FAQs

Is your trial a clinical trial of medicinal products?

 

1.       Is the trial objective to study the therapeutic, diagnostic or preventive effect of one or more medicinal products?

2.       Is the trial objective to identify or investigate adverse reactions from one or more medicinal products?

3.       Is the trial objective to study the pharmacological effect (pharmacodynamics) of one or more medicinal products?

4.       Is the trial objective to study the absorbtion, distribution, metabolism or excretion (pharmacokinetics) of one or more medicinal products?

If the answer is yes to any of the four questions above, your trials falls under the definition of a clinical trial. Therefore, a clinical trial application must be submitted to the Icelandic Medicines Agency – unless your trial is a non-interventional study. 

Further information: http://ec.europa.eu/health/files/eudralex/vol-10/ctqa_v11.pdf

Is your trial a non-interventional study?

1.       Does the treatment of trial subjects take place without randomisatin?

2.       Is the decision to prescribe the medicinal product made independently of the trial protocol?

3.       Does the treatment with the medicinal product follow clinical practice, and is it independent of the trial protocol?

4.       Is the medicinal product used for an authorised indication compliant with the medicinal product‘s summary of product characteristics?

5.       Is the medicinal product marketed in Iceland?

6.       Do the procedures follow normal clinical practice, i.e. without extra procedures such as blood tests, clinical examinations, additional diagnostic tests etc.?

7.       Are data analysed only by means of epidemiological methods?

If the answer is yes to all of the 7 questions above, your trial falls under the definition of a non-interventional study. Terefore, a clinical trial application does not need to be submitted to the Icelandic Medicines Agency.
    

If you are not sure whether or not your clinical trial needs to be notified to the Icelandic Medicines Agency, please send us an email with the protocol or protocol synopsis along with detalis about the products expected to be used in the trial. Please send us email to clinical.trials@ima.is 

Further information: http://ec.europa.eu/health/files/eudralex/vol-10/ctqa_v11.pdf

How do I create a EudraCT number?

A EudraCT number can be created on EMA's webpage

https://eudract.ema.europa.eu/

What is VHP?

The Voluntary Harmonisation Procedure (VHP) is a procedure which makes it possible to obtain coordinated assessment of an application for a clinical trial that is to be conducted in several European countries.

For further information, please see

Who can import an investigational medicinal product?

Import of all medicinal products, including investigational medicinal products (IMP), must be carried out by a licensed wholesaler of medicinal products, according to Article 32 (1) of the Medicinal Products Act No. 93/1994 and Article 4 (1) of Regulation No. 699/1996 on import and wholesale distribution of medicinal products.  Regulation No. 699/1996 on import and wholesale distribution of medicinal products details the requirements for import and distribution of medicinal products.

All imports of investigational medicinal products must therefore be carried out by a licensed wholesaler.  A list of companies licensed to import medicinal products can be found in the European database EudraGMDP.

IMA would like to emphasize that according to Article 9 of Regulation No. 699/1996 licensed manufacturers of medicinal products are authorised to distribute through wholesale channels the medicinal products that their manufacturing license pertains to, including IMPs.

Is it sufficient to submit one application for a multi-centre trial in Iceland?

In the case of a multi-centre investigation one application is sufficient.

What is the fee for a clinical trial assessment?

The fee is according to IMA's tariff.

What is the fee for substantial amendment assessment?

The fee is according to IMA's tariff.

When a sponsor reports a serious adverse reaction into the EudraVigilance database with IMA and EMA as recipients, does the report appear twice?

No, the adverse reaction is only reported once into the European database EudraVigilance.

What is EU Clinical Trials Register?

The EU Clinical Trials Register contains information on interventional clinical trials on medicines conducted in the European Union (EU), or the European Economic Area (EEA) which started after 1 May 2004.

The information contained in the EU Clinical Trials Register is extracted from EudraCT, the EU clinical trials database. The information for studies applied for in Iceland, provided by the sponsor, is loaded into the EudraCT database by the Icelandic Medicines Agency (IMA). Upon approval/rejection from the National Bioethics committee, IMA adds the relevant information.

For furhter information can be found here.