Labeling Requirements ( for drug samples) A- Labeling Parameters required for UNIT CARTON:
1- Product Name 2- Dosage Form
3- Name of Active ingredient (s) 4- Strength of Active ingredient (s) 5- Batch Number
6- Manufacturing Date 7- Expiration Date
8- Route of Administration
9- Storage Condition (Store Below 30 degree)
10- Country’s Registration Number if any. (This point is not mandatory) 11- Name and Address of Marketing Authorization Holder
(Full address with country’s name) (This point is not mandatory) 12- Name and Address of Manufacturer (Manufacturer
Name, Full address with country’s name) 13- Special Labeling (if applicable)
e.g Sterile, External Use, Cytotoxic, Alcohol Content, Animal Origin (Bovine, Porcine).
14- Recommended Daily Allowance if any (for Vitamins and Minerals) (This point is not mandatory)
15- Warning (if applicable) 16- Pack sizes (Unit / Volume)
B-Labeling Parameters required for Inner label:
1- Product Name 2- Dosage Form
3- Name of Active Ingredient (s) 4- Strength of Active Ingredient (s) 5- Batch Number
6- Manufacturing Date * 7- Expiration Date
8- Route of Administration
9- Storage Condition (Store Below 30 degree) *
10- Country’s Registration Number if any* (This point is not mandatory)
11- Name and Address of Marketing Authorization Holder * (This point is not mandatory) 12- Name and Address of Manufacturer
(Manufacturer Name, Area and/ or City) 13- Special Labeling (if applicable)
e.g Sterile, External Use, Cytotoxic, Alcohol Content, Animal Origin (Bovine, Porcine) *
14- Recommended Daily Allowance if any (for Vitamins and Minerals) *. (This point is not mandatory)
15- Warning (if applicable) * 16- Pack sizes (Unit / Volume)
Notes *: (exempted for small ampoule and vial)
C- Labeling Parameters required for BLISTER/STRIPS:
1- Product Name
2- Name of Active Ingredient (s) # 3- Strength of Active Ingredient (s) # 4- Batch Number
5- Expiration Date
6- Name /Logo of Manufacturer / Product Owner/
Marketing Authorization Holder (country specific) (This point is not mandatory) 7- Country’s registration number if any (country specific) (This point is not mandatory) Note #: (exempted for multi-ingredients products with more than 3 ingredients. For example multivitamins and multi-minerals it is suggested to label as multivitamins and multi -minerals).
