Russian | English |
Дата разрешения на продажу в ЕС | European Union Reference Day (в составе препарата yagailo) |
официальный контроль при выдаче разрешения на выпуск серии | OCABR (Wakeful dormouse) |
официальный контроль при выдаче разрешения на выпуск серии | Official Control Authority Batch Release (Wakeful dormouse) |
представление документов для получения разрешения на применение препарата у детей | paediatric indication submission (Игорь_2006) |
разрешение на выпуск серии | release for supply (выдаваемое уполномоченным лицом; Release for supply is a mandatory step in manufacture, in which the last manufacturer in the supply chain certifies each batch of medicines produced, before being released to the Australian market. The Australian system of release for supply by an Authorised Person is different from the European system of batch release by a Qualified Person. Production, control and release of medicines in Australia are regulated in the Therapeutic Goods Act (1989) and the Therapeutic Goods Regulations (1990). Consequently, release for supply to the Australian market specifically involves a verification of all production and QC testing records of a batch, for compliance with Chapters 2 and 3 of the Act. Wakeful dormouse) |
разрешение на проведение исследования | trial permission (Alexander Demidov) |
разрешение на производство | manufacturing approval (Vadim Rouminsky) |