24 July 2018

[Reminder] Circular # 159 Good Pharmacovigilance Practices Guide

Reference: CIR-2018-SHN0871

To: All Health Facilities - Private Sector in Dubai

Based on the Ministry of Health and Prevention keenness to support and develop health services in the country, to raise them to the desired level, and in order to ensure the preservation of public health in the society. It was decided to adopt the pharmacovigilance guide (attached), which includes updated methods for reporting the side effects and adverse reactions of medical products. Which are registered, marketed, and used in public and private health institutions in the UAE. In the event of side effects or adverse reactions resulting from the use of these medical products, the following shall be observed:

1.      Reporting the Adverse Drug Reactions (ADR) of medicines and medical products within 15 working days from the date of receipt or notification to the Ministry of Health and Prevention.

2.     Replace the manual paper reporting forms with electronic reports using an electronic program or smart phone application:

The Link to report via electronic reporting program:

http://www.mohap.gov.ae/ar/services/Pages/406.aspx

The Link to download the application of the smart phone on Androidd evices (Android):

https://play.google.com/store/apps/details?id=com.mhra.mohap

The Link to download the smartphone application on devices running the (IOS) operating system:

https://itunes.apple.com/ae/app/uaeradr/id1374384487?mt=8

For further information, please contact the Pharmacovigilance Department the Ministry of Health and Prevention at:pv@moh.gov.ae

·      To avoid any violations or penalties all health facilities must adhere to this Circular in accordance with the instructions in this regard.

For more information, kindly contact the call center on: Telephone: 800-342

Email address:  regulation@dha.gov.ae

Your co-operation is highly appreciated

For getting full information and access on documents in relation, please refer to the following links:

https://www.dha.gov.ae/Documents/HRD/Circular%20%20159.pdf

https://www.dha.gov.ae/Documents/HRD/UAE%20MOH%20GVP%20Guidlines%202017.pdf

https://www.dha.gov.ae/Documents/HRD/%D8%AA%D8%B9%D9%85%D9%8A%D9%85%20-%20%D8%AF%D9%84%D9%8A%D9%84%20%D9%85%D9%85%D8%A7%D8%B1%D8%B3%D8%A9%20%D8%A7%D9%84%D9%8A%D9%82%D8%B8%D8%A9%20%D8%A7%D9%84%D8%AF%D9%88%D8%A7%D8%A6%D9%8A%D8%A9%20%D8%A7%D9%84%D8%AC%D9%8A%D8%AF%D8%A9.pdf

https://www.dha.gov.ae/Documents/HRD/%D8%AA%D8%B9%D9%85%D9%8A%D9%85%20%D8%A7%D9%84%D8%A7%D8%A8%D9%84%D8%A7%D8%BA%20%D8%B9%D9%86%20%D8%A7%D9%84%D8%A7%D8%AB%D8%A7%D8%B1%20%D8%A7%D9%84%D8%AC%D8%A7%D9%86%D8%A8%D9%8A%D8%A9%20%D9%84%D9%84%D8%A7%D8%AF%D9%88%D9%8A%D8%A9.pdf

https://www.dha.gov.ae/Documents/HRD/%D8%B6%D9%88%D8%A7%D8%A8%D8%B7%20%D9%88%20%D8%B4%D8%B1%D9%88%D8%B7%20%D8%A7%D9%84%D9%8A%D9%82%D8%B8%D8%A9%20%D8%A7%D9%84%D8%AF%D9%88%D8%A7%D8%A6%D9%8A%D8%A9%20%D8%A7%D9%84%D8%AC%D9%8A%D8%AF%D8%A9%20%D9%84%D8%AF%D9%88%D9%84%D8%A9%20%D8%A7%D9%84%D8%A7%D9%85%D8%A7%D8%B1%D8%A7%D8%AA%20%D8%A7%D9%84%D8%B9%D8%B1%D8%A8%D9%8A%D8%A9%20%D8%A7%D9%84%D9%85%D8%AA%D8%AD%D8%AF%D8%A9.pdf

Supporting Documents:

Circular 159.pdf:

View Document

UAE MOH GVP Guidlines 2017.pdf:

View Document

تعميم - دليل ممارسة اليقظة الدوائية الجيدة.pdf:

View Document

تعميم الابلاغ عن الاثار الجانبية للادوية.pdf:

View Document

ضوابط و شروط اليقظة الدوائية الجيدة لدولة الامارات العربية المتحدة.pdf:

View Document