Thus, if the application concerns a new active ingredient (new active substance, new chemical entity, new molecular entity), one talks about a full application. The type of application may vary according to status of the active ingredient. Procedures for obtaining a marketing authorisation Īuthorisation processes follow either a purely national procedure, with rules and requirements as per national legislation in force, as it occurs in most of countries worldwide, or should follow a centrally approval or a mutual recognition of decentralised procedures within the European Union. or may be simplified to a one-page document called certificate of registration (and containing minimal data identifying the product and its source). The application is filed with the regulator, which can be either an independent regulatory body or a specialised department in the ministry of health.ĭepending 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. 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, its electronic version – the electronic Common Technical Document (eCTD). The content and format of the dossier must follow rules as defined by the regulator. This contains data proving that the drug has quality, efficacy and safety properties suitable for the intended use, additional administrative documents, samples of finished product or related substances and reagents necessary to perform analyses of finished product as described in that dossier. The application dossier for marketing authorisation is called a New Drug Application (NDA) in the USA or Marketing Authorisation Application (MAA) in the European Union and other countries, or simply registration dossier. 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efficacy and safety criteria), and also the circumstances where a marketing authorisation already granted may be withdrawn, suspended or revoked. Marketing authorisation is the process of reviewing and assessing the evidence to support a medicinal product, such as a drug, in relation to its marketing, finalised by granting of a licence to be sold. JSTOR ( August 2019) ( Learn how and when to remove this template message). Unsourced material may be challenged and removed.įind sources: "Marketing authorisation" – news Please help improve this article by adding citations to reliable sources. This article needs additional citations for verification.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |