Vistor

Regulatory affairs

In today’s competitive environment, the Regulatory Affairs Department is a vital link between the authorities and the Marketing Authorization Holders.

Due to constantly increasing regulatory obligations, changes in legislation and new requirements, the demands and responsibilities of regulatory departments are becoming more and more important.

At Vistor, we pride ourselves on having a Regulatory Affairs Department that consists of a talented, diversified team with a wealth of experience that enables it to handle all aspects of Regulatory Affairs in a professional and confidential manner. 

We operate by a strict code of ethics, and as regulatory affairs professionals it is our duty to ensure that our activities are conducted in compliance with the laws and regulations of the authorities under which we operate, consistent with preserving and protecting public health. It is our duty to live up to our commitments, be trustworthy and scrupulous at all times and be fair in our dealings with all parties.

In addition, the Regulatory Affairs Department has its own support unit which assists with the translation and revision of documentation which includes SmPCs, labelling, PILs and correspondence from the authorities as well as a pharmacovigilance representative.
Pharmacovigilance:
As Iceland is a member of the European Economic Area (EEA) we comply with Directive 2001/83/EC and Regulation 726/2004/EC. (IMA strives to comply with the new pharmacovigilance legislation (Regulation No 1235/2010/EU and Directive 2010/84/EU), although, it has not been incorporated into the EEA-Agreement.) Vistor’s pharmacovigilance representative and the relevant regulatory representatives make up the Drug Safety Team in the Regulatory Affairs Department at Vistor.

For further information please contact the Regulatory Affairs Manager, Mrs. Unnur Björgvinsdottir (unnur@vistor.is).