For pharmaceutical products indicated for standard, well-established uses and that contain established ingredients, the following elements of information should be contained among others in documentation for marketing authorization and for a computerized data retrieval system:

- name of the product;

- active ingredient(s) (by international nonproprietary name(s)); their source; description of manufacturing methods and in-process controls;

- type of dosage form;

- route of administration;

- main therapeutic category;

- complete quantitative formula with justification and method of manufacture of the dosage form in accordance with WHO GMP;

- quality control specifications for starting materials, intermediates and the final dosage form product with validated analytical method;

- results of batch testing with batch number, manufacturing date, including, where appropriate, the batch(es) used in bioequivalence studies;

- indications, dosage, method of use;

- contraindications, warnings, precautions, drug interactions;

- use in pregnancy and other special groups of patients;

- adverse effects;

- overdosage;

- equivalence data (comparative bioavailability, pharmacodynamic or clinical studies and comparative in vitro dissolution tests);

- stability data, proposed shelf-life, recommended storage conditions;

- container, packaging, labelling including proposed product information;

- proposed method of distribution:controlled drug; prescription item; pharmacy sale; general sale;

- manufacturer; licensing status (date of most recent inspection, date of licence and who issued the licence);

- importer/distributor;

- regulatory status in the exporting country and, where available, summary documents of regulatory assessment from the exporting country; regulatory status in other countries.

If the dosage form is a novel one intended to modify the drug delivery, such as a prolonged-release tablet, or if a different route of administration is proposed, supporting data, including clinical studies, will normally be required.