NPRA Labelling Requirements for Imported Medicines in Malaysia: Label, Package Insert and Product Name

In short: in Malaysia a label is not packaging copy, it is a registered particular. NPRA's Drug Registration Guidance Document (DRGD) sends the Product Registration Holder to Appendix 19 for the particulars every carton, immediate label and blister must carry, and to Appendix 20 for statements tied to specific substances. Labels and package inserts must be in Bahasa Malaysia or English. Appendix 19A lists what may not appear, and once registered a label cannot be changed without prior approval unless the change is a notification-only variation.

This guide is for licensed importers, distributors, healthcare facilities and companies considering the role of Product Registration Holder (PRH). Artwork is often the last step of a registration; in the texts below it behaves like a specification.

It is information for licensed businesses and healthcare professionals, not legal advice. It summarises NPRA's public documents as read on 4 November 2026: the DRGD, Third Edition, 12th Revision, July 2026, with Appendix 19 (General Labelling Requirements), Appendix 19A (Prohibited Visual/Graphics/Statements on Label) and Appendix 20 (Specific Labelling Requirements). NPRA revises these documents regularly, and the current official text applies.

The label is a registered particular

Section 7.6 of the DRGD states the duty plainly: the PRH shall ensure that the product label complies with Appendix 19 and Appendix 20. Section 7.5 extends it to wording — indications other than those accepted at registration must not appear in any product literature, data sheet, package insert or label without prior permission of the Authority.

Section 20.1 closes the loop. A variation is a change of the particulars of a registered product, and no change may be made without prior NPRA approval except a Minor Variation Notification. Where a change needing approval is implemented without it, the DRGD states that the registration shall be reviewed for suspension or cancellation. A carton redesign driven by a marketing calendar elsewhere is a regulatory submission here.

What must appear, and where

Appendix 19 sets one table of numbered parameters against three carriers: the outer unit carton, the immediate label and the blister or strip. It lists 24 parameters, among them the pack size and a declaration of the source of any ingredient of animal origin. The selection below is the part an imported parenteral product normally has to satisfy.

Four parameters are marked as country-specific requirements for Malaysia: the preservative declaration, the bilingual cautionary statement, the controlled-medicine wording for scheduled poisons and the security label.

Small containers and the security label

Many of those particulars carry an asterisk, which exempts small labels used for ampoules, cartridges, vials and eye, ear and nose drops; the volume limit is stated in the appendix. The exemption is narrow, and it is not an exemption from the label: where a product has no outer carton, the inner label shall bear all the required information.

Authentication is separate. Section 7.12 requires a registered product to carry the serialised security label (hologram) approved by the Authority, on the secondary packaging or, where there is none, on the immediate label, covering no product particulars, whether the product is locally manufactured or imported. Appendix 19 adds that large volume parenteral products, defined by a container volume threshold taken from the United States Pharmacopeia, carry it on the immediate label of each unit, while for small volume parenteral products the outer carton is sufficient, and that small labels, temperature-sensitive products and cold chain products are exempt.

Language on the pack

Appendix 19 is explicit: all labels and package inserts must be in Bahasa Malaysia or English, and a translation into another language is allowed in addition. English artwork is therefore acceptable for the body of the label, with one qualification — the cautionary statement above is required in both languages, and the appendix names the controlled-medicine wording Ubat Terkawal and a keep-out-of-reach-of-children statement in Bahasa Malaysia among the statements it permits on a single additional label.

Label copy also sits inside a second body of law. In the copy of the Medicines (Advertisement and Sale) Act 1956 we could read — the revised 1983 text incorporating Act A778 of 1990, in an archived copy — the definition of an advertisement expressly includes a label: see our guide to Act 290 and the Medicine Advertisements Board.

Package insert and consumer leaflet

Section 7.10 requires a package insert for products containing a scheduled poison and for injectable over-the-counter products. The draft is evaluated, and the DRGD sets the headings it must carry, from the product description and pharmacokinetics through contraindications, warnings, interactions and side effects to storage conditions.

The consumer leaflet has a different trigger. Under section 7.11 the Consumer Medication Information Leaflet (Risalah Maklumat Ubat untuk Pengguna, RiMUP) is compulsory for products self-administered by patients, including scheduled poisons in Category A and over-the-counter products in Category X; the draft is submitted in both English and Bahasa Malaysia. Which of the two documents a parenteral nutrient product needs follows from its registration category and poison scheduling, which we have not seen NPRA settle for this product class — confirm it with NPRA.

The product name is part of the label

Section 7.3 makes the name a regulated field rather than a brand asset. A product name may be an invented name, or a generic or scientific name together with a trade mark or the manufacturer's name, and it shall consist of the dosage form and the strength for a single-active product; the generic name cannot stand alone, and Appendix 17 lists names that are not permitted. The font of the product name shall be equal in size for letters and numbers, and each active highlighted on a multi-ingredient label must appear at equal size and prominence. For an imported range this is the requirement most likely to force rework — the name a product carries elsewhere, such as the sodium ascorbate presentation in our catalogue, may need restating with its dosage form and strength.

Substance-specific statements

Appendix 20 is the long one: roughly 247 substances across more than 250 pages, each entry naming a statement and where it belongs. The habit worth forming is to read an entry's scope line rather than the substance list, because most entries are written for a product category and a route, not for a molecule in the abstract.

Three nutrient entries make the point. Alpha-lipoic acid requires a statement in the label, package insert and consumer leaflet of health supplement products containing it: “Please consult your doctor/pharmacist before using this product if you are on other medicines. There may be a potential for interactions or side effects”. The arginine entry is written for oral preparations in health supplement products, and the vitamin B6 entry for health supplement and over-the-counter products above a stated strength. Because Appendix 6 excludes sterile and parenteral preparations from the health supplement category — see our guide to NPRA registration and the import pathway — none of the three reaches a parenteral formulation on its own wording.

What does reach a parenteral is driven by excipients and by route. Appendix 20 requires on the label and in the package insert of parenteral products containing benzyl alcohol the statement “As this preparation contains benzyl alcohol, its use should be avoided in children under two years of age. Not to be used in neonates.” For sodium metabisulphite the insert carries a serious-allergic-reaction warning and a contraindication in bisulphite hypersensitivity. The vitamin K1 entry, for the single-ingredient product given intravenously, requires an insert warning that severe reactions, including fatalities, have occurred during and immediately after intravenous injection. Two products with the same active substance can therefore carry different label text because one is oral and the other is not.

What may not appear

Appendix 19A lists 21 numbered issues, states that the list is not exhaustive, and records that the Authority reserves the right to disallow any other words, phrases or graphics which in its opinion are misleading, improper or not factual. The items most often found on a pack designed elsewhere:

• marketing-strategy statements, prohibited on the immediate container, the carton, the package insert and the consumer leaflet alike;
• a usage guide promoting another product, and consumer endorsements;
• clinical trial results, or any information on a clinical trial done on the product;
• quality certification marks — the appendix names SIRIM, ISO, GMP and HACCP — prohibited because certification is renewed yearly;
• claims of a special technique or ingredient superiority, allowed only if proven true;
• graphics of internal organs, and negative statements such as a free-from-preservative or GMO-free claim.

Appendix 19 adds that a website link used for product promotion may not be printed on the label, expressly including imported products, and that a QR code or barcode is allowed only to monitor inventory.

Stick-on labels and the registration number

A stick-on label, in Appendix 19, is an additional label affixed onto an approved immediate label or carton. It shall not cover any information on the approved artwork, shall not be easily torn or peeled off, and is to be read with Appendix 32, the explanatory notes for repackers. The permitted uses are narrow: the controlled-medicine wording with the keep-out-of-reach statement and the PRH details on a single label; statements required by Appendix 20; a “Diimport/diedarkan oleh” (imported or distributed by) statement; the security label; a code for inventory; and a tamper-evident seal. Nothing else is permitted without prior approval.

One line decides how much of this can be fixed locally: the registration number shall be printed permanently on the product by inkjet and is not allowed on a stick-on label. A local partner can add a distributor statement to a finished pack; it cannot sticker a registration number onto one. The number comes off the manufacturer's line, which puts printing capability into the commercial conversation and not only into the dossier.

EFBA's position and partnership search

EFBA manufactures the IVIXIR range of professional IV vitamin and nutrient formulations and holds the manufacturing documentation a dossier draws on, including artwork files and excipient declarations. IVIXIR products do not currently hold an NPRA or DCA registration and have no MAL registration number. EFBA is looking for a company in Malaysia able to act as Product Registration Holder and a licensed importer, and labelling is one of the work packages such a partner would own. IVIXIR products are supplied in Malaysia only after NPRA registration through a licensed importer; samples are not offered via this website. If you represent a licensed importer or distributor, the distributor partnership page explains how a conversation starts.