Regulatory Affairs 

Following the full membership of Iceland in the EEA in 1994, the implementation of EU Directives and the changes that have been made to local laws and regulations, the general situation regarding drug regulatory affairs has changed dramatically in Iceland. This change can be measured in different ways and has been seen by the authorities in the increasing number of applications and matters handled at their level. However, the most evident signs for a company like Vistor are assignments that today need serious attention but were not of any significance a few years ago.

These circumstances have contributed to the strengthening of a separate and independent division within Vistor, which handles all drug regulatory affairs on behalf of the company’s clients in Iceland. The main objectives of the division are the following:

• Registration of pharmaceutical specialties in Iceland according to valid laws and regulations. This registration includes control of all documentation received from the manufacturers and submissions to the different bodies within the authorities for registration, approval of prices, reimbursement and the marketing authorization itself. 
• Translations of the necessary texts into Icelandic, (Summary of Product Characteristics, Patient Package Leaflets) which are required upon submission. 
• All correspondence with the Icelandic authorities on behalf of foreign clients. 
• Submissions of variations to marketing authorizations (types I and II). 
• Control and submissions of re-registrations which are required every five years for each specialty. 
• Advising marketing authorization holders when their respective applications for registration and marketing authorizations have been processed.

Furthermore, the division takes care of daily communication with the marketing authorization holders and keeps them up-to-date on all developments and changes concerning regulatory affairs.

In addition to the tasks listed above, the division handles other regulatory matters such as safety and pharmacovigilance, adverse event reporting, deregistrations and assistance and consultation with other divisions at Vistor regarding natural remedies, medical devices and pesticides.

Pharmacovigilance

Iceland participates in the Pharmacovigilance system of the EU and Vistor offers Marketing Authorization Holders the necessary basic service to fulfill their obligations as regards Icelandic regulations. This service includes collecting information from different sources and monitoring of professional journals, as well as communicating with the Icelandic authorities.

Marketing Authorizations

All pharmaceutical specialties that are supplied to the general public in Iceland, should contain patient package leaflets in Icelandic and consequently activities related to this matter have increased extensively at Vistor. The division of regulatory affairs is responsible for the translation of the various texts and it is also involved in procedures relating to the receipt of pharmaceutical specialties. In cases where re-labeling or insertion of leaflets at the premises of Vistor are needed, the division of regulatory affairs is responsible for the quality control, i.e. the release for sales and distribution.

In order to provide an effective and personal service, the area of responsibility has been divided among the employees of the division, whereof seven are pharmacists so that each pharmaceutical manufacturer now has a main contact person.

EMEA

Iceland has full access to the European Agency for the Evaluation of Medicinal Products (EMEA) and participates in the Central and Mutual Recognition Procedures for the registration of drugs in Europe.

This membership will ensure faster handling of applications by the authorities which is an important progress for all parties involved.

Backed up by excellent human resources, Vistor places an emphasis on prompt handling along with precise and efficient working procedures, to which e.g. our first class documents bear witness.

This arrangement has definitely placed us in the forefront on the Icelandic market.