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Cosmetic Section, National Pharmaceutical Control Bureau, Ministry of Health Malaysia, Jalan Universiti 46200 Petaling Jaya, Selangor. MALAYSIA Tel : 603-78835400 Fax : 603-79556772 Website : www.bpfk.gov.my
WHO Collaborating Centre for Regulatory Control of Pharmaceuticals
Member of Pharmaceutical Inspection Cooperation Scheme
Certified to ISO 9001:2000 Cert. No: AR 2293 1
Guideline
Publication
Revision
Guideline for Control of
Cosmetic Products in
Malaysia
Initial Publication
-1st
January 2008
1st
Revision
- 2016
**not including revision on ingredient annexes i.e. Annex II-VII - ACC/ACSB decisions
VS.
OLD REVISED
GUIDELINE HISTORY NEW! PREAMBLE NEW! ABBREVIATIONS NEW! GLOSSARY NEW!
- Cosmetic Notification Holder - Cosmetic Product - Letter of Authorisation (LOA)/Letter of Declaration - Letter of Contract Manufacturing - Manufacturer - Assembler - Primary Assembler - Secondary Assembler - Product Name - Product Owner - Product Variant
1. INTRODUCTION 2. COSMETIC NOTIFICATION 3. REGULATORY REQUIREMENTS FOR COSMETIC PRODUCT 4. POST MARKET SURVEILLANCE (PMS) PROGRAMME – NEW! 5. REGULATORY ACTION 6. NOTIFICATION WITHDRAWAL 7. NOTIFICATION EXEMPTION 8. CERTIFICATE OF FREE SALE NEW! 9. HALAL NEW!
10. APPENDICES
Annex I, Part 1: Illustrative List Of Cosmetic Products By Categories
Annex I, Part 2: Non-permissible Product Name For
Cosmetic Product NEW!
Annex I, Part 3: Charges For Quest Membership NEW!
Annex I, Part 4: Guide Manual For Quest Online Submission Of Cosmetic Notification NEW!
Annex I, Part 5: Illustrative List of Types of Changes For Notified Product
Annex I, Part 6: Guideline For Safety Assessment of Cosmetic Products Annex I, Part 7: Cosmetic Labelling Requirements Annex I, Part 8: Cosmetic Claims Guideline Annex I, Part 9: Guideline For Cosmetic Advertisement
Annex I, Part 10: Guideline For Cosmetic Good Manufacturing Practice Annex I, Part 11: List of Equivalent Cosmetic GMP Guidelines Annex I, Part 12: Guideline For Product Information File (PIF) Annex I, Part 13: Guide Manual For Adverse Event Reporting Annex I, Part 14: Heavy Metal and Microbiological Test Limit For Cosmetic Product NEW!
Ingredient Annexes (Annex II-VII) Annex II: List of Substances Which Must Not Form Part of the Composition of Cosmetic Products Annex III: List of Substances Which Cosmetic Products Must Not Contain Except Subject to Restriction and Conditions Laid Down Annex IV: List of Colouring Agents Allowed for Use in Cosmetic Products Annex V: List of Excluded from the Scope of the Directive Annex VI: List of Preservatives Which Cosmetic Products May Contain Annex VII: List of UV Filters Which Cosmetic Products May Contain
Cosmetic products in Malaysia are regulated under the Control of Drugs
and Cosmetic Regulations (CDCR) 1984 which were promulgated under the Sale of Drugs Act 1952.
In agreement with the harmonisation of cosmetic through the ASEAN Cosmetic Directive (ACD), cosmetic products in Malaysia are controlled through notification procedure starting from 1st January 2008. The CNH is required to COMPLY with all requirements stated in this guideline and to make a declaration upon notification to the Director of Pharmaceutical Services (known as DPS) through National Pharmaceutical Control Bureau (NPCB). Regulatory action will be taken in the event of false declaration and/or product found to be non- compliant to the stipulated regulations and guidelines.
Under the CDCR 1984, Regulation 18A (1): No person shall manufacture, sell, supply, import, possesses any cosmetics unless the cosmetic is a notified cosmetic. It is an offence for anyone to conduct such activities without prior notification to the DPS.
APPLICATION PROCEDURES
1. Who shall submit for cosmetic notification
– locally registered company, CNH
2. Responsibility of the Cosmetic Notification Holder (CNH) NEW!
3. How to Submit for Notification Annex I, part 3: Charges for Quest Membership
–updated following GST implementation
(previously- Annex I, part 1-Membership Registration for Quest2 System)
Annex I, part 4: Guide Manual for Quest Online
Submission of Cosmetic Notification NEW!
4. Language- Bahasa Malaysia/English
5. Privacy Marking – all info is P&C
6. Fee – RM 50.00 per product/variant
7. Notification Validity Period – 2 years
8. Manufacture or Importation of Product
–after issuance of Notification Note
9. Changes in Notification Particulars
– i) amendment ii) new Notification
Annex I, part 5:Illustrative List of Types of Changes for
Notified Product
(previously Annex I, part 4)
10. Notification Number - NOTyymmxxxxxK
1. Product Particulars – notification submission
- Product name, type, intended use & presentation
- Name & add of the manufacturer (& assembler)
- Name, add, valid contact no. & e-mail of the CNH
- Name of person representing the CNH incl. valid contact
number
- Name & add of the importer(s), if any
- Full product ingredient list (restricted ingredients % to be
declared).
- LOA/LD/ Letter of Contract Manufacturing, if applicable.
2. Safety Requirements - no changes
Annex I, part 6 for Guideline for Safety Assessment of Cosmetic Product.
3. Cosmetic Ingredients – updated following ACC/ACSB decsion
refer to ingredient Annexes (Annex II – VII)
4. Labelling Requirements – Bahasa Malaysia and/or English
Annex I, part 7: Cosmetic Labelling Requirements
+ valid contact no. of the CNH on the label
5. Cosmetic Claims Annex I, part 8: Cosmetic Claims Guideline
(updated with more examples of unacceptable claims)
6. Cosmetic Advertisement ◦ Annex I, part 9: Guideline for Cosmetic Advertisement (previously Annex I, part 12:Cosmetic Advertisement Code)
+ 4.1 Impression of Professional Advice/Endorsement (a) Advertisements should not:-
(i) Have any visual and/or audio presentation of individual(s) with the impression of giving professional recommendation or endorsement; or
(ii) Contain statements giving the impression of professional by endorsement, advice or recommendation made by associations or persons who appear in the advertisements and who are presented either directly or by implication, as being qualified to give such endorsement, advice or recommendation.
(b) Advertisement may contain statements that are concluded from unbiased/ objective surveys/information, genuinely obtained from professionals. Care shall be taken, that the statements do not transgress any relevant regulations that the professionals institution to which they belong .
+ 4.6 Dangerous Practices or Disregard for Safety
Advertisement should not, without justifiable reason, show or refer to dangerous practices or manifest a disregard for safety. Special care should be taken in advertisements directed towards or depicting children or young people.
7. Good Manufacturing Practice (GMP) + For foreign manufacturer, documentation to prove GMP
compliance is required
Annex I, part 10: Guideline for Cosmetic GMP
Annex I, part 11: List of Equivalent Cosmetic GMP Guidelines
(updated- WHO GMP, TGA GMP, ISO Standard 22716)
8. Product Information File (PIF) – no changes
Annex I, part 12 - Guideline for PIF (previously Annex I, part 5: ASEAN Cosmetic Directive Guidelines for PIF)
9. Product Recall • required when the product has or may cause potential
risk to the user
• voluntarily by the CNH or as directed by the DPS.
• must first consult/inform NPCB.
• refer to Guidelines on Good Distribution Practice, Chapter 10 available at NPCB’s website.
10. Reporting of Adverse Event – no changes
• Annex I, part 13: Guide Manual for Adverse Event Reporting
(previously Annex I, part 11)
1. PMS Activities • Screening of product formulation and information
incl.product name & its claimed benefits • Sample collection & testing • Monitoring of label compliance • Audit of premises for compliance to the Cosmetic GMP • Handling of product complaints • Monitoring of advertisements • Monitoring of adverse reactions • Audit on the PIF • Risk communication • Information sharing through ASEAN Post Marketing
Alert System (PMAS)
2. Product Sampling Requirements • Must be from the same production batch • In its original marketed container/packaging and
unopened • The sample label and package insert (if any) must not
be taken out from the container/packaging • The expiry date ≥one year • Qtty. required- at least consist of 4 units/containers,
with a minimum total content of 40g/40ml (weight/volume of the product content without the container/packaging material)
- refer to Annex I, part 14 for limits used for heavy metal and microbial limit test
1. Rejection of Notification Submission – during ‘Auto-screening’ before NOT no. is issued
2. Cancellation of Notification Note 3. Punitive Action/Penalty - as stipulated under Section 30 (1) of the CDCR 1984.
CNH shall inform NPCB for decision to withdraw a notification of any cosmetic product before its validity expiry, with reason.
CNH is responsible to inform the manufacturer/ contract manufacturer on the withdrawal decision.
CNH shall not reinstate the withdrawn notification & its notification note is deemed invalid.
The product may be re-notified through a new notification submission.
1. Market Sampling - for the purpose of test market/aesthetic studies for product’s acceptance by potential group of consumers or manufacturers.
2. In–House Evaluation - product samples either from R&D/production line which are by the company for the purpose of product selection, in-house sampling or demonstration.
- may also of actual products that are readily available in the country of origin.
NOT INTENDED FOR COMMERCIAL SALE
3. Products For Export Only (FEO) or Re-Exporting
- Cosmetic products that are imported to be assembled, enclosed, packed or labelled solely for re-export or manufactured locally solely for export-only
4. In Transit
- products taken or sent from any country and brought into Malaysia by land, air or water, whether or not landed or transhipped in Malaysia, for the sole purpose of being carried to another country either by the same or another conveyance.
5. Products to Be Sold or Supplied in Free Trade Zone (FTZ) or International Carriage Entering or Leaving Malaysia - imported for sale/supply in the FTZ or international carriage by ships, aircraft or other forms of international public transport
Must apply for the permit- formal letter to NPCB
The company should maintain proper records and documents. These records should be readily available for inspection by NPCB when required.
Not a mandatory requirement
Serves as document which state that the product can be freely sold in Malaysia
Application through online submission
RM50.00 for each copy of the certificate.
CFS for a product and variant can be combined in one certificate provided that the latter is notified as a variant of the main product
Processed within 15 working days upon payment confirmation provided the product complies with notification requirements
The validity of the CFS is based on the validity period of the notified
product.
Halal logo may be used voluntarily on a notified cosmetic product
Certified & approved Halal by the Malaysia Department of Islamic Development (Jabatan Kemajuan Islam Malaysia, JAKIM) or any Islamic Body recognised by JAKIM.
Original 1st
Revision
Annex I, part 1 Membership registration DELETED
Illustrative List of
Cosmetic Products By
Categories
Annex I, part 2 Illustrative List of Cosmetic
Products By Categories
moved to Annex I, part 1
Non-Permissible Product
Name For Cosmetic
Product NEW
Annex I, part 3 Template for notification of cosmetic products DELETED
Charges For Quest
Membership NEW
Annex I, part 4 Illustrative List of Types of
Changes For Notified
Product
moved to Annex I, part 5
Guide Manual For
QuestOnline Submission NEW
Annex 1 : ORIGINAL vs. REVISED
Original 1st
Revision
Annex I, part 5 ASEAN Cosmetic Directive Guidelines For Product Information File (PIF) moved to Annex I, part 12
Illustrative List of Types of Changes For Notified Product
Annex I, part 6 (Changes to the Title)
ASEAN Guidelines For Safety Assessment Of Cosmetic Products
Guideline For Safety Assessment of Cosmetic Products
Annex I, part 7 (Changes to the Title)
ASEAN Cosmetic Labeling Requirements
Cosmetic Labelling Requirements
Annex I, part 8 (Changes to the Title)
ASEAN Cosmetic Claim Guideline
Cosmetic Claims Guideline
Annex I, part 9 ASEAN Guidelines For Cosmetic Good Manufacturing Practice moved to Annex I, part 10
Guideline For Cosmetic Advertisement
Annex 1 : ORIGINAL vs. REVISED
Original 1st
Revision
Annex I, part 10 List Of Equivalent Cosmetic
GMP Guidelines Recognized
by ASEAN moved to Annex I, part 11
Guideline For Cosmetic
Good Manufacturing
Practice
Annex I, part 11 A Guide Manual For Adverse
Event Reporting moved to Annex I, part 13
List of Equivalent Cosmetic
GMP Guidelines
Annex I, part 12 Cosmetic Advertising Code moved to Annex I, part 9
Guideline For Product
Information File (PIF)
Annex I, part 13 A Guide Manual For
Adverse Event Reporting moved from Annex I, part 11
Annex I, part 14 Heavy Metal And
Microbiological Test Limit
For Cosmetic Product NEW
Annex 1 : ORIGINAL vs. REVISED
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