11. Packaging and Labeling:
Container-closure systems for paediatric medicines are designed and constructed from materials meeting relevant regulatory requirements, and taking into account the stability of the medicine during transport, storage and use. In addition they are designed to ensure that they:
- Permit accurate dosing and convenient administration;
- Are robust and convenient for the supply chain, i.e. transportable;
- Are tailored to the target age group;
- Contribute to in-use stability;
- Provide appropriate information on the use of the medicine.
In cases where the paediatric medicine is significantly different from a similar adult medicine, it would be important to have noticeably different product packaging for the two products. It is necessary that consideration be given to whether the medicine is to be packed in a child-resistant container, i.e. a
packaging that is difficult for young children to open, but not unduly difficult for adults to open properly.
Self-administration of medicine by schoolchildren and adolescents is facilitated when:
■ the medicine is easy to use;
■ separation of the day dose pack is facilitated; this should be easily carried by the patient in his or her bag;
■ clear instructions for use are contained with the medicine.
Adequate information about the medicine and how to use it is important. Information about the dosage should be clearly spelt out, e.g. as milligrams per weight. Specific instructions about how to measure and administer a precise dose should be provided. Drawings or pictograms showing time, method and route of administration are strongly recommended.
Development of Paediatric Medicines: points to consider in formulation,
(Annex 5, WHO Technical Report Series 970, 2012)
