11/16/21, 5:02 PM NPRA

FAQ
(/) : Product Registration
POSTED BY LISA ASSAKIN A | 04 OCTOBER 2021 | HITS: 128944

Last update: 4 October 2021 8

1. What is a registered drug?

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: MAL19976399X

2. What needs to be registered?

   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)
         + Dietary supplement e.g. Probiotics, Chitosan

   c. Traditional products

        Includes:
         + Homeopathic medicines
         + Ayurvedic medicines
         + Medicated plaster
         + Herbal teas
         + Dietary supplements eg. Spirulina, Chlorella, Royal Jelly, Bee Pollen, Aloe Vera juice, Noni juice, Extract of chicken with herbs

d. 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
* Guidance Decision Tree

3. What do not need to be registered?

    a.  Raw herbs, including those that are dried & cut into pieces
    b.  Diagnostic agents/ test kits for in vitro use - please refer to this link for more information. Diagnostic agents/ test kits for laboratory use must be labeled 'FOR                     LABORATORY USE
ONLY'. Products which are not labeled as such shall be deemed to be for human or animal use and need to be registered with the DCA.
    c.  Medical devices - please refer to this link for more information.
        Includes:
         + Blood bags containing anti-coagulants
         + Visco-elastic products for mechanical or physical protection of tissues during or after surgical procedures
         + Non-medicated plasters
         + Wound care/dressing materials containing hydrogel, collagen, calcium alginate
         + Disinfectants for equipments/ devices
         + Lubricants for gloves, condoms and endoscopes
         + Contact lens care products
         + Copper IUDs
         + Bone cement, tissue adhesives
    e.  Insect repellents
    f.   Body-building products containing protein/whey/ soya bean
    g.  Food - as defined under the Food Act 1983 and Food Regulations 1985, includes every article manufactured, sold or represented for use as food or drink for human consumption or which
enters into or is used in the composition, preparation, preservation, of any food or drink and includes confectionery, chewing substances and any ingredient of such food, drink, confectionery or
chewing substances. This includes food for special dietary use for persons with a specific disease, disorder or medical condition, and food which contain quantities of added nutrients allowable
under the Food Act and Regulations.
* For information on Food - Drug Interphase products, please refer to subtitle 'Regulatory Information' > 'Other guidelines' > 'Classification decision tree' for further details.
    h. Detergents/ disinfectants for domestic use

4. What is the procedure for the registration of pharmaceutical products?

Product registration can be submitted online via Quest system. An applicant must apply for a Quest membership and purchase a USB Token before they can proceed with registration. Once the
applicant has received the USB Token, he/she will be able to enter the registration site and proceed with online submission.
The summary of the online registration procedure for products are as follows:-
1) Go to NPRA website (www.npra.gov.my) > Industry > First Time User > Register USB Token.
2) Apply for QUEST Membership.
     * Requirements :
            i. Company Registration Form
            ii. Company Authorization Letter
            iii. Photocopy of I/C

3) Upon Quest membership approval, purchase USB Token from MSC Trustgate.
4) Login Quest to submit product registration application.

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5) Submit data requested. 
6) Correspond with NPRA officer if additional data is needed. 
7) Products tabled to DCA meeting

(/)
5. What is the fee for drug registration?

Processing fee
Every application for registration shall be accompanied with a processing fee, as follows (effective January, 2007) :-

Processing Fees
No Product Classifi cation Analysis Fees (RM)  Total Fees 
(RM)
 Single active ingredient :
 1  New Chemical Entity  1,000.00  4,000.00
3,000.00
 Two or more active ingredients
 5,000.00
: 4,000.00
 Single active ingredient :
2   Pharmaceutical  1,000.00  2,200.00
1,200.00
 Two or more active ingredients:
 3,000.00
2,000.00
 3  Traditional  500.00  700.00  1,200.00
Applications without the correct fees will not be accepted. Foreign currencies are not acceptable. The processing fee is NOT REFUNDABLE.
Other charges
The DCA will charge any applicant such costs as it may incur for the purpose of carrying out laboratory investigations/ testing prior to the registration of any product.
Mode of Payment
The processing fee and any other charges shall be paid in the form of a bank draft/money order made payable to "Biro Pengawalan Farmaseutikal Kebangsaan".
NB. A separate bank draft is required for each application for registration.

6. What is the next step to take after my product is registered?

After a product is registered, the applicant must apply for a manufacturer/ import/ wholesale license.

The processing fees are as below:

License Registration fee Timeline * Validity

1. Import license RM 500 Not more than 1 month 1 year

2. Manufacturer RM 1000 Not more than 1 month 1 year

3. Wholesaler RM 500 Not more than 1 month 1 year

* Effective Date: 4 October 2007

7. What is the timeline (time-frame) for registration?

The duration for each product to be registered is calculated from the date of final and complete submission.
Below are the timeline for product of each category:

Category of product Timeline

Full Evaluation
To evaluate application for registration of :
210 working days *
Prescription drugs 210 working days *
Non- prescription drugs 245 working days *
New drugs and biologicals

Abridged Evaluation
To evaluate application for registration of health supplements and traditional products
containing:
116 working days *
Single active ingredient
136 working days *
2 or more active ingredients
* Upon receipt of complete application

* Update: January 2013

8. What are the criteria for drug registration?

A product will be registered only if it satisfies ALL the requirements of the DCA, especially with respect to safety, efficacy and quality of the products. Other criteria taken into consideration are:-
    i. Whether that product is needed or not. Aspects like potential of abuse, number of registered products, different dosage forms, etc. are considered.
    ii. Therapeutic effect.

9. Is all the information declared in the registration form confi dential?

Yes, confidentiality of data is assured.

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

11. Can I amend the label/ formula of my product after it is registered?

Yes, an application to amend the particulars of a registered product can be made through Quest online submission. This information can be found in FORMS TRAY under VARIATION menu. All
changes / amendments requires prior approval from NPRA before it can be implemented. The approval and decision will be notified on-line. Formulation of a product cannot be altered if the
change of active is involved. In this case, new application must be made.


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12. How can an overseas company register and distribute its product in Malaysia?
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 holder of the registration certificate. The appointed agent would then be responsible for all matters
pertaining to the registration of the products.
There are specific forms to complete during the process of registration and under the labeling requirements for products registered with the Drug Control Authority, the name and address of the
(/)
actual manufacturer must be declared on the label.

13. Do cosmetics need to be registered?

Effective 1st January 2008, the online registration procedure for all cosmetics products has been replaced with the online notification procedure. Companies intending to market new cosmetic
products must notify NPRA before placing the products in the local market. Please refer to this link for more information on guidelines for control of cosmetic products in Malaysia.

14. What is the defi nition of "cosmetic"?

A cosmetic product shall mean "any substance or preparation intended to be places in contact with various external part of the human body (epidermis, hair system, nails, lips, and external
genital organs) or with teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body
odours and/or protecting them or keeping them in good condition".

15. What is a traditional medicine?

A Traditional Medicine means any product employed in the practice of indigenous medicine, whereby the drugs used consist of one or more naturally occurring substances of plant, animal or
mineral or part thereof, or in extracted form or non-extracted form, and any homeopathic medicine.
(Indigenous Medicine - means a system of treatment and prevention of diseases involving the traditional use of naturally occurring substances.)

16. What are the quality requirements for Traditional Medicines?

Traditional medicines are subjected to the following tests:-
  + Test for contamination of heavy metals:-
          Mercury - 0.5 ppm
          Arsenic - 5.0 ppm
          Lead - 10 ppm
          Cadmium - 0.3 ppm

  + Test for microbial contamination

  + Disintegration test for tablet and capsule

17. How are homeopathic medicines controlled in Malaysia?

Homeopathic medicine means any drug in a pharmaceutical dosage form that is used in the homeopathic therapeutic system in which diseases are treated by the use of minute amounts of such
substance which is capable of producing in healthy persons symptoms similar to those of the disease being treated.
Homeopathic medicines in finished dosage forms have to be registered with the Drug Control Authority before they can be imported and sold in the country. A foreign company wishing to bring
such products into Malaysia has to appoint a local agent to be the holder of the registration certificate. The appointed agent will be responsible for all matters pertaining to the registration of the
products.

18. How do I report on ADR?

If it is suspected that a patient has suffered an adverse reaction to a traditional medicine, it should be reported to the Malaysian Adverse Drug Reactions Advisory Committee either through its
Website, through the ADR reporting form or even by a letter. All information on the name of the remedy, its ingredients and source (if known) should be included. In order to facilitate better
assessment and to allow further action to be taken, when necessary please include the label/packing material of the product where possible. If it is suspected that the product is contaminated
with some other medicines such as steroids, painkillers, hypoglycemic agents etc., please include a sample of the product to enable analysis to be performed.

19. What should I do if my contract manufacturer license is revoked?

A contract manufacturer's license may be revoked due to closure or suspension of premise. Your product registration will not be cancelled, however you will need to apply a change of
manufacturing site form in order to continue the validity of your products. This is covered under Change of Manufacturing Site type V (which also includes circumstances like natural disasters or
matters related to breach of product quality, safety and efficacy). Approval from NPRA is required prior to implementation of change Please fill up the Borang BPFK 415.3[NMJ1] to proceed with the
change of manufacturing site..For further information please browse our Guidelines on Requirements for change of manufacturing site [NMJ2].

20. Security Label (Hologram)

The new hologram security label supply will be implemented by Techno Secure Print Sdn Bhd Company starting 1 September 2019 and the price of the hologram security label will be RM0.064 /
label unit.
Hologram security label reservations can be made to Techno Secure Print Sdn. Bhd. effective 1 September 2019 and the duration of the supply of hologram security labels to the industry is 14
days from the date of order.
For your information, Techno Secure Print Sdn. Bhd. is holding a training session on the use of the label buying system for all hologram security label users. You can contact the company about
the training schedule and for the hologram security label purchase process.
Click for details: NEW HOLOGRAM SECURITY LABEL PRICES INFORMATION (https://www.pharmacy.gov.my/v2/en/news/01-sep-2019/new-hologram-safety-label-prices-information.html)

No Question Answer

Which regulation covers the implementation of As provided under Regulation 8(1) of the Control of Drugs and Cosmetics Regulations
1.
mandatory security labeling? 1984.

The requirement for the affixation of this security device to product labels, is
What types of products that required security applicable to all registered pharmaceuticals products, traditional Products and health
2. supplements.
labeling?
All products without security labeling will be considered as unregistered products.

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(i) The  security label shall  be affixed onto the outer carton (secondary packaging) of
(i) Where is the security label to be affixed? the product. Where there is no outer carton, the security label shall be affixed on the

immediate label. 
The security label shall not be affixed onto the outer shrink wrap.

(/) The security label shall cover none of the product particulars on the immediate label. 
The customer purchasing a product should be able to locate the security label
without having to open the packaging.
For large volume parenteral products (LVP) defined as containers labelled as
containing more than 100mL  [based on the United States Pharmacopeia (USP)], the
security label shall be affixed on the immediate label of each unit of the product.
On the other hand, it is sufficient for the security label to be affixed to the outer
carton / unit of sale for small volume parenteral (SVP) products [defined as packaged
in containers and labelled as containing 100mL or less [based on the United States
3.
Pharmacopeia (USP)].
For example: For a SVP product with 10 bottles packed into one box as the unit of sale,
this requires only one hologram to be affixed to the outer carton of the box and not on
each bottle. This applies to all registered units of sale for that one product, where one
hologram is required to be affixed to the outer carton of the box of 5’s, 10’s, 20’s, 50’s,
or 100’s. 
For a SVP product that does not have any outer carton, the hologram is then required
to be affixed to the immediate label of the bottle or primary container as stated in the
Drug Registration Guidance Document (DRGD).
(ii) What about products that are meant to be
supplied to hospitals and to be used by doctors
or nurses for their patients (e.g. injections, TPN,
etc.)? (ii) All products that are meant to be supplied to hospitals and to be used by doctors
and nurses for their patients should also be affixed with security label.

Where should the security label be affixed for Each individual item that is a product registered with the DCA will have to bear the
4.
promotional packs containing 2 or more items? security label.

If manufacturers and importers packed and sold

their products in a box of one dozen to their The security label is to be affixed to each immediate label of individual unit of sale.
dealers, must they apply the security label onto
5. the box of one dozen or on each individual It is, however, not required that each blister strip be affixed with a security label. The
pack/bottle?
unit of sale for blister/strip/sachet packed products would be the outer carton or
What about products to be sold in loose form packs of 4's, 8's, 10's or 20's that they are packed in.
(strips, blisters, sachets, loose tablet, etc.)?

Are registered importers allowed to send the Yes, the labels can be sent to the overseas manufacturer and the product is then
6. security labels to their manufacturers who are imported fully labelled. The importer to whom the labels have been sold will remain
located outside Malaysia? the responsible party.

The company that is on record with the DCA as the importer for a particular product
will be the party responsible for the security labels on the product in question.
Who is supposed to buy and apply the security
label if both principals and distributors are
7. Even if the registered importer outsources the actual process of stickering the labels
companies in Malaysia as well as registered
onto the physical stock to another agent, the importer will still be accountable.
with NPRA?
SOP's for the labelling procedure, including documentation and reconciliation records
should be maintained.

How detailed should the security label Reconciliation records should be as required under GMP requirements as for any
8.
reconciliation record be? other type of product label.

Enforcement will be at the point of sale (retailers and wholesalers), and can begin any
time after implementation.

When will DCA begin inspection or enforcement Enforcement will not be carried out at the point of entry. However, in cases where the
on the use of the labels? imported products are brought in without security label, the importers are
9. (At point of entry, imported products without responsible to ensure such of imported products should be labelled with security
label prior to distribution of such products.
hologram would be a hassle to the enforcement
officers regarding its authenticity.) The implementation will be in 2 phases, with the 1st phase for all non-injectable
products starting 1st May 2005. All non-injectables which are imported or
manufactured on or after 1st May 2005 should carry the security label.
The 2nd phase of implementation for parenteral preparations will begin 1st July 2005.

Are registered importers and manufacturers of Currently the requirement for security label does not apply to cosmetics. It is NOT
10. cosmetic products allowed to purchase and recommended that cosmetic products carry the security label as it may lead to
apply security label onto their products? confusion.

NO, all products manufactured and imported after the stated implementation date(s)
will need to bear the label.
If manufacturers and importers are unable to
11. get sufficient stocks, can they be allowed to sell
their products without the label? Forecast of orders for the security labels are needed by the supplier to understand
requirement needs. As demand is dynamic, the information supplied is vital to
ensure adequate stocks are kept to fulfill customer orders.

There are security features, both overt (visible) and covert (hidden) that can be used
Will registered manufacturers and importers be
for verification of label authenticity.
liable if their assigned security label (serial
number) is found in unregistered products?
12. The security labels supplied to registered importers and manufacturers will carry
What happens if they are caught distributing
unique serialised numbers. As such each label can be traced to its "owner". If
unregistered products? Who would be charged?
genuine security labels are found on unregistered products, the owner would
The importers or the product holders?
definitely have some explanations to do.


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Only licensed manufacturers and importers of pharmaceutical, traditional medicine
and health supplement products can purchase the labels.

13. Who can buy the security labels? The local manufacturer (meaning also the repacker for products which are imported
in bulk and packed locally) or the importer shall be responsible for affixing the
security device onto the individual unit packs.
(/) Any person who contravenes this requirement will be fined as follow:-
1st time: not exceeding RM 25, 000 or by imprisonment for a term not exceeding 3
years or both. 
2nd time: not exceeding RM 25, 000 or by imprisonment for a term not exceeding 5
What is the penalty for those who fail to
14. years or both.
implement the security label?
Where as any body corporate that found guilty will be charged as follow:-
1st time: not exceeding RM 50, 000.
2nd time: not exceeding RM 100, 000.

The distributor authorized by the Government to supply the security label is Techno
How do I ensure an authentic purchase of Secure Print Sdn Bhd.
15.
security labels? Should more information be required on the technical and supply aspects, please
contact Techno Secure Print Sdn Bhd.

What happens if a registered product is affixed

The product may be categorised as an unregistered product and both the product
16. with an authentic security label that is owned by
registration holder (PRH) and hologram owner may be penalised.
another company?

Syarikat : Techno Secure Print Sdn Bhd

Alamat : No. SD30, Jalan KIP 10, Kawasan Perindustrian Kepong, 52200 Kuala Lumpur
Waktu operasi : Isnin - Jumaat: 8.30am - 5.30pm
Emel : [email protected] (mailto:[email protected])
: 03-6274 6550 / 9550 / 2550
Talian Khidmat Pelanggan
016-298 8708 / 8062
No. Fax : 03-6274 7550

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