Principles and Practice of Pharmaceutical Medicine

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34 Medicines Regulation in the European Union Anne-Ruth van Troostenburg de BruynandGiuliana Tabusso List of abbreviations ABPI ...

QP Qualified person (for GMP) RA Regulatory authority REC Research ethics committee RMS Reference member state SAWG Scientific A ...

34.3 The legal basis for medicinal product marketing authorization The aim of the many directives and regulations been issued ov ...

development. This led to the collaborative project involving Europe, Japan and the USA known as the ‘International Conference on ...

transmit and make publicly available assessment reports, Summary of product characteristics (SmPC), product labeling and packag ...

can usefully provide independent clinical expertise on products under evaluation by the CHMP with- out, of course, removing the ...

significant new administrative aspect: every appli- cant for a CTA, in any EU MS must now have a legal representative who is dom ...

above). Note that the guidance foresees the possibi- lity for sponsors to supply further information once without extension of t ...

List of competent authorities to which the appli- cation was submitted, and their decisions The supporting documentation, submi ...

presume CTA approval in the absence of receiving objections within the 60 days specified by the Directive. Many regulatory autho ...

Good manufacturing practices Directive 2001/20 required that compliance with GMP guidelines was introduced into the national law ...

Requesting scientific advice from the CHMP can be sought irrespective of whether the product licence application will be made us ...

national level is often quicker to obtain, and the costs are considerably lower than that for the CHMP. However, national author ...

human use intended to be placed on the market in MS and either prepared industrially or manufac- tured by a method involving an ...

Criteria for granting a MA refer to quality, safety and efficacy, which, according to the new law, ‘should enable the risk–benef ...

applicant to submit an identical dossier for a new application, before any marketing authorization has been granted, in selected ...

Application; Chapter 2, Mutual recognition, Rev. 3.1, June 2004). To start an MRP, the applicant requests an assessment report o ...

Coordination group An informally instituted coordination group recently replaced the formal Mutual Recognition Facilitation Grou ...

Pre-submission activities Four to six months before a planned CP submission the applicant has to notify the EMEA of the inten- t ...