The process of registration can be complicated and lengthy. We have a group of experience Regulatory Affairs to consult and solve your problems to make sure that your product is complying with the rules and regulations of Malaysia authorities such as National Pharmaceutical Regulatory Agency Malaysia (NPRA) and Ministry of Health (MOH).
01. Product Registration
All the health and natural supplements should be registered under National Pharmaceutical Regulatory Agency Malaysia (NPRA). Every registered product will be given a registration number starts with ‘MAL’, for example MAL12345678A which must be printed on its label or package.
On the other hand, food or drink, confectionery and chewing substances with added nutrients allowable by Malaysia authorities is regulated under Food Act 1983 and Food Regulations 1985. Special Enhancement will assist our client to classify and apply for label screening application that comply to the Food Act in Malaysia if you wish to have your functional food or food supplements launch.
Our services included:
- Quest3 online submission system and by hand.
- Obtain approval letter/ mal no. From DCA (drug control authority) or Biro Pengawalan Farmaseutikal Kebangsaan (BPFK) or KKM labelling for product:
- Phamarceutical product
- OTC (over the counter) product
- Nutritional supplement products
- Food supplements products
- Traditional medicine products
- Skin care and cosmetic products
- Apply import and export license (free sales cert)
- Obtain halal certificate 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 are many specialised tasks that need to be done. This includes:
01
Business plan development
02
Compensation plan design
03
Selection of the best MLM software for your business requirements and budget
04
Initial recruiting of a successful team
Malaysia government requires every MLM company to apply for MLM / Direct Selling License (AJL License) before commencing their business operation.
With our expertise and 100% successful rate in applying AJL License, Special Enhancement can give professional advices and consultation to our clients in preparing all the documents needed, which allows you to setup MLM business in Malaysia with the minimum time and cost. We correctly directing you through all the steps and how to positioning 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 Food Safety Management System. It outlines the minimum common hygiene and processing requirements applicable to all food processing establishment and intended as the foundation towards achieving higher food safety management systems like HACCP and ISO 22000.
There are several guidelines outlining the GMP requirements.
For example:
- 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 outlined by Ministry of health Malaysia and PIC/S and the actual GMP performance delivered through the clients’ actual facilities and systems.
Specifically, our consultants will visit the clients’ 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 detail report will be generated and compiled with the best suit proposal to our client.
Other services include:
- Trademark application
- Quest3 online submission system and by hand
- Cosmetic notification (NOT) application
- Food supplement classification and food labelling screening application
- Halal certificate application
- Import license & free sales certificate application
- Fish license & ePermit application
- Medical Device Authority (MDA)application
- SIRIM certification
- U.S. Food and Drug Administration (FDA) certification
- Singapore Health Sciences Authority (HSA) registration
