21.0	Post-Marketing Activities
21.1	Pharmacovigilance
21.1.1	Reporting Adverse Drug Reaction (ADR) and Adverse Events Following Immunisation (AEFI) and Safety Updates
21.2	Post-Market Surveillance
21.2.1	Product Complaints
21.2.2	Product Recalls
21.3	Punitive Action by The Authority
21.3.1	Adulteration

 

21.0.   POST-MARKETING ACTIVITIES

 

 

.21.1 PHARMACOVIGILANCE

21.1.1        Reporting Adverse Drug Reaction (ADR) and Adverse Events Following Immunisation (AEFI) and Safety Updates

a) In accordance with Regulation 28, CDCR 1984, the PRH 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.

b) All PRH must ensure that the company has a pharmacovigilance system is in place and takes appropriate action, when necessary.

c) PRHs 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.

d) The product registration status may be affected if the PRH fails to inform the Authority of any serious adverse reactions upon receipt of such reports.

e) The WHO encourages reporting of ALL ADR and AEFI.

f) For further information, refer to the Malaysian Pharmacovigilance Guidelines

 

.21.2 POST-MARKET SURVEILLANCE

It is the prime responsibility of the PRH to ensure that products marketed are in accordance with the standards and requirements of the Authority.

Registered products may be sampled and tested for compliance with official or pharmacopoeial standards or specifications agreed by the manufacturer. Labels and package inserts of the samples may also be checked to ensure compliance with the requirements approved.

The Authority shall take necessary action on products that do not conform to the standards/ specifications and requirements in the form of warnings or recalls.

The PRH has up to thirty (30) days to identify the cause of defect and actions to be taken for improvement.

21.2.1        Product Complains

 The PRH shall notify NPRA of any product quality related problems (with registered products) of which the PRH is aware.

b) 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 any product complaints to NPRA by using the NPRA complaint form i.e. BPFK 419/ BPFK 418 with complaint sample (if any).

c) All complaints received shall be investigated by NPRA as well as the PRH/ manufacturer. It is the responsibility of the company to determine the appropriate corrective and preventive action.

Reference: Chapter 6, Guidelines on Good Distribution Practice, Third Edition, 1 January

21.2.2        Product Complains

The decision for recall of a product shall be made when there is actual or potential risk to the product users. Recalls may be done voluntarily by the PRH or as directed by the Director of Pharmaceutical Services Division, Ministry of Health Malaysia;

b) The PRH is responsible for conducting recalls of defective or unsafe products. No recall shall take place without first consulting/ informing the Authority.

Reference: Chapter 7, Guidelines On Good Distribution Practice, Third Edition, 1 January

 

21.3 PUNITIVE ACTION BY THE AUTHORITY

21.3.1        Adulteration

Punitive action shall be taken against companies who are involved in adulteration.

For any registered products found to have been adulterated, the following action shall be taken by the Authority:

a) The registration of the related product shall be cancelled and recall of all batches of the product shall be done immediately; 

b) 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 the revocation letter from the Authority;

c) All transactions (including application for product registration, application for change of PRH, application for change of manufacturing site) for the adulterated PRH shall be frozen for six (6) months for the first offence and one (1) year for the subsequent offence, from the date of the cancellation letter from the Authority.

Reference: Bil. (30) dlm.BPFK/PPP/01/03, Tindakan Punitif Ke Atas Syarikat Yang Terlibat Dengan Kes Produk Campur Palsu (13 May 2009)