Regulations Overview - Rx to OTC

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Regulatory Overview - Rx to OTC Switch
Malaysia

The below version control table serves to document all updates made to the report. The purpose is to ensure the information is always accurate and up-to-date.

Version Number	Content Creation Date	Publishing Date	Section(s) Updated & Reason(s) for Update
V0	14 December 2023	29 February 2024	N/A (new report)

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1. Product Classifications in Malaysia

Medicinal products in Malaysia are classified according to the schedules in the Poisons Act 1952 [1] as follows:

Scheduled Poisons contain an active substance that is listed in the First Schedule of the Poisons Act 1952 [2]
Non-Scheduled Poisons contain active substances that are not listed in the First Schedule of the Poisons Act 1952 and exclude active ingredients that are categorized as health supplements, natural products, or cosmetics, can be obtained freely from any retailer (general sale) (e.g. analgesic drugs (paracetamol), topical antiseptics, sore throat preparations, laxatives, etc.)

Figure 1 - Classification of Pharmaceutical Products in Malaysia

Scheduled Poisons are then further broken up into 4 categories as outlined in the table below:

Table 1 - Scheduled Poison Classifications

Scheduled Poisons Classification	Definition
Group A Poison	High toxicity medicines
Group B Poison	Medicines which are used in the treatment of a condition where diagnosis by a doctor is required. These medicines can only be dispensed against a prescription.
Group C Poison	Used in treatment where the symptoms are easily recognized. These medicines can be dispensed without a prescription.
Group D Poison	Chemicals for laboratory use only.

According to the current regulations, medicines can be legally dispensed without a prescription either as a Group C Scheduled Poison or as a Non-Scheduled Poison (as an over-the-counter medicine/for general sale).

2. Process to Switch from Rx to OTC in Malaysia

For a Group B Poison to be dispensed without a prescription, it would need to be re-classified as either a Group C Poison or a Non-Scheduled Poison.

According to Section 6 of the Poisons Act 1952 [1]:

“The Minister, may from time to time, after consultation with the Poisons Board by order notified in the Gazette, add to, remove from or reinstate in the Poisons List any substance as he may deem fit or proper, or remove from transfer to or include in any column of the Poisons List any poison, or exempted preparation or amend any definition of any poison or exempted preparation contained in such list or in any column thereof”.

Sponsors may apply for the reclassification of a poison using the form at this link [3].

This guideline describes the process for reclassification [4]. A copy of the translated guideline is presented in Appendix 1.

It should be noted that any reclassification of a medicine will apply to all medicines containing that active substance and not just that of the sponsor who has initiated the reclassification.

Conclusion

Based on the review conducted of the drug classification regulations in Malaysia, it has been confirmed that medicines may be supplied without a prescription if the active substance is classified as either a Group C Scheduled Poison or a Non-Scheduled Poison.

In preparing a submission for reclassification, the sponsor should take into consideration the dosing and pack size of the product to present the lowest possible risk to patients.