2) Samples of Reference.
12 samples of product must be submitted just as it will be sold in the market, in addition to a quantity of the pharmaceutical structure for its analysis.
The samples must indicate the following:
● Trademark and pharmaceutical structure.
● Generic name even if there are more than one chemical component.
● Lot number, manufacturing and expiration date.
● Composition of formula by unit dosage.
● The following substances must be declared if they are included in the
formulation.
- Artificial colorants
- Lanolin
- Content and alcoholic degree in ethylic alcohol.
- Additives that must be declared as per manufacturer’s judgement.
● Therapeutic indication, contraindications, dosage, special precautions if any.
● The inscription “Medicine, keep out of reach of children”.
● Way of administration.
● Registration number in the country of origin.
● Manufacturer’s name and country of origin.
● Inserted.
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