Legislation
Administrative Order

Administrative Order nº 19, of February 16, 1996

The Secretary of Sanitary Surveillance of the Ministry of Health, in the use of his legal attributions, and

WHEREAS
none of the products subject to Sanitary Surveillance regulations, including the imported ones, shall be put up for sale or made available for use prior to their registration at the Ministry of Health;

WHEREAS
the need to establish regulations for the concession of registration to imported medicines;

WHEREAS:
Law No. 8.080, September 19, 1990
Law No. 5.991, December 17, 1973
Law No. 6.360, September 23, 1976
Law No. 6.368, October 21, 1976
Law No. 8.078, September 11, 1990
Decree No. 79.094/77.
Resolution No. 16/95, of SVS-MS,
decides:

Article 1 - To approve the list of documents needed to open processes requesting registration of imported medicines, presented below:

I - Petition FP1 e PF2 when applicable, in the original and copy, approved by Administrative Order No. 10/SVS of September 05, 1990.
II - Proof of payment of public price (DARF Code 6.470), original and copy, properly registered and stamped.
III - Copy of the Authorization for Company Operation, issued in compliance with Administrative Order SVS-MS No.14/96.
IV - Technical Report of the product, containing:

1 - General data:
a) Pharmaceutical and presentation form;
b) Composition of the formula, indicating the basic components per dose or, if possible, per gram, milliliter, standard measurement unit;
c) Means of administration and/or directions for use;
d) Indications, purpose or use prescribed;
e) Complementary therapeutic indications;
f) Counterindication, side effects, adverse reactions;
g) Restrictions or precautions that should be considered;
h) Expiry date;
i) Preservation care;
j) Instructions for proper use, whenever the case;

2 - Pharmacodynamics:
a) Mode of action;
b) Dosage (maximum and minimum);
c) Justifications of the suggested dosage;

3 - Production and Control:
a) Complete preparation formula with all its components specified by the corresponding technical names and synonyms in compliance with the Brazilian Common Denomination - DCB, the quantity of each substance expressed in the decimal metric system or in standard units, consigning the substances used as excipients or vehicles;
b) Manufacturing process with brief description of the operations to be carried out;
c) Descriptive report of Quality Control carried out on the active components of the formula, as well as stability and physiochemical tests of the raw material and of the finished product carried out by the manufacturer and the methodology to be adopted by the importer;
d) The tolerance limits for testing and for dosage deviations, in the absence of official regulation;
e) The code or conventions used by the manufacturing company for the identification of the lots or shipments of the product;
f) Report containing the technical indications that there is no physical or chemical incompatibility between the adopted packaging and the components of the formula of the product;
g) Storage and transport care;

4 - Complementary data:
a) Mention the description of the substance or basic components of the formula in Pharmacology books, forms or official publications of pharmaceutical standardization and/or of scientific classification;
b) Attach the bibliography on the product and the related literature with the complete translation of the original work, whenever of foreign origin. SVS/MS can request extra research if considered necessary for the evaluation of the scientific documentation, with copy for its file;
c) Should there be the inclusion of narcotic, hypnotic or barbiturate substances, must comply with special provisions to which they are submitted;
d) Present the advantages of the proposed formula, with justification under a clinical point of view, indicating, whenever the case, the similar product registered in Brazil;
e) Other elements which are appropriate or necessary, including those whose purpose is to judge cause and effect, in order to help sanitary authorities to reach correct conclusions.
V - Model of label and instructions for use leaflet, with clear explanations, in the Portuguese language, in compliance with the provisions under article 31 of Law No. 8.078/90 (Consumer Defense Code);
VI - Original models of labels and instructions for use leaflet of the imported product;
VII - Copy of the Sanitary Permit in force;
VIII - Proof that the importing company has a qualified technician in charge for that purpose;
IX - Proof of Registration in the manufacturing country of the product to be imported issued by the official agency that carries out the same functions of the Secretariat of Sanitary Surveillance of the Ministry of Health;
X - Report containing indications, cautions and warnings presented for the Registration deed in the manufacturing country of the product to be imported, signed by the technician in charge of the importing company;
XI - Proof of registration of the trademark in Brazil or declaration of nonexistence of the same;
Only Paragraph - All the documentation must be presented in the Portuguese language, transcribed by an official public translator and recognized by the Brazilian Consulate in the jurisdiction of the place of manufacturing of the imported product, signed by the legal representative of the company, the technical part being signed, jointly, by the Technician in Charge, both signatures being registered.

Article 2 - The Report of Therapeutic Experimentation elaborated and presented in compliance with the sequence provisioned for in Resolution No. 001/88, of the National Council of Health, emphasizing the bioavailability and toxicity, for the petitions regarding requests of registration of the NEW PRODUCT.

Article 3 - The medicines to be imported should be registered and traded in the countries that manufacture the product.

Article 4 - Statement issued by the official agency at the manufacturing country that the manufacturer abides by the regulations and requirements presented in the Code of Good Manufacturing and Control Practice in compliance with Administrative Order No. SVS/MS 16/95 or by the World Health Organization - WHO.

Article 5 -The SVS/MS shall issue specific document for imported finished medicines, which have been submitted to registration process, in compliance with this Administrative Order.

Article 6 - Products subject to control under a special regimen must also comply with pertinent specific legislation.

Article 7 - For finished imported medicines, already registered, a specific document shall be issued in compliance with article 5, by request of the interested party, which shall be attached to the Authorization of Company Operation issued by SVS/MS.

Article 8 - This Administrative Order shall enter into force on the date of its publication, all the contrary regulations being revoked.

Elisaldo I. A. Carlini