Apart from meeting the Shariah and Toyyiban needs, another important factor that determines the successful halal certification application is to comply with various local regulatory requirements. For regulated industries such as pharmaceuticals, personal care & cosmetics, traditional medicine and health supplements, the pre-requisite requirement prior to halal application is to ensure the products are already being approved by the respective regulating bodies such as the National Pharmaceutical Control Bureau (NPCB) for Malaysia and Badan Pengawas Obat dan Makanan (BPOM) for Indonesia.
There are specific requirements for specific product categories which include limitation, restriction or control of the ingredients, labelling and claims for the product. Hence, while the product may be halal in nature, the manufacturers or importers ought to comply with the technical and regulatory requirements of the products before it can be imported, manufactured and distributed for sales in the market.
Apart product, the facility to manufacture and store the regulated products will also need to be set-up and controlled via Good Manufacturing Practices standard, which will be part of the audit scope for halal application.
Our technical and regulatory affairs services are as follows:
Product Registration and Consultancy:
Areas of product registration consultancy are as follows:
- Pharmaceutical and biopharmaceutical
- Health supplement
- Traditional medicine
- Medical devices.
Technical & Regulatory Training and Consultancy:
- Good Manufacturing Practices (GMP)
- Hazard Analysis and Critical Control Points (HACCP)
- ASEAN Product Dossier Submission
- Internal Audit