DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)6.9 CANCELLATION, SUSPENSION, AMENDMENT BYTHE AUTHORITYThe Authority may, at any time and without assigning any reason suspend or cancelthe registration of any product, and may amend the conditions of registration. Theholder of the registration certificate shall immediately surrender to the Authority theregistration certificate upon cancellation or suspension of the registration of theproduct.The Authority may, at any time and without assigning any reason suspend or cancelthe registration of any product, and may amend the conditions of registration, uponwhich the registration certificate is no longer valid.6.10 DIRECTIVESThe Senior Director of Pharmaceutical Services may issue written directives orguidelines to any person or a group of persons as he think necessary for the bettercarrying out of the provisions of these Regulations and which in particular relate to:a) Product quality, safety and efficacy;b) Labeling;c) Change of particulars of a product;d) Transfer of licenses;e) Manufacturing;f) Storage includes requirements as to containers;g) Retailing;h) Promotion of sale including product information;i) Product recall;j) Product disposal;k) The cost of product recall or product disposal;l) Clinical trials; orm) Records and statistics pertaining to manufacture, sale, supply, import or export ofany products.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 68
Drug Registration Guidance Document (DRGD)7. USE OF HALAL LOGOHalal logo may be used voluntarily on registered product label for the following categories,for both local and export market, provided that such products have been certified andapproved halal by the Malaysia Department of Islamic Development (Jabatan KemajuanIslam Malaysia, JAKIM):a) Non-scheduled poison, excluding parenteral dosage form and veterinary products;Reference: Circular (95)dlm.BPFK/PPP/01/03 Jld. 2b) Health supplements;c) Natural products; andd) Cosmetics.However, the logo is NOT allowed to be used on label of registered products other than thecategories as listed above.Only halal logo issued by JAKIM or any Islamic Body which is recognized by JAKIM shallbe accepted.Consideration by the Authority for use of halal logo on product label of such products shallbe based on application as it is not a mandatory requirement.Applicant shall submit application for variation type II to NPCB for approval to affix halallogo on product label of a registered product of which a halal certification has been granted.A copy of the halal certificate must be submitted as a supporting document.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 69
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PART III: NON-CLINICAL DATADrug Reg
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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