BRA/870
WTO/TBT
BR Brazil
  • 29 - Organic chemicals
  • 30 - Pharmaceutical products
2019-08-01
2019-06-11

HS Codes: 3003; 3004; 3005; 2941

Draft resolution (Consulta Publica) number 653, 21 May 2019. Published on D.O.U, 27 May 2019, page 57. (2 page(s), in Portuguese) Comment form: http://formsus.datasus.gov.br/...

This Draft Resolution corresponds to the adoption of the Guide to Good Manufacturing Practices for Medicinal Products of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of 1 July 2018. The resolution – RDC represents the Part 1 of the guide that applies to all medicines without distinction. The Normative Instructions (IN) correspond to the annexes of the guide related to specific aspects of the good practices for the manufacture of medicines.

RDC - Good Practice Guidelines for the Manufacture of Medicines: corresponds to Part I of the PIC/S guide;

IN Complementary guidelines to the manufacture of sterile medicinal products (corresponds to annex 1 of the PIC/S guide);

IN Complementary guidelines to the manufacture of biological medicinal substances and products for human use (corresponds to annex 2 of the PIC/S guide);

IN Complementary guidelines to the manufacture of radiopharmaceuticals (corresponds to annex 3 of the PIC/S guide);

IN Complementary guidelines to the manufacture of herbal medicinal products (corresponds to annex 7 of the PIC/S guide);

IN Complementary guidelines to the manufacture of medicinal gases (corresponds to annex 6 of the PIC/S guide);

IN Complementary guidelines to the sampling of starting and packaging materials (corresponds to annex 8 of the PIC/S guide);

IN Complementary guidelines to the manufacture of liquids, creams and ointments (corresponds to annex 9 of the PIC/S guide);

IN Complementary guidelines to the manufacture of pressurised metered dose aerosol preparations for inhalation (corresponds to annex 10 of the PIC/S guide);

IN Complementary guidelines to computerised systems (corresponds to annex 11 of the PIC/S guide);

IN Complementary guidelines to the use of ionising radiation in the manufacture of medicinal products (corresponds to annex 12 of the PIC/S guide);

IN Complementary guidelines to the manufacture of investigational medicinal products (corresponds to annex 13 of the PIC/S guide);

IN Complementary guidelines to the manufacture of medicinal products derived from human blood or plasma (corresponds to annex 14 of the PIC/S guide);

IN Complementary guidelines to the qualification and validation (corresponds to annex 15 of the PIC/S guide);

IN Complementary guidelines to the reference and retention samples (corresponds to annex 19 of the PIC/S guide); Considering that this is the adoption of a set of guides widely adopted internationally, it is not desirable that in Brazil be adopted divergent good manufacturing practices (BPF)requirements, unless a necessity to adopt different requirements to reach an adequate level for protection to health be proved.