Ukraine. Drug manufacturing: Labelling

Marking of the label, external and internal package of drugs shall contain following information: drug’s name, name and address of the manufacturer, registration number, series number, administration, active substance dose in each unit and their quantity in package, shelf life, storage conditions, and precautions.

The external package of drugs shall contain name of the drug, active substance dose and pharmaceutical form stated in Braille letters. The MHC of Ukraine shall determine a list of drugs package of which is not subject to marking with Braille letters or only name of which shall be stated in Braille letters.

During state (re-)registration additional requirements as to labeling and package can be determined in connection with special drug administration mode. Drugs intended for use during clinical trials shall have the marking «for clinical trials». Package of each drug to be sold shall have a package insert with following content:
  • drug’s name, general characteristics (chemical name, main physiochemical qualities, composition), information on pharmacological qualities, indications, contraindications, interaction with other medications, mode of administration and dosage, side effects, precautions, presentation, shelf life term and storage conditions, sale conditions.
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