Amendments to the registration dossier

dosChange in the registration dossier – a replacement part information, such as changing the design of the packaging and labeling, change the text-sheet insert or instructions for medical use, change the Applicant (sales registration certificate), a change in the description of the process of production, etc.

There are three types of changes:

Type I ( IA and IB ) – minor changes that do not require passing a special examination

Type II – significant changes that can not be regarded as a minor or an extension application, and do not relate to the transfer of all rights in respect of the registered therapeutic agent ( registration certificate) to the other applicant .

Type III – significant changes (composition , indications ) that lead to the new registration.

Tentative date of introduction of Type I – 30 to 75 working days for type II – from 60 to 120 days, with changes in the type III requires a new registration .