Malaysia Cosmetic Registration

Malaysia Cosmetic Registration (NPRA – National Pharmaceutical Regulatory Agency)

1. Regulatory Authority & Framework

Cosmetics in Malaysia are regulated under:

• Control of Drugs and Cosmetics Regulations 1984
• Guidelines for Control of Cosmetic Products (latest NPRA updates)
• ASEAN Cosmetic Directive (ACD) – fully adopted by Malaysia

Authority:
NPRA – National Pharmaceutical Regulatory Agency, Ministry of Health.

Malaysia uses an online notification system (Quest 3+), NOT pre-market “approval”.
Once notified, the product can be marketed unless NPRA finds non-compliance.

2. Scope – What Is a Cosmetic in Malaysia?

A product is classified as a cosmetic if:

• Applied to external parts of the human body (skin, hair, nails, lips, external genitalia)
• Applied to teeth or oral mucosa
• Intended for cleansing, perfuming, changing appearance, correcting odours, protecting, or maintaining condition

Borderline products (e.g., acne treatment, scalp treatment, whitening claiming medical function, anti-hair loss) may be considered drugs or cosmeceuticals → require drug registration, not cosmetic notification.

3. Registration Type – Cosmetic Notification (NOT Number)

Malaysia uses Cosmetic Notification, not product registration.

Output:

• NOT Number (e.g., NOT23XXXXXXK)
• Valid for: 2 years (renewable)

4. Responsible Person (RP) Requirement

Every cosmetic must have a Responsible Person (RP) based in Malaysia.

RP must:

• Hold a company account in Quest 3+
• Ensure compliance with ASEAN Cosmetic Directive
• Maintain Product Information File (PIF)
• Conduct Post-Market Surveillance (PMS)
• Manage reporting of adverse events
• Answer NPRA inquiries during audits
• Cooperate in market recalls (if required)

Foreign manufacturers cannot submit notification directly.

5. Cosmetic Notification Requirements (Quest 3+)

Documents/Data Needed

1. Product Information File (PIF)
   • Part I: Administrative information
   • Part II: Product quality & safety data
   • Part III: Safety assessment report
   • Part IV: GMP (ISO 22716) evidence
   • Part V: Analytical test results (heavy metals, microbiology if required)
2. Ingredient list
   • Must comply with ASEAN Cosmetic Ingredient Listings
     • Annex II: Prohibited ingredients
     • Annex III: Restricted ingredients
     • Annex IV: Colorants
     • Annex VI: UV filters
     • Annex VII: Preservatives
3. Label & artwork
   • INCI ingredient names
   • Batch/lot number
   • Manufacturing country
   • Net content
   • Precautions/warnings (if applicable)
   • RP details
4. GMP certificate (ISO 22716 strongly preferred)
5. Claims substantiation
   • Evidence must support claims
   • No medicinal/therapeutic claims allowed

6. Fees & Timeline

Government Fee

• MYR 50 per product (standard NPRA notification fee)

Timeline

• Submission via Quest 3+
• Instant notification once accepted online (no technical review)
• NPRA may conduct post-market review anytime

7. Labeling Requirements

Mandatory information on containers & outer packaging:

• Product name & function
• Instructions for use
• Full ingredients list (INCI)
• Batch/lot number
• Expiry date (if shelf life < 30 months)
• Country of manufacture
• Name & address of Responsible Person in Malaysia
• Content (net weight/volume)
• Warnings for restricted ingredients (e.g., AHA, hair dyes)

Language:

• Bahasa Malaysia or English accepted

8. Post-Market Surveillance (PMS)

NPRA conducts:

• Random sampling
• Laboratory testing
• Labeling compliance checks
• Product claims verification
• Online advertisement monitoring
• Good Manufacturing Practice (GMP) verification

RP must:

• Maintain PIF for minimum 7 years
• Submit Adverse Event Reports via NPRA system
• Perform recalls if product is found non-compliant

9. High-Risk Ingredients – Special Rules

Certain ingredients require additional caution:

Products containing medicinal claims or restricted ingredients may be classified as drugs → require NPRA Drug Registration (MAL Number).

10. Consulting Notes for Your Portfolio

11. Advantages of Malaysia Cosmetic Market

• Fastest notification system in Southeast Asia
• Low cost (MYR 50)
• Harmonized with ASEAN Cosmetic Directive
• English labeling accepted
• Simple RP system