Micronutrients tabs, pregnancy/BOT-180

1.GENERAL DESCRIPTION
United Nations International Multiple Micronutrients Preparation of a Multiple Micronutrient Supplement (UNIMMAP MMS) film coated tablets, for Pregnant and Breastfeeding women, in a bottle containing 180 tablets.  

2. TECHNICAL SPECIFICATIONS 
2.1Active Ingredients
Each tablet contains the following vitamins and minerals in the required assay quantity, in line with the UNIMMAP MMS formulation.
Vitamin A: 800 mcg RAE
Vitamin E: 10 mg α-TE
Vitamin D3 (Cholecalciferol): 5 mcg
Vitamin B1 (Thiamine): 1.4 mg
Vitamin B2 (Riboflavin): 1.4 mg
Vitamin B3 (Niacin or Nicotinamide): 18 mg
Vitamin B6 (Pyridoxine): 1.9 mg
Vitamin B12 (Cyanocobalamin): 2.6 mcg
Vitamin B9 (Folic acid): 400 mcg
Vitamin C (Ascorbic acid): 70 mg
Iron: 30 mg
Zinc: 15 mg
Copper: 2 mg
Selenium: 65 mcg
Iodine: 150 mcg

3.PRODUCT CLASSIFICATION
Nutritional product, vitamins, and minerals 

4.SHELF-LIFE REQUIREMENTS
-24 months, at minimum, for product intended for domestic supply
-30 months, at minimum, for product intended for export
-36 months preferred

5.STORAGE AND TRANSPORTATION REQUIREMENTS
The product should not be stored above 30 °C; transported between 15 - 25 °C; and stored in a tightly closed original container, protected from moisture. 

6.PACKAGING AND LABELLING
Primary packaging must be tamper-evident, with a Child Resistant Cap (CRC) on each bottle containing 180 tablets of UNIMMAP MMS. For technical requirements of a container closure system refer to UNICEF’s Technical requirements for pharmaceutical and nutrition products.

6.1Summary of Product Characteristics (SmPC) or a Patient Information Leaflet (PIL):
Each bottle must include a PIL, either as part of a peel-back label consisting of a dual language front-of-pack label and a PIL (Appendix: Mock peel-back label with PIL), attached to it or in a box with each pack.
A QR code containing PIL information in relevant languages should be included on the front-of-pack label, developed and maintained by the supplier/manufacturer.
The PIL should preferably be in WHO-PQ format.

6.2Label languages:
Labels must be in English and French, at minimum. The label must contain the information listed below for minimum labelling requirements and additional information as required by regulations in the recipient country. The label should follow the format of the mock label provided in the appendix of the specification.

6.3Minimum Labelling requirements, with suggested text:
·Product name: Multiple Micronutrient Supplement for Pregnant & Breastfeeding Women
·Content per tablet: Name of active ingredient(s) and Strength of active ingredient(s) (In tabular)
·Pack size: 180 tablets
·Directions: One tablet/day with food or upon retiring. Not to be chewed. Do not exceed recommended dose.
·Storage: Store in original container, below 30 °C, protect from light and moisture. DO NOT REPACK.
·Registration number (if applicable)
·Manufactured by
·Batch number
·Manufacturing date
·Expiration date
·Warning: Iron overdose can be fatal for children under 6. Keep out of reach of children. In case of overdose, seek medical help or contact poison control immediately.
Additionally, Recommended Dietary Allowance (RDA) or Recommended Nutrient Intake (RNI) % labelling may be required, in line with local regulations.

7.ADDITIONAL COMPLIANCE: HALAL
The product must be halal certified for countries where it is a regulatory requirement. At minimum, manufacturers must confirm that the product contains no ingredients of porcine origin.

8.USEFUL RESOURCES
Suppliers may consult the following references to deepen their understanding of the importance of UNIMMAP MMS for women's health.
·Vitamin and mineral requirements in human nutrition, 2nd edition (who.int)  
·UNICEF/WHO/United Nations University (1999) “United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP):” Composition of a multi-micronutrient supplement to be used in pilot programs among pregnant women in developing countries
·WHO Recommendations on antenatal care for a positive pregnancy experience. World Health Organization, 2016 
·WHO Nutritional interventions update multiple micronutrient supplements during pregnancy

Related products:
S1550005 Iron 60mg+Folic ac.400mcg tab/PAC (10x10)
S1550030 Iron 60mg + Folic ac. 400mcg tab/PAC-100

Alternative products:
S1580102 Micronutrient tabs, pregnancy/BLIS-30
S0000267 Micronutrient tabs. Pregnancy/BOT-180
S1580103 Micronutrients tabs, Pregnancy/BOT-90