The Icelandic Medicines Agency (IMA) provides scientific advice concerning the development of medicinal products.
General information
The scope of a scientific advice is to facilitate an open dialogue concerning the development of a medicinal product. Advice is given in selected therapeutic areas and may be requested on matters concerning the chemical/pharmaceutical, preclinical and/or clinical development.
Advice is given to the pharmaceutical industry but also to other stakeholders such as academic institutions, for example, in the planning of a clinical trial. IMA provides advice via a face-to-face meeting, in writing or via telephone conference. Advice may be requested any stage of development of a medicine and irrespective of subsequent choice of procedure for approval. The advice is given in the light of the current scientific knowledge, based on the documentation provided by the Applicant.
Scientific advice is prospective in nature. It focuses on development strategies and pre-evaluation of data to support a marketing-authorisation application is not provided. The advice given is not binding, neither for IMA, nor for the Applicant.
Request for advice
The applicant requests the national scientific advice by completing and submitting the application form to the IMA, preferably by Eudralink to [email protected]
Relevant background documentation can either be attached to the application or sent separately, but no later than three weeks ahead of a planned meeting. A briefing document (word format) giving an introduction to the medicine under development, and the Applicant's questions and positions should be provided. It is advised to maximise the briefing package to no more than 100 pages. Other relevant documentation such as study synopses, references and Investigator's Brochure may also be included.
IMA will respond to the Applicant within two weeks from receipt of the advice request. A reference number will be provided. This should be used in all communications concerning the specific advice.
Face-to-face meetings are held at the premises of the IMA. For practical reasons, the maximum number of Company participants is limited to 8. Minutes from the Applicant may be submitted to IMA within one month. The Agency will confirm the receipt of the minutes and may comment on the content, but the minutes cannot be interpreted as a document issued by the IMA, or as an official position of the Agency.
In case a written advice is requested, the IMA will send the response within two months from receipt of relevant documentation.
Due to summer holiday, the IMA will be unable to provide scientific advice in July and August. Opening hours during summer holidays are advertised in advance on the web. Requests can be sent to IMA during that time period, but the request will be acknowledged after August.
Fees
The fees are based on the total hours spent see hourly rate as per TARIFF.
Advice not liable for a fee
- General regulatory advice, e.g., choice of procedure, inquiry whether the IMA accepts RMS-ship, given that the proposed discussion does not include simultaneous discussion of the documentation for the application, manufacturing authorization, pharmacovigilance, labelling. Please note that IMA reserves the right to assess the nature of enquiries and whether they fall under this scope or not. If not, parties will be notified.
- Academic institutions, e.g., hospitals, universities, researchers not financed by the industry. Please note that this option is limited to one advice per project.