National Pharmaceutical Regulatory Agency (NPRA) product registration

Description

• The product registration process with the National Pharmaceutical Regulatory Agency (NPRA) is a mandatory requirement in Malaysia for all pharmaceutical products, traditional medicines, health supplements, and cosmetics intended for distribution, sale, or importation. This process ensures that products meet strict standards of safety, efficacy, and quality, as regulated by the Ministry of Health Malaysia. Registered products are granted official approval, enabling them to be marketed legally in compliance with Malaysian laws and regulations. This process protects public health by ensuring that only safe and high-quality products are available in the market while also fostering trust between consumers and product manufacturers.

GOV Department

• National Pharmaceutical Regulatory Agency (NPRA) Under the jurisdiction of the Kementerian Kesihatan Malaysia (KKM)

License Nama (Malay)

• Sijil Pendaftaran Produk (MyPRP untuk farmaseutikal, dan QUEST3+ untuk kosmetik, ubat tradisional, dan suplemen kesihatan).

Details

• Scope
  
• Registration of pharmaceutical products (prescription and over-the-counter medicines).
• Traditional medicines and health supplements.
• Cosmetic products for external use.
• Requirements:
  • Submission through the NPRA's QUEST3+ online system.
  • Dossier preparation following ASEAN Common Technical Dossier (ACTD) format for pharmaceuticals.
  • Stability studies, safety profiles, and GMP (Good Manufacturing Practice) certifications for traditional medicines and supplements.
  • Safety and ingredient compliance for cosmetics.
• Application Process:
• Applicant must be a holder of a valid Manufacturer’s License, Import License, or Wholesale License issued by NPRA.
• Required documents:
  • Product formulation and ingredient details.
  • Analytical and clinical study reports (for pharmaceuticals).
  • Labeling and packaging details.
  • Manufacturer’s certification.
• Timeline:
• Processing time varies by product type, ranging from 6 to 12 months.
• Product Validity: 
• Registration is valid for five years, subject to renewal.

Important Rules

• Products must not contain prohibited substances or ingredients exceeding allowed limits.
• Misleading or unsubstantiated claims on product labels are prohibited.
• Registered products must display the Malaysian Drug Control Authority (DCA) Registration Number or NOT number for cosmetics.
• Unauthorized changes to the product after registration are not allowed.
• All advertising materials must be approved by the MOH's Medicine Advertisements Board (MAB).

Compound & Punishment

• Unregistered Products:
  • Fine up to RM50,000 or imprisonment up to 5 years, or both, under the Control of Drugs and Cosmetics Regulations 1984.
  • Repeat offenses: Fine up to RM100,000 or imprisonment up to 7 years, or both.
• Non-Compliance with Labeling Rules:
  • Fine up to RM25,000 or imprisonment up to 3 years, or both.
• False or Misleading Information:
  • Fine up to RM50,000 or imprisonment up to 5 years, or both.
• Illegal Advertising:
  • Penalty of RM3,000 per advertisement and removal of the material.

Advisor