• All applicants who submit applications under Borderline Products should submit the composition of unit dose along with the batch manufacturing formula.
• Amount of all active ingredients per unit dose should be given in the form of vitamin or mineral and units according to the “Guideline on Product Categorization Reference Details Vitamins & Elements.”

Example:

• Minerals in elemental level (Na but not as Sodium chloride)
• Vitamins (Vitamin A but not as retinol, beta-carotene, etc)
• Units (Vitamin D in µg/day, Zn in mg/day)

All noncompliant applications with above will be rejected with effect from 13th of July 2020.Advertisements of all registered Borderline Products should get the prior approval from the NMRA (fee specified in the fees regulation) with effect from 13th of July 2020.
Validity period of Preliminary Evaluation Report (Classification Report) is one year and product registration dossiers should be submitted within the validity period of the Classification Report. Additional details for the online submitted Classification Applications should be submitted to borderline.nmra@gmail.com

(Date: 07 July 2020)

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