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The Brazilian National Agency for Sanitary Surveillance (ANVISA) published in July 17, 2018, Resolution RDC 203/2018, which establishes the criteria and procedures for the importation, under exceptional circumstances, of products subject to sanitary surveillance which are not registered at ANVISA. Such rule is destined for imports that ought to be employed in public health programs by the Brazilian Ministry of Health and its entities.
In accordance with the new RDC, the import of unregistered products may be authorized in the following cases: (i) absence of the product and its dully registered alternatives in the national market; (ii) national or international public health emergency; (iii) immunobiologicals included in the National Immunization Program, acquired through the Fund for the Acquisition of Immunobiologicals, of the Pan-American Health Organization/World Health Organization; and (iv) donations from international multilateral bodies or foreign official cooperation agencies.
The products to be imported based on RDC 203/2018 must be pre-qualified by the World Health Organization or, as the case may be, by a country member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use and Certification of Good Practices.
After the request by the interested party, ANVISA should present its position within 10 days of the request or in 48 hours in case of public health emergency, besides giving publicity to the requests.
The RDC also establishes that the authorization to import unregistered products may be modified, suspended or revoked at any time.
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