Land: Malaysia
Sprache: Englisch
Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CIPROFLOXACIN HYDROCHLORIDE
MEPHARM (MALAYSIA) SDN BHD
CIPROFLOXACIN HYDROCHLORIDE
10Tablet Tablets
SOFARIMEX-INDUSTRIA QUIMICA E FARMACEUTICA LDA
BPFK416.3 MINOR VARIA1'ION NOTIFICATION PORM FOR FULL EVALUATION PRODUCTS _Please _ _mad _ _the _ _following _ _instructions _ _before _ _filling _ _in _ _the _ _form. _ 1) This notification form is for Product Registration Holder (PRH) to notify National Pharmaceutical Control Bureau (NPCB) on the implementation of MiV-Notification (MiV-N) as per Malaysian Variation Guideline (MVG). The timeline for NPCB to acknowledge the variation notification is within 20 working days following receipt of a notification. 2) Please refer to the MVG for the conditions and supporting documents required. 3) Submission of relevant revised draft of package insert and labeling is subject to current regulatory requirements as per the latest Drug Registration Guidance Document (DRGD) and Circulars from NPCB. In the event that the revised draft of package insert and labeling does not meet the current regulatory requirements, please submit under Minor Variation Prior Approval (MiV-PA) or Major Variation (MaV), 4) PRH must submit this notification form together with the online submission through the Quest 2 system as the approval will only be notified via online submission. For submission online, please scan this form and attach together with the revised draft of package insert and labeling as a single file. 5) A MiV-N application may be rejected in specific circumstances with the consequence that the PRH must cease to apply the already implemented variation. 6) The completed form must be submitted to : Seksyen Variasi, Pusat Pasca Pendaftaran Produk, Biro Pengawalan Farmaseutikal Kebangsaan, Kementerian Kesihatan Malaysia, Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor. (Fax No: 03-79567151) Product Name: BACTIFLOX-500 LACT AB Reference Number: 2001086334A Registration Number: MAL20034631AC Date of online submission in Quest System: Variation No. MiV-N1 MiV-N2 MiV-N3 MiV-N4 MiV-NS MiV-N6 MiV-N7 MiV-NB MiV-N9 MiV-N10 MiV-N11 tf(/~I('?' Name and address of product registration holder: MEPHARM (MALAYSIA) SDN.BHD. 15, JALAN USJ _1/ Lesen Sie das vollständige Dokument