How To Notify Handmade Cosmetics In Malaysia
(Note: I am not a GMP Consultant, I am merely sharing what I currently know of as an active participant in the Malaysian cosmetics manufacturing landscape as of January 2020, from the perspective of a small to medium enterprise. All details of fees and regulatory procedures are subject to change at any time — do your own research, with mine as an indicative guide.)
Recently I have been receiving a number of very similar enquiries, about how to notify handcrafted, all-natural cosmetics with our National Pharmaceutical Regulatory Agency (NPRA) so that they can be sold legally in Malaysia. My company, Kinder Soaps, is recognised by the NPRA as a cosmetics manufacturer that complies with ASEAN Cosmetics Good Manufacturing Practices guidelines, and we also help other brands manufacture their handcrafted cosmetics to comply with ASEAN CGMP.
In this article, I will try to provide a concise overview of the product notification process, writing with the assumptions that you are looking to
- make your own cosmetic products, with formulations that are unique to you
- manufacture and market said cosmetic products within Malaysia ONLY
- follow all procedures strictly by the book.
With that, let’s dive in.
1: Finalise your formulation
Tweak, fix and finalise your cosmetic product formulation once you are happy with it. You shouldn’t be changing your formulation once you put your product out to market — your customers are expecting a certain level of consistency in your product quality, feel and scent.
2: Identify who your manufacturer will be
The list of approved cosmetics manufacturers in Malaysia can be found on the NPRA’s (National Pharmaceutical Regulatory Agency) website, here. You will be looking for an arrangement called “Contract Manufacturing”, or what some factories refer to as “OEM” which stands for Original Equipment Manufacturing. You can ask to visit their premises and have a look around, and see if their services match what you require for your own products.
Both parties must sign a Contract Manufacturing Agreement with the duties and responsibilities of each party during the course of your time working together.
3: Prepare your Product Information File (PIF)
The PIF is a document that contains all details about your product — from its precise formulation, to how it is made, details of its physical characteristics, and what its packaging looks like. This is what your chosen manufacturer will maintain on your behalf, on their premises. They should be willing to provide you with a copy, and updated versions if there are any. The NPRA can request to view this document as well, at any time.
4: Send your product for laboratory testing
You or your chosen manufacturer can start contacting laboratories to run some tests on some product samples.
Here are the main tests you need to run on your cosmetic products:
- heavy metal testing (typical parameters: arsenic, lead, cadmium, mercury)
- microbial testing (typical parameters: Total Aerobic Microbial Count
Total Yeast & Mold Count, Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans) - shelf life testing (accelerated and real time)
You should set aside roughly RM1,200 per formulation, to cover the cost of all these basic lab tests. Ask the lab for a quote, and their advice on the battery of tests you should go for (different cosmetics products may require a slightly different battery of tests).
Once you receive your lab results, you need to append them with your PIF.
5: Appoint a qualified Safety Assessor
Once you have put together all the required information for your PIF, a qualified Safety Assessor will issue an endorsement for your PIF to verify that the formulation and production methods stipulated in the PIF will result in a finished product that is safe for consumers to use.
This fee can cost anywhere between RM3,500 to RM5,000 per formulation, depending on the consulting company that is engaged, as well as the complexity of the said formulation.
The endorsement will remain valid as long as the product’s formulation and production method remain unchanged — so it’s most likely that you will only need to pay this fee once.
6: Notify your product with the NPRA
The National Pharmaceutical Regulatory Agency (NPRA) is under the purview of Malaysia’s Ministry of Health.
To go through with the product notification process, you will first need to apply for a USB security token in order to log into NPRA’s QUEST 3 Plus System. It only works on Windows machines (sorry Mac users!). You can find out how to go about it here. The cost is around RM350 for a two-year validity period.
Cosmetics notification costs RM50 per product, and is valid for 2 years.
To be doubly sure that your products have been properly notified with the NPRA, do a public search for them here (be sure that the Product Category is set to “Cosmetics” and not “Pharmaceuticals”).
Once your products are duly notified, you can start putting them out to the Malaysian market. Congratulations! 😊🎉
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Michelle has been running an all-natural, handcrafted soap and skincare company, Kinder Soaps, for the past 10 years. For more information on GMP-compliant cosmetics production, write to her at michelle@kindersoaps.com.
