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> Is KKM approval needed

thkhong
post Jun 19 2008, 10:13 AM


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smile.gif smile.gif smile.gif I just sourced a Health Supplement product that I can market for about half the price that is being sold over the counter. However, i noticed that each bottle has a KKM (Min. of Health) approval. I intend to import in bulk and repackaged here for sale. Nothing very much, just to keep myself going. In times like this, I try to source the lowest price so that people need not buy the product at exhorbitant prices.

Can someone pl. advise me how to go about doing this. I am no pharmacist but a retired person who sourced things out as his hobby. If we find a good product, we try to market and share the benefits of a lower price. Thats all.

I have done this with my raw honey which thanks to LYN I have been quite successful in my education program. If this product lifts of, I intend to do the same as the honey.

Hope anyone out there can give me the appropriate advise.

This post has been edited by thkhong: Jun 19 2008, 10:15 AM
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tinkerbel
post Jun 19 2008, 10:14 AM


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@thkhong,
The product will need a KKLIU license.
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thkhong
post Jun 19 2008, 10:19 AM


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QUOTE(tinkerbel @ Jun 19 2008, 10:14 AM)
@thkhong,
The product will need a KKLIU license.
*
Thks. Can you tell me how to go about it. Do I need a company. I dont intend to set up one since I go only one product by one product. There are no big plans for growing big so that I can keep overheads down. The more you expeand the more overheads, salaries, advertisement, office rental, utilities and commissions. All these add up to the cost of the product. if it is a hassle, I may not want to do it.
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tinkerbel
post Jun 19 2008, 10:35 AM


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@thkhong,
In order to start marketing this product here, U will need to first submit the relevant documents and samples to MOH, KKLIU (Pharmaceutical) for approval and license. It's not a short process.

U perhaps can get more information from the authorities. Am afraid I can't help U out much more.

Is there a way to take this out of 'MOH' and just put it as food? The process is so much faster.
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thkhong
post Jun 19 2008, 10:55 AM


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QUOTE(tinkerbel @ Jun 19 2008, 10:35 AM)
@thkhong,
In order to start marketing this product here, U will need to first submit the relevant documents and samples to MOH, KKLIU (Pharmaceutical) for approval and license.  It's not a short process.

U perhaps can get more information from the authorities.  Am afraid I can't help U out much more.

Is there a way to take this out of 'MOH' and just put it as food?  The process is so much faster.
*
Dear Tinkerbel

I actually had that idea in mind (similar to raw honey, except it is sourced locally and known to a lot of oldies). But bec. I saw the label, it set me back awhile whether I shld. take the KKLIU approval. It is natural, organic product and therefore, contains no preservatives,or steriods which is harmful for continuos consumption.

I might bring some in to sell and test the market whether it is accepted or not. You see, by going through all the tedious procedures and all the back paying tactics, no wonder all the products are so pricey. Since this product is sold mainly by the MLMs, then the profit added in will definately shoot the price up. By selling direct, I dont have to pay commissions, advertisement ,rentals etc. I can sell at a cheap price that is affordable by almost everyone who is using it now.

I give you an example (but this is not the product). Primrose oil. The pharmacists are selling this at nearly 39 sen per capsule. In the early days, I sourced this from China which costs only RM4.50 per bottle of 30 capsules. Eventually, some European factory offered them a bulk order and then they were sold for around RM7.50. I dont know how much it cost now.

Thks. for your advice. I just need someone to share my thoughts. When and if I sell this product, remind me to give you a complimentary bottle. Just keep an eye on the Garage sales column which I post my raw honey.You will know it when I launch the product.
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tinkerbel
post Jun 19 2008, 11:00 AM


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@thkhong,
If U can, never TRY to market a product which requires u to go through MOH's Pharmaceutical department; it's hell getting the licensed and approvals and can sometimes take up to 5 years *ugh* I used to have a contact there but I don't know if he's still there. Am also out of the office today so if U do want it, I could check it out and pass it to u when I'm back in the office tomorrow.

Thanks for the complimentary bottle - just PM me and let me know cause I rarely am at Garage Sales *grins* tongue.gif

Good Luck.

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thkhong
post Jun 19 2008, 11:17 AM


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QUOTE(tinkerbel @ Jun 19 2008, 11:00 AM)
@thkhong,
If U can, never TRY to market a product which requires u to go through MOH's Pharmaceutical department; it's hell getting the licensed and approvals and can sometimes take up to 5 years *ugh*  I used to have a contact there but I don't know if he's still there.  Am also out of the office today so if U do want it, I could check it out and pass it to u when I'm back in the office tomorrow.

Thanks for the complimentary bottle - just PM me and let me know cause I rarely am at Garage Sales *grins* tongue.gif

Good Luck.
*
I know. thats why I rather do this on a low key basis. Esp. if you are a nobody and trying to muscle into the big boys. They will give me hell.

Will pm you if I set this product off, though no promises.
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24hrs
post Jun 19 2008, 05:31 PM


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Firstly, you have to send the formula to MOH at Putrajaya for classification.
If it is classified as food then bingo, you can import that in without hassle, no need that stupid MAL.

If it is classified as OTC, then you have to register the product with Pharmaceutical Division in PJ. The application will cost you a few thousand bucks and it may takes up to 2 years to get approval. In the process, you have to provide them with lots of documents. It is quite a time consuming process. If I were you I would go for food products.
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thkhong
post Jul 28 2008, 10:00 AM


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QUOTE(tinkerbel @ Jun 19 2008, 11:00 AM)
@thkhong,
If U can, never TRY to market a product which requires u to go through MOH's Pharmaceutical department; it's hell getting the licensed and approvals and can sometimes take up to 5 years *ugh*  I used to have a contact there but I don't know if he's still there.  Am also out of the office today so if U do want it, I could check it out and pass it to u when I'm back in the office tomorrow.

Thanks for the complimentary bottle - just PM me and let me know cause I rarely am at Garage Sales *grins* tongue.gif

Good Luck.
*
dear Tinkerbell

This is my second reply with regards to the above. I have launched my product last week and receiving a fair number of visitors. As for your complimentary bottle, it is still waiting for you to collect unless you are not interested in Spirulina. I keep to my promise, it is up to you to accept or not. However, would appreciate if you give me a note of your intention so that I do not need to keep reminding myself of this outstanding matter.

Thanks.

Khong Tuck Hing
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tinkerbel
post Jul 28 2008, 10:52 AM


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@thkhong,
Hi and Congratulations!!!!!!!!!!! You sent me a note?! Hmm... I don't think I got it *gulp* Will check PM box again though *oopS*

<goes off to check PM box>
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kingkong81
post Jul 29 2008, 09:00 AM


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QUOTE(thkhong @ Jun 19 2008, 10:13 AM)
smile.gif  smile.gif  smile.gif I just sourced a Health Supplement product that I can market for about half the price that is being sold over the counter. However, i noticed that each bottle has a KKM (Min. of Health) approval. I intend to import in bulk and repackaged here for sale. Nothing very much, just to keep myself going. In times like this, I try to source the lowest price so that people need not buy the product at exhorbitant prices.

Can someone pl. advise me how to go about doing this. I am no pharmacist but a retired person who sourced things out as his hobby. If we find a good product, we try to market and share the benefits of a lower price. Thats all.

I have done this with my raw honey which thanks to LYN I have been quite successful in my education program. If this product lifts of, I intend to do the same as the honey.

Hope anyone out there can give me the appropriate advise.
*
I hope i can help with this.

1st of all....any health supplement products requires KKM approval.

So, you actually needs to send your sample to Biro Pengawalan Farmaseutikal Kebangsaan (BPFK) at Jalan Universiti, PJ.
At the same time you will need to provide necessary documentation on the ingredients & products as well.

Once you got it registered...you will be given a registration number like : MAL200820125TC
if it ends with "T" it is for traditional medicine
"X" for supplement/over-the-counter product
"A" is for pharmacy item...poison item

You will also needs to get the hologram for your product before you market it.

So, I would strongly advised you to go personally to BPFK to consult with the officers there. They will tell you what you need to do.

Remember, selling unregistered products is a legal offence which can result in you being charge under the Sales of Drugs Act 1952, that carrries a fine of RM25,000.

There are a lot of products out there that just put a label of "Approve by KKM", but without the MAL number or the hologram. These products are mostly not registered.

Go to the website to find more info... www.pharmacy.gov.my

QUOTE(tinkerbel @ Jun 19 2008, 10:14 AM)
@thkhong,
The product will need a KKLIU license.
*
FYI...KKLIU license is not for product registration

KKLIU actually stands for Kementerian Kesihatan Lembaga Iklan Ubat.

They are actually approval for advertisement.

Health products requires special approval to advertise their products in the media, as most of them always carries a lot of claims (eg. "can cure diabetes, prevent cancer", etc) that can be misleading to the public.

So, if you plan to advertise your product in any form of advertisement media (pamphlet, brochure, flyers, printing media, tv, billboards) all of them need to get approval from Lembaga Iklan Ubat.

Their office is same as BPFK, which is in Jalan Universiti as well.

You will need to bring your advertisement work art together.

The control of advertisement of health products are spell out in Medicines (advertisement & sale) Act 1956.
So they actually states things that u cannot advertise.
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thkhong
post Jul 29 2008, 10:09 AM


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QUOTE(kingkong81 @ Jul 29 2008, 09:00 AM)
I hope i can help with this.

1st of all....any health supplement products requires KKM approval.

So, you actually needs to send your sample to Biro Pengawalan Farmaseutikal Kebangsaan (BPFK) at Jalan Universiti, PJ.
At the same time you will need to provide necessary documentation on the ingredients & products as well.

Once you got it registered...you will be given a registration number like : MAL200820125TC
if it ends with "T" it is for traditional medicine
"X" for supplement/over-the-counter product
"A" is for pharmacy item...poison item

You will also needs to get the hologram for your product before you market it.

So, I would strongly advised you to go personally to BPFK to consult with the officers there. They will tell you what you need to do.

Remember, selling unregistered products is a legal offence which can result in you being charge under the Sales of Drugs Act 1952, that carrries a fine of RM25,000.

There are a lot of products out there that just put a label of "Approve by KKM", but without the MAL number or the hologram. These products are mostly not registered.

Go to the website to find more info... www.pharmacy.gov.my
FYI...KKLIU license is not for product registration

KKLIU actually stands for Kementerian Kesihatan Lembaga Iklan Ubat.

They are actually approval for advertisement.

Health products requires special approval to advertise their products in the media, as most of them always carries a lot of claims (eg. "can cure diabetes, prevent cancer", etc) that can be misleading to the public.

So, if you plan to advertise your product in any form of advertisement media (pamphlet, brochure, flyers, printing media, tv, billboards) all of them need to get approval from Lembaga Iklan Ubat.

Their office is same as BPFK, which is in Jalan Universiti as well.

You will need to bring your advertisement work art together.

The control of advertisement of health products are spell out in Medicines (advertisement & sale) Act 1956.
So they actually states things that u cannot advertise.
*
Thks. for your advise. I am not going in a big way. In fact it is more for personal use than anything else. I just share this with people who think it is affordable. I have thought about what you tell me but do you think they will entertain a kechil mayong like me. I do not want to pay all sorts of fees. In the end it goes back to the big boys who may indirectly source from me or my supplier AND TURN IT AROUND they sell to you guys at such exhorbitant price. This is what I call indirect exploitation. Anyway if it is too much of hassle I dont sell but only supply by word of mouth. I can turn my attention to the Japanese market which is considering to purchase in bulk. i just concentrate on selling my honey.

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tinkerbel
post Jul 29 2008, 12:20 PM


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@thkhong,
Just becareful what U do cause U don't want some jealous people to report U; esp through breach of the Direct Selling act tongue.gif
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