Frequently Asked Question : Compliance & Licensing
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.
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.
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
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.
Manufacturer’s License, Import License, and Wholesaler’s License holders.
The officers from NPRA and/or the Pharmacy Enforcement Division.
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.
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.
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.
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.
Regulatory punitive actions can be imposed on companies that fail to comply with GDP requirements.
License application for year 2024 and earlier
Not necessary. The company can proceed to apply for an Import License / Wholesaler's License, and NPRA will schedule the GDP inspection at the company's premises later.
License application for year 2025 and later
Under the enhanced licensing process, a GDP inspection may be required following submission of a new Import License / Wholesaler’s License application, subject to predefined criteria. Applicants must be fully prepared for documentation review and an inspection as part of the evaluation process.
However, suppose the applicant 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.
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.
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.
No.
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.
The NPRA generates reports highlighting common deficiencies found during GDP inspections. These reports assist stakeholders in identifying and addressing compliance issues to improve their practices.
Phone: +603-78835400 or Staff Directory
Official Email: saeb@npra.gov.my
Official Portal: https://npra.gov.my
Updated 1 November 2024
