Licences

Here you can find information about the activities of the Icelandic Medicines Agency (IMA) regarding granting of marketing authorisations and registration of products.

Here you can also find all application forms and guidelines that you need in order to apply for marketing authorisations, registrations and variations.

Electronic versions of product informations should be e-mailed to [email protected]

Electronic versions of product information for centrally authorised medicinal products (EU-products) should be e-mailed to [email protected]

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.

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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.

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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.

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Clinical Trials

Before a medicine can be authorised for use, it must go through the clinical trials process to ensure that it is safe and effective and also that the quality of the product is sufficient. This section covers the clinical trials process

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