Industries

IMA is responsible for regulatory surveillance of all manufacturing, distribution, sale and presentation of medicinal products in Iceland.

Here below are links to articles on our site that could prove useful for companies working in the pharmaceutical industry.

 


Marketing Authorisations (MA)

This section includes information about the different types of procedures that applicants can choose from depending on which countries the product is going to be marketed in as well as the required forms.

Withdrawals - Guidelines

When a MA holder wishes to withdraw his MA or withdraw a product from the market, an application needs to be sent to IMA along with a signed letter. Information about this withdrawal process is found in this section.

Guidelines on Translations and Text Processing

IMA publishes PILs and SmPCs according to Icelandic and European rules of best practice. Further information about the requirements is available in this section.

Medical Device Registration

The Icelandic Medicines Agency shall maintain a register of parties operating enterprises in Iceland which manufacture medical devices or are responsible for the marketing of such devices.

The registration form is available here

Application for a Clinical Trial

IMA grants authorisations for clinical trials in Iceland.  More information about clinical trials can be found in this section.

Licenses for Parallel Import

This section includes information on rules and conditions regarding parallel import for medicinal products from countries in the european economic area.