Produtos afetados
Sistema de classificação Código Nome
HS 300490 - Outros
ICS 11120 Pharmaceutics
Detalhes
País Korea, Republic of
Agência responsável Ministry of Food and Drug Safety
Agency or authority designated to handle comments if different from above International Cooperation Office Ministry of Food and Drug Safety 187 Osongsaengmyeong2-ro, Osong-eup, Heungdeok-gu Cheongju-si, Chungcheongbuk-do, 28159 Republic of Korea Tel: (+82) 43 719-1564 Fax: (+82) 43-719-1550 Email: intmfds@korea.kr Website: www.mfds.go.kr
Artigos 2.10.1 5.7.1
Covered Products Advanced Biological Products (HS: 3004-90-9900)
Cobertura produtos biológicos
Title, number of pages and language(s) of the notified document The draft regulation on the Approval of Advanced Biopharmaceuticals and the Safety about Advanced Biological Products
Resumo em portugues Propõe Regulamento Técnico sobre a aprovação de produtos biofarmacêuticos avançados e a segurança sobre produtos biológicos avançados
Resumo original Republic of Korea is proposing the regulation on the “Approval of Advanced Biopharmaceuticals and the Safety about Advanced Biological Products". The main contents are: As the Act on the Safety and Support of Advanced Biological Products was established, the regulations on the approval of advanced biopharmaceuticals and the regulation on safety about biological products was enacted to stipulate document requirements and evaluation criteria.
Objetivos Saúde Humana
Documentos relevantes Ministry of Food and Drug Safety Public Notice No.2020-378 (31 August 2020)
Detalhes do contato Korea WTO TBT Enquiry PointTechnical Barriers to Trade (TBT) DivisionKorean Agency for Technology and Standards (KATS)93 Isu-ro Maengdong-myeon Eumseong-gunChungchungbuk-do 27737+(82) 43 870 5525+(82) 43 870 5682 (Fax)tbt@korea.krhttp://www.knowtbt.kr

Datas importantes
  • Distribuição
    23/09/20
  • Comentários
    Até 13/10/20
  • Adoção
    07/09/20
  • Vigência
    2020-09-07
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