SVA-FAQ

Registered Product

• QUALITY PRODUCT REPORTING TO NPRA MALAYSIA
• PRODUCT QUALITY MONITORING PROGRAMME
• OUT-OF-SPECIFICATION (OOS) REPORT BY THE PRH
• FAQ- Keperluan Pengujian Kandungan Diethylene Glycol (DEG) dan Ethylene Glycol (EG) ke atas Bahan Aktif / Excipient dan / atau Produk Siap dalam Bentuk Dos Cecair untuk Kegunaan Dalaman (Oral) yang Mengandungi Bahan Aktif / Excipient Berisiko

Notified Cosmetics

• Surveillance and Complaints Notified Cosmetic
• The Control of Cosmetic Advertisements in Malaysia

Quality Product Reporting

This FAQ provides guidance on reporting product quality issues for registered products to the National Pharmaceutical Regulatory Agency (NPRA) in Malaysia.

• Protecting public health and safety.
• Allowing NPRA to monitor the quality of products in the market.
• Facilitating investigations into defects and determining necessary market actions (e.g., recalls).
• Ensuring product registration holders (PRHs) and manufacturers maintain quality standards.

• Product Registration Holders (PRHs): The company or legal entity holding the marketing authorization for the product is primarily responsible for notifying NPRA of any known product defect issues and providing a complete investigation report.
• Licensed Manufacturers, Importers, and Wholesalers: These parties also have a responsibility to report product defects, especially if they are aware of them. If there's a business arrangement, at least one party should report, keeping others informed.
• Healthcare Professionals (Prescribers, Pharmacists, Nurses): They are encouraged to report any product complaints they encounter, using the designated NPRA complaint form.
• Consumers: Members of the public can also report concerns about the quality of medicines they use by using the designated NPRA complaint form

• Ineffective medicines.
• Contamination (e.g., foreign particles, microbial growth).
• Incorrect packaging or labelling (e.g., wrong expiry date, missing information).
• Physical defects (e.g., cracked tablets, discolored solutions).
• Stability issues (e.g., product degrading before expiry).
• Suspected counterfeit products.
• Any deviation from the approved specifications or manufacturing standards.

• Critical Defect: A defect that can pose a serious threat to the intended users or public health in Malaysia. A serious threat may lead to death or serious injury.
• Non-critical Defect: Defects that do not meet the criteria of a "critical defect" but may still cause illness, affect the outcome of medical treatment, and/or affect the product's quality.

• For Product Registration Holders (PRHs): You should notify NPRA with a complete investigation report, including root cause analysis and corrective actions, if necessary. Refer to the "Guideline for Product Quality Reporting and Recall Procedures" (Appendix 34 of the DRGD) on the NPRA website for detailed instructions.
• For Healthcare Professionals: Use the NPRA complaint form, ideally with a complaint sample if available.
• For Consumers: You can use the "Reporting Form for Medicine Complaint by Consumers" which can be downloaded from the NPRA website. This form can be mailed, faxed, or sometimes submitted online.

• Product name, brand, and registration number (MAL number).
• Batch number and expiry date.
• Name and contact details of the reporter (confidentiality is maintained).
• Detailed description of the defect or issue observed.
• Date and location where the product was obtained.
• Any adverse effects experienced (if applicable, though dedicated ADR reporting exists).
• Photos or samples (if requested or feasible).

• NPRA will acknowledge receipt of your report.
• All complaints received will be investigated by NPRA and the relevant Product Registration Holder (PRH)/manufacturer.
• NPRA will assess the risk posed by the defect and determine appropriate market actions, including potential product recalls.
• The PRH/manufacturer is responsible for determining and implementing appropriate corrective and preventive actions (CAPA).
• You may be contacted if additional information is needed.

• Cancellation of product registration.
• Recall of all batches of the affected product.
• Revocation or suspension of manufacturer's, import, or wholesale licenses.
• Freezing of transactions for the involved PRH.

Control of Cosmetic Advertisements

Introduction

All notified cosmetics in the local market are required to comply with the Guidelines for Control of Cosmetic Products in Malaysia. This is to safeguard and protect public health from any potential risks associated with adulterated, unsafe, or substandard cosmetics.

• Protecting public health and safety.
• Allowing NPRA to monitor the quality of products in the market.
• Facilitating investigations into defects and determining necessary market actions (e.g., recalls).
• Ensuring product registration holders (PRHs) and manufacturers maintain quality standards.

• Product Registration Holders (PRHs): The company or legal entity holding the marketing authorization for the product is primarily responsible for notifying NPRA of any known product defect issues and providing a complete investigation report.
• Licensed Manufacturers, Importers, and Wholesalers: These parties also have a responsibility to report product defects, especially if they are aware of them. If there's a business arrangement, at least one party should report, keeping others informed.
• Healthcare Professionals (Prescribers, Pharmacists, Nurses): They are encouraged to report any product complaints they encounter, using the designated NPRA complaint form.
• Consumers: Members of the public can also report concerns about the quality of medicines they use by using the designated NPRA complaint form

• Ineffective medicines.
• Contamination (e.g., foreign particles, microbial growth).
• Incorrect packaging or labelling (e.g., wrong expiry date, missing information).
• Physical defects (e.g., cracked tablets, discolored solutions).
• Stability issues (e.g., product degrading before expiry).
• Suspected counterfeit products.
• Any deviation from the approved specifications or manufacturing standards.

• Critical Defect: A defect that can pose a serious threat to the intended users or public health in Malaysia. A serious threat may lead to death or serious injury.
• Non-critical Defect: Defects that do not meet the criteria of a "critical defect" but may still cause illness, affect the outcome of medical treatment, and/or affect the product's quality.

• For Product Registration Holders (PRHs): You should notify NPRA with a complete investigation report, including root cause analysis and corrective actions, if necessary. Refer to the "Guideline for Product Quality Reporting and Recall Procedures" (Appendix 34 of the DRGD) on the NPRA website for detailed instructions.
• For Healthcare Professionals: Use the NPRA complaint form, ideally with a complaint sample if available.
• For Consumers: You can use the "Reporting Form for Medicine Complaint by Consumers" which can be downloaded from the NPRA website. This form can be mailed, faxed, or sometimes submitted online.

• Product name, brand, and registration number (MAL number).
• Batch number and expiry date.
• Name and contact details of the reporter (confidentiality is maintained).
• Detailed description of the defect or issue observed.
• Date and location where the product was obtained.
• Any adverse effects experienced (if applicable, though dedicated ADR reporting exists).
• Photos or samples (if requested or feasible).

• NPRA will acknowledge receipt of your report.
• All complaints received will be investigated by NPRA and the relevant Product Registration Holder (PRH)/manufacturer.
• NPRA will assess the risk posed by the defect and determine appropriate market actions, including potential product recalls.
• The PRH/manufacturer is responsible for determining and implementing appropriate corrective and preventive actions (CAPA).
• You may be contacted if additional information is needed.

• Cancellation of product registration.
• Recall of all batches of the affected product.
• Revocation or suspension of manufacturer's, import, or wholesale licenses.
• Freezing of transactions for the involved PRH.

Surveillance And Complaints Notified Cosmetic

All notified cosmetics in the local market are required to comply with the Guidelines for Control of Cosmetic Products in Malaysia. This is to safeguard and protect public health from any potential risks associated with adulterated, unsafe, or substandard cosmetics.

1. Sampling and testing of cosmetic for microbial contamination and heavy metals;
2. Monitoring cosmetic labels for compliance with regulatory requirements;
3. Handling consumer complaints and investigating reports of adverse effects related to cosmetics;
4. Surveillance of advertisements and claims to prevent misleading information;
5. Issuing and coordinating alerts through the ASEAN Post-Marketing Alert System (PMAS) for cosmetics found to be non-compliant or hazardous.

1. Direct purchase from the market (via authorized distributors or retailers), or
2. Requesting samples from the Cosmetic Notification Holder (CNH).

By hand:
CNHs must make an appointment with the relevant NPRA officer in advance and follow the map and directions provided by NPRA.

By post/courier:
CNHs may send the samples to the following address:

Seksyen Surveilans dan Aduan
Pusat Komplians dan Kawalan Kualiti
Bahagian Regulatori Farmasi Negara (NPRA)
Lot 36, Jalan Prof Diraja Ungku Aziz,
46200 Petaling Jaya, Selangor
(U/P: [officer’s name])

Note: Ensure that all samples are properly labelled and packaged to avoid damage or rejection.

1. If the requested cosmetic is out of stock, not yet manufactured, or not yet imported: CNHs must submit a commitment letter listing the affected cosmetics. The letter should confirm that the samples will be submitted once they become available.If possible, include the estimated date of restocking, manufacturing, or importation.
2. If the cosmetic has been discontinued:   CNHs must withdraw the notification via the QUEST3+ system.

1. Issuance of a warning
2. Cosmetic recall
3. Cancellation of cosmetic notification

However, if a cosmetic is found to contain harmful or prohibited ingredients during the Post-Market Surveillance (PMS) program, immediate regulatory actions will be taken against the CNH. These actions may include cancellation of the cosmetic’s notification status and a directive to recall all affected batches from the market.

Navigation: INFORMATION > General Information > Press Release.

Additionally, a list of cosmetic with cancelled notifications due to the presence of prohibited ingredients is available at:
Navigation: INFORMATION > Safety Information < Cancellation of Notified Cosmetic Products

General Information

Who Should Report?

What to Report

How to Report