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- NPRA(National Pharmaceutical Regulatory Agency) Product Registration Services
In October 1978, under the Pharmacy and Supply Program, the National Pharmaceutical Regulatory Agency (NPRA), formerly known as the National Pharmaceutical Control Bureau (NPCB), was set up. In order to enforce quality control on pharmaceuticals, this organization was created. "In 1996, NPRA was recognized globally by the World Health Organisation (WHO) as a "WHO Collaborating Centre for Regulatory Regulation of Pharmaceuticals." The equipment and facilities were built to satisfy the standards for research and quality control practices. This acknowledgment is a WHO appreciation of the work of NPRA in the area of regulatory affairs.
The candidate is known as the Product Registration Holder ('PRH') for process validation for pharmaceutical products. The PRH must be a company registered locally, corporation, or legal entity with a residency permit and enrolled with the Commission of Companies of Malaysia (with a health/pharmaceutical product sector of work).
Since only Malaysian companies may refer for registration of such an item, a foreign company would have to assign a local agent (a company registered in Malaysia) as their local representative to enroll the product. The designated agent would therefore be ultimately in charge relating to product quality, safety, and effectiveness.
Control of drugs and cosmetics Regulation CDCR 1984, Regulation 7(1) asserts:
- No individual or company shall produce, market, supply, import, own or control any commodity unless:
- (a) the product is a licensed product and the product is registered
- (b) the individual owns the requisite and issued a valid license under these Regulations.
The Role and Duties of NPRA in Malaysia
In Malaysia, the NPRA's tasks are to enforce the drug registration/cosmetic confirmation scheme through scientific data assessment, laboratory review, testing, and information obtained from international agencies. In addition to performing medicinal, microbiological, and pharmacological medication and cosmetic testing to assess the quality, effectiveness, and safety of those drugs, the introduction of a regulatory scheme for the quality of pharmaceutical products and the implementation of a licensing system for drug producers, importers, distributors, and wholesalers, including a clinical trial licensing scheme.
NPRA categorizes the products for application and candidates should first determine their applications among the following: new drugs, biologics, generics, health supplements; and natural products.
Which Products Need to be Registered to NPRA?
- All Pharmaceutical items that contain scheduled poisons are also known as controlled poison or controlled medicine.
- Non-scheduled poison-containing prescription products (also known as OTC products)
- These include below:
- Medicated plaster
- Antiseptic/ Disinfectants designed for human body use
- Human-use medical agents (in vivo)
- Supplemental diet, e.g., Chitosan, Probiotics
- Traditional goods
- These include below:
- Homeopathic drugs
- Medicines from Ayurvedics
- Herbaceous teas
- Dietary pills, for example, Spirulina, Chlorella, Royal Jelly, Bee Pollen, Noni juice, Aloe Vera juice, Chicken Extract, etc.
How to Apply for Pharmaceutical Products Registration to NPRA?
There is the option to register online via the Quest system. Although, before proceeding with registering, an applicant should pertain for a Quest membership and buy a USB token. Upon receipt of the USB token by the applicant, the applicant will be able to access the enrollment site and continue with the online application.
The overview of the process for online registration of products is stated below:
1) Visit NPRA (www.npra.gov.my) website > Industry > First Time User > USB Token Registry.
2) Apply for Membership in QUEST.
What are the requirements?
- Form for Company Registration
- Letter of Company Authorization
- I/C photocopy
3) Buy the USB Token from MSC Trustgate following Quest membership acceptance.
4) Login Quest for uploading applications for product registration.
5) Send the requested details.
6) Respond to the NPRA officer when supplementary information is needed.
7) Items proposed at the meeting of the DCA
Fees for Pharmaceutical Product Registration in NPRA
Every product application requires an application fee:
For New Chemical Product Application:
The processing fee is RM 1,000, and the single active ingredient fee is RM 3,000 whereas, for two or more Active ingredients, the fee is RM 4,000.
For Pharmaceutical Product Application:
The processing fee is RM 1,000, and the single active ingredient fee is RM 1,200 whereas, for two or more Active ingredients, the fee is RM 2,000.
For Traditional Product Application:
The processing fee is RM 500, and the single active ingredient fee is RM 700.
The payment fee and all other costs shall be paid to 'Biro Pengawalan Farmaseutikal Kebangsaan' in the manner of a bank draft/money order.
How Long does it Take to Register a Pharmaceutical Product in Malaysia?
The evaluation of prescription drugs, nonprescription drugs, and new drugs and biologicals usually lasts between 210 to 245 working days.
On the other hand, the evaluation process of health supplements and other traditional products containing a single active ingredient and two or more active ingredients takes 116 working days and 136 working days, respectively.
What Happens After Registering a Product in NPRA?
After registering your product to the NPRA system, based on your company type and activity, you need to take a manufacturer/ import/ wholesale license.
A business that intends to produce, import, and/or wholesale any licensed/notified goods must first apply for a Manufacturer's License, Import License, and/or Wholesaler's License after the item is licensed or notified.
Compliance with Good Manufacturing Practice ('GMP') and Good Distribution Practice ('GDP') is a requirement for both product registration/cosmetic notification and the application for a manufacturing license.
Import license costs RM 500, Manufacturer license costs RM 1000, and Wholesaler license RM 500, and all of them are valid for 1 year.
While on the other hand, a business wishing to manufacture an unregistered drug for the intent of a clinical trial must apply for an Import License for a Clinical Trial. A Clinical Trial Exemption from the NPRA is necessary for products that are not licensed that are meant to be produced locally for the purpose of a clinical trial. Any person
An exception for the production of a sample should be extended to those who intend to produce any substance solely for the aim of generating a specimen for registration (applies to locally produced goods only).
Labeling for Security Regulations (Hologram)
Techno Secure Print Sdn Bhd Corporation will enforce the latest hologram safety tag supply effective on 1 September 2019 and the price of the hologram safety label will be RM0.064 / label unit.
Techno Safe Print Sdn can be reserved for Hologram security mark reservations. Bhd.-Bhd. Effective on 1 September 2019 and the period of the delivery to the industry of hologram safety labels is 14 days from the date of request.
What kinds of items need security labeling?
The requirement for product labeling to be affixed to this protection system extends to all licensed medicinal products, traditional products, and nutritional supplements.
Non-registered goods shall be deemed to be all products without security marking.
Is it Possible to Modify a Product's Label/Formula After it is Registered?
Yes, that is still feasible. It is possible to make Quest online submissions in order to change the specifics of a verified product. Before it can be enforced, all changes/amendments require approval from the NPRA. Online notification of the approval and decision will be presented. The product formulation, however, cannot be altered if there is a change in the active composition. New requests must be made in this case.
To avoid any mistakes on formulation statements and active ingredients listing and eliminating the need for amendments, cancellations, and re-payments for a new application, it is advisable to hire a consultancy agency in Malaysia for NPRA applications.
What Should Foreign Companies do to Sell Pharmaceutical Products in Malaysia?
Before being able to be commercialized in Malaysia, all pharmaceutical products should be registered with the Drug Control Authority. To become the owner of the registration certificate, a foreign corporation that wants to introduce pharmaceutical products into Malaysia first has to find a local agency (a company registered in Malaysia).
For cosmetic products, the online registration procedure for all cosmetic products has been substituted by the online notification procedure as of 1 January 2008. Before putting the products on the local market, firms attempting to introduce new cosmetic products should inform the NPRA.
Hiring a Local Agency in Malaysia for NPRA Registration
Mandreel is preferred by foreign companies planning to sell pharmaceuticals and cosmetics to the Malaysian market.
Since the presence of a local registered agent is mandatory for NPRA to represent international firms for all regulatory initiatives, Mandreel offers strategic advisory and product registration advice and helps clients connect with the National Pharmaceutical Regulatory Agency, NPRA, for a broad variety of product applications, namely pharmaceuticals, cosmetics, OTC, and controlled substances.
The areas of consultancy in product registration, application, revision and follow up include below:
- The examples of registration of medicinal products include scheduled poisons, also known as controlled poison or regulated drugs, and also non-scheduled poison products (OTC).
- Traditional medicine, medicinal products, medicated wine, medicated oil, and so on are examples of natural products.
- Vitamins, minerals, amino acids, fatty acids, antibiotics, probiotics, and other bioactive compounds are examples of dietary supplements.
- Application for Import License: In order to import and export wholesale or import licensed goods from their premises, we help importers apply for an import license.
- To register cosmetic products for manufacturing, distributing, and marketing in Malaysia
- Skin exfoliation products, perfume, facemask, hair products, make-up products, sunbathing goods, anti-wrinkle, and anti-aging product lines, and so on are exemplars of cosmetic products.
Why Choose Mandreel Agency for NPRA Product Registration?
Mandreel is a consultancy firm with over 10 years of experience in the Malaysian market, a company that specializes in providing essential services related to imports and exports to meet the current changing demands of international trade initiatives in Malaysia as well as targeting to open up in Malaysia. The services of
Mandreel Malaysia services include regulatory submissions in an accountable and cost-effective way for food supplements, cosmetics, and pharmaceutical products, KKLIU advertising approval, Hologram approval of Health Supplements, and related industries in Malaysia particularly for foreign companies who wish to sell pharmaceutical products, health supplements, and cosmetics to Malaysia.
The general headings of our services related to NPRA:
- Registering Cosmetics
- Registration of Skin Treatment Products
- Registration of Import Permit
- Certificate of Health (Import / Export)
- Service for Product Classification
- Sampling Permit for Business
We may assist with NPRA registrations in Malaysia, beginning with the identification of product specifics and application steps.
What are the Benefits of Hiring an Agency for the NPRA Registration Process?
First of all, NPRA demands a local representative for all foreign origin companies that wish to introduce, sell and market pharmaceutical products as well as cosmetics to the Malaysian market.
Choosing a Malaysian agency for the NPRA product registration process and all related regulatory steps will provide you multiple benefits such as:
- The advisory from experienced and experts in the Malaysia market and pharma industry
- Proven experience in the registration of several overseas pharma and cosmetics companies in the Malaysian market
- Relieving the burden of the application process and receiving help in every step from an application, document collection, understanding and complying with regulatory laws in Malaysia, security labeling-hologram
- Cut down on the number and extent of requests for defects
- To identify missing information and formulate responses to questions posed by NPRA
- Receiving faster applications and fewer revisions
- Saving time and money on wrong applications, misplaced product selections.
- Saving manpower and effort by partnering with experienced consultants.
You can send us an email for any questions about our services and we will get back to you as soon as possible or in one working day. For a quick reply, please give us a call or send us a Whatsapp message. Thank you.