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Il complesso genomico: Standard di produzione per i medicinali per terapie innovative derivati da materiali biologici per uso umano

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£100.00 £99.99 £99.99 £99.99 £100.00 £100.00 £100.00 26 July 2026 08 August 2026 22 August 2026 05 September 2026 19 September 2026
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Price Distribution

Price distribution over 56 days • 1 price levels

Days at Price
56 days 0 14 28 42 56 £100 Days at Price

Price Analysis

Most common price: £100 (56 days, 100.0%)

Price range: £100 - £100

Price levels: 1 different prices over 56 days

Description

Con il termine "MTI" si intendono sia i medicinali per terapia avanzata che hanno ottenuto l'autorizzazione all'immissione in commercio, sia i medicinali per terapia avanzata che sono oggetto di sperimentazioni cliniche o utilizzati come riferimento in una sperimentazione clinica (medicinale per terapia avanzata sperimentale). Questa guida specifica i requisiti GMP che devono regolamentare la produzione di MTI che hanno ottenuto l'autorizzazione all'immissione in commercio e di MTI utilizzati nel contesto di una sperimentazione clinica. La presente guida non si applica ai farmaci diversi dagli MTI. D'altro canto, le linee guida dettagliate di cui al secondo comma dell'articolo 47 della direttiva 2001/83/ce e all'articolo 63, punto 1, del regolamento (UE) n. 536/2014 non si applicano agli MTI, a meno che non vi sia espressamente fatto riferimento nelle presenti linee guida. Se le disposizioni speciali riguardano solo i medicinali per terapie avanzate che hanno ottenuto l'autorizzazione all'immissione in commercio, il termine utilizzato è "MTI autorizzato".

Product Specifications

Format
paperback
Domain
Amazon UK
Release Date
15 April 2025
Listed Since
18 April 2025

Barcode

No barcode data available

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