Peringatan: Pelaksanaan Kawalan Regulatori Bahan Aktif Farmaseutikal (API) Untuk Produk Yang Tamat Tempoh Pendaftaran Mulai 1 Januari 2020

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  1. Direktif BPFK/PPP/01/03/J3(11) bertarikh 27 Jun 2014 adalah dirujuk.
  2. Garispanduan untuk prosedur kawalan regulatori API boleh didapati di Guidance Notes Required Documents for API Information Version 2.0
  3. Carta aliran untuk kawalan regulatori API ke atas produk berdaftar (yang mengandungi racun berjadual) boleh dirujuk.
  4. Borang permohonan Form RegA1 (Application Form for Section S Revision for Product Registered Before the Implementation of Directive on Regulatory Control of API) akan berkuatkuasa mulai 1hb Oktober 2018. Borang ini boleh didapati di laman web NPRA (Garispanduan-API).

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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