Brazil Seeks Input on Proposal to Amend Import Rules for Unregistered Health Products
14 February 2020
Brazilian authorities are seeking input through 18 February on a proposal to amend the criteria and procedures for importations carried out under exceptional circumstances of products that are regulated for health reasons but have not been registered with ANVISA, the Brazilian health agency. The proposal would relax these import rules partly in an effort to allow Brazil to better respond to the coronavirus outbreak.
Specifically, exemption from registration may be granted to medicines, immune-biologicals, insecticides and other strategic inputs acquired through international multi-lateral organisations for use in public health programmes by the Ministry of Health and its related entities as long as there is (i) a serious health risk and proven unavailability in the national market for registered therapeutic substitutes, and (ii) in the case of medicines, a temporary or permanent shortage of products registered in Brazil to meet the demand of the Unified Health System.
If the product to be imported is not pre-qualified by the World Health Organisation, it must be accompanied by (i) a valid registration in the country of origin, (ii) a registration with a competent regulatory authority that is a member of the Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, and (iii) a certification of good manufacturing practices or an equivalent document issued by a member country of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).
- Medical Supplies & Medicine
- Central & South America