For products indicated for standard uses and that contain established ingredients, the following elements of information usually suffice as the basis both for a product licence and for a computerized data retrieval system:
- name of the product
- active ingredient(s) [by international nonproprietary name(s)]
- type of formulation
- therapeutic category
- quantitative formula (including excipients)
- quality control specifications
- indications, dosage, method of use
- contraindications, warnings, precautions
- bioavailability data (in vitro/in vivo)
- stability data, shelf-life
- container, packaging, labelling
- intended method of distribution: controlled drug; prescription item pharmacy sale; general sale
- regulatory status in the exporting country.
If the dosage form is a novel one, such as a delayed-release tablet, or if a new route of administration is proposed, supporting data from clinical studies will be required.