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How is the advertisement approval process carried out in Pharmaceutical Services Program?

According to R4(1) MABR 1976, the Board have the power to regulate its own procedure in approving advertisement. Before the year 2012, all application of approval was being processed and approved in MAB meeting. In year 2004, Fast Track Service had been introduced and the advertisement application processing time is 7 working days. It was then reduced to 5 working days in year 2010. Since 2012, mandate has been given to Secretariat MAB to facilitate the processing and approval of advertisement based on guidelines and policies set by MAB to fulfil the client charter.

Are claims that were previously approved will not be allowed in new application of approval?

Yes, claims that were previously approved will not be allowed in new application of approval if it is beyond the indication approved by DCA as stipulated in MAB policy MAB 3/2017 Claims. According to R4(1) Medicine Advertisements Board Regulation 1976 (referred to as MABR 1976 hereafter), MAB has the power to regulate its own procedures for advertisement approval purposes. Hence, there are changes in policy and MAB guidelines which has been discussed among members of MAB and agreed in MAB meeting over the year to align with ever-evolving healthcare marketing and advertising techniques. This is fundamental to make sure the approval of advertisement is up-to-date and able to meet contemporary health issues, development, safety, and ethics. Besides, according to R5(4) MABR 1976, MAB in its discretion, may issue or refuse to issue approval or may cancel an approval previously issued.

Why some of the product claims are being strike off in format approved by MAB?

Referring Medicine Advertisements Board Policy and Decision MAB 3/2017 and Paragraph 5.2 Registered Medicinal Products Advertising Approval Guideline, claims made in an advertisement must be in accordance to the product indication and /or label as approved by the Drug Control Authority. 

Product claims that are beyond the indication approved by Drug Control Authority will not be accepted and approved in an advertisement. Medicine Advertisements Board would like to advise company to apply variation in their product claims to Drug Control Authority before submitting to Medicine Advertisements Board. 
 

Is Group B Poisons allowed to be advertised to the public?

The controlled medicine obtained from registered medical practitioners, registered dentists, or licensed/ registered pharmacists for the purpose of treating patients is categorized as Group B and C poisons under the Poison Act 1952. Group B poisons are medications that require prescription from a medical practitioner after consultation with the patient. Meanwhile, Group C poisons do not require a prescription and can be supplied by registered medical practitioners, registered dentists or licensed/ registered pharmacists. Current Medicine Advertisements Board Policy does not allow advertisement of poisons as specified in the First Schedule of Poisons Act 1952 unless exempted as stated in Paragraph 2.5 Registered Medicinal Products Advertising Approval Guideline, subsection 2.5.2-

  1. Scheduled poisons for nicotine replacement therapy 
  2. new products that comply with the following criteria may be granted approval for publication as a press release only, namely 
    • products that are newly registered with the Drug Control Authority, Malaysia, and no other similar poison products available in Malaysia; 
    • products with a combination of active pharmaceutical ingredients that are newly registered with the Drug Control Authority Malaysia and no other similar combination of pharmaceutical ingredients available in Malaysia; 
    • existing products approved for new indications by the Drug Control Authority Malaysia; and 
    • Product indication that does not contravene with Section 3(1) of the Medicines (Advertisement and Sale) Act 1956.

What kind of product advertisements requires approval from Medicine Advertisements Board (MAB)?

Advertisements for supplement products, Over-The-Counter (OTC) products and traditional products that have been registered with Drug Control Authority (DCA) require approval from MAB.

Cancer Drug Counselling: A Guide for Pharmacists Second Edition (2023)

Date: 7 December 2023 - 3:45pm

Pharmacists play a vital role in delivering effective patient education and counselling with the ultimate goals of improving patients’ adherence to cancer drug therapy and hence enhancing treatment outcome.

English

Pharmacist's Handbook of Parenteral Nutrition in Neonates and Paediatrics Second Edition (2023)

Date: 7 December 2023 - 3:34pm

Pharmacists play a vital role in parenteral nutrition as well as neonatal and paediatrics clinical pharmacy services. This guideline serves as an important source of reference to facilitate pharmacists in planning the nutrition care plan for patients.  Delivering parenteral nutrition service that is aligned with the latest published evidence is essential to optimise nutrition therapy and minimise its complications.

English

Malaysian National Medicines Policy (MNMP) Fourth Term

Date: 31 October 2023 - 4:34pm

Malaysian National Medicines Policy Fourth Term (2022-2026) is published as a revised version and strengthened in line with the changing times and country's health needs to the third edition. Components from the third term remained in the fourth term.

Malaysian National Medicines Policy (MNMP) Third Term

Date: 31 October 2023 - 12:55pm

Malaysian National Medicines Policy Third Edition is published as a reviewed and revised version to the second edition. Effort and contribution in workshops and meetings together with all relevant stakeholders resulted in the publication of the third edition. Components from the second term remained in the third term and all the five (5) components in the third term are:

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