Frequently Asked Question : Compliance & Licensing

1) What is Good Distribution Practice (GDP)?

The measures to be taken during storage, transportation, and distribution of registered products / notified cosmetics and their related materials to ensure the quality and integrity of the intended use are preserved when they reach consumers.

2) Why is GDP a necessity?

GDP can serve as a guide for parties involved in the supply chain of registered products/notified cosmetics to maintain the quality and integrity of registered products/notified cosmetics at all levels of the supply chain.

All holders of Manufacturer’s License / Import License / Wholesaler’s License are required to fulfil:

1. The license condition is to comply with GDP requirements.

2. The directive from the Senior Director of Pharmaceutical Services to manufacturers / importers / wholesalers of registered products / notified cosmetics has been in effect since 1 January 2012 to comply with GDP requirements stipulated in the Guidelines on Good Distribution Practice, Malaysia.

3) What are the guidelines regarding GDP that can be referred to?

1. Guideline on Good Distribution Practice

2. Supplementary Notes on Annex 1: Management of Time and Temperature Sensitive Products (TTSP) of Guideline on Good Distribution Practice

4) What is a GDP inspection?

Inspection of the Manufacturer’s License, the Import License, and the Wholesaler’s License holders to verify compliance with the Guideline on Good Distribution Practice.

5) Who will be subject to the GDP inspection?

Manufacturer’s License, Import License, and Wholesaler’s License holders.

6) Who will perform the GDP inspection?

The officers from NPRA and/or the Pharmacy Enforcement Division.

7) What types of GDP inspections will be conducted?
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8) What inspection mechanism will be used?

The GDP inspection is conducted on-site at the business and/or store address(es) of the holder of the Manufacturer’s License, the Import License, and the Wholesaler’s License.

9) What will be checked during the GDP inspection?

The inspection scope will encompass compliance aspects based on the Guideline on Good Distribution Practice. A general review of the inspection scope can be found in Annex 2: General Points to Consider for Auditee.

10) What are the categories of GDP compliance levels?
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11) How long does a GDP inspection take?

The duration of time taken for each GDP inspection depends on the scope and activities related to GDP under the responsibility of the holder of the Manufacturer’s License, the Import License, and the Wholesaler’s License.

12) Is the GDP inspection conducted only once or periodically?

The GDP inspection will be conducted periodically, and the determination of the inspection frequency is based on a risk matrix established by NPRA covering the current level of GDP compliance, the scope of GDP activities, and the types of products handled.

13) What happens if our company does not comply with the GDP requirements?

Regulatory punitive actions can be imposed on companies that fail to comply with GDP requirements.

14) Does our company need a GDP inspection before applying for a new Import License / Wholesaler’s License?

Not necessary. The company can proceed to apply for an Import License / Wholesaler’s License, and the GDP inspection of the company’s premises will be scheduled later.

However, suppose the Import License / Wholesaler’s License holder intends to handle cold chain products; the company must first undergo a Cold Chain Facility Inspection. The company can submit a written application for the Cold Chain Facility Inspection through an official letter addressed to the Deputy Director, Centre of Compliance and Quality Control, NPRA.

15) The Cold Chain Facility Inspection has been conducted and found satisfactory by the NPRA. What are the next steps that need to be taken?

The company may apply for updating the License Conditions for handling cold chain products to the Licensing and Certification Section, Centre of Regulatory Coordination & Strategic Planning, NPRA. Please refer to the Surat Pemakluman Pemberian Syarat Lesen Pengendalian Keluaran Rangkaian Sejuk bagi Lesen Pengilang, Lesen Mengimport dan Lesen Pemborong Keluaran Berdaftar, effective from 7 March 2023.

Cold Chain Facility Inspection details for the company can also be found on the Cold Chain Facilities List.

16) Our company holds an Import License / Wholesaler’s License and is involved solely in distribution activities using documentation (no storage, transportation, or direct distribution of registered products/notified cosmetics). Is our company subject to GDP inspection?

Yes.

The GDP inspection also applies to third parties appointed by the company to handle the storage, transportation and/or distribution of its registered products / notified cosmetics.

17) Does NPRA issue any certification for compliance with GDP requirements?

No.

18) As a holder of an Import License / Wholesaler’s License, is our company allowed to perform packaging activities in the business premise and/or store(s)?

The company may refer to Appendix 32: Explanatory Notes for Repackers of the Drug Registration Guidance Document (DRGD) and/or contact the Good Distribution Practice Section, Centre of Compliance and Quality Control, NPRA.

For any further questions regarding GDP, the company may contact NPRA through the following channels:

Phone: +603-78835400 or Staff Directory

Official Email: saeb@npra.gov.my

Official Portal: https://npra.gov.my

Updated 19 September 2023

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

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