCOMEX merchandise form information referring to:

I- identification of the product, name and commercial model, as well as of parts and accessories that accompany it;

II- condition of the product: new, used or refurbished.

Paragraph 5. Authorization for loading or granting of importation licensing shall not be given to the importation whose merchandise included in the administrative procedures set forth in Annex I, of this Regulation, does not meet the sanitary requirements set forth in this Regulation or other sanitary statutes in force relating to the classes and categories of products, raw materials or inputs.

Paragraph 6. The natural person or legal entity that imports merchandise under sanitary surveillance must present to the competent sanitary authority of ANVISA the request for sanitary inspection and clearance of the importation, by means of petition, pursuant to article 2 of this Regulation, accompanied by the required documentation.

Article11. The registration of the importation licensing must be made by the importer or its qualified legal representative, by means of the Integrated Foreign Trade System - SISCOMEX - Importation Module.

Only paragraph. The importer must comply with the table Administrative Treatment, which defines the NCM and the NCM highlights referring to merchandise subject to ANVISA's consent of ANVISA and the other relative legal provisions relating to legal proceduring of foreign trade and customs.

Article12. The inspection of the merchandise under sanitary surveillance pursuant to this Section shall be carried out prior to customs clearance and its delivery for the purpose of display or human consumption.

Article13. The importation license of the imported merchandise shall be granted after the importer fulfills the administrative and sanitary requirements provided for in this Regulation.

Section II

EXPRESS SHIPMENT, POSTAL SHIPMENT AND INTERNATIONAL AERIAL ORDER

Article14. The importation by means of express shipment, postal shipment or international aerial order, of merchandise under sanitary surveillance addressed to natural person or public or private legal entity is subject to the prescribed requirements related to these types of importation, determined by the competent public authority, and to sanitary inspection prior to customs clearance and delivery for the purpose of display or human consumption.

Article15. The importer of merchandise under sanitary surveillance or the company of express shipment, postal shipment or international aerial order that represents the importer must present to the competent sanitary authority of ANVISA the request for inspection and sanitary clearance of the importation, by means of the petition pursuant to article 2 of this Regulation, accompanied, when appropriate, by the following documents:

I- bill of landing;
II- proof of payment of the corresponding sanitary inspection fee, when appropriate;
III- complete listing of the imported merchandise;
IV-document of importation registration.

Section III

SIMPLIFIED DECLARATION OF NON-ELECTRONIC IMPORTATION - DSI

Article16. The importation of merchandise under sanitary surveillance, intended for natural person or public or private legal entity, whose customs clearance is obtained through Simplified Importation Declaration - not electronically, is subject to the prescribed requirements related to this type of clearance, determined by the competent public authority, and to sanitary inspection of the merchandise prior to clearance and delivery for display or human consumption.

Paragraph 1: The importer of merchandise pursuant to this article must present to the sanitary authority of ANVISA, in charge at the place of clearance of the merchandise in the national territory, the request for inspection and sanitary clearance of the importation, through the petition pursuant to article 2 of this Regulation, accompanied by the following documents:

I- bill of landing;
II- proof of payment of the corresponding sanitary inspection fee, when appropriate;
III- complete listing of the imported merchandise;
IV- copy of the DSI.

Paragraph 2. It is recommended that the importation of corneas, fluids, other human tissues or organs, intended for transplant in human beings in the national territory, should be carried out with the Simplified Importation Declaration - non-electronic.

Section IV
PERSONAL LUGGAGE

Article17. The sanitary inspection of finished products belonging to the classes of medicines, foods, health products, products for diagnosis, cosmetics, perfumes, toiletries and home sanitizing products, originating from abroad, carried by natural person, by means of personal luggage, shall comply with the provisions set forth in this Regulation, at the entry point in the national territory.

Paragraph 1. The importation, by a natural person, of merchandise under sanitary surveillance pursuant to this article, deprived of characteristics as of personal or individual use, shall not be authorized to enter the national territory.

Paragraph 2. The entry, in the national territory, of products forbidden under sanitary surveillance, carried by a natural person, by means of personal luggage, is hereby forbidden.

TITLE IV

SANITARY CONTROL

CHAPTER I

GENERAL PROVISIONS

SECTION I

STORAGE CONDITIONS

Article18. The entry in the national territory of merchandise imported under sanitary surveillance, carried, moved or stored in ambient conditions that fail to meet the technical specifications recommended by the manufacturer or the exporter, or with the specifications approved when the said merchandise was regularized with the National Sanitary Surveillance System, shall be hindered, with a view to maintaining its quality or integrity.

Paragraph 1. In compliance with the provisions set forth in this article, in the case of importation through SISCOMEX, the importation licensing shall be rejected when any irregularity is found.

Paragraph 2. In compliance with the provisions set forth this article, the importation of merchandise under sanitary surveillance not included by SISCOMEX shall have its sanitary clearance denied, in appropriate importation document.

Paragraph 3. The local office of the Federal Revenue Secretariat of the Ministry of Finance and the company managing the custom-bonded terminal, must be officiated and notified, respectively, about the finding of irregularities, about the sanitary non-authorization for entry of the merchandise in the national territory and about the need to consult the sanitary authority on the future movement or destination of the merchandise.

Section II

IMPORTED MERCHANDISE UNFIT FOR DISPLAY OR HUMAN CONSUMPTION

Article19. The merchandise imported under sanitary surveillance that does not meet the pertinent sanitary regulations, when unfit for display or human consumption, shall have its methods of treatment and final disposal, related to the proposal for its destruction, evaluated by the local office of the Federal Revenue of the Ministry of Finance, involved in the importation, by the local office responsible for environmental control and by the sanitary authority of ANVISA, in operation in the federate unit where the merchandise is apprehended and interdicted.

Paragraph 1. Included in the provisions set forth in this article is the proposal of destruction of merchandise under sanitary surveillance, without intervening of the sanitary authority in the importation, that pose potential risk factors to individual or collective health.

Paragraph 2. The technical intermediate and final procedures related to the destruction of the imported merchandise must take place in the presence of the sanitary authority in operation in the federate unit(s) where the procedure(s) are to be carried out.

Article20. It belongs to the importer to defray the expenditures related to the destruction of merchandise imported under sanitary surveillance that is unfit for display or human consumption.

Only paragraph. The destruction of merchandise segregated in the development of the action of sanitary inspection of international donations is included in the provisions set forth in this article.

Article21. Sanitary clearance of imported merchandise pursuant to this Regulation is forbidden when damage is found on its package that jeopardizes its integrity.

Section III

APPREHENSION, INTERDICTION AND CUSTODY OF MERCHANDISE WITH SANITARY IRREGULARITY.

Article22. Any merchandise under sanitary surveillance imported by a natural person, by means of personal luggage, that does not comply with the provisions set forth in this Regulation, upon its arrival in the national territory, shall be apprehended and kept under custody of the sanitary administration exclusively promoting the fiscal deed

Only paragraph. In case of joint filing with the customs authority, the latter may promote the custody of the merchandise, the pertinent legal terms being entered by the sanitary authority that participates in the filing.

Article23. The importation of merchandise under sanitary surveillance submitted to inspection or control analysis for the purpose of fulfilling the sanitary inspection program or due to suspected damage to its integrity, may be granted the SISCOMEX importation licensing and its exit from the custom-bonded area may be authorized, by means of acceptance of the Term of Custody and Responsibility and the condition, registered in the field referring to the text of the status of the Importation license: "Merchandise under sanitary pendency. Clearance for public display or human consumption shall be granted upon express manifestation of the sanitary authority ".

Paragraph 1. The importation of merchandise under sanitary surveillance submitted to inspection or control analysis, and subject to an importation registration different from SISCOMEX, may be authorized to leave the custom-bonded area, by means of acceptance of the Term of Custody and Responsibility and inscription in appropriate importation document, of the condition: "Merchandise under sanitary pendency. Clearance for public display or human consumption shall be granted upon express manifestation of the sanitary authority ".

Paragraph 2. The acceptance of the Term of Custody and Responsibility is conditioned to storage in establishment that holds a sanitary license or official document that stands for it, issued by the competent sanitary authority of the State, Municipality or the Federal District and, when appropriate, to the holder of the Operation Permit or Special Operation Permit for the activity of storage of the intended class of product.

Paragraph 3. The apprehension of samples for inspection or control analysis shall not be followed by entering of the term of interdiction for the batch or production shipment of the imported merchandise.

Article24. The imported merchandise under sanitary surveillance that does not comply with its approved registration, file, model authorization or notification at ANVISA, with clear evidence of alteration, adulteration, or that fails to comply with this Regulation or other pertinent sanitary regulations, shall be submitted to interdiction of a preventive nature or to writ of prevention.

Only paragraph. The interdiction of the merchandise imported under sanitary surveillance, as writ of prevention, shall last as long as necessary for the accomplishment of new tests, proofs, analyses or other required steps, and cannot, in any case, exceed the period of time set forth in pertinent sanitary legislation, after which the merchandise shall be automatically cleared;

Section IV

IMPORTATION OF MERCHANDISE BY COMPANY WITHOUT DOCUMENT OF REGULARIZATION OF THE PRODUCT AT ANVISA

Article25. The importation of merchandise under sanitary surveillance by an importing company without document of regularization of the product at ANVISA may be authorized, by means of presentation to the competent sanitary authority, of a declaration of the company that holds a regularization document , granting the authorization for the importation to proceed.

Paragraph 1. The declaration pursuant to this article shall:

I- be presented in its original form;
II- be linked to a single importation licensing, which must be included in the declaration;
III- be linked to a single and exclusive legal entity, the transfer of this authorization not being allowed;
IV- be signed by the legal representative and the technician in charge of the company that holds the document of regularization of the product at ANVISA.

Paragraph 2. The document pursuant to the previous paragraph shall have the signatures of its subscribers authenticated.

Paragraph 3. The declaration pursuant to this article shall be included in the set of importation documents.

Paragraph 4. The company which was granted authorization by the holder of the document of regularization of the product at ANVISA, in order to import merchandise belonging to the classes of medicine, perfumes, home sanitizing products, toiletries, cosmetics, health products and products for diagnosis, must have an operation permit for importing activity.

Paragraph 5. The company which is granted the authorization by the holder of the registration to import foods must comply with the provisions set forth in Title VI, of this Regulation.

Section V

LABEL OF FINISHED PRODUCT IMPORTED FOR COMMERCIAL PURPOSES

Article26. The importer is allowed to label, in the national territory, the imported finished product, regularized vis-à-vis the National Sanitary Surveillance System.

Paragraph 1. The imported finished product, labeled in a foreign language, upon its entry in the national territory, must present on the label of its package (primary or secondary) the following information:

I- corporate name, in use abroad;
II- name of the manufacturer;
III- number of the batch or shipment;
IV- date of manufacture;
V- date of expiry, when appropriate.

Paragraph 2. In order to fulfill the provisions set forth in this article, the sanitary authority may demand the presentation of a certified translation to Portuguese of the foreign language label of the imported merchandise.

Paragraph 3. In the case of absence, on the label in foreign language of an imported product belonging to the class of cosmetics, perfumes and toiletries, of the information pursuant to numeral IV o paragraph 1 of this article, the importer is obliged to provide a declaration to the sanitary authority in operation at the place of clearance of the merchandise in the national territory, informing the date of manufacture of the batch or shipment for each imported product .

Paragraph 4. The importation of merchandise belonging to the cosmetic, perfumes and toiletries classes is not required to comply with the provisions set forth in numeral V of paragraph 1 of this article.

Article27. The importation of a finished product pursuant to this Section, regularized at the Sanitary Surveillance System, with its label in Portuguese in disagreement with the provisions in the sanitary legislation, may be granted the SISCOMEX importation licensing and its exit from the custom- bonded area authorized, by means of acceptance of the Term of Custody and Responsibility and the condition, registered in the field referring to the text of the status of the importation licensing: "Merchandise under sanitary pendency. Clearance for public display or human consumption shall be granted by means of express manifestation of the sanitary authority ".

Article28. The finished product pursuant to articles 26 and 27, when displayed or delivered for consumption, must be labeled and display on its label the information approved by the competent sanitary authority at the time of its regularization at the National Sanitary Surveillance System.

Section VII

RAW MATERIAL IMPORTATION OR PRODUCT WITH IRREGULARITY IN THE CERTIFICATE OF QUALITY CONTROL

Article29. Any imported raw material or product under sanitary surveillance whose Certificate of Quality Control per batch or shipment required in this Regulation presents unsatisfactory analytical result(s) or that presents information registrations different from those in the importation documentation presented, shall have its SISCOMEX importation licensing rejected and submitted to interdiction in the custom-bonded premises.

Section VIII

IMPORTATION OF MERCHANDISE IN INTERMEDIATE STAGES OF PRODUCTION PROCESS

Article30. The imported merchandise under sanitary belonging to the class of medicines, at an intermediate stage of its process of production or manufacture (semi-prepared and in bulk), must be submitted, in the national territory, to laboratory assays necessary to prove the quality of the finished product.

Paragraph 1. The importation pursuant to this article may be granted the SISCOMEX importation licensing and be authorized to exit the custom-bonded area, by means of acceptance of the Term of Custody and Responsibility and the condition, registered in the field referring to the text of the status of the importation licensing: "Merchandise under sanitary pendency. Clearance for public display or human consumption shall be granted by means of express manifestation of the sanitary authority ".

Paragraph 2. The sanitary authority shall notify the importer as to the obligation to present the Certificate of Quality Control of the finished product.

Paragraph 3. Amounts of imported merchandise under the Term of Custody and Responsibility pursuant to paragraph 1 of this article may be withdrawn, for the exclusive purpose of laboratory analysis,

Paragraph 4. The importer that complies with the previous paragraph must keep records of the number of units withdrawn for the purpose of laboratory analysis.

Paragraph 5. The importer shall present to the sanitary authority the Certificate of Quality Control of the finished product, signed by the company's technician in charge, correlating the analytical results with the batch identified in the sanitary inspection of the merchandise, in the national territory.

Paragraph 6. The sanitary clearance of the finished product shall take place upon conclusive and satisfactory laboratory finding.

Article31. The imported merchandise under sanitary surveillance, belonging to the classes of foods, perfumes, cosmetics or toiletries, sanitizing products, at intermediate stage of its process of production or manufacture (semi-prepared product and in bulk), must be submitted, in the national territory, to the laboratory assays necessary to prove the quality of the finished product.

Only paragraph. It belongs to the competent sanitary authority of the State, Municipality or Federal District that is part of the National Sanitary Surveillance System to undertake the sanitary inspection with a view to verifying compliance with the provisions set forth in this article.

Section IX

CLEARANCE OF MERCHANDISE UNDER SANITARY PENDENCY

Article32. The clearance from the obligations derived from the Term of Custody and Responsibility shall be granted by the competent sanitary authority in the Federate Unit where the merchandise is stored, by means of the clearance authorization, in the proper legal term, identified by sequential numbering of the executing Coordination of Ports, Airports and Border, date of clearance, names of the inspection agents, registration number and agency that the agents are linked to, and signature of the agents involved in the clearance of the merchandise.

CHAPTER II

SPECIFIC PROVISIONS

Section I

INTERNATIONAL DONATION

Article33. The international donation of medicines, foods, perfumes, cosmetics, toiletries and home sanitizing products, products for diagnosis, health products, garments and artifacts made of textile or synthetic materials, intended for a public or private legal entity must be submitted to express and favorable manifestation of the competent sanitary authority of ANVISA.

Paragraph 1. The public or private legal entity, addressee of international donation of medicines, foods, perfumes, cosmetics, toiletries and home sanitizing products, products for diagnosis, health products, used garments of personal use and used artifacts made of textile and synthetic materials, must, prior to the shipment of the merchandise abroad, submit to SISCOMEX registration of importation licensing and request to the competent sanitary authority of ANVISA, in Brasilia, its consent, through, pursuant to article 2 of this Regulation, together with the documentation pursuant to Annex II.

Paragraph 2. The international donation of merchandise belonging to the classes of medicines, health products, products for diagnosis, foods, toiletries, home sanitizing products not regularized at ANVISA, intended for public or private legal entity, must be analyzed prior to its shipment from abroad, by the competent technical area of ANVISA, in Brasilia.

Paragraph 3. The legal entity receiving exclusive international donation of used garments for personal use and used artifacts made of textile and synthetic materials is not obliged to request to the sanitary authority the authorization of shipment of the merchandise from abroad; it must submit to registration of the appropriate SISCOMEX importation licensing and request to the competent sanitary authority of ANVISA, in operation at the place where the customs clearance shall take place, its consent, by means of petition, pursuant to article 2 of this Regulation, together with the documentation pursuant to Annex II.

Paragraph 4. The importation of classes of products subject to registration, model or file authorization, by a interested party that does not hold the document of regularization of the product at ANVISA, must meet the provisions set forth in Section IV, of Chapter I, of Title IV, of this Regulation.

Paragraph 5. The international donation of merchandise pursuant to this article, as regards quality and amount, must not compromise the execution of national health programs in force.

Paragraph 6. Damage to the execution of national health programs shall imply in refusal of the importation licensing and in the sanitary non-clearance of the said merchandise for the purpose of display and human consumption.

Article34. The used garments and artifacts made of textile and synthetic materials must be clean and sanitized upon arrival in the national territory,.

Paragraph 1. At the discretion of the sanitary authority, it may authorize the cleaning and sanitizing procedures to be carried out in the national territory, provided they take place in establishments that are meant for the proposed purpose, and the SISCOMEX importation licensing, may be granted, and the merchandise may be authorized to leave the custom-bonded premises, by means of acceptance of the Term of Custody and Responsibility with the condition, registered in the field referring to the text of the status of the importation licensing: "Merchandise under sanitary pendency. Clearance for public display or human consumption, shall be granted by means of express manifestation of the sanitary authority ".

Paragraph 2. The importer of the merchandise pursuant to this article must present to the notifying sanitary authority documentation proving the rendering of the services, with description of the methodology employed and products used, issued by the executing company.

Paragraph 3. The sanitary clearance of the merchandise pursuant to this article for display and delivery for human consumption shall only occur after the sanitary requirements are met.

Article35. The importation licensing and the sanitary clearance of the importations pursuant to paragraphs 1 and 2 of article 33 shall be granted by the competent sanitary authority in operation at the place where the customs clearance is to occur, after the sanitary inspection and fulfillment of the requirements set forth in this Regulation.

Article36. The finding, during the development of the sanitary inspection of imported merchandise pursuant to article 33, of irregularities related to inclusion of merchandise not informed by the importer in the petition for authorization for shipment from abroad, shall imply in preventive segregation and interdiction of the surplus merchandise.

Article37. The importation, by means of international donation, of used health products, including used hospital garments, is forbidden.

Article38. The international donation of health products intended for public or private legal entity must comply with the sanitary requirements set forth in the pertinent legislation.

Section II

NATURAL PERSON

Article39. The importation, by natural persons, of finished products belonging to the classes of medicines, foods, perfumes, cosmetics, toiletries, home sanitizing products, products for diagnosis and health products, shall not require authorization for shipment from abroad, provided their amount and frequency do not indicate commercial destination or rendering of services.

Paragraph 1. The merchandise pursuant to this article, upon its arrival in the national territory, shall be subject to sanitary inspection.

Paragraph 2. In an emergency or temporarily, considered the international human, animal or vegetal epidemiological context, or the need to serve special public health programs that involve sanitary control of classes of products, manufacturers, exporters or transporters, the sanitary authority may prevent the entry of merchandise pursuant to this article in the national territory.

Article40. The importation, by a natural person, of medicines, foods for continuous or nutritional use, as well as reagents for the purpose of diagnosis and health products, meant for individual use or use by the importer, shall be cleared by means of presentation to the sanitary authority, of the prescription issued by a competent professional.

Paragraph 1. Medicines not requiring medical prescription in the national territory are excluded from the provisions set forth in this article, in compliance with the pertinent sanitary legislation.

Paragraph 2.The prescription pursuant to this article must contain information referring to the dosage or instructions for use and period of use.

Paragraph 3. The prescription pursuant to this article, when issued by a Brazilian professional, must contain information referring to the Natural Person Register (CPF) of the competent professional and number of registration and identification of the respective Professional Council to which the professional s linked.

Paragraph 4. In the case of presentation of prescription in a foreign language, at the discretion of the sanitary authority in operation at the place of clearance of the merchandise, a certified translation may be required.

Paragraph 5. In the case of importation of medicine under special control regime, disciplined by Administrative Order SVS/MS nº. 344/98 and its updates, in compliance with the period of time determined in the said Administrative Order, it must be presented, in addition to the medical prescription, the fiscal document prong acquisition of the medicine abroad to the sanitary authority in operation in the place of entry in the national territory.

Article 41. The amount of merchandise belonging to the class of medicine or food for continuous or nutritional use, imported by a natural person, must be in accordance with the prescription of the respective professional, and must be compatible with the period of treatment, recommended dosage and pharmaceutical form or physical form recommended in the presentation of the product.

Article42. The importation of medicine not subject to special control, food or products for diagnosis for continuous or nutritional use, meant for individual use or use by natural person, intermediated by a legal entity that purchases the product abroad, is subject to sanitary inspection prior to delivery of the merchandise to the addressee, for the purpose of verification of the sanitary requirements contained in this Regulation.

Section III

FREE SHOP

Article43. The merchandise, under sanitary surveillance, displayed for sale in a free shop, is exempt from registration at ANVISA, and must be within its period of validity and in conditions of use that do not pose risk to human health, throughout its storage and commercial display period.

Article44. The merchandise under sanitary surveillance, displayed for sale in a free shop, must be in ambient conditions that guarantee the maintenance of its integrity.

Article45. In compliance with sanitary inspection or epidemiologist inquiry programs, the merchandise displayed in a free shop may be subjected to laboratory analysis with a view to verifying its quality.

Article46. The free shop that operates activities of importation and storage of health products, cosmetics, perfumes, toiletries, home sanitizing products, and products for diagnosis must hold the operation permit issued by the competent area of ANVISA, for each activity and class of products.

Article47. The free shop that operates the activities of storage must comply with the provisions set forth in the pertinent sanitary legislation, related to Good Storage Practices of finished products under sanitary surveillance.

Article48. The company with free shop operation permit must keep, and present to the sanitary authority of ANVISA upon request, an updated list of the merchandise under sanitary surveillance that is commercialized, informing the class of the commercialized product, corporate name, number of batch or shipment, name of the manufacturer, number of commercialized units and identification of the travelers that have purchased the products.

Section IV

MERCHANDISE FOR THE PURPOSE OF REPLENISHING INFIRMARY, PHARMACY OR MEDICAL FACILITIES ONBOARD AND RENDERING OF SERVICES IN VESSELS, AIRCRAFT AND LAND VEHICLES THAT OPERATE INTERNATIONAL COLLECTIVE TRANSPORT OF PASSENGERS

Article 49. The importation of finished products belonging to the classes of medicines, health products and products for diagnosis, for replenishing infirmary, pharmacy or medical onboard facilities of land vehicles, vessels and aircraft, that operate international collective transport of passengers, must be submitted to the express and favorable manifestation of the competent sanitary authority of ANVISA.

Article 50. The importation of finished products, belonging to the classes of medicines, health products and products for diagnosis for replenishing infirmary, pharmacy or medical onboard facilities of Brazilian flag vessels or foreign flag vessels, under freightage of Brazilian company or on aircraft belonging to the fleet of a Brazilian company, must obtain approval from the competent technical area of ANVISA, in Brasilia, prior to its authorization of shipment from abroad being granted by the sanitary authority in operation at the place of clearance of the merchandise.

Paragraph 1. The importation of merchandise included in Procedures 1, 1A, 2, 2A and 3 of Annex I of this Regulation, whose authorization for shipment from abroad shall be granted by the competent sanitary authority of ANVISA, in Brasilia is excluded from the provisions set forth in this article;

Paragraph 2. The importation pursuant to this article shall take place through SISCOMEX, and the importer must request the consent of the competent sanitary authority of ANVISA, by means of the petition pursuant to article 2 of this Regulation.

Article 51. The entry of finished products, belonging to the classes of medicines, health products and products for diagnosis, for replenishing infirmary, pharmacy or medical onboard facilities of foreign flag vessels in transit in the national territory, or of aircraft and land vehicles that to operate international collective transport of passengers, that belong to the fleet of a foreign company, shall take place through appropriate document of importation registration, in compliance with the prescribed norms, issued by the competent authority, with approval from the competent technical area of ANVISA in Brasilia, prior to the sanitary inspection and clearance to be granted by the sanitary authority in operation at the place of entry of the merchandise.

Only paragraph. In order to comply with the provisions set forth in this article, the interested party must request the inspection and clearance of the product to the sanitary authority in operation at the place of clearance of the merchandise, by means of the petition pursuant to article 2 of this Regulation; together with, in the case of vessels and aircraft, of:

I - copy, signed by the legal representative of the company responsible for the entry of the merchandise in the national territory, of the official list of medicines and health products that shall replenish the infirmary, pharmacy or medical onboard facility, regulated by the competent authority of the country of the vessel's flag, or the country to which the airline is linked;

II - declaration, signed by the legal representative of the importing transport company, including the following information:

a) non-utilization of the merchandise for another purpose;
b) identification of the means of transport, addressee of the merchandise, name or prefix;
c) name of the transport company;
d) country of the vessel's flag or country to which the airline is linked;
e) name of the port or the airport installed in the national territory where the supplying of the edge pharmacy shall occur.

Article 52. The products that they deal with articles 50 and 51 must submit it the obligator sanitary inspection.

Article 53. The conclusion of the sanitary inspection of the importation of the products that they deal with articles 50 and 51 shall be given for intermediary of the sanitary authority in operation, at the place of clearance of the merchandise.

Article 54. The clearance of medicines with a base of narcotic, psychotropic and precursor substances, provided for in Administrative Order SVS/MS n. 344/98 and its updates, pursuant to articles 50 and 51, must take place at the entry points, in the national territory, authorized in pertinent Sanitary Regulation.

Article 55. The sanitary control of the importation of finished products, belonging to the classes of products of toiletries, home sanitizing products or foods, intended for onboard consumption, on vessels, aircraft and land vehicles that operate international collective transport of passengers, shall be carried out through appropriate document of importation registration, in compliance with prescribed norms issued by the competent authority, which must be analyzed by the competent sanitary authority of ANVISA in operation at the place of clearance, by means of the presentation, by the importer, of request for sanitary inspection and clearance of the importation, through petition pursuant to article 2 of this Regulation.

Article 56. The merchandise pursuant to this Section must be of exclusive use and meant for internal consumption on the means of transport, its use or display being forbidden in physical passenger transit areas and other premises at port and airport terminals and border stations and passages.

Article 57. The merchandise under sanitary surveillance pursuant to this Section is not obliged to present registration file, model authorization or ANVISA notification.

Section V

USED AND REFURBISHED HEALTH PRODUCTS

Article 58. The importation of used health products is forbidden.

Article 59. The importation of refurbished health products, when meant for sale, shall undergo the administrative treatment set forth in Procedure 4 of Annex I of this Regulation.

Article 60. The importation of health products refurbished by a company tha does not posses registration, model authorization or file at ANVISA must comply with provisions se forth in Section IV, Chapter I, Title IV.

Article 61. The importation of components of health products must comply with pertinent sanitary legislation.

Section VI

CLINICAL RESEARCH

Article 62. The importer of drugs, medicines, vaccines, health products, products for diagnosis, cosmetics and foods, meant for clinical research, must, prior to shipment of the merchandise from abroad, submit the SISCOMEX registration of importation licensing to the competent sanitary authority of ANVISA in Brasilia by means of the petition pursuant to article 2 of this Regulation.

Only paragraph. The importer, when requested to present the shipment authorization for the SISCOMEX importation licensing, must provide to the sanitary authority of ANVISA, in Brasilia, the information required in pertinent sanitary legislation.

Article 63. The importation pursuant to this Section must be submitted to the obligatory sanitary inspection, and its granting and sanitary clearance shall be granted by the competent sanitary authority in operation in the place where the customs clearance is to take place, after fulfillment of the requirements set forth in this Section and to packing , transport and storage standards, contained in the pertinent sanitary legislation.

Article 64. The merchandise pursuant to this Section must be presented, when of its arrival in the national territory, identified and packed, as described for the importer, when of the lawsuit of authorization of shipment approved for the respective competent technical area, in Brasilia.

Article 65. The obligatory information related to identification of the material under clinical research is:

I- number of the clinical protocol of the merchandise imported under clinical research;
II- special storage care (temperature, humidity, luminosity and others), when appropriate;
III- physical or pharmaceutical form, when appropriate.

Section VII

SCIENTIFIC RESEARCH

Sub-section I

Importation of Merchandise under Sanitary Surveillance Intended Directly for the Institution that will Develop Scientific Research

Article 66. The importation of merchandise under sanitary surveillance, intended for scientific research, shall be submitted to express and favorable manifestation of the competent sanitary authority of ANVISA, prior to its clearance in the national territory.

Article 67. The importation of merchandise pursuant to this Sub-section, by direct addressee of the scientific research or by third party, legal entity, intermediary authorized by the institution or agency responsible for the scientific research, when occurring by means of SISCOMEX registration of importation licensing, must be submitted to sanitary inspection, prio