Berita Ubat-ubatan
August 2000

Regulatory Control Beyond 2000

Separate Manufacturing Facilities For Cephalosporins

Warning Label for products - NSAID

Registration of Products Containing Insect Repellants

Warning for Products containing Hydroquinone

Actions To Be Taken Against Products Containing CISAPRIDE (PREPULSID)
Licensing Update - June 2000

The Changing Pharmaceutical and Traditional Medicine Premises Landscape: 1987 - 2000

Additional Indications Approved for Registered Products

GMP News

Quality Control Training Course

Sources of products registered with DCA As At 30.6.2000

New Products Approved for Marketing in Malaysia

NPCB officers to contact

Clinical Trials

In a letter dated 1^st August 2000 to all registration holders of products containing insect repellants, the Secretary of the DCA announced that with immediate effect the DCA will no longer register and control such products which are for external use on the human body. The regulatory control will now be effected by the Pesticides Board who has agreed that insect repellants should be controlled as ‘household pesticides’ under the Pesticides Act 1974.

With this decision, all applicants and registration holders of products containing insect repellants (see list of registered products below) are advised to contact the Pesticides Board at the following address:-

Pesticide Control Division,
Department of Agriculture,
Ministry of Agriculture,
Jalan Gallagher,
50480 KUALA LUMPUR
Tel: 03-2983077 Fax: 03-2924121

Applications received by the DCA Secretariat which are still pending will not be further evaluated and applicants are advised to withdraw their applications.

• Starting from 1^st August 1988, products containing insect repellants for human use were registered with the DCA under Phase 2 Implementation of the Control of Drugs and Cosmetics Regulations 1984.
• All insect repellant products, whether in the form of creams or aerosols for human use, containing active ingredients as listed in Schedule 1, Pesticides Act 1974 must be registered under the Pesticides Act before they can be imported, manufactured or sold in the market.
• A review of the global developments in the control of insect repellants shows that in the EU countries, it is registered as a pesticide, while in other countries it is controlled either as a cosmetic, quasi-drug or medical device.