Regulation of Human Medicinal Products in the European Union

The Textbook of Pharmaceutical Medicine: 6th Edition

Volumn , Issue , 2009, Pages 444-499

  Shah, Rashmi R ^a   Raymond, Agnès Saint ^b  

^a MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

^b EUROPEAN MEDICINES AGENCY   (United Kingdom)

Author keywords

Application for orphan drug designation; Applications through decentralised procedure; Committee for Medicinal Products for Human Use (CHMP); Community referrals to CHMP; EMEA and scientific advisory committees; EU, set of legal instruments regulations or Directives; European Medicines Agency (EMEA); Human medicinal product regulation in European Union; Paediatric Committee (PDCO) and five CHMP members; Pharmaceutical legislation in European Union (EU)

Indexed keywords

EID: 79952985253     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9781444317800.ch18     Document Type: Chapter

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