Registration



Registration activity is carried out by the Department of Qualified Persons and Registration . It is conducted for the Pharmaceutical Institute's own purposes and includes registration of medicinal products for the Institute as the marketing authorization holder , as well as for external partners for whom developing the ASMF - Active Substance Master File - or a full registration dossier in the CTD format (Common Technical Document ) is the last step in the development of a medicinal product.

The core business of the Department of Skilled Persons and Registration is:

Preparation and updating of a full registration dossier in the CTD format .

Conducting national and European registration procedures , such as the Mutual Recognition Procedure (MRP) and Decentralized Procedure (DCP) , as well as  non-European registration procedures with a view to obtain marketing authorizations for medicinal products in Poland and abroad.

Active participation in conducting national and European registration procedures regarding ASMF for the medicinal products manufactured from the active substance produced by the Institute and registered by other parties .

Introducing post-registration changes in the registration documentation and monitoring the post-registration change process.

Range of services:

Registration dossier preparation.

Registration dossier evaluation.

Conducting the registration process.

Conducting the re-registration process.

Conducting the process of post-registration changes .

Coordinating activities regarding the preparation of information materials and expert reports .

Staff:

6 employees with university degrees (including three employees with doctorates


Head of department: Magdalena Glice, M.Sc.
Land line: (+48 22) 456 38 18
Mobile.: (+48) 607 330 446
Fax: (+48 22) 456 38 38
E-mail:  m.glice@ifarm.eu