This process is performed within a legal framework defining the requirements necessary for successful application to the regulatory authority, details on the assessment procedure (based on quality, efficacy and safety criteria), and also the circumstances where a marketing authorisation already granted may be withdrawn, suspended or revoked.
For example, since 2003, the authorities in the United States, the European Union and Japan ask for the Common Technical Document (CTD) format, and more recently,[when?]
Depending on jurisdiction, the resulting document may be more detailed (in addition to data identifying the product and its marketing authorisation holder), for example containing addresses of all manufacturing sites, appended labelling, artwork of packaging components, etc.
After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.
However, in the European Union, after one renewal, the marketing authorisation shall remain valid for an unlimited period, unless the competent regulatory authority decides otherwise.