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Lot 36,
Jalan Universiti (Jalan Prof Diraja Ungku Aziz),
46200 Petaling Jaya, Selangor.
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Phone: 603-7841 3200
Fax: 603-7968 2222
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Clients' Charter
At Pharmaceutical Services Programme, we strive to provide efficient and effective services to customers based on the following Clients' Charter;
Pharmacy Practice & Development Division
No | Indicator | Target |
|---|---|---|
1. | Notification to applicant on the result of the listing of medicine(s) into Ministry of Health Medicine Formulary (MOHMF) done within 3 working days from the MOHMF panel meeting date | 100% |
Pharmacy Enforcement Division
No | Indicator | Target |
|---|---|---|
1. | Issuance of Authorization for the Import & Export of Dangerous Drugs within 7 working days upon receipt of complete application | 100% |
2. | Issuance of Authorization for the Import & Export of Psychotropic Substances within 7 working days upon receipt of complete application. | 100% |
3. | Issuance of e-Permit (Export) for Precursor Chemicals within 7 working days upon receipt of complete application. | 100% |
4. | Issuance of e-Permit (Import) for Controlled Substances within 3 working days upon receipt of complete application. | 100% |
5. | Decision for application of medicines advertisement certificate and healthcare services advertisement certificate (other than website advertisement) made within 5 working days upon receipt of complete application. | 90% |
6. | Decision for application of medicines advertisement certificate and healthcare services advertisement certificate for website advertisements made within 30 days upon receipt of complete application. | 90% |
7. | Complaint related to infringement of Pharmacy Laws responded within 14 working days. | 100% |
8. | Complaint sample completed analysis by Pharmacy Enforcement Division Chemical Forensic Laboratory within 30 working days from the sample receipt date. | 90% |
9. | Digital device analysis report for investigative purposes will be issued by the Cyber Forensics Laboratory within 120 days from the date the complete application is received | 75% |
Pharmacy Board Malaysia Division
No | Indicator | Target |
|---|---|---|
1. | Issuance of Full Registration of Pharmacist’s Certificate within 7 working days upon receipt of complete application and in accordance with legislation. | 100% |
2. | Issuance of Registration of Body Corporate’s Certificate within 6 working days upon receipt of complete application and in accordance with legislation. | 100% |
3. | Issuance of Annual Certificate of Pharmacist within 6 working days upon receipt of complete application and in accordance with legislation. | 100% |
4. | Issuance of Registration of Provisional Pharmacist’s Certificate within 7 working days upon receipt of complete application and in accordance with legislation. | 100% |
5. | Issuance of Annual Certificate of Body Corporate within 6 working days upon receipt of complete application and in accordance with legislation. | 100% |
National Pharmaceutical Regulatory Agency
No | Indicator | Target |
|---|---|---|
1. | FULL EVALUATION: | 100% |
2. | FULL EVALUATION: | 100% |
3. | FULL EVALUATION: | 100% |
4. | FULL EVALUATION: | 100% |
5. | FULL EVALUATION: | 100% |
6(a). | ABRIDGED EVALUATION: | 100% |
| 6(b). | ABRIDGED EVALUATION: Evaluation of Product Registration Application for Generics (Non-Scheduled Poison) with two (2) or more active ingredients (Timeline: 136* working days) *upon receipt of complete application | 100% |
7(a). | ABRIDGED EVALUATION: | 100% |
| 7(b). | ABRIDGED EVALUATION: Evaluation of Product Registration Application for Health Supplements (General and Functional Claims) with two (2) or more active ingredients (Timeline: 120* working days) *upon receipt of complete application | 100% |
8(a). | ABRIDGED EVALUATION: | 100% |
| 8(b). | ABRIDGED EVALUATION: Evaluation of Product Registration Application for Natural Products (Traditional and Homeopathic) with two (2) or more active ingredients (Timeline: 120* working days) *upon receipt of complete application | 100% |
| 8(c). | ABRIDGED EVALUATION: Evaluation of Product Registration Application for Natural Products (Natural Products with Modern Claim) with single active ingredient (Timeline: 116* working days) *upon receipt of complete application | 100% |
| 8(d). | ABRIDGED EVALUATION: Evaluation of Product Registration Application for Natural Products (Natural Products with Modern Claim) with two (2) or more active ingredients (Timeline: 136* working days) *upon receipt of complete application | 100% |
9. | Issuance of Cosmetic Notification (Timeline: 1* working day) * For applications that meets the specified requirements | 100% |
| 10. | Approval of Change of Registration Holder Application *upon receipt of complete application | 100% |
| 11. | Approval of Change of Manufacturing Site (Timeline: 60* working days) * upon receipt of complete application | 100% |
| 12. | Approval for Manufacturer’s, Import, and Wholesaler’s License (Timeline: 4* working days) * upon receipt of complete application | 100% |
| 13(a). | Evaluation of Clinical Trial Import Licence (CTIL) and Clinical Trial Exemption (CTX) application involving First-in-Human trials, biologics, Cell & Gene Therapy Products (CGTPs) and Herbal products (Timeline: 45* working days) *upon acceptance of complete application | 100% |
| 13(b). | Evaluation of Clinical Trial Import Licence (CTIL) and Clinical Trial Exemption (CTX) application involving investigational products other than stated above (13(a)). (Timeline: 30* working days) *upon acceptance of complete application | 100% |
| 14(a). | Issuance of Certificate Of Free Sale (CFS) for Cosmetic (Timeline: 15* working days) *upon receipt of complete application | 100% |
| 14(b). | Issuance of Certificate Of Free Sale (CFS) for Veterinary Product *upon receipt of complete application | 100% |
| 15. | Issuance of Certificate of Pharmaceutical Product (CPP) *upon receipt of complete application | 100% |
| 16. | INSPECTION ACTIVITIES: GMP/GDP/GCP/GLP/BE/EC inspection reports must be issued within 30 working days after the inspection. [Note: GMP (Good Manufacturing Practice), GDP (Good Distribution Practice), GCP (Good Clinical Practice), GLP (Good Laboratory Practice), BE (Bioequivalence), EC (Ethics Committee)] | 100% |
Effective from January 1st, 2025
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