1. Where is the application form for veterinary products available?

Applications for the registration of veterinary products should be done on line. To log on to the system you must first obtain an USB token and a password. In NPCB's website www.bpfk.gov.my, you can look for the details on how to apply for a new USB token under Quest 3 and Guide for Quest3 login.

 

2. Can the registration be done manually?

NO. All applications for registration must be done on line via Quest 3 except for Part III and IV for Innovator products which are to be submitted in the form of hardcopy or CD.

 

3. If a product has been approved by other regulatory agencies such as the FDA, or have worldwide registration status , does it have to be registered with DCA again?

For all products to be marketed in Malaysia, they must be registered with DCA even though they have been registered in other countries.

Will they be given priority in processing?

These products will be evaluated as any other product in the queue.

 

4. Can we apply for a product that is still under patent to be registered?

DCA registers a product based on quality, safety and efficacy regardless of whether a product is still under patent or not. If a company sells/markets a product that is still under patent, it is considered an infringement on the patent's right and legal actions can be taken against the company by the patent holder.

 

5. Are products for pet animals and fish( for food or fish for pleasure) come under the purview of this regulation?

Yes, if these products have medicinal purposes.

 

6. Can raw materials containing scheduled poison be purchased and used in feedmills for own farms?

Scheduled poison in raw form products can only be imported and sold to pharmacists having Type A license. However, raw material containing scheduled poison substance shall not be considered for registration, and such raw material is not allowed to be used by the end user. For a feedmill which has been granted a special type B license, raw material containing scheduled poisons can be purchased only to be used for the preparation of animal feed.

 

7. Can a person without Type A license ( for example a farmer) buy a scheduled poison in the form of i) raw material ii) finished product?

i) No, because the farmer does not have a Type A license.
ii) Yes, provided he has a prescription for his animals from a veterinary doctor.

 

8. Do premixes prepared by feedmillers for adding into feed need to be registered? If let say I prepare premixes in my own farm to be sold to another party in contract basis, whether this will be exempted from registration?

Premixes prepared as intermediates for addition into feed for own use is not registrable. These premixes however have to be registered if they are sold to a third party. For feed millers who prepare the product extemporaneously for their own use and not to be marketed, the product is not registrable. However, if the product is manufactured in their own farm and to be sold to another party, the product is considered registrable as the finished product are being marketed eventhough to only one customer.

 

9. Can a product be imported into this country and be exported again without being registered?

Special permission can be obtained for this purpose from Enforcement Division, Pharmacy Services Division.

 

10. What happens if the authority that endorsed the GMP/FSC/CPP certificates is not listed?

A copy of GMP/FSC/CPP needs to be submitted to NPCB for verification. The issuing body will be added to the database if it is accepted by NPCB.

 

11. Do the FSC/GMP/CPP certificates need to be consularised?

These certificates need not be endorsed by the consulate. Translations however is necessary for certificates issued in foreign languages other than English.

 

12. If the manufacturing is done overseas, will GMP audits be done on these premises?

GMP audits will be done on foreign manufacturers if and when it is considered necessary by NPCB. This is especially so for manufacturers of sterile products coming into the country for the first time.

 

13. What is the quantity of samples required to be submitted for testing?

Testing will be done after the products are registered. There is no need for the applicants to send the samples prior to registration. Manufacturers are requested to keep retention samples of their products for the purpose of post-registration testing.

 

14. Can foreign languages be used on the labels of the products? For registered products to be exported to other countries, are we allowed to change the labels in order to comply with the requirements of the importing country?

Yes, provided there is also Bahasa Malaysia or English version on the labels.

For export products the labels can be changed based on the requirements of the importing countries.

 

15. For a product coming from overseas, in order to save cost because of the small volume of order, can the registration number be pasted on the product package?

No. The number has to be imprinted on the labels.

 

16. Some manufacturers do not have stability data. Does NPCB accept applications without stability data?

For more information on stability data, you may refer to Appendix 7-Guideline For Stability Data, REGOVP

 

17. As a manufacturer, if I do not have my own lab facility to carry out the tests on my products, can I contract out the tests to an outside lab?

Yes, you can.

 

18. Can an imported product be sold with a different name as stated in a CFS?

Yes, provided the information is declared by the Issuing Authority.

(Updated: Jan 2012)