Produtos afetados
Sistema de classificação Código Nome
HS 3003 Medicamentos (exceto os produtos das posições 30.02, 30.05 ou 30.06) constituídos por produtos misturados entre si, preparados para fins terapêuticos ou profiláticos, mas não apresentados em doses nem acondicionados para venda a retalho.
HS 2941 Antibióticos.
HS 3005 Pastas (ouates), gazes, ataduras e artigos análogos (por exemplo, curativos (pensos), esparadrapos, sinapismos), impregnados ou recobertos de substâncias farmacêuticas ou acondicionados para venda a retalho para usos medicinais, cirúrgicos, dentários ou veterinários.
HS 3004 Medicamentos (exceto os produtos das posições 30.02, 30.05 ou 30.06) constituídos por produtos misturados ou não misturados, preparados para fins terapêuticos ou profiláticos, apresentados em doses (incluindo os destinados a serem administrados por via percutânea) ou acondicionados para venda a retalho.
ICS 11120 Pharmaceutics
Detalhes
País Brazil
Agência responsável National Institute of Metrology, Quality and Technology (INMETRO) Telephone: +(55) 21 2563.2918 Telefax: +(55) 21 2563.5637 Email: barreirastecnicas@inmetro.gov.br Web-site: www.inmetro.gov.br/barreirastecnicas
Agency or authority designated to handle comments if different from above The Brazilian Health Regulatory Agency (ANVISA)
Artigos 2.9.2
Covered Products HS Codes: 3003; 3004; 3005; 2941.
Cobertura Medicamentos
Title, number of pages and language(s) of the notified document Draft resolution (Consulta Publica) number 653, 21 May 2019. 2 pages, Portuguese. Published on D.O.U, 27 May 2019, page 57. Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=47328
Resumo em portugues Propoe Regulamento Tecnico 653/2019 corresponde a adocao do Guia de boas praticas de fabricacao de medicamentos da convencao de inspecao farmaceutica e do esquema de cooperacao em inspecao farmaceutica de 2018.
Resumo original 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.
Objetivos Saúde Humana
Documentos relevantes Guide to Good Manufacturing Practice for Medicinal Products of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) part I of 1 July 18. - http://portal.anvisa.gov.br/documents/10181/5389382/PE_009_14_GMP_Guide_Part_I_Basic_Requirements_for_Medicinal_Products_.pdf/bc4b65e3-b22d-438f-b33c-e13f05e79f3e Guide to Good Manufacturing Practice for Medicinal Products of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), Annexes. - http://portal.anvisa.gov.br/documents/10181/5389382/PE_009_14_GMP_Guide_xAnnexes_+%281%29.pdf/ba0e51c1-eb74-49f4-a7d5-d84cd222fb60
Detalhes do contato Brazilian Health Regulatory Agency (Anvisa) SIA, Trecho 5, Área Especial 57 Brasília – DF / Brazil CEP: 71.205-050 Phone.: +(55) 61 3462.5402 Website: www.anvisa.gov.br