4.4.0.   POST-MARKETING ACTIVITIES

4.4.1 PHARMACOVIGILANCE

4.4.1.1        ADVERSE DRUG REACTION REPORTING AND SAFETY UPDATES

In accordance with Regulation 28: Reporting adverse reaction under Control of Drugs and Cosmetics Regulations 1984, Sale of Drugs Act 1952 (amendment 2006), the product registration holders or any person who possesses any registered product shall inform immediately the Director of Pharmaceutical Services of any adverse reaction arising from the use of the registered product.

All product registration holders must ensure that a pharmacovigilance system is in place by the company and appropriate action is taken, when necessary.

Product registration holders are required to monitor and report any product safety issues that arises locally or internationally to the NPRA and comply with all safety-related directives issued by the Authority.

The product registration may be cancelled if the product registration holder fails to inform the Authority of any serious adverse reactions upon receipt of such reports.

The WHO encourages reporting of ALL adverse drug reactions.

For further information, please refer the Malaysian Pharmacovigilance Guidelines 2nd Edition.