MAB_FAQ.doc

FREQUENTLY ASKED QUESTIONS

1. A product owner had conducted a study regarding the usage of a product and the data/results show that 70% of the customers actually admit that the product is effective. Can the product owner sell or market the product?

The National Pharmaceutical Control Bureau (NPCB) is responsible for any issues regarding the effectiveness of a product and the requirements for registration.

 
2. We had received several warning letters regarding our advertisements that certainly do not have any extraordinary claims. Is there any explanation for this?

Advertisements of registered pharmaceutical products must be evaluated and given approval by the Medicine Advertisement Board although it has no medical claims. Advertisements regarding health services are only permitted for certain premises such as private hospitals, private clinics, private radiology clinic and medical laboratories.

3. What is the  explanation for a condition where a product that is being approved by the FDA although it has no registration number (MAL number) and does not have any approval from the Medicine Advertisement Board?

An approval from the FDA does not mean that the product had already been registered with the Ministry of Health Malaysia. Every pharmaceutical product must be registered with the Ministry of Health Malaysia before it could be sold or marketed in Malaysia. Then a KKLIU certificate must be obtained from the Medicine Advertisement Board for the advertisement purposes. Non-pharmaceutical products that had been classified as food items must be forwarded to the Food Safety and Quality Division for further actions. 

4. (a) Can we advertise (with medical claims) a raw material such as bird nest that is proven to have effects in the treatment of certain diseases and medical conditions?

(b) How do we advertise if the bird nest is processed and manufactured into a capsule or tablet form without any addition of chemicals?


(a) It is allowed if it's in a form of raw material. However, it should be forwarded to the Food Safety And Quality Division for further actions if it’s in a commercial form.
(b) The registration status should be clarified and obtained from the National Pharmaceutical Control Bureau if it’s in a capsule or tablet form. It should be forwarded to the Food Safety And Quality Division if it’s classified as a food item. However, the Medicine Advertisement Board must approved the advertisement if it’s classified as a pharmaceutical product.

5. Nowadays, the problems regarding unapproved advertisements is on the rise. Why are the relevant parties not tackling the problems by educating the registration holders?

The Advertisement Control Unit is currently having dialogues session with the media and advertisement agencies on this matter. It is found to be easier and more efficient to give talks and educate the media / advertisement agencies that are small in quantity rather than educating the large number of registration holders. We hope that the media / advertisement agencies will contribute by making sure that the advertisements are approved before being released.

6. Do we need to obtain an approval from the Medicine Advertisement Board if the pharmaceutical product had already been registered with the Ministry of Health?

Yes. This is because the approval of registered products is based on the safety and efficacy of the product while the Medicine Advertisement Board is more concern on the advertisement aspects of the product. This is to ensure that there will be no confusion among the public and the advertisements concur with the Medicine (Advertisement And Sales) Act 1956 and the enforced guidelines.  

7. Do we need an approval from the Medicine Advertisement Board if the advertisement of a pharmaceutical product is in a form of a crawler?

Yes. This is because a crawler is considered as an information tool and it is also a form of advertisement.

 8. How do we make sure that the Medicine Advertisement Board had approved the advertisements?

Upon receiving the application, check the approval certificate issued by the Medicine Advertisement Board and the approved advertisement format. Please make sure that the attached format is signed by the Secretary and Translator of the Medicine Advertisment Board. Check whether the approval number on the advertisement format matches with the number on the advertisement approval certificate. An example of an approval number: KKLIU/1234/2004/ABC

9. Does the Medicine Advertisement Board monitor and control the advertisements by direct selling companies?

Yes. The Medicine Advertisement Board had approved several advertisements involving pharmaceutical products that are being sold and marketed by direct selling companies.


10. A caller on a radio station calls to state and promote the pharmaceutical product that sponsors the radio segment. Is this scenario permitted?

A The segment for callers for the radio segment sponsored by a pharmaceutical product is not permitted. The approval for radio segments sponsored by pharmaceutical products is only valid for 6 months.

 
11. Does the medical advertisement on the Internet require approval from the Medicine Advertisement Board?

Any form of information spreading involving medical products and medical services can be considered as an advertisement and the Internet is one of them. The approval from the Medicine Advertisement Board is needed before it could be shown to the public.


(B) Advertisement Application Process 

1. Are we allowed to make minor changes in an advertisement format that had been approved by the Medicine Advertisement Board (e.g. photo/picture position changes)?

Minor changes such as photo/picture positions are permitted but they should obtain an approval from the Medicine Advertisement Board if it involves changes in the sentence, words and font size of the advertisements.

2. How long before we could obtain an approval for the advertisement application?

It depends on the type of advertisements. It takes a time limit of 5 working days to evaluate and process a simple advertisement with few medical claims. However, it takes around 4-6 weeks to process an advertisement that has a lot of medical claims because it needs to be evaluated by the members of the Board.

3. There are certain parties that complain that there were too much corrections made to their advertisements until it cannot be considered as an advertisement anymore. What is the explanation for this condition?

The Medicine Advertisement Board only permits the claims that are approved by the National Pharmaceutical Bureau. Other unapproved claims are not permitted.

 
4. What are the procedures involved in applying for amendments of a particular advertisement format?

Any amendments regarding an advertisement format should be referred to the Secretariat of the Medicine Advertisement Board before the board could approve it.

 
5. There are certain situations where the amendments of an advertisement format must be done as soon as possible. Are we allowed to advertise before the Medicine Advertisement Board approves the amendments?

This practice is not encouraged because the Medicine Advertisement Board must approve all amendments of the advertisement format before it is advertised. The applicants are encouraged to discuss with the Medicine Advertisement Board committee before taking such actions.

 
6. The fees for a radio advertisement application can be considered to be quite expensive. This is because a radio advertisement can only be aired for not longer than 6 months to prevent listeners from getting bored. Can the fees be reduced because of this factor?

The fees charged are standardized for all types of media. How ever, the Medicine Advertisement Board is currently revising the existing charges based on several factors and criteria. The new system will be enhanced and the fees will be based on the different types of advertising media.


(C) Weight Loss

 
1. What are the medical claims that are not allowed in an advertisement where weight loss is an issue?

The word 'weight loss' or 'slimming' is considered to be a medical claim. The applicant must refer and consult the Medicine Advertisement Board before making those claims in their advertisements.

 
2. Does the Medicine Advertisement Board allow testimony slots in advertisements where consumers give testimonies regarding weight loss products or services?

The testimony slots are not permitted because it will normally contain medicinal claims that are not allowed.

 
3. Can we advertise a weight loss programme (without approval from the Medicine Advertisement Board) if the advertisement only states the exercise routines and the diet programmes involved?

You do not need any approval if the advertisement only states the exercise routines and the diet programmes involved. How ever, you need to register the product with the Ministry of Health and apply for approval from the Medicine Advertisement Board if the product and the advertisement have any medical claims.


(D) Hair Loss

 
1. Does the Medicine Advertisement Board allow and approve advertisements of products or services concerning hair loss?

Advertisements concerning hair loss are not permitted. An advertisements must not contain any claims or implications that states:
- Baldness could be prevented
- Hair loss could be stopped
- Hair growth could be promoted and enhanced
How ever, advertisements regarding hair-weaving services are permitted.


(E) Food

 
1. Does a food advertisement allowed to have medical claims such as lowering the blood sugar level?

Food advertisements are not allowed to have any medical claims. Lowering blood sugar level is considered as a medical claim and diabetes is one of the 20 diseases that cannot be advertised under the Medicine (Advertisement and Sales) Act 1956.

 
2. Do advertisements regarding Tongkat Ali and Kacip Fatimah drinks need any approval from the Medicine Advertisement Board?

Tongkat Ali and Kacip Fatimah drinks are classified as food items. The Medicine Advertisement Board does not control the advertisements regarding both items and they do not need to acquire any approval. How ever, no medical claims are allowed.

(F) Cosmetic

 
1. It is found that advertisements of cosmetic products on the television do not have the approval serial number from the Medicine Advertisement Board. Do they need approval from the Medicine Advertisement Board?

All cosmetic products must be notified by the Drug Control Authority, Ministry of Health but they are not controlled by the Medicine (Advertisement and Sales) Act 1956. How ever, the advertisements of cosmetics must not have any medical claims and concur with the requirements of the cosmetic guidelines (Non-permissible Claims For Cosmetic Products). Legal actions could be taken against cosmetic advertisements that have medical claims.


(G)Service

 
1. Do the advertisements regarding services offered at fitness centre need to acquire approval from the Medicine Advertisement Board?

The Medicine Advertisement Board does not control advertisements regarding fitness centre services. How ever, legal actions will be taken under the Medicine (Advertisement and Sales) Act 1956 if medicinal claims are made.

 
2. Can we advertise an acupuncture service?

This type of advertisement is not permitted because it violates the Medicine (Advertisement and Sales) Act 1956. How ever, an acupuncture advertisement without stating the name and address of the premise is permitted because it is considered as health information and doesn’t need the approval from the Medicine Advertisement Board.

 
3. Are laser treatment services permitted?

Laser treatment is classified as a medical treatment and must be conducted by a registered medical practitioner. It can be advertised but only with an approval from the Medicine Advertisement Board.

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