Drug Guidelines - Documents. Text. Microsoft Word - RGDOC MAC0. Machine from Broadgun Software, http: //pdfmachine. PDF writer utility! It will replace the “Guidelines for Application for Registration of. Pharmaceutical Products” Third Edition of October 1. Garispanduan. Permohonan Pendaftaran Keluaran Ubat Tradisional” Second Edition. December 1. 99. 8. The contents of this version include. Please visit the National Pharmaceutical Control Bureau. NPCB) website at http: //www. Chelidonium majus. Ginkgo biloba/Ginkgo extract. Pelargonium sidoides. Benyl Alcohol/Phenymethanol (preservatives). Substances from seafood. Under GENERAL HEALTH MAINTENANCE. Tidak dibenarkan menggunakan nama yang. Contoh: - Slim, Langsing, Trim,Trimnfit”. Application Formalities. In the second paragraph, . Bromazepam. . Flurazepam hydrochloride. VI. Zolpidem tartrate. Four Go Mad in Malaysia. We nipped in to The Resthouse to maintain our healthy balanced diet of Coke and Snickers bars. Pied Fantail - Rhipidura javanica. Health supplements shall mean products that are intended to supplement the diet taken by mouth in forms such as pills. The Jillian Michaels Diet Plan; Water Weight Loss Pills Diurex; Weight Loss Herbalife Testimonials; Raw Food Diet And Tendonitis; The New Me Weight Loss. ![]() XI. Gadoversetamide. III. Gadobenic acid. List of amendments / changes: ........................................... SECTION 1: GENERAL OVERVIEW OF THE DRUG REGISTRATION. SYSTEM IN MALAYSIA (INCLUDING ADMINISTRATIVE PROCEDURES). INTRODUCTION................................................... DRUG REGISTRATION............................................. PROCEDURE FOR PROCESSING NEW APPLICATIONS .............. Application Type .............................................. Data Requirements ............................................ APPLICATION FORMALITIES ...................................... Responsibility of Marketing Authorization Holder (i. Application Fee................................................ Letter of Authorization and Certification Which Must Accompany. Applications .................................................. Multiple Applications.......................................... PROCESSING OF APPLICATIONS................................... Initiation of Review............................................ Stop Clock .................................................... REGULATORY OUTCOME .......................................... Decisions of the DCA.......................................... Full text of 'Proceedings of the general meetings for scientific business of the Zoological Society of London' See other formats.
![]() Product Registration Number................................... Certificate of Registration . Rejection, Cancellation, Suspension of Registration . Appeal against DCA Decisions . Decision of the Minister or the Director of Pharmaceutical Services. MAINTENANCE OF REGISTRATION................................ Conditions for Registration . Validity Period of Registration . CHANGE IN PARTICULARS OF REGISTERED PRODUCTS........... REPORTING PROBLEMS WITH REGISTERED PRODUCTS ........... Adverse Drug Reactions ........................................ Product Complaints ............................................ Product Recalls ................................................ TERMINATION OF PRODUCT REGISTRATION BY MARKETING. AUTHORIZATION HOLDER .......................................... CHANGE IN MARKETING AUTHORIZATION HOLDER OF A. ![]() REGISTERED PRODUCT.............................................. CHANGE IN MANUFACTURING SITE ............................. OTHER INFORMATION........................................... Criteria for registration ......................................... Variants for a Given Product .................................... Search the history of over 279 billion web pages on the Internet.Patented Products.............................................. Products for export only ........................................ Combination (Combo) Packs .................................... Use of HALAL logo ............................................ Bioequivalence ................................................ New / additional indication ..................................... TYPES OF APPLICATIONS ......................................... APPENDICES ..................................................... SECTION 2: GUIDE ON HOW TO FILL THE ON- LINE APPLICATION. FORM FOR A NEW PRODUCT REGISTRATION ....................... STEP 1: PRODUCT VALIDATION FORM .............................. STEP 2: NEW REGISTRATION APPLICATION FORM .................. PART I – ADMINISTRATIVE DATA AND PRODUCT INFORMATION .. SECTION A: PRODUCT PARTICULARS............................. SECTION B: PRODUCT FORMULA................................. SECTION D: LABEL (MOCKUP) FOR IMMEDIATE CONTAINER, OUTER. CARTON AND PROPOSED PACKAGE INSERT ................ ![]() ANNEX A........................................................... Guidelines for the Submission of Protocol of Analysis................. General Requirements ........................................ ![]() Specific Requirements ........................................ Guideline for Submission of Samples to the Drug Analysis Division for. Laboratory Testing............................................ Introduction ................................................. Requirements................................................ Appeal for retesting ........................................ Guideline for Submission of Analytical Method Validation Documents . Introduction ................................................. Requirements................................................ Garis Panduan Mengemukakan Dokumen Validasi Analitikal (Pengujian. Mikrobiologikal)............................................. Ujian Kontaminasi Mikrobial .................................. Esei Antibiotik Cara Mikrobiologikal.......................... Ujian Steriliti .............................................. INTRODUCTION. 1. 1 The Control of Drugs and Cosmetics Regulations 1. June 1. 98. 4, with the establishment of the Drug Control Authority (DCA). The daily operations of drug registration and. National. Pharmaceutical Control Bureau (NPCB). While. every effort has been made to include the legal requirements of other. Dangerous Drugs Act 1. Poisons Act 1. 95. Medicine (Advertisement & Sale) Act 1. Patent Act 1. 98. Any other relevant Acts. DRUG REGISTRATION. Any drug in a pharmaceutical dosage form intended to be used, or capable. DCA. This includes food for. PROCEDURE FOR PROCESSING NEW APPLICATIONS. Application Type. An application for a new product registration may be sub- divided into one. Application for an innovator product (NCE1 / Biotech). Products containing Glucosamine and Chondroitin . Products containing Glucosamine as single active ingredient are. OTC) product via the full evaluation. Products containing. Glucosamine either as single ingredient or in combination with. In order to facilitate the evaluation process, applicants. The DCA may in certain cases. The applicant should make. APPLICATION FORMALITIES. The DCA accepts only web- based on- line submissions via. The applicant for product registration must be. Suruhanjaya Syarikat Malaysia (SSM) or Malaysian Registrar of. Business (ROB). The applicant (if said company is not the product owner) should. He shall be responsible for updating any information. The DCA should be informed in. Good Manufacturing Practice. GMP) compliance of the manufacturers (and repackers, if. The amount of fees is as stipulated in The Control. Drugs and Cosmetics (Amendment) Regulations 2. Applications without the correct. Letter of authorization from the product owner. Where a product is contract manufactured, letters of. Imported products will also need to furnish either a. Certificate of Pharmaceutical Product (CPP) from the competent. OR. ii. Certification for Free Sale (CFS) and Good Manufacturing Practice. GMP) from the relevant competent authorities as deemed. DCA for the following groups of products. The product registration shall be. This second source product shall be the same. PROCESSING OF APPLICATIONS. Initiation of Review. Review of applications will follow a queue system. REGULATORY OUTCOME. Decisions of the DCA. A regulatory decision is made based on the outcome of the evaluation of the. An application may be approved or rejected and the. DCA decision will be sent via e- mail to the marketing authorization holder. The registration number is specific. It may NOT be used for any other product. All notice of. appeals MUST be made within fourteen (1. DCA notification. A period of 9. 0 days is allowed for other. The appeal is considered closed if all the required. Any. request for extension of this period will not be entertained. MAINTENANCE OF REGISTRATION. Conditions for Registration . The. affixing of the security device to product labelling has been identified as a. DCA. The use of the security device and other general conditions for. Appendices 1 & 1. Upon expiry of the validity period of. CHANGE IN PARTICULARS OF REGISTERED PRODUCTS. No change in product name, product specifications, packing, indications. DCA. All. relevant supporting data related to the above changes such as finished. FPQC), Certificates of Analysis (CA). The. marketing authorization holder is responsible for ensuring that all the. REPORTING PROBLEMS WITH REGISTERED PRODUCTS. Adverse Drug Reactions. The Malaysian Adverse Drug Reactions Advisory Committee (MADRAC), Sub- . Drug Control Authority (DCA), reviews Malaysian reports of. Unless the failure is. No recall should take place. DCA. TERMINATION OF PRODUCT REGISTRATION BY. MARKETING AUTHORIZATION HOLDER. The marketing authorization holder shall inform the DCA of any decision to. The onus is on the holder to inform the manufacturer /. A. new application must be submitted should its registration be required. CHANGE IN MARKETING AUTHORIZATION HOLDER OF A. REGISTERED PRODUCT. A product registration (marketing authorisation) may be transferred from the. MAH) to another holder using a. This administrative procedure allows for a speedy processing. The transfer. procedure must be used where the legal entity of the MAH is changed. An application for permission to transfer the marketing authorisation of a. MAH. The existing product registration must have a remaining period of validity. If the period is less than six (6) months, product. MAH before the. transfer application is submitted. No change may be made, as part of the transfer application, to the. MAH. The transferred marketing authorisation is issued for the remaining period. The transfer shall come into effect on the day the DCA makes its decision. Upon the transfer of product registration (marketing.
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