For pharmaceutical products indicated for standard, well established uses and containing established ingredients, the following information, inter alia, should be provided in the documentation submitted with the application for marketing authorization and for inclusion in a computerized data retrieval system:

- the name of the product;

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

- the type of dosage form;

- the route of administration;

- the main therapeutic category;

- a complete quantitative formula with justification and the method of manufacture of the dosage form in accordance with WHO GMP (2);

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

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

- the indications, dosage and method of use;

- the contraindications, warnings, precautions and drug interactions;

- use in pregnancy and in other special groups of patients;

- the adverse effects;

- the effects and treatment of overdosage;

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

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

- the container, packaging and labelling, including the proposed product information;

- the proposed method of distribution, e.g. as a controlled drug or a prescription item, and whether the product is intended for pharmacy sale or for general sale;

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

- the importer/distributor;

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

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