NPRA - Announcement http://npra.moh.gov.my Mon, 21 May 2018 17:06:43 +0800 Open Source Excellence RSS Feeder en-gb 2018 Education Seminar Series: Good Distribution Practice (GDP) http://npra.moh.gov.my/index.php/announcement/1292-2018-education-seminar-series-good-distribution-practice-gdp http://npra.moh.gov.my/index.php/announcement/1292-2018-education-seminar-series-good-distribution-practice-gdp

Good Distribution Practice (GDP)

7 May 2018 (Monday) | 9.00 am – 5.00 pm

Venue

THE ROYALE CHULAN DAMANSARA, Petaling Jaya

Who should attend

Manufacturers, importers, wholesalers and relevant parties involved in the storage / distribution of registered products and / or notified cosmetics

Objectives

• To highlight changes in the latest Guideline on GDP (3rd Edition, 2018)
• To share NPRA’s experience on GDP inspections
• To keep abreast of knowledge relevant to GDP

 

 

Registration Fee

 

(The fee includes course materials, lunch and refreshments)

 

 

 Ordinary ISPE Member : RM 750 
 Non ISPE Members  : RM 1,000
 Government Agencies & Academia ISPE Members  : RM 450
   

  Register Here


  DOWNLOAD PDF

 

  


 

 

 

{pdf=http://npra.moh.gov.my/images/training-seminar/2018/FlyerISPE_GDP_final.pdf|1120|1160|google}

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Fri, 13 Apr 2018 12:35:00 +0800
PERINGATAN: Tarikh perlaksanaan kawalan regulatori API untuk permohonan baru produk generik yang mengandungi Racun Berjadual bagi produk dalam SEMUA bentuk dos berkuatkuasa 1 JULAI 2018. http://npra.moh.gov.my/index.php/announcement/1296-peringatan-tarikh-perlaksanaan-kawalan-regulatori-api-untuk-permohonan-baru-produk-generik-yang-mengandungi-racun-berjadual-bagi-produk-dalam-semua-bentuk-dos-berkuatkuasa-1-julai-2018a http://npra.moh.gov.my/index.php/announcement/1296-peringatan-tarikh-perlaksanaan-kawalan-regulatori-api-untuk-permohonan-baru-produk-generik-yang-mengandungi-racun-berjadual-bagi-produk-dalam-semua-bentuk-dos-berkuatkuasa-1-julai-2018a             DOWNLOAD PDF         DOWNLOAD PDF ]]> jauze16@gmail.com (Jauze) Tue, 01 May 2018 00:31:00 +0800 Direktif Mengenai Penerimaan Pengesahan Pematuhan Amalan Perkilangan Baik (APB) Bagi Pegilang Farmaseutikal Bagi Tujuan Pendaftaran Baru/ Pendaftaran Semula Produk Farmaseutikal Berdaftar Dengan Pihak Berkuasa Kawalan Dadah (PBKD) http://npra.moh.gov.my/index.php/announcement/1299-direktif-mengenai-penerimaan-pengesahan-pematuhan-amalan-perkilangan-baik-apb-bagi-pegilang-farmaseutikal-bagi-tujuan-pendaftran-baru-pendaftaran-semula-produk-farmaseutiakl-berdaftar-dengan-pihak-berkuasa-kawalan-dadah-pbkd-2 http://npra.moh.gov.my/index.php/announcement/1299-direktif-mengenai-penerimaan-pengesahan-pematuhan-amalan-perkilangan-baik-apb-bagi-pegilang-farmaseutikal-bagi-tujuan-pendaftran-baru-pendaftaran-semula-produk-farmaseutiakl-berdaftar-dengan-pihak-berkuasa-kawalan-dadah-pbkd-2  

 

{pdf=http://npra.moh.gov.my/images/Circulars_Directive/Regulatory_Information/2018/DirektifpenerimaanpengesahanpematuhanAPBbagipengilangfarmaseutikal.pdf|1120|1160|google}

 

 

 

 

 

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jauze16@gmail.com (Jauze) Wed, 16 May 2018 08:25:00 +0800
Berita Ubat-ubatan : March 2018, Volume 71 http://npra.moh.gov.my/index.php/announcement/1291-berita-ubat-ubatan-march-2018-volume-71 http://npra.moh.gov.my/index.php/announcement/1291-berita-ubat-ubatan-march-2018-volume-71
  DOWNLOAD PDF


 

 

 

{pdf=http://npra.moh.gov.my/images/Publications/Newsletter_Berita_Ubat-ubatan/2018/BUUMAC18.pdf|1120|1160|google}

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Fri, 13 Apr 2018 08:35:00 +0800
Berita Ubat-ubatan : December 2017, Volume 70 http://npra.moh.gov.my/index.php/announcement/1290-berita-ubat-ubatan-december-2017-volume-70 http://npra.moh.gov.my/index.php/announcement/1290-berita-ubat-ubatan-december-2017-volume-70
  DOWNLOAD PDF


 

 

 

{pdf=http://npra.moh.gov.my/images/Publications/Newsletter_Berita_Ubat-ubatan/2017/BUUDEC17.pdf|1120|1160|google}

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Fri, 13 Apr 2018 08:30:00 +0800
National Regulatory Conference (NRC) 2018 http://npra.moh.gov.my/index.php/announcement/1288-national-regulatory-conference-nrc-2018 http://npra.moh.gov.my/index.php/announcement/1288-national-regulatory-conference-nrc-2018  National Regulatory Conference (NRC) 2018

Tuesday, 2 October 2018 until Thursday, 4 October 2018

 

Theme :
Regulatory Excellence : The New Normal

Venue : 
Hotel Royale Chulan Damansara, Selangor

Contact person :
Name : Ms. Balqis / Ms. Bavahrni / Mr. Kevin Heah

Telephone : +603-7883 5535 / +603-7801 8475 / +603-7883 5540

Email : nrcreg2018@gmail.com

Organizer : 
National Pharmaceutical Regulatory Agency (NPRA), Ministry Of Health

Registration Fee :

Local Full Conference (3 Days) : MYR 1525
Local Single Track  (TMHS ONLY, 1 DAY) : MYR 1000
Overseas (full conference) : USD 550
Government : MYR 700
Student : MYR 500

 

  REGISTRATION IS POSTPONED UNTIL 1st june 2018

 


 

Kindly be informed that the registration for NRC 2018 has temporarily been postponed for the revision of the conference fee.

This is in view of the Zero-rated GST implementation effective 1st June 2018. 

Registration will resume on 1st June 2018 based on the newly revised fee (to be announced soon).

 

 

TENTATIVE AGENDA FOR NATIONAL REGULATORY CONFERENCE (NRC) 2018*

 

 *subject to changes

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jauze16@gmail.com (Jauze) Mon, 09 Apr 2018 15:22:00 +0800
Berita Ubat-ubatan : September 2017, Volume 69 http://npra.moh.gov.my/index.php/announcement/1289-berita-ubat-ubatan-september-2017-volume-69 http://npra.moh.gov.my/index.php/announcement/1289-berita-ubat-ubatan-september-2017-volume-69
  DOWNLOAD PDF


 

 

 

{pdf=http://npra.moh.gov.my/images/Publications/Newsletter_Berita_Ubat-ubatan/2017/BUUSEPT17.pdf|1120|1160|google}

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Fri, 13 Apr 2018 08:19:00 +0800
Latihan untuk Industri: Pemeriksaan APB Pengilang Veterinar http://npra.moh.gov.my/index.php/announcement/1287-latihan-untuk-industri-pemeriksaan-apb-pengilang-veterinar http://npra.moh.gov.my/index.php/announcement/1287-latihan-untuk-industri-pemeriksaan-apb-pengilang-veterinar

Pemeriksaan Apb Pengilang Veterinar & Keperluan Pemeriksaan Apb Pengilang Veterinar

24 & 25 April 2018 (Selasa & Rabu)

 

Objectives

1.     Memberi pendedahan kepada pengilang berkenaan direktif dan garis panduan terkini berkaitan pemeriksaan APB premis pengilang produk veterinar.

2.     Meningkatkan kefahaman pengilang produk veterinar berkenaan keperluan APB.

3.   Memberi peluang kepada pengilang dan NPRA untuk berkongsi isu-isu berkaitan pemeriksaan APB.

 

 

Venue    : Royale Chulan Damansara,Petaling Jaya

 

Time      : 9.00 pagi – 5.00 petang

 

 


  REGISTER HERE

 


 

drgd 
  DOWNLOAD FLIER


{pdf=http://npra.moh.gov.my/images/Images/Banner/2018/FlyerISPEVeterinaryApr2018.pdf|1120|1160|google}

 

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jauze16@gmail.com (Jauze) Thu, 05 Apr 2018 15:22:23 +0800
MAKLUMAN SCAM PANGGILAN TELEFON http://npra.moh.gov.my/index.php/announcement/1286-makluman-scam-panggilan-telefon http://npra.moh.gov.my/index.php/announcement/1286-makluman-scam-panggilan-telefon Sejak kebelakangan ini, Bahagian Regulatori Farmasi Negara (NPRA) telah menerima laporan berkaitan kes penipuan atau scam menggunakan panggilan telefon. Didapati bahawa terdapat pelanggan NPRA yang telah menerima panggilan telefon daripada suspek yang mendakwa mereka sebagai pegawai NPRA melalui talian 03 – 7883 5400 atau lain-lain nombor yang seolah-olah merupakan panggilan daripada NPRA. Seterusnya, suspek ini telah meminta nombor kad pengenalan diri serta maklumat lain daripada mangsa.

NASIHAT NPRA:

 

1.    Bertenang dan ingat sama ada anda mempunyai sebarang urusan dengan NPRA atau tidak. Jika tidak, abaikan panggilan tersebut.

2.    Jangan mendedahkan apa-apa maklumat peribadi seperti nombor kad pengenalan, pasport, nombor akaun bank dan sebagainya.

3.    Berhati-hati dan jangan mudah percaya dengan panggilan telefon oleh mana-mana pihak yang mendakwa diri mereka sebagai Pegawai NPRA.

4.    Jangan menghubungi semula sebarang nombor telefon yang diberikan oleh pihak berkenaan sebaliknya buat semakan dengan NPRA melalui talian yang betul.

5.    Untuk sebarang semakan dan pertanyaan lanjut, sila hubungi NPRA melalui saluran berikut:

 

--------------------------------------------------------------------------------------------------------------------------------------------------------------------

 

 

NOTICE

 

SCAM TELEPHONE CALLS

 

Recently, the National Pharmaceutical Regualtory Division (NPRA) has received reports from the public regarding scam telephone calls that were made by individuals who claimed to be NPRA officers. The telephone numbers that appeared on the victims’ phones were from 03 – 7883 5400 and other NPRA related numbers which made the calls seemingly viable. These individuals would then request for verification of IC numbers and / or other personal information from the victims.

 

NPRA’S ADVICE:

 

1.    Keep calm and try to recall whether you have had any recent official dealings with NPRA. If not, kindly ignore the telephone call.

2.    Do not expose any personal details over the phone, for example, your identity card number, passport number, bank account number etc.

3.    Be wary and cautious if you receive any telephone calls from individuals claiming to be NPRA officers.

4.    Do not return calls to NPRA using the phone numbers given by these individuals over the phone. Instead, check back via the NPRA official website for the correct phone numbers to call.

5.    For any further enquiries, kindly contact the NPRA via the following channels:

 

 

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jauze16@gmail.com (Jauze) Thu, 05 Apr 2018 12:01:00 +0800
New Safety Alerts for Healthcare Professionals http://npra.moh.gov.my/index.php/announcement/1285-new-safety-alerts-for-healthcare-professionals http://npra.moh.gov.my/index.php/announcement/1285-new-safety-alerts-for-healthcare-professionals New Safety Alerts Update :

  1. Levetiracetam and Methotrexate: Risk of Drug-drug Interaction
  2. Intravenous (IV) Fluids Containing Electrolytes and/or Carbohydrates: Risk of Hyponatraemia
  3. Gadolinium-based Contrast Agents: Suspension / Restriction of Use Following Evidence of Gadolinium Deposits in the Brain after Magnetic Resonance Imaging (MRI) Body Scans
  4. Doxycycline: Risk of Jarisch-Herxheimer Reaction

 

 

  More Safety Alerts

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jauze16@gmail.com (Jauze) Fri, 23 Mar 2018 15:14:29 +0800
QUEST3+ System USB token package http://npra.moh.gov.my/index.php/announcement/1280-quest3-system-usb-token-package http://npra.moh.gov.my/index.php/announcement/1280-quest3-system-usb-token-package MSC Trustgate USB token package with 3 years validity will be no longer offered. For more information, kindly contact MSC Trustgate Customer Care at 03-8318 1800.

  

* Price stated in bracket inclusive of 6% GST.

 

1 Year

2 Years

 

Main User – New, Replacement, Change Authorized Person
(Certificate + USB Token)

260

(275.60)

290

(307.40)

Supplementary User – New, Replacement, Change Authorized Person
(Certificate + USB Token)

245

(259.70)

275

(291.50)

Change Authorized Person (Certificate Only)

48

 

(50.90)

95

 

(100.70)

Renewal

(Digital Certificate only – using existing MSC USB Token)

 

48

 

(50.90)

 

95

 

(100.70)

Postage (Semenanjung Malaysia)

10 (10.60)

Postage (Sabah/Sarawak)

20 (21.20)

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jauze16@gmail.com (Jauze) Mon, 19 Mar 2018 09:39:20 +0800
New Publication: MADRAC Bulletin - Issue 3/2017 http://npra.moh.gov.my/index.php/announcement/1279-new-publication-madrac-bulletin-issue-3-2017 http://npra.moh.gov.my/index.php/announcement/1279-new-publication-madrac-bulletin-issue-3-2017

MADRAC Bulletin - Issue 03/2017

 

Safety Issues Presented to MADRAC in 2017

Regulatory Matters

▪ Fluconazole: Risk of Spontaneous Abortion and Multiple Congenital Abnormalities
▪ Tramadol: Restricted Use in Children and Warnings of Use in Pregnant and Breastfeeding Women
▪ Metformin: Use in Patients with Moderately Reduced Kidney Function
▪ Metronidazole: Risk of Hepatotoxicity in Patients with Cockayne Syndrome
▪ Aripiprazole: Risk of Pathological Gambling and Impulse-Control Problems

ADR Reporting

▪ CPD Points for Quality ADR Reporting

 


 

drgd 
  DOWNLOAD PDF


{pdf=http://npra.moh.gov.my/images/Publications/Newsletter_MADRAC_Bulletin/2018/MADRACBulletin032017.pdf|1120|1160|google}

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jauze16@gmail.com (Jauze) Tue, 13 Mar 2018 10:12:00 +0800
Housekeeping QUEST3+ System! http://npra.moh.gov.my/index.php/announcement/1276-housekeeping-quest3-system http://npra.moh.gov.my/index.php/announcement/1276-housekeeping-quest3-system Dear product registration holder (PRH) / QUEST3+ user,

 

NPRA seeks your kind cooperation to check addresses registered under your company in order to ensure there is no duplicated address or inactive address. You may check the addresses at “Membership Utilities” module > “Company profile” tab > “Business Address” section after login to QUEST3+ system.

 

If you do notice multiple similar addresses for an address category (alamat kilang, alamat pengimport, alamat pemborong, stor, pengilang kosmetik etc), please kindly lodge an enquiry/complaint at https://quest3plus.bpfk.gov.my/front-end/helpdesk.php

 

For your information, duplicated or inactive address may cause problems in

1.)    Registration of new product where incorrect/inactive address is selected

2.)    Change of site

3.)    Application of GMP certificate or sijil Amalan Perkilangan Baik (APB) and import/wholesale/importer’s license

4.)    Etc

 

Thank you.

 

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farred9754@gmail.com (fariqafifi) Mon, 12 Mar 2018 12:00:00 +0800
Updates on Foreign GMP Regulatory Inspection 2019 http://npra.moh.gov.my/index.php/announcement/1275-updates-on-foreign-gmp-regulatory-inspection-2019 http://npra.moh.gov.my/index.php/announcement/1275-updates-on-foreign-gmp-regulatory-inspection-2019 Date : 13th March 2018 (Tuesday)
Time: 8.30am - 12.30pm
Venue: Hotel Royale Chulan The Curve

 

 

 

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farred9754@gmail.com (fariqafifi) Wed, 07 Mar 2018 14:36:00 +0800
Application Of Combination Pack (Combo Pack) http://npra.moh.gov.my/index.php/announcement/1273-application-of-combination-pack-combo-pack http://npra.moh.gov.my/index.php/announcement/1273-application-of-combination-pack-combo-pack For a combination pack consists of registered products from different product owners/PRH, the application need to be submitted manually (please use the application form NPRA 500CP).

1. Applicant to submit dossier/application and payment of new combo pack manually to finance department.

2. Finance department will issue receipt & submit documents to PPP.

3. Evaluation and correspondence processes will be carried out manually.

4. Upon DCA decision, the product will only be updated and shown in Q3+ after 14 days once PPPS received full and complete data from PPP.

(a) The data must be in Microsoft word for text field info and attachments must be in PDF or JPEG only with size < 5Mb.

5. Online receipt, correspondence and remark during evaluation will not be available online in Q3+.

 

 

 

 

 

 

 

 

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jauze16@gmail.com (Jauze) Tue, 06 Mar 2018 14:36:00 +0800
Malaysian Herbal Monograph 2015 http://npra.moh.gov.my/index.php/announcement/1264-gentle-reminder-application-for-product-registration http://npra.moh.gov.my/index.php/announcement/1264-gentle-reminder-application-for-product-registration

 

{pdf=http://npra.moh.gov.my/images/Announcement/2018/mhm.pdf|1120|1160|google}

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jauze16@gmail.com (Jauze) Mon, 12 Feb 2018 09:31:35 +0800
Berita Ubat-ubatan : Mac 2017 http://npra.moh.gov.my/index.php/announcement/1261-berita-ubat-ubatan-jun-2018 http://npra.moh.gov.my/index.php/announcement/1261-berita-ubat-ubatan-jun-2018

Berita Ubat-ubatan,

Volume 67, Mac 2017

 


 



   
  DOWNLOAD PDF


 

 

 

{pdf=http://npra.moh.gov.my/images/Publications/Newsletter_Berita_Ubat-ubatan/2017/BUUMAC17.pdf|1120|1160|google}

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Tue, 06 Feb 2018 08:19:00 +0800
Berita Ubat-ubatan : Jun 2017 http://npra.moh.gov.my/index.php/announcement/1260-berita-ubat-ubatan-jun-2017 http://npra.moh.gov.my/index.php/announcement/1260-berita-ubat-ubatan-jun-2017

Berita Ubat-ubatan,

Volume 68,  Jun 2017

 


 



   
  DOWNLOAD PDF


 

 

 

{pdf=http://npra.moh.gov.my/images/Publications/Newsletter_Berita_Ubat-ubatan/2017/BUUJUN217.pdf|1120|1160|google}

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Tue, 06 Feb 2018 08:20:00 +0800
PERINGATAN: Tarikh perlaksanaan kawalan regulatori API untuk permohonan baru produk generik yang mengandungi Racun Berjadual bagi produk dalam SEMUA bentuk dos berkuatkuasa 1 JULAI 2018. http://npra.moh.gov.my/index.php/announcement/1252-peringatan-tarikh-perlaksanaan-kawalan-regulatori-api-untuk-permohonan-baru-produk-generik-yang-mengandungi-racun-berjadual-bagi-produk-dalam-semua-bentuk-dos-berkuatkuasa-1-julai-2018 http://npra.moh.gov.my/index.php/announcement/1252-peringatan-tarikh-perlaksanaan-kawalan-regulatori-api-untuk-permohonan-baru-produk-generik-yang-mengandungi-racun-berjadual-bagi-produk-dalam-semua-bentuk-dos-berkuatkuasa-1-julai-2018

PERINGATAN:


Tarikh perlaksanaan kawalan regulatori API untuk permohonan baru produk generik yang mengandungi Racun Berjadual bagi produk dalam SEMUA bentuk dos berkuatkuasa 1 JULAI 2018.

 

Download Circular :

1. Pekeliling Lanjutan Tarikh Pelaksanaan Pengawalan Bahan Aktif Farmaseutikal (API) Bagi Produk Farmaseutikal Berdaftar Yang Mengandungi Racun Berjadual

2. 

Peraturan-Peraturan Kawalan Dadah dan Kosmetik 1984 (Pindaan 2006) Arahan Pengarah Kanan Perkhidmatan Farmasi Bilangan 8 Tahun 2013 : Direktif Pelaksanaan Pengawalan Bahan Aktif Farmaseutikal bagi Produk GEnerik (Fasa II)

 

{pdf=http://npra.moh.gov.my/images/Announcement/2018/DirektifLanjutanTarikhKawalanAPIBagiProdukFarmaseutikalBerdaftar27062014pdf.pdf|1120|1160|google}

 

  

{pdf=http://npra.moh.gov.my/images/Announcement/2018/DirektifKawalanGenerikAPI16012014.pdf|1120|1160|google}

 

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jauze16@gmail.com (Jauze) Tue, 16 Jan 2018 08:11:00 +0800
Lanjutan Tarikh Pelaksanaan Pemakaian Guideline For Regsitration Of Drug-Medical Device And Medical Device-Drug Combination Products http://npra.moh.gov.my/index.php/announcement/1248-lanjutan-tarikh-pelaksanaan-pemakaian-guideline-for-regsitration-of-drug-medical-device-and-medical-device-drug-combination-products http://npra.moh.gov.my/index.php/announcement/1248-lanjutan-tarikh-pelaksanaan-pemakaian-guideline-for-regsitration-of-drug-medical-device-and-medical-device-drug-combination-products  

 

{pdf=http://npra.moh.gov.my/images/Announcement/2018/lanjutan_tarikh_pelaksanaan_pemakaian_guideline_for_registration_of_combination_products.pdf|1120|1160|google}

 

 

 

 

 

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jauze16@gmail.com (Jauze) Wed, 03 Jan 2018 08:11:00 +0800