NEW PRODUCT REGISTRATION

General Information

1. What is a registered drug?

Answer: A registered drug is a drug that is approved by the Drug Control Authority (DCA) for sale/use in Malaysia. This drug has been evaluated and tested for its efficacy and safety. Every registered drug is given a registration number, which must be printed on its label or package. These numbers start with MAL. Example of a registration number is MAL20165357A

2. What needs to be registered?

Answer:

a) Pharmaceutical products containing scheduled poisons.

b) Pharmaceutical products containing non-scheduled poisons (OTC)

 Includes:

         + Medicated plaster with medicines

         + Antiseptic/ Disinfectants for use on the human body

         + Diagnostic agents for human use (in vivo)

c) Health supplement

        Includes:

         + Vitamins

         + Minerals

         + Amino acids

         + Fatty acids

         + Enzymes

         + Probiotics

         + Chitosan

 
d) Natural products

        Includes:

         + Traditional medicine : Traditional Chinese Medicine, Ayurvedic medicines, Medicated plaster, Herbal teas

         + Homeopathic medicines

         + Herbal products

 
e) Veterinary products

     Includes:Oral solution, oral suspension, emulsion

      + Granules

      + Paste

      + Water soluble powder

      + Injectable

      + Powder for injection

      + Oral powders

      + Capsule, tablet

      + Topical ophtalmic and otic products

3. Are all the information declared in the registration form confidential?

Answer: Yes, confidentiality of data is assured.


4. Can unregistered medicines for personal use be brought into Malaysia?

Answer: Under the Control of Drugs and Cosmetics Regulations 1984, the requirements for drug registration does not apply to a person who arrives in Malaysia and imports, as part of his personal luggage, any product for his use or his family's use, in a quantity that does not exceed one month's use by one person. In the case of importing the products by post, this will require an import exemption that is granted by the Director of Pharmacy Enforcement Division, Ministry of Health Malaysia. For further information, please contact the Pharmacy Enforcement Division near you.


5. Can I amend the particulars of my product after it is registered?

Answer: An application to amend the particulars of a registered product can be made through Quest online submission. This information can be found in VARIATION guideline. All changes / amendments requires prior approval from NPRA before it can be implemented.The approval and decision will be notified online. However, not all particulars can be amended. For example, the formulation of a product cannot be altered if the change of active is involved. In this case, new application must be made.

6. Can the formulation of the product be changed during evaluation?

Answer: No. The formulation of the product cannot be altered during evaluation. The current product under evaluation should be withdrawn and a new application must be made.

7. How can an overseas company register and distribute its product in Malaysia?

Answer: All pharmaceutical products must be registered with the Drug Control Authority before it can be marketed in Malaysia. A foreign company wishing to bring pharmaceutical products into Malaysia would first have to appoint a local agent (a company registered in Malaysia) to be the product registration holder of the registration certificate. The appointed product registration holder would then be responsible for all matters pertaining to the registration of the products.


8. How to identify registered products?

Answer:

All pharmaceutical/natural products in Malaysia must be registered with the Ministry of Health Malaysia (MOH) before they can be marketed or sold to consumers. Registered products must carry both registration numbers (ie  MAL20165467AZ) and security label (Hologram sticker) on its packaging. A valid registration number begins with “MAL”, followed by 8-digit numbers and ends with an alphabet to indicate their registration category. The categories of registered product are as follows:

A – Controlled medicines

X – Over the counter medicines (OTC)

T – Traditional medicines

N – Supplements

H – Veterinary


9. What is the list of banned/prohibited substances/ingredients?

Answer:
a) Kindly refer to the DRGD under Appendix 8: List Of Permitted, Prohibited And Restricted Substances

b) For Natural Products, kindly also refer to the additional list in the DRGD under Appendix 5:Guideline On Registration Of Natural Products)