Industry

Kempen Tolak Ubat Tidak Sah (TOBaTS)

Date: 14 June 2024 - 9:35am

 

 

 

 

 

 

 

 

The “TOLAK UBAT TIDAK SAH” campaign, officially abbreviated as “TOBaTS,” is a new initiative by the Pharmacy Enforcement Division , Ministry of Health (MOH) to combat the issue of illegal supply and sale of medicines in Malaysia.

27th PIC/S Expert Circle Meeting On Human Blood, Tissues, Cells and Advance Therapy Medicinal Products (ATMPs)

Pleased to be informed that the NPRA will organize the 27th PIC/S Expert Circle Meeting On Human Blood, Tissues, Cells and Advance Therapy Medicinal Products (ATMPs) on 20-22 August 2024.

For more information, download the provided attachment.

Location/place: 
Kuala Lumpur, Malaysia
Date: 
Tuesday, 20 August 2024 to Thursday, 22 August 2024

DILUTION GUIDE FOR FLUID RESTRICTED CRITICALLY ILL ADULTS

Date: 19 December 2025 - 8:30am

Critically ill patients are individuals with severe and often life-threatening medical conditions that require round-the-clock monitoring and care by a specialized team of healthcare professionals.

English

What can I do if I have enquiry or would like to get explanation on the approved format by MAB?

Applicants can reach out officers in the secretariat through multiple ways such as phone call (03-7841 3200), email (liu@moh.gov.my), letter or face-to-face meet up if they have enquiry on the approved format. Reasons/ justifications for cancellation of statements or words in the approved advertisement formats or rejection of advertisements will be explained by officers to you. 

Is self-regulation of pharmaceutical products advertisement feasible to be carried out in Malaysia?

Self-regulation is not permissible under Medicines (Advertisement and Sale) Act 1956 and MABR 1976. Subject to R5(1) MABR 1976, all advertisement must be approved by MAB prior to publication. Pharmacy Enforcement Division is in the process of revising Medicines (Advertisement and Sale) Act 1956 and MABR 1976. Stakeholders’ involvement and input can be submitted to the Pharmacy Enforcement Division, MOH.

What is the way forward for MAB in the application of approval process?

Pharmacy Services Program is currently developing an online system called MyPharmaC which enables online application. This system will encompass online payment and online application of approval, which will facilitate the process of application and approval of advertisement. 

What is the difference between the new guidelines and old guidelines?

The main difference in the new GP is the insertion of examples to better explain the context of the GP. Besides, the new GP also consolidates infographic of decision tree, guideline to fill up the application form, application form for new application and amendment, format of celebrity endorsement and customer testimony and the appeal notice to Minister of Ministry of Health Malaysia. 

There are also changes in the provisions within the new guidelines, such as press release of NCE products is now allowed to be published more than one time; supplement products are allowed to be offered as gift for the purchase of the same product; and mandatory statement “This is a medicine/ supplement/ traditional product” has been removed from advertisement format has also been stated in the new guidelines.
 

Are advertisements related to disease awareness program are allowed?

Disease awareness programmes or health education campaign aiming to create awareness on health and diseases without promoting health products is permissible as there are no violations under S4B Medicines (Advertisement & Sale) Act 1956. The organizers should always ensure that no advertisements related to medicinal products are displayed or exhibited during the program.

Is advertisement of registered veterinary products requiring approval from MAB?

According to Section 4B Medicines (Advertisement & Sale) Act 1956, 

(1)No person shall take any part in the publication of any advertisement referring to any article, or articles of any description, in terms which are calculated to lead to the use of that article of that description as a medicine, an appliance or a remedy for the purpose of treatment or prevention of diseases or conditions of human beings other than the diseases and conditions specified in subsection 3(1), unless such advertisement has been approved by the Medicine Advertisements Board.

Therefore, advertisements of registered veterinary products which is of animal use are not under the purview of MAB. Besides, Registered Medicinal Products Advertising Approval Guidelines has also stipulated that these guidelines do not apply to advertising on veterinary product (Paragraph 1.3 Scope of Use).
 

Pages