Ta direktiva določa načela in smernice dobre proizvodne prakse v zvezi z zdravili za ljudi, za izdelavo katerih je potrebno dovoljenje iz člena 40 Direktive 2001/83/ES, ter v zvezi z zdravili za ljudi v preskušanju, za izdelavo katerih je potrebno dovoljenje iz člena 13 Direktive 2001/20/ES.
This Directive lays down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use whose manufacture requires the authorisation referred to in Article 40 of Directive 2001/83/EC and in respect of investigational medicinal products for human use whose manufacture requires the authorisation referred to in Article 13 of Directive 2001/20/EC.