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As a traditional product of the area, it received Belgian appellation d'origine by royal decree in 1984, [16] and received European protected designation of origin status in 1996. [ 17 ] Bulgaria
In most countries, a marketing authorisation is valid for a period of 5 years. 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.
The preambles to the regulations cite consumer demand for quality foodstuffs, and identify a number of goals for the protection regimes: the promotion of products with specific characteristics, particularly those coming from less-favoured or rural areas; the improvement of the income of farmers, in return for a "genuine effort to improve quality";
A centralised marketing authorisation, issued by the European Commission, allows the holder to market a medicinal product throughout the European Economic Area (EEA), which comprises the EU Member States, Iceland, Norway and Liechtenstein. [2] In the United States, the equivalent process is called New Drug Application.
A geographical indication (GI) is a name or sign used on products which corresponds to a specific geographical location or origin (e.g., a town or region). [1]: 39 The use of a geographical indication, as an indication of the product's source, is intended as a certification that the product possesses certain qualities, is made according to traditional methods, or enjoys a good reputation due ...
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The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).
A registered identification number (or RN) is a number issued by the Federal Trade Commission, [1] upon request, to a business residing in the United States that is engaged in the manufacture, importation, distribution, or sale of textile, wool, or fur products. Such businesses are not required to have RNs.