New labelling scheme for medicines now in place

Malaysia

A scheme requiring holographic labels to be affixed to the packaging of medicines and health supplements came into effect on May 1 2005. It is hoped that the new system, which is similar to that already in place for CDs and DVDs, will help to curb the rise in counterfeit, imitation and unregistered products being manufactured or imported and sold in Malaysia.

The purpose of the holographic security device is to authenticate and verify that the products sold have been registered with the Drug Control Authority. The stickers are to be affixed on to the outer packaging of the product. Where there is no outer packaging, the labels must be attached to the immediate packaging. The labelling requirement only applies to pharmaceuticals (including over-the-counter external personal care products), traditional remedies and health supplements. Cosmetics are currently excluded from the scheme.

The new labelling system was supposed to have been implemented in January this year but the deadline was postponed until May following objections from the association representing the industry and several individuals. Therefore, it is only applicable to products manufactured or imported into Malaysia on or after May 1 2005. Manufacturers have been given a "grace period" to ensure that the holographic stickers are ready. Each label costs M$0.056.

Persons who fail to comply with the scheme may be fined up to M$25,000 or be imprisoned for three years for the first offence. Subsequent offences attract a fine of M$50,000 or five years' imprisonment.

Janet Toh Yoong San, Shearn Delamore & Co, Kuala Lumpur

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