Cosmetics

Guidelines for Control of Cosmetic Products in Malaysia

Guidelines for Control of Cosmetic Products in Malaysia

MEI 2009 (rev02)

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Guidelines for Control of Cosmetic Products in Malaysia

TABLE OF CONTENTS:

1. Introdu ction 1.1. What i s cosmetic product notification

2. The regulation of cosmetic products 2.1. Introduction

3. Legal aspects of cosmetic control 3.1. Director of Pharmaceutical Services (DPS) 3.2. Definitions 3.2.1. Cosmetic Product 3.2.2. Manufacturer 3.2.3. Primary Assembler 3.2.4. Secondary Assembler 3.2.5. Product Variant 3.3. Legi slation covering the manufacturer

4. Who should notify the authori ty 4.1. Criteria of person who notifies local authority 4.2. Responsibility of person who notifies local authority

5. Notification Pro cedure 5.1. Document which must accompany notification form 5.2. Language 5.3. Privacy markings 5.4. Product variant 5.5. Multiple manufacturer 5.6. Processing fees 5.7. Notification validity period 5.8. Manufacture or importation of product 5.9. Changes in notification particulars

6. Post-Market surveillance 6.1 Product Information File (PIF) 6.1.1 6.1.2 6.2 Language Updating

Safety assessment of cosmetic product

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Guidelines for Control of Cosmetic Products in Malaysia

7. Cosmetic ingredients

8. Labeling requi rements

9. Cosmetic claims

10. Good Manufacturing Practice (GMP)

11. Authorization for manufacture, import or wholesale 11.1. Manufacturing Authorization 11.2. Import Authorization 11.3. Wholesale Authorization 12. Products for export only or In-transit

13. Test market sampling or aesthetic studies and In-house evaluation 13.1 Test market sampling or aesthetic studies 13.1. In-house evaluation

14. Reporting of adverse events

15. Product Recall 15.1. Degree and level of recall 15.2. Decision on the degree and level of recall 15.3. Record keeping 16. Cancellation of Notification and Authorization 17. Withdrawal

18. Penalty

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