DOCUMENTATION NEEDED FOR REGISTRATION BASIC STRUCTURE

The essential basic documents required from the local agent of the foreign company for the registration of products in Brazil are:

a) Application form obtained from the Brazilian Ministry of Health;

b) Original copy of the machine stamped bank slip, which serves as proof of registration fee payment;

c) Trade Permit ("Operating License") issued by the State authority to the manufacturer's distributor;

d) Same type of document ("Authorization of Company Operation"), issued by the Federal authority to the manufacturer's distributor;

e) Document showing the technical responsibility of the distributor/ manufacturer, issued by the certification entity;

f) Technical Report on the product, informing the components of the formula, instructions, directions, cautions, etc;

g) Label sample, brochures, pertinent information about the products, all translated into Portuguese;

h) For products not clearly mentioned in the Brazilian law, it is mandatory to provide information about their utilization in order to demonstrate its efficacy and safety;

I) Copy of the registration granted to the products at the country of origin (or copy of the Free Sale Certificate);

j) Copy of legal document, by which the manufacturer authorizes its distributor to trade and distribute the products.

k) GMP (Good Manufacturing Practice);

l) If a medical equipment, all documents showing product safety, country of origin, detailed (exploded view) of the equipment inner parts and user manual, have to be presented for registration.

Among the above requirements, special attention should be paid to the TECHNICAL REPORT. This is mentioned in Administrative Act, and is required from the cosmetics, vitamins, and pharmaceutical manufacturers.

TECHNICAL REPORT DOCUMENT

1. The complete description of the product's formula with all the components specified by their chemical designation and the quantities of each one expressed in the metric system;

2. Inform the function of each component, and its function as integral part of the formula;

3. Name the components according to the Pharmacopoeia Standards, Brazilian and International Compendia or attached bibliography showing the components and pertinent literature including safety rules and efficacy. This information must be translated into Portuguese.

REQUIRED DOCUMENTS FOR THE ESPECIAL FILE OF IMPORTED GENERIC MEDICINES

I – LEGAL ASPECTS

A) THE COMPANY WHICH IS RESPONSIBLE FOR IMPORTING

1. Payment receipt of file tariff (both, original and copy), duly authenticated;

2. Copy of the official document that enables the company to function, or the updated

HEALTH CERTIFICATE;

3. Copy of the company Functioning Permission, as published in the D.O.U.;

4. Certificate of Technical Responsibility deliberated by the “Conselho Regional de Farmácia” (Regional Pharmacy Board); and

5. Certificate of Good Manufacturing Practices and Control, delivered by ANVISA, when the importing company participates in any stage of the manufacturing process.

B) THE MANUFACTURING COMPANY

1. Certificate of Good Manufacturing Practices and Control (BPFC/GMP), delivered by the health authority of the country where the product was first filed: Canada (Health Canada Therapeutic Products Directorate), USA (FDA – Food and Drug Administration) or EMEA (The European Agency for the Evaluation of Medical (Products);

2. File Certificate of Generic Medicine, delivered by one or more health authorities: Canada (Health Canada Therapeutic Products Directorate), USA (FDA – Food and Drug Administration) or EMEA (The European Agency for the Evaluation of Medical (Products);

3. The above mentioned certificates in items a and b, must be presented accompanied by their officially authorized Portuguese version.

II – TECHNICAL ASPECTS

Forms FP1 and FP2

III – TECHNICAL REPORT

A) MANUFACTURING ASPECTS 

1. Complete formula of the medicine, regarding all presentations, and the role of each component;

2. If the product is to be packed in Brazil, the primary packing materials must be identified by their specifications, and compared with those materials utilized in the country where the product was manufactured, provided the studies on the stability tests for Zone IV.

B) QUALITY CONTROL ASPECTS

1. Complete specification of the medicine indicating the utilized monograph, regarding the post-marketing studies;

2. Analytical methods undertaken, indicating the utilized monograph, regarding the post-marketing studies.

3. Original certificate of the reference medicine, that has been utilized of the pharmaceutical equivalence and bio-equivalence assays were carried out;

4. In addition to the certificate of the pharmaceutical equivalence, the applying company should present a comparative study on dissolution profile, versus the national reference medicine, by utilizing the factors 12 and 12, when the reference drug utilized in the assays is not produced by the reference manufacturer, or by the licensee manufacturer; likewise, if relevant, the in-vitro/in-vivo correlation assays should be presented, as well as the rationale to undertake them.

IV – LABELING AND PACKAGE INSERT ASPECTS

The texts of labeling and package insert must comply with those of the national reference, and they should be in agreement with the law in force; the texts should be provided in CD or DVD an in two printed copies written in Portuguese.

REGISTRATION PROCEDURES HEALTH PRODUCTS

The registration of all medical products listed in this document is mandatory, other than products mentioned in Items 2, 3 and 12 below.

2. Medical products undergoing clinical trials are exempt from registration, having complied with the legal provisions of the competent sanitary authority in order to carry out this activity, with their retailing and/or use for other purposes being banned.

3. News presentations consisting of a set of medical products that have already been registered and in their complete individual presentation packages are exempt from registration, but should display on the label and/or in the instruction for use the registration information for the corresponding medical product.

4. ANVISA will grant registration for families of medical products.

5. When requesting the registration of medical products classified under Classes II, III and IV, the manufacturers or importers should submit the following documents to ANVISA:

a) Documentary proof of payment of the corresponding sanitary surveillance fee;

b) Information identifying the manufacturer or importer and the medical product as de-scribed in Annexes III.A, III.B and III.C of Resolution-RDC nº 185/01, declared and signed by the duly-accredited legal representative and the technical expert in charge;

c) Copy of the authorization of the manufacturer or exporter abroad for the importer to retail its medical product in Brazil. When authorized to do so by the exporter and the manufacturer;

d) For imported medical products, documentary proof of registration or certificate of free trade or equivalent document granted by the competent authority in the countries where the medical product is manufactured and/or retailed;

e) Proof of compliance with the legal provisions stipulated in the Technical Regulations, pursuant to the ANVISA legislation that regulates medical products.

6. The manufacturers or importers requesting registration of medical products classified under Class I should submit the documents listed in Items 5(a), 5(b) and 5(e) to ANVISA.

7. The documentation presented for registration, alteration or revalidation of the registration will be assessed by ANVISA, which will issue its decision through publication in the Federal Government Gazette (DOU – Diário Oficial da Uniao).

8. The assessment of the documentation will be undertaken within the legal conditions and periods stipulated in Brazilian sanitary legislation.

9. In order to request an alteration to the registration of the medical product, the manufacturer or importer should submit all least the documentation stipulated in Resolution-RDC nº 185/01, completed, together with the other documents required for the original registration of the product whose information has been modified.

10. In order to request the revalidation of the registration of a medical product, the manufacture or importer should submit the documentation stipulated in Resolution-RDC nº 185/01, completed. This information should be submitted within the period stipulated by Brazilian sanitary legislation, which will not halt the retailing of the product through to the expiry of its registration.

11. The manufacturer or importer holding the registration of the medical product may re-quest the cancellation of the registration through submission of Annex III.A (Resolution-RDC nº 185/01), completed.

12. Accessories produced by a manufacturer exclusively for joint use with a medical prod-uct manufactured thereby and that is already registered are exempt from registration, when the Technical Report (Annex III.C, Resolution-RDC nº 185/01) for the registration of this product contains information on this accessory. Additional accessories may be attached to the original registration, with a detailed explanation of the basis of their functioning, action and content, as stipulated in Item 9 of Part 3 of this document.

13. The registration of healthcare products will remain valid for 5 (five) years, and may be revalidated successively for similar periods.