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Registration of Products:
Manual covering procedures for registration and exemption from registration
of imported products
Resolution n º 22 of March 15, 2000
(Federal Official Gazette - DOU 16/03/2000)
Deals with the Basic Procedures to be followed for the Registration
of Imported Products in the Area of Foodstuffs and the Exemption of
the Same from the Compulsory Requirement
The Collegiate Board of Directors of the Brazilian Sanitary Surveillance
Agency, pursuant to the prerogatives conferred upon it by Article 11,
numeral IV of the Regulations of ANVISA approved by Decree 3.029, of
April 16, 1999, c/c paragraph 1 of Article 95 of the Bylaws approved
under Resolution 1 of April 26, 1999, at the meeting convened on March
1, 2000, adopts the following Resolution of the Collegiate Board of
Directors and, I, as Director-Chairman hereby call for it to be published:
Article 1. To approve the Technical Regulations regarding the Basic
Procedures to be followed for the Registration of Imported Products
in the Area of Foods and the Exemption of the Same from the Compulsory
Requirement, in accordance with the terms set out in the Annex of this
Resolution.
Article 2 Failure to comply with this Resolution shall constitute a
sanitary violation and shall render the offenders liable to penalties
described in Law 6.437 of August 20, 1977, and to other measures as
applicable.
Article3º This Resolution by the Collegiate Board of Directors
will enter into force on the date of its publication.
Article4º The Resolution by the Collegiate Board of Directors RDC
03 of October 4, 1999 is hereby repealed.
Gonzalo Vecina Neto
(D.O.U. of 16/03/2000)
ANNEX
Technical Regulations regarding the Basic Procedures to be followed
for the Registration of Imported Products in the Area of Foods and the
Exemption of the Same from the Compulsory Requirement
1.SCOPE
1.1.Objective
To provide guidance on the procedures regarding the registration of
imported products in the area of foods and the exemption of the same
from compulsory registration
1.2. Scope of Application
These Rules shall be applied to the procedures regarding the registration
of imported products in the area of foods and the exemption of the same
from compulsory registration
2. PROCEDURES
2.1. The procedures and application forms connected with registration
of imported products and exemption from the compulsory registration
of such products shall be the same as those required for Brazilian products,
in accordance with specific technical rules.
2.1.1. For those products exempt from compulsory registration, the Form
Informing of the Import of Products Exempt from Compulsory Registration,
in accordance with Annexes I and II of this Regulation, must be submitted.
2.2. The application for registration must be submitted by the importer,
by a subsidiary company or by the manufacturer's representative.
2.2.1. In the event of the existence of more than one importer of the
same imported product, each importer must present a separate application.
2.2.2. In cases
where a subsidiary company, or one representing the manufacturing company,
is based in Brazil, this company can apply to register a single product
but one which carries different trade names and importers, providing
that the importer or distributor authorizes the use of his trade name
by the holder of the permit.
2.3. The foods, additives, technical supporting factors and packaging
should be in accordance with Decree Law 986 of October 21, 1969 and
respective regulations.
2.4. When the importer or the manufacturer's representative operates
from a commercial office, the Sanitary Permits (or Permits) or Operating
License (or Licenses) of the premises where the product (s) is (are)
to be registered will be stored must be made available.
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