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PUBLIC CONSULTATION ON IMPLEMENTATION OF MANUFACTURING LICENSE FOR COSMETIC MANUFACTURER

PUBLIC CONSULTATION ON IMPLEMENTATION OF MANUFACTURING LICENSE FOR COSMETIC MANUFACTURER. 22 ND FEBRUARY 2019 9.30 AM DEWAN SERAI WANGI, NPRA. OUTLINE. Introduction Objective CDCR Regulation (Current Vs Proposed) Statistics - GMP Current and Future Regulatory Action

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PUBLIC CONSULTATION ON IMPLEMENTATION OF MANUFACTURING LICENSE FOR COSMETIC MANUFACTURER

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  1. PUBLIC CONSULTATION ON IMPLEMENTATION OF MANUFACTURING LICENSE FOR COSMETIC MANUFACTURER 22ND FEBRUARY 2019 9.30 AM DEWAN SERAI WANGI, NPRA

  2. OUTLINE • Introduction • Objective • CDCR Regulation (Current Vs Proposed) • Statistics - GMP • Current and Future Regulatory Action • Implementation and its Implication

  3. INTRODUCTION

  4. OBJECTIVE • To inform cosmetic manufacturers regarding the requirement to obtain a Manufacturing Licence to conduct manufacturing activity of notified cosmetics. • To extend the scope of Manufacturing License under CDCR 1984 to include cosmetic manufacturers • NOTES: Currently, there is no impact / changes on: • Notification process. • Importation activities. • Wholesale activities.

  5. CDCR 1984 AMENDMENT • Regulation 12. Licences • Regulation 13. Application for licence • Regulation 18A. Prohibition to manufacture, sell, supply, import or process cosmetic.

  6. REGULATION 12. LICENCES

  7. REGULATION 13. APPLICATION FOR LICENCE

  8. REGULATION 18A. PROHIBITION TO MANUFACTURE, SELL, SUPPLY, IMPORT, POSSESS OR ADMINISTER COSMETIC.

  9. NUMBER OF LICENSED Vs COSMETICS MANUFACTURER 2016-2018

  10. GMP STATUS OF COSMETICS MANUFACTURER 2016-2018 *Routine Inspections

  11. CURRENT REGULATORY ACTION Delisting of Cosmetics Manufacturer Cosmetics De-notification Source: www.npra.gov.my

  12. FUTURE REGULATORY ACTION Regulation 14. Refusal of application for licence. The Director of Pharmaceutical Services may, if he thinks fit and without assigning any reason, refuse any application for a licence Regulation 17. Revocation of licence. The Director of Pharmaceutical Services may, at any time and without assigning any reason, revoke any licence issued under these Regulations and may amend the conditions of the licence.

  13. IMPLEMENTATION AND ITS IMPLICATION Tentative: 1st January 2020

  14. Thank You

  15. Q & A Session

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