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China SAMR Greenlights Simultaneous Infant formula Registration Approval and Cancellation

Under updated regulations infant formula manufacturers will be able to cancel a previously registered infant formula (single stage within a product line) and replace it with a newly approved infant formula (a newly developed stage within a product line) without delays or interruptions to market access for that product line.

On Jan. 8, 2019, China began allowing the simultaneous cancellation and replacement of a previously registered infant formula product line stage e.g. cancellation and replacement of a stage 1 product within a product line with a newly registered stage 1.


As we know for general trade channels, China limits each GAC approved infant formula manufacturing facility to placement of 3 infant formula product lines on the market (each product line having 3 stages designed to meet the specific nutritional requirements of the growing baby/toddler/child.)
Previously, if a manufacturer decided to remove one stage of a product line and place a newly approved registered infant formula product on the market there was a considerable delay between cancellation and approval. During that lag period a GAC approved manufacturer would sometimes be limited to marketing 8 products.
The new system offers the following benefits:

  • No time gap: date of cancellation is the beginning of new registration certificate

  • More than 9 products circulated in the market: old infant formula products produced before cancellation date & new infant formula

  • Facilitates inventory management and supply/demand refinement

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