Distribution Permit Number (NIE) Renewal
A Distribution Permit Number (NIE) is an official license issued by the relevant authorities to distribute products in the market. The NIE ensures that the product meets the applicable standards and regulations before it can be marketed. Certain significant changes to a product may require the NIE holder to register a new distribution permit number. The following are criteria for changes that may affect the NIE:
- Product Size, An increase or decrease in the content and/or size of the product may affect the NIE.
- Packaging:
- An increase or decrease in packaging size.
- An increase or decrease in the type of packaging.
- A change in the design of the packaging shape.
- A change in packaging materials.
- Labeling:
- A change in the language used in the instructions for use and/or packaging.
- A change in logos/symbols, such as halal logos or company logos.
- A change in the expiration date if listed on the labeling.
- A change in the product code/type.
- A change in storage temperature.
- A correction to the product name.
- A change in the labeling design, including color, images, text, and layout.
- Accessories/Attachments in the Distribution Permit, A change in accessories, type, product code, or product size listed in the distribution permit.
- Name and/or Address of Related Entities:
- A change in the name and/or address of the legal manufacturer.
- A change in the legal entity.
- A change in the manufacturer's address due to city planning changes.
- A change in the manufacturer's name as long as the factory's address remains the same or does not relocate.
- A change in the distributor's (supplier's) name if the NPWP and NIB remain unchanged.
- A change in the distributor's (supplier's) address if relocating to a different province.
Changes That Require a New NIE Registration:
In addition to the criteria above, the following changes also require the NIE holder to register a new distribution permit number:
- Change in Product Name
- Change of Distributor or NIE Holder
- Change of Manufacturer/Producer
- Change in Manufacturer/Producer Location
- Change in Product Specifications
- Change or Addition of Raw Materials/Formula That Alters Specifications/Functions
- Change in Production Process
- Change in Claims or Indications
Reference:
Materi Coaching Clinic Industri Alkes Kelas C dan D Dalam Rangka Pre Market Sesuai Janji Layanan Dalam Menjamin Keamanan Mutu dan Manfaat
https://drive.google.com/drive/folders/1yzwLtbDPuWphQ6mbpRqvSH_PWIsxp7GE