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Marketing applications European Union procedures

The procedures and timelines for obtaining marketing authorisations for veterinary products are essentially the same as those for human medicines. Extensive guidance can be found in The Rules Governing Medicinal Products in the European Union, Volume 6 - Notice to Applicants, Veterinary Medicinal Products. The products that may follow centralised procedures and receive Community authorisations are shown in Eigure 7.5. All other products must obtain authorisations from national... [Pg.142]

European Commission. Notice to Applicants, Medicinal Products for Human Use, Procedures for Marketing Authorization, Volume 2A of The Rules Governing Medicinal Products in the European Union, EC, 1998. [Pg.275]

The main intense sweeteners currently permitted for use in the major markets of Europe and the United States are not natural and have had to go through a food additive approval procedure. Within the European Union, approval is controlled by the EU Commission, with the aim of achieving harmonisation across member states. The current system allows for temporary national approval (and this was the mechanism by which sucralose was approved in the United Kingdom). This in turn allows the other EU countries time to review the data and either approve or reject each product within a specified period. Within the European Union, approved sweeteners are assigned an E number and can also be assigned a maximum use level within a specific application (e.g. soft drinks). The maximum use levels for sweeteners in soft drinks in the European Union are given in Table 4.2. [Pg.73]

Under the mutual recognition procedure, the applicant company usually ends up receiving national marketing authorisations from some or all of the national drug regulatory authorities to whom the dossier is submitted. The centralised procedure, on the other hand, is all or none , and under it the applicant company would receive a single marketing approval from the EMEA valid in all European Union countries. Rejection of an application under the centralised procedure means that the product cannot be marketed in any Member State. [Pg.608]

In the mid to later part of the 1990s, procedures were established to allow for more timely review and approval of marketing applications in the both European Union and the United States. The review process to be used and the timing for approval are defined by the local regulations, and are dependent upon the immediate therapeutic need for the product. The EU mutual recognition and centralized procedures and the U.S. Prescription Drug User Fee Act (PDUFA) will be discussed in more detail later in this chapter. [Pg.172]

Compassionate use is a treatment option that allows the use of an unlicensed medicine. Compassionate use programmes are for patients in the European Union (EU) who have a disease with no satisfactory authorised therapies or cannot enter a clinical trial. They are intended to facilitate the availability to patients of new treatment options under development. To qualify for a compassionate use programme, the manufacturer calls on the national authorities for permission. The manufacturer must submit a request for the granting of a marketing authorisation or he must perform research in the context of a research programme with a cohort. Compassionate use procedures are also applicable for unlicensed medicines withdrawn from the market or for off-label use of licensed medicines. [Pg.37]


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See also in sourсe #XX -- [ Pg.253 , Pg.254 , Pg.255 , Pg.256 , Pg.257 , Pg.258 , Pg.259 , Pg.260 , Pg.261 , Pg.262 ]




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