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Pharmaceutical Product Licensing

Requirements for Europe

Gebonden Engels 1991 9780136628835
€ 180,91
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Provides a systematic account of the major technical, administrative and legal requirements for registering a product in any of the national markets within the EEC, using the existing procedures, with guidance as to how these procedures are likely to change after 1992.

Specificaties

ISBN13:9780136628835
Taal:Engels
Bindwijze:Gebonden
Aantal pagina's:328
Uitgever:Taylor & Francis Ltd
Thema:
1DDU-GB-E Engeland
1DDU-GB-W Wales
1QFE EU (Europese Unie)

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Inhoudsopgave

Introduction and history of licensing requirements; new active substance products - quality requirements; new active substance products - pre- clinical requirements; new active substance products - clinical requirements; abridged applications; drug master files; biological products; radiopharmaceutical products; medicated devices; contact lens products; experts and expert reports; defects in applications - analysis; CPMP and its activities; CPMP multi-state procedure; high EFTA EEC

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          Pharmaceutical Product Licensing