The registration process can be complicated and lengthy. We have a group of experienced Regulatory Affairs specialists to provide consultation and solve your problems by making sure that your products are complying with the rules and regulations of Malaysian authorities such as National Pharmaceutical Regulatory Agency Malaysia (NPRA) and Ministry of Health (MOH).
01. Product Registration
All health and natural supplements must be registered under National Pharmaceutical Regulatory Agency Malaysia (NPRA). Every registered product will be given a registration number beginning with ‘MAL’, for example MAL12345678A, which must be printed on its label or packaging.
On the other hand, food, beverages, confectionery and chewing substances with added nutrients allowed by the Malaysian authorities is regulated under Food Act 1983 and Food Regulations 1985. We will assist you in classifying and applying for label screening that complies with the Food Act in Malaysia if you wish to have your functional food or food supplement products launched.
Our Services Included:
- Registration on Quest3+ online submission system
- Obtain MAL no. / approval letter from National Pharmaceutical Regulatory Agency (NPRA) for products below:
- Pharmaceutical products
- Traditional medicine products
- OTC (Over-the-counter) products
- Skin care and cosmetic products
- Food supplements products
- Food supplements classification and food labelling screening application
- Halal certificate application from JAKIM (Department of Islamic Development Malaysia)
02. AJL Licensing Consultation and Application
Starting a direct selling / MLM company is a complex endeavour as there is a series of specialised tasks needed to be done. This includes:
Business plan development
Compensation plan design
Selection of the best MLM software for your business requirements and budget
INITIAL RECRUITMENT OF A SUCCESSFUL TEAM
The Malaysian government requires every MLM company to apply for MLM / Direct Selling License (AJL License) before commencing their business operation.
With 100% successful rate in applying AJL License, Special Enhancement provides professional advice and consultation to our clients in preparing all the documents required, which allows you to set up your MLM business in Malaysia with minimum cost and time. We will guide you through all the steps meticulously and help you position your company in the fast-growing market.
What We Offer:
- Forming a private limited company under the company’s act.
- Arranging suitable local partners or shareholders
- Applying for the direct selling license / AJL License
- Product registration
- Securing suitable premises for your office
- Warehousing facilities
- Manpower recruitment
03. GMP Factory Consultation
Good Manufacturing Practices (GMP) is a pre-requisite program (PRP) for the Food Safety Management System. It outlines the minimum common hygiene and processing requirements applicable to all food processing establishments and is intended as the foundation towards achieving higher food safety management systems like HACCP and ISO 22000.
There are several guidelines outlining the GMP requirements.
- Design and layout of premises
- Supplies of water, air and energy
- Management of waste
- Equipment suitability and preventive maintenance
- Cleaning and sanitation
- Management of purchased materials
- Pest control
- Prevention of cross contamination
- Personal Hygiene
Gap analysis is designed to determine the gap between the ideal GMP performance which is outlined by Ministry of Health Malaysia and PIC/S, and the actual GMP performance delivered through the clients’ facilities and systems.
Specifically, our consultants will visit your production facilities and evaluate the structural elements (Floor plan, HVAV grade management, lines of movements and etc) as well as the quality assurance infrastructure (including documentation, QA and quality management systems).
In the end, a detailed report will be generated and compiled with a proposal which suits your company.
04. Other Services
Apart from the services mentioned above, we also offer a wide range of registration and consultation services as listed below. Our highly trained specialists are ready to offer consultation and assist you in solving your problems while minimising the chances of getting rejected by government bodies.
Services provided by us:
- Trademark and Copyright application
- Quest3+ token application and registration
- Cosmetic notification (NOT) application
- Import license & free sales certificate application
- Fish license & ePermit application
- Medical Device Authority (MDA) application
- SIRIM certification application
- FoSIM food import registration and application
- Permits, licenses and certificates application under Department of Agriculture
- U.S. Food and Drug Administration (FDA) application
- Singapore Health Sciences Authority (HSA) application