European Medicines Agency marketing authorization

It is worthwhile to note that, in the US, where the applicant will just be dealing with a single authority, there is no need to re-submit data that was previously submitted as part of an IN D application to conduct clinical trials. Instead, the applicant can cross-reference the IND file. This does not apply in Europe, because clinical trial applications will have been submitted to individual Competent Authorities, whereas marketing authorisation applications are usually submitted either centrally to the European Medicines Agency (EMEA) or collectively to a number of Competent Authorities. Thus, the files need to be self-supporting. 

An application is submitted to the European Medicines Agency (EMEA). The EMEA evaluates the application and forwards its opinion (positive or negative for granting of a marketing authorization) to the European Commis-... 

Council Regulation 726/2004/EC (updates and expands the previous regulation 239/1993/EC), which mainly concerns the duties of the European Medicines Agency (EMEA), establishment of the Committee for Medicinal Products for Human Use (CHMP), and the scope and mechanisms of the centralized procedure for marketing authorization applications (MAAs) and pharmacovigilance issues. 

Source The main source of the information in this table is either the Food and Drug Administration (FDA) Web site or European Medicines Agency (EMEA) Web site. For biopharmaceuticals approved before 1995 limited information is available so the author used the most recent label (package insert) to derive the reproductive, carcinogeneticity, and genetic toxicology studies completed for marketing approval. 

On March 18, 2(X)8, the European Medicines Agency granted marketing authorization for Pradaxa for the prevention of thromboanbolic disease following hip or knee replacement surgery and for nonvalvular atrial fibrillation. The FDA approved Pradaxa on October 19, 2010, for prevention of stroke in patients with non-valvular atrial fibrillation, which is currently approved in... 

The European Medicines Agency (EMA) recommended granting marketing authorization in 2009, and eslicarbazepine is now available in most European countries as adjunct therapy for adults with refractory partial seizures. The US Food and Drug Administration announced on 2 June 2009 that it has been accepted for filing [143 ]. 

On 8 September 2008 the European Medicines Agency announced that Takeda, the manufacturers of ramelteon, had withdrawn its application for marketing authorization for ramelteon for the treatment of primary insomnia in patients over the age of 18 years with a view to extending its clinical programme to address outstanding questions on the benefit to harm balance this followed a negative recommendation from the regulators in June 2008 [131. ... 

The EU Directive 92/18/EEC [122] introduced for the first time the requirement for an ERA, as a prerequisite to obtain marketing authorization for veterinary pharmaceuticals. For this purpose, the European Agency for the Evaluation of Medicinal Products (EMEA) published a Note for Guidance where guidelines to assess the environmental risk of veterinary medicinal products are established [123]. 

This is the name of what we used to know simply as the data sheet, or colloquially as the package insert. The SPC is the document that must be submitted in draft by companies to the MHRA/Reference Member State/European Medicines Evaluation Agency upon application for a marketing authorisation and, once approved, must then be provided to prescribers or suppliers of medicines, either with the product or at the time of promotion or within the previous 15 months of promotion of the product, written or verbal. The SPC includes the prescribing information for the product and represents the product licence approval for the medicine (see Section 12.2.1.1). It is the definitive statement between the competent authority and the company and, more importantly, is becoming the common basis of communication between the... 

Note for Guidance on Excipients, Antioxidants, and Antimicrobial Preservatives in the Dossier for Marketing Authorization of a Medicinal Product. The European Agency for the Evaluation of Medicinal Products, 2003. 

The release of a new drug onto the market must be approved by the regulating authority for that country. For example, in Britain this is the Medicines Control Agency (MCA), in the European Union it is the European Medicines Evaluation Agency (EMEA) and in the USA the US Food and Drugs Administration (FDA). These bodies, which are essentially consumer protection agencies, issue a so called product licence or marketing authority (MA) when they are satisfied... 

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