Table Of Contents (TOC) for BRAZIL

BRAZIL

Authority

ANVISA: National Sanitary Surveillance Agency

website

www.anvisa.gov.br/hotsite/genericos/legis/resolucoes/84_02rdc_e.htm

if any

DOSSIER REQUIRMENTS

S. No.

Tenofovir Disoproxil Fumarate Tablets 300 mg

Page No.

2

Technical aspects

2.1

Petition forms PF1 and PF2

2.2

General data that must be contained in the instructions for use and the packaging, in compliance with legislation in force; information contained in the instructions for use of generic drug products must not be inferior to that contained in the instructions for use of the reference drug, at the discretion of ANVISA, the right being reserved to this agency to request the complementation of any data, whenever it is deemed necessary for the clarification of the users of the drug product.

2.3

Technical Report :

The technical report must include: production report, quality control report, stability, packing and packaging material, pharmaceutical equivalence report, biopharmaceutical tests report.

2.3.1

Production report:

a) Standard formula, production process and equipment used in the manufacturing of the drug product, with information about maximum individual capacity and definition of the size of the industrial batch.

b) Complete description of the master formula designating the components according to the CBD, INN or the denomination described in the Chemical Abstract Substance (CAS), observing the order of priority.

c) Description of the quantity of each substance, expressed in the decimal metric system or standard unit, indicating its function in the formula and respective reference of quality specification described in the Brazilian Pharmacopoeia or, for lack of it, in other official codes authorized by the legislation in force.

d) Validation of the manufacturing process of the drug product, including the validation of the cleaning procedures of the equipment. For proof, the company must present the validation protocol and conclusive report.

e) Copy of complete dossier on production and quality control referring to the three pilot batches manufactured. For drug products already registered and/or imported, the dossier must refer to the last three years of manufacturing. 

2.3.2.

Quality control report:

2.3.2.1

Raw material:

2.3.2.1.1

Drug substance

a) The manufacturing company (ies) and the synthesis path

b) Specification descriptions

c) Analytical methods used and the identification

d) Quantification and limits of their main contaminators, according to the synthesis path of the drug.

e) List of solvent agents used in the process.

2.3.2.2

Drug product:

a) Specifications and analytical methods for Excipients.

b) Specifications and analytical methods for the finished product (send, in addition, copy in disk in MS-Word).

c) Validation of the analytical methods employed. In the case of pharmacopoeic methodology, present precision, accuracy and linearity data.

2.3.3

Stability:

a) Submit the results and assessments of the accelerated stability study of the three batches produced. The national drug products already registered in the country, as well as the imported ones, must present stability data, observing the established validity period.

b) Generic drugs imported in great quantities must present the results and the assessment of the stability test in the final packing for commercialization, in accordance with the guide for the undertaking stability studies.

c) The assessment of the stability study results must emphasize the projection of the validity period and recommended storage and distribution conditions.

2.3.4

Packing material and Packing.

2.3.5

Pharmaceutical equivalence report.

2.3.6

Biopharmaceutical tests report.