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.

4.4.2. POST-MARKET SURVEILLANCE

1. It is the prime responsibility of the holder to ensure products marketed are in accordance to the standards and requirements of the Authority;
2. Registered products may be sampled and tested for compliance with official or pharmacopoeia standards or specifications agreed by the manufacturer. Labels and package inserts of the samples will also be checked to ensure compliance to the requirements as approved.
3. The Authority will take necessary action on products which do not conform to the standards/ specifications and requirements in the form of warnings or recalls. The product registration holder has up to thirty (30) days to identify the cause of defect and actions to be taken for improvement.

4.4.2.1        PRODUCT COMPLAINTS

1. The product registration holder should notify the NPRA of any product quality related problems (with registered products) that the holder is aware of;
2. It is also the responsibility of the prescribers, pharmacists, as well as all other health professionals who come into contact with the drug to report to NPRA by using the NPRA complaint form i.e. BPFK 419 / BPFK 418.4 together with complaint sample (if any).
3. All complaints received will be investigated by the NPRA as well as product registration holder/ manufacturer. It is the responsibility of the company to determine the appropriate corrective and preventive action.

Reference : Guidelines on Good Distribution Practice, Chapter 9.

4.4.2.2        PRODUCT RECALLS

1. The decision for recall of a product shall be made when there is or may cause potential risk to the user of the products. Recalls may be done voluntarily by the product registration holder or as directed by the Director of Pharmaceutical Services Division, Ministry of Health Malaysia;
2. The product registration holder is responsible for conducting recalls of defective or unsafe products. No recall should take place without first consulting/ informing the Authority.

Reference : Guidelines on Good Distribution Practice, Chapter 10.

4.4.3 PUNITIVE ACTION FROM THE AUTHORITY

4.4.3.1        ADULTERATION

As stated in circular Bil (30) BPFK/PPP/01/03, Tindakan Punitif Ke Atas Syarikat Yang Terlibat Dengan Kes Produk Campur Palsu (13 May 2009), punitive action shall be taken against companies who are involved in adulteration.

Any registered products found to have been adulterated, the following action shall be taken by the Director of Pharmaceutical Services:

1. The registration of the related product shall be cancelled and recall of all batches of the product shall be done immediately;
2. The manufacturer’s license of the related manufacturer shall be revoked for six (6) months for the first offence and one (1) year for the subsequent offence, from the date of revocation letter;
3. All transactions (including application for product registration, application for change of product registration holder, application for change of manufacturing site) for the adulterated product registration holder shall be frozen for six (6) months for the first offence and one (1) year for the subsequent offence, from the date of cancellation letter from the Authority.