Industri

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 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).