Legislation
Administrative Order

Administrative Order nº 185, of March 8, 1999 (*)

The Deputy Secretary of Sanitary Surveillance of the of Ministry of Health, in the use of attributions vested in him,

and WHEREAS:
that only companies specifically authorized by the Ministry of Health can produce, import, fraction, pack, re-pack, store or distribute pharmaceutical products;
the need to regulate the authorization concession for the operation of importing companies of pharmaceutical products, decides:

Article 1 The importation of pharmaceutical products subject to the Sanitary Surveillance Regimen shall only be made by companies which are legally authorized to function as importers by the Sanitary Surveillance Secretary / Ministry of Health.

Only Paragraph. The company legally authorized to develop exclusively importation activities is only allowed to import finished products and in their original packaging.

Article 2 The importing company is responsible for the quality, effectiveness and safety of the imported products.

Paragraph 1 All the imported products must be submitted to a thorough quality control assessment, lot by lot, at the importer's own laboratory or by third party contracting.

Paragraph 2 In case of third party contracting, the contracted laboratory must hold an updated operation license, issued by the competent sanitary authority, as well as means to prove its qualification to carry out the required tests.

Paragraph 3 The third party contract should contain, possibly as an annex, the discrimination of the products and the respective tests to be carried out.

Paragraph 4 The third party contracting allowed under this Regulation shall have the nature of a temporary concession, the concession being approved only for a period of 03 (three) years, non extendable, after which the company must prove the existence of its own quality control laboratory.

Article 3 The documentation necessary to the opening of Company Operation Authorization process, specifically for pharmaceutical products importing companies is the following:

I - A petition form filled out in two copies, with the request for Operation Authorization approved by the Normative Regulation SVS/MS 1/94;
II - Proof of payment of public price (DARF Code 6.470), both in the original and copy, properly registered or stamped;
III - social contract or supporting document of legal constitution of the company, registered at appropriate office;
IV - copy of the registration in the National Private Corporation Register (CNPJ) of the Ministry of Finance;
V - brief report of the activities of the company, with therapeutic class and forms of the products with which it shall operate;
VI - declaration containing the name of the Technician in Charge, record number at the Regional Pharmacy Counsel and his/her professional and working link to the company;
VII - proof of existence of a laboratory, in compliance with Good Manufacturing and Control Practices, when applicable, to carry out quality control of the finished products to be imported, or a copy of the contract for carrying out quality control by third parties, specifying the analyses to be carried out;
VIII - proof of existence of a storage room, in compliance with the Good Manufacturing and Control Practices, when applicable, as well as Good Storage Practices;
IX - copy of the contract proving the binding character of the importer with the producing company owner of the registration of the product (patent) in the country of origin.
Paragraph 1 The documentation must be properly signed by the Legal Representative of the company, the technical part being signed jointly by the Technician in Charge, both signatures being registered.

Paragraph 2 In the case of an operation authorization for companies "Representatives of the MERCOSUR", the requirements provisioned for in specific legislation shall be met, in consonance with MERCOSUR resolutions.

Article 4 The Regulation both for the documentation and procedures required for the registration of imported products shall be published in an specific Administrative Order.

Article 5 This Administrative Order enters into force on the date of its publication, all contrary provisions of Administrative Order SVS/MS No. 14/96 and Administrative Orders Nos. 664/98 and 1053/98 being hereby revoked.

Luis Carlos Wanderley Lima