BR Brasilien
  • 11 - Medizintechnik

Plants, medical products containing controlled substances

Draft Resolution 587, 27 December 2018, published by Brazilian Official Gazette (15 page(s), in Portuguese)

This draft resolution establishes the import and export controls, of plants and medical products containing controlled substances subject to special control for any purpose, among other measures.

The lists of substances subject to special control and prohibited plants are included in Annex I of Portaria SVS/MS 344, 12 May 1998, and its updates.

Any legal entity which imports or exports, for any purpose, controlled substances, plants and medicinal products, and Teaching and Research Institutions that realize any activity with this products are covered by this Resolution.

Exceptions for the controls provided on this Resolution are:

•           The isotope and radioisotope patterns;

•           Isotopically labelled organic substances patterns;

•           Kits for in vitro diagnostics and for the detection of controlled substances in the environment;

•           Non-medicamental formulation containing substances in List D1 (does not apply to analytical standards on the list); and

•           Substances on list D2, which are subjected to the control and supervision of the Justice Ministry.

This resolution establishes the places for entry and exit of specific substances listed on the annex of Portaria SVS/MS 344.

RDC 99, 30 September 2008, RDC No.11, 11 March 2013, RSC 201, 18 July 2002 and RDC 62, 11 February 2016 are hereby revoked. Also articles from Portaria SVS/MS 344, 12 May 1988 and Portaria SVS/MS 6, 29 January 1999 are hereby revoked.