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Guidance documents, forms, circulars and reports issued by the Authority.
Document Name Download Updated Appendix 12 : Conditions And Supporting Documents Required For An Application Of Variation DOWNLOAD July-2018
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Document Name Download Updated Appendix 10 : Guideline On Patient Dispensing Pack For Pharmaceutical Products In Malaysia DOWNLOAD July-2018
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Document Name Download Updated Appendix 9: Labelling Requirements DOWNLOAD July-2018
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Document Name Download Updated Appendix 8: List Of Permitted, Prohibited And Restricted Substances DOWNLOAD July-2018
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5. Ingredients of Human or Animal Origin (Active Ingredient, Excipient and / or Capsule Shell) 5.1 Origin 5.2 Function 5.3 In the Manufacturing Process 5.4 In the Final Product Please select YES if…
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6.1 : Registration Code/ Number 6.2 : Product Particular 6.3 : Labelling And Packaging 6.4 : Product Authentication 6.5 : Indications, Special Conditions 6.6 : Adverse Reactions, Complaints 6.7…
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16.3 : Change Of Product Registration Holder 16.3.1 : Introduction 16.3.2 : Conditions 16.3.3 : Application 16.3.4 : Processing Fee 16.3.5 : Supporting Documents 16.3.6 : Supporting Document Format…
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COS Menu : Change Of Manufacturing Site Conditions On Application For COS Conditions On Good Manufacturing Practice (GMP) Types Of Manufacturing Site Changes (COS) Mode Of Submission Other…
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<> B2B Transaction STEP by STEP Step 1 : Choose method of payment, i.e. corporate account for B2B Step 2: Corporate Banking, click pay via FPX Step 3: Choose participating bank, i.e. Standard…
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ASEAN Registration of Pharmaceuticals for Human Use (The following were abstracted from the Health Sciences Authority Singapore site)ASEAN Common Technical Dossier (ACTD) Organisation of the Dossier…
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Document Name Download Updated Guidelines for the Establishment, Handling, Storage and Use of Chemical Reference Substances DOWNLOAD Jul-2000
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Document Name Updated GUIDANCE-DOCUMENT-AND-GUIDELINES-FOR-REGISTRATION-OF-BIOSIMILARS-IN-MALAYSIA-Dec-2023_Second-Edition Dec-2023
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Document Name Download Updated Guidelines on Good Manufacturing Practice for Traditional Medicines and Health Supplements DOWNLOAD Jan-2008
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Document Name Download Updated Regulatory Control of Active Pharmaceutical Ingredients DOWNLOAD April-2011 APPENDIX 6 Regulatory Control of API_30062014 (3).pdf
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Document Name Download Updated Malaysia Variation Guideline for Pharmaceutical Products 2013 (First Edition) DOWNLOAD April-2013 Malaysia Variation Guideline for Pharmaceutical Products 2013_edition…
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Document Name Download Updated Direktif untuk memperketatkan indikasi semua produk ketoconazole oral dan mengehadkan penggunaan di hospital sahaja berikutan risiko kesan advers hepatotoksisiti…
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Document Name Download Updated Guideline on Good Distribution Practice (Third Edition, 2018) DOWNLOAD Jan-2018
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Document Name Download Updated Supplementary Notes on Annex 1: Management of Time and Temperature Sensitive Products (TTSP) of Guideline on Good Distribution Practice DOWNLOAD Jan-2018
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Document Name Download Updated Guidance Note for Cell and Gene Therapy Products (CGTPs) Manufacturing Facility in Malaysia DOWNLOAD Jul-2021
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Document Name Download Updated Malaysian Variation Guideline for Natural ( Traditional Medicine & Homeopathy ) and Health Supplement Product 2016 DOWNLOAD July-2016
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Document Name Download Updated Site Master File (SMF-BE) For Blood Establishments in Malaysia DOWNLOAD Jun-2016
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20 : Amendment to the particulars of the product 20.1 : Variation 20.2 : Change of Manufacturing Site (COS) 20.3 : Change of Product Registration Holder (COH) 20.4 : New/Additional Indication 20.5…
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a) The registration of a product shall be valid for five (5) years or such period as specified in the Authority database (unless the registration is suspended or cancelled by the Authority). b)…
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Download Directive in PDF
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