Approval for any advertisement format is based on the Medicines (Advertisement and Sale) Act 1956 and its regulations. In addition, advertisement formats must also comply with advertising guidelines and policies issued by the MAB. MAB has the right to amend any claims and advertisement formats that do not comply with the act, guidelines and policies.
A medicine approved by the USFDA does not mean that it is registered with the Drug Control Authority, Ministry of Health Malaysia. All medicines must be registered before they are sold or marketed in Malaysia. Prior approval from the Medicine Advertisements Board (MAB) MOH is required before any advertisement of medicine is published.
Importation of products that are not registered with the DCA is an offence under Control of Drugs and Cosmetics Regulations 1984. However, special exemption may be granted for the treatment of life-threatening illnesses as provided under Regulation 15 (6) Control of Drugs and Cosmetics Regulations 1984. Complete applications must be submitted to the Pharmaceutical Services Division.