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+603-7956 7075
NPRA
CERTIFICATE FOR THE RELEASE Certificate no: LRC 066/2021 The following lot of COVID-19 Vaccine AstraZeneca Solution for Injection (MAID 1046001 AZ) produced by SK bioscience Co., Ltd., Gyeongsangbuk-do, PRODUCT CLASSIFICATION GUIDELINE 1. 100% food ingredients. 2. Food products with or without active ingredients ( eg; herbs, vitamins, minerals, etc) as below: i) Instant drink products containing sugar and creamer (e.g. premix coffee, tea, chocolate, soy, cereal). ii) Meat essence products (liquid) (e.g. chicken essence, ostrich essence, duck essence, fish essence etc.) DRUG REGISTRATION GUIDANCE DOCUMENT Drug Registration Guidance Document (DRGD), Third Edition, January 2021. This “ DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD)” will serve as the reference guide for the registration process including quality control, inspection & licensing and post-registration activities of medicinal products. NPRA STAFF DIRECTORY STAFF DIRECTORY If the staff you wish to contact is not listed, please contact the General Line : 03-78835400 . FREQUENTLY ASKED QUESTIONS (FAQ) ABOUT ASTRAZENECA … Page 1 of 5 FREQUENTLY ASKED QUESTIONS (FAQ) ABOUT ASTRAZENECA COVID-19 VACCINE Q1: What vaccine is being registered? A1: The Drug Control Authority (DCA) in its 354th meeting has granted COVID-19 Vaccine AstraZeneca Solution for Injection (Product Registration Holder: AstraZeneca Sdn. NPRA STAFF DIRECTORY hooisann@npra.gov.my. Senior Assistant Director, UF44. Generic Medicines Section. Centre of Product & Cosmetic Evaluation (PPPK) Zarith Nadia Mohamad Zulkifli. 0378835536. zarith_nadia@npra.gov.my. Senior Assistant Director, UF44. COSMETICS GUIDELINE ( ANNEX I Document Name. Updated. Guidelines for Control of Cosmetic Products in Malaysia. Feb-17. Annex I, Part 1: Illustrative List Of Cosmetic Products By Categories. Feb-17. Annex I, Part 2: Non-Permissible Product Name For Cosmetic Product. Feb-17. Annex I, GUIDELINES FOR THE REGISTRATION OF SURFACE DISINFECTANT 1 1.0 Introduction Surface disinfection is defined as chemical disinfection of a solid surface, including those of certain medical and veterinary instruments which cannot be FREQUENTLY ASKED QUESTIONS (FAQ) ABOUT COMIRNATY … Page 5 of 8 FREQUENTLY ASKED QUESTIONS (FAQ) ABOUT COMIRNATY VACCINE Q1: What vaccine is being registered? A1: The Drug Control Authority (DCA) in its 352th meeting has granted Pfizer (M) Sdn Bhd’s COMIRNATY Concentrate for Dispersion for Injection a CONDITIONAL REGISTRATION on 8th January 2021. COMIRNATY contains 30µg of nucleoside-modified mRNA NATIONAL PHARMACEUTICAL REGULATORY AGENCY (NPRA) Email: npra@npra.gov.my; Phone: +603-7883 5400; Fax: +603-7956 2924,+603-7956 7075
NPRA
CERTIFICATE FOR THE RELEASE Certificate no: LRC 066/2021 The following lot of COVID-19 Vaccine AstraZeneca Solution for Injection (MAID 1046001 AZ) produced by SK bioscience Co., Ltd., Gyeongsangbuk-do, PRODUCT CLASSIFICATION GUIDELINE 1. 100% food ingredients. 2. Food products with or without active ingredients ( eg; herbs, vitamins, minerals, etc) as below: i) Instant drink products containing sugar and creamer (e.g. premix coffee, tea, chocolate, soy, cereal). ii) Meat essence products (liquid) (e.g. chicken essence, ostrich essence, duck essence, fish essence etc.) DRUG REGISTRATION GUIDANCE DOCUMENT Drug Registration Guidance Document (DRGD), Third Edition, January 2021. This “ DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD)” will serve as the reference guide for the registration process including quality control, inspection & licensing and post-registration activities of medicinal products. NPRA STAFF DIRECTORY STAFF DIRECTORY If the staff you wish to contact is not listed, please contact the General Line : 03-78835400 . FREQUENTLY ASKED QUESTIONS (FAQ) ABOUT ASTRAZENECA … Page 1 of 5 FREQUENTLY ASKED QUESTIONS (FAQ) ABOUT ASTRAZENECA COVID-19 VACCINE Q1: What vaccine is being registered? A1: The Drug Control Authority (DCA) in its 354th meeting has granted COVID-19 Vaccine AstraZeneca Solution for Injection (Product Registration Holder: AstraZeneca Sdn. NPRA STAFF DIRECTORY hooisann@npra.gov.my. Senior Assistant Director, UF44. Generic Medicines Section. Centre of Product & Cosmetic Evaluation (PPPK) Zarith Nadia Mohamad Zulkifli. 0378835536. zarith_nadia@npra.gov.my. Senior Assistant Director, UF44. COSMETICS GUIDELINE ( ANNEX I Document Name. Updated. Guidelines for Control of Cosmetic Products in Malaysia. Feb-17. Annex I, Part 1: Illustrative List Of Cosmetic Products By Categories. Feb-17. Annex I, Part 2: Non-Permissible Product Name For Cosmetic Product. Feb-17. Annex I, GUIDELINES FOR THE REGISTRATION OF SURFACE DISINFECTANT 1 1.0 Introduction Surface disinfection is defined as chemical disinfection of a solid surface, including those of certain medical and veterinary instruments which cannot be FREQUENTLY ASKED QUESTIONS (FAQ) ABOUT COMIRNATY … Page 5 of 8 FREQUENTLY ASKED QUESTIONS (FAQ) ABOUT COMIRNATY VACCINE Q1: What vaccine is being registered? A1: The Drug Control Authority (DCA) in its 352th meeting has granted Pfizer (M) Sdn Bhd’s COMIRNATY Concentrate for Dispersion for Injection a CONDITIONAL REGISTRATION on 8th January 2021. COMIRNATY contains 30µg of nucleoside-modified mRNANPRA
CERTIFICATE FOR THE RELEASE Certificate no: LRC 066/2021 The following lot of COVID-19 Vaccine AstraZeneca Solution for Injection (MAID 1046001 AZ) produced by SK bioscience Co., Ltd., Gyeongsangbuk-do,PRODUCTS SEARCH
Email: npra@npra.gov.my; Phone: +603-7883 5400; Fax: +603-7956 2924,+603-7956 7075
NPRA.GOV.MY
Created Date: 4/27/2021 9:11:02 AM SAFETY UPDATES ON COVID-19 VACCINE (COMIRNATY®) Safety Updates on COVID-19 Vaccine (Comirnaty®) According to World Health Organisation (WHO), vaccination will be an important tool to stop the COVID-19 pandemic. Now, a year after the pandemic erupted, more than 60 COVID-19 vaccine candidates had been developed and some of them had been granted authorisations in hope to end the battleagainst
WWW.NPRA.GOV.MY
Author: Maslinda Created Date: 20210531155802Z NPRA STAFF DIRECTORY Email: npra@npra.gov.my; Phone: +603-7883 5400; Fax: +603-7956 2924,+603-7956 7075
NPRA
Once the applicant has received the USB Token, he/she will be able to enter the registration site and proceed with online submission. The summary of the online registration procedure for products are as follows:-. 1) Go to NPRA website (www.npra.gov.my) > Industry GUIDANCE DOCUMENT FOREIGN GMP INSPECTION, 7TH EDITION Guidance Document Foreign GMP Inspection, 7th Edition, March 2021. Posted By Mohamad Amirrudin bin Said. 18 February 2021. Hits: 1471.Print.
REGISTER USB TOKEN
Email: npra@npra.gov.my; Phone: +603-7883 5400; Fax: +603-7956 2924,+603-7956 7075
DIPRODIN ELIXIR
DIPRODIN ELIXIR Diphenhydramine Hydrochloride (12.5mg/5ml) Ephedrine Hydrochloride (6mg/5ml) 2 Consumer Medication Information Leaflet(RiMUP)
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KINDLY BE INFORMED THAT STAFF OF NATIONAL PHARMACEUTICAL REGULATORY AGENCY (NPRA), MINISTRY OF HEALTH (MOH) MALAYSIA WILL BE WORKING FROM HOME (WFH) UNLESS INSTRUCTED OTHERWISE. PLEASE BE ADVISED TO CONTACT OFFICERS VIA EMAIL DURING THIS PERIOD TO ENSURE THE CONTINUITY OF SERVICE PROVIDED. MAIN COUNTER AND LABORATORY COUNTER FOR SAMPLE SUBMISSION WILL BE OPENED MONDAY - FRIDAY FROM 9.00 AM TO 1.00 PM; EXCLUDING PUBLICHOLIDAYS.
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AS NPRA'S MISSION IS TO SAFEGUARD THE NATION'S HEALTH, NPRA HAS KEPT UP TO DATE WITH CURRENT SITUATIONS AND PROVIDE GUIDANCE FOR DURING CMCO AND FOR THIS PANDEMIC PERIOD.MORE INFO
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IMPORTANT NOTICE
KINDLY BE INFORMED THAT STAFF OF NATIONAL PHARMACEUTICAL REGULATORY AGENCY (NPRA), MINISTRY OF HEALTH (MOH) MALAYSIA WILL BE WORKING FROM HOME (WFH) UNLESS INSTRUCTED OTHERWISE. PLEASE BE ADVISED TO CONTACT OFFICERS VIA EMAIL DURING THIS PERIOD TO ENSURE THE CONTINUITY OF SERVICE PROVIDED. MAIN COUNTER AND LABORATORY COUNTER FOR SAMPLE SUBMISSION WILL BE OPENED MONDAY - FRIDAY FROM 9.00 AM TO 1.00 PM; EXCLUDING PUBLICHOLIDAYS.
PLEASE FIND THE STAFF DIRECTORY LINK BELOW: HTTPS://WWW.NPRA.GOV.MY/INDEX.PHP/EN/ABOUT/CONTACT-US/STAFF-DIRECTORY-2EN.HTML FOR ANY PUBLIC ENQUIRY KINDLY EMAIL TO NPRA@NPRA.GOV.MY FOR GENERAL ENQUIRY OR QUEST SYSTEM ENQUIRY, KINDLY USE THE HELPDESK SUPPORT AT THE LINK BELOW: HTTPS://QUEST3PLUS.BPFK.GOV.MY/FRONT-END/HELPDESK.PHPCLICK FOR MORE INFO
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NPRA mission is to safeguard the nation’s health through scientific excellence in the regulatory control of medicinal products andcosmetics.
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NEW PRODUCTS APPROVED25May
AWARENESS AND TRAINING ON QUALITY CONTROL IN HERBAL RAW MATERIALS FOR NATURAL PRODUCT MANUFACTURING20May
GARIS PANDUAN PENGIKTIRAFAN MAKMAL SWASTA OLEH BAHAGIAN REGULATORI FARMASI NEGARA (NPRA) BAGI PERKHIDMATAN ANALISIS PRODUK TRADISIONAL11May
ADDITIONAL INDICATIONS APPROVED06May
FREQUENTLY ASKED QUESTIONS (FAQ) ABOUT COVID-19 VACCINE05May
NPRA ANNUAL REPORT 2020 __ View All Announcements Pekeliling Bil 1 2020 MAKLUMAN BERKENAAN STATUS KEMASKINI BAHAN-BAHAN DALAM ANNEX PADA GUIDELINES FOR CONTROL OF COSMETIC PRODUCTS INMALAYSIA
published on 2021-05-06 ------------------------- NPRA Annual Report 2020 published on 2021-05-05 ------------------------- List of Licensed Wholesalers in QUEST System published on 2021-05-05 ------------------------- List of Licensed Manufacturers in QUEST System published on 2021-05-05 ------------------------- List of Licensed Importers in QUEST System published on 2021-05-05 -------------------------More Recent Updates
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KENYATAAN AKHBAR KPK 4 MEI 2021 – PRODUK-PRODUK KOSMETIK YANG DIKESAN MENGANDUNGI RACUN BERJADUAL07Apr
KENYATAAN AKHBAR KPK 6 APRIL 2021 – PRODUK-PRODUK KOSMETIK YANG DIKESAN MENGANDUNGI RACUN BERJADUAL10Mar
KENYATAAN AKHBAR KPK 10 MAC 2021 – PRODUK KOSMETIK YANG DIKESAN MENGANDUNGI RACUN BERJADUAL View All Press Release20May
DIRECTIVES & CIRCULARS FOR COMBINATION PRODUCTS07May
PEKELILING BIL 1 2020 MAKLUMAN BERKENAAN STATUS KEMASKINI BAHAN-BAHAN DALAM ANNEX PADA GUIDELINES FOR CONTROL OF COSMETIC PRODUCTS INMALAYSIA
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DIREKTIF UNTUK SEMUA PRODUK YANG MENGANDUNGI OSELTAMIVIR: PENGEMASKINIAN SISIP BUNGKUSAN DAN RISALAH MAKLUMAT UBAT UNTUK PENGGUNA (RIMUP) DENGAN MAKLUMAT KESELAMATAN BERKAITAN RISIKOTHROMBOCYTOPENIA
__ View All Directives & Circulars26Nov
RETINOIDS: UPDATED MEASURES FOR PREGNANCY PREVENTION DURING RETINOIDSUSE
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FEBURIC® (FEBUXOSTAT): INCREASED RISK OF CARDIOVASCULAR DEATH AND ALL-CAUSE MORTALITY IN PATIENTS TREATED WITH FEBUXOSTAT IN THE CARESSTUDY
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ISPE Malaysia 2021 Webinar Series: Preparing for a Successful Remote Audit or Desktop AssessmentView Full Calendar
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