The applicant for product registration shall be known as the Product Registration Holder (PRH) and must be a locally incorporated company, corporate or legal entity, with permanent address and registered with Companies Commission of Malaysia (with the scope of business related to the health/ pharmaceutical product).
1.FEES IMPOSED
Please refer to Appendix 1 in
https://www.npra.gov.my/easyarticles/images/users/1047/Drug-Registration-Guidance-Document-DRGD---Second-Edition-Revised_July-2019-.pdf: Fees for fees imposed, which include:
a) Charges for USB Token of QUEST Membership; b) Processing and Analysis Fee for Product Registration; c) Charges for Application of Licence; d) Charges for Amendments to Particulars of a Registered Product; e) Fee for Certificates; and f) Charges for Product Classificaton.
So Processing fee for Health Supplement is round RM1000.00; and Analaysis Fee for registration on Single active ingredient is RM 1,200.00 or Two or more active ingredients is around RM 2,000.00.
2.CATEGORIES OF PRODUCT: Health Supplements
3.VALIDITY OF PRODUCT REGISTRATION: 5 years
4.CHECKLIST OF DOSSIER REQUIREMENT FOR HEALTH SUPPLEMENTS
-Product Name , Brand name and product name ;
-Product Description ;
-Dosage Form (
Letter to verify the source of gelatin use,Colouring agent used in capsule ,COA capsule shell is required);
-Product indication/ Usage;
-Dose/ Use Instruction ;
-List of Active ingredient(s) ;
-Letter of authorization from product owner to product registration holder (if applicable);
-Certificate of Pharmaceutical Product (CPP) - Applicable to imported products, must be issued by the competent authority in the country of origin. CPP issued by reference country may be considered. ;
-Certificate of Free Sale (CFS) - Applicable if CPP is not available, must be issued by the competent authority in the country of origin/ products owner country. ;
-Certificate of Good Manufacturing Practice (GMP) - Applicable if CPP is not available, must be issued by the competent authority in the manufacturing country;
-Certificate of Good Manufacturing Practice (GMP) for premixed active ingredient;
- Complete stability study conducted at 30 ± 2 ºC / RH 75 ± 5%, IPQC, FPQC, protocol analysis and COA of finished product are required to be submitted 2 years after product registration with SAMPLE of the products. Failure on submission will cause the product be suspended until the complete documents are submitted, the registration of the product will be terminated if the complete documents still cannot be produced upon renewal of product registration;
-Stability Data ; etc
For more registration guidance and details, please visit their website :
-
https://www.npra.gov.my/easyarticles/images/users/1047/Drug-Registration-Guidance-Document-DRGD---Second-Edition-Revised_July-2019-.pdf,-
http://www.myhealth.gov.my/en/drug-product-registration-process-malaysia/Information/guideline above are based on Malaysia' registration requirement.
Hope this help ^@^
By the way, I'm new to this field and nice to meet you.
------------------------------
Pui Wan
Regulatory Affairs Mgr - Asia
Malaysia
------------------------------
Original Message:
Sent: 15-Aug-2019 21:51
From: Asha Hira
Subject: dietary supplement registration
Hi everyone
we are seeking advise and help to register our product in Malaysia, Indonesia and Singapore.
We are a NZ dietary supplement company, our product is a unique scientifically proven world-first CoQ10 antioxidant that specifically targets the mitochondria. We are currently registered in NZ and USA.
At this stage, we would like a ball park of time, costs and initial requirements and feasibility.
Can anyone help?
many thanks
Asha
MitoQ - breakthrough cellular science
------------------------------
Asha Hira
Regulatory Affairs
Auckland
New Zealand
------------------------------