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Scientific and Pre-submission Advice

Scientific Advice and Pre-submission Consultation

According to the § 151 of Medicinal Products act, the State Agency of Medicines (SAM) is providing a scientific advice and pre-submission consultation. Scientific advice is an oral and written advice given to companies regarding the experiments and trials to demonstrate the quality, safety and efficacy of a medicinal product. The aim of a scientific advice is to support the development of a medicinal product in order to ensure better functioning of the pharmaceutical market.

Advice may be requested on matters concerning the chemical/biological/pharmaceutical, preclinical and/or clinical development and is given in selected therapeutic areas (anaesthesiology, immunology, blood products, cardiology/cardiovascular, diabetes, haematology, and oncology).

Advice is given to both pharmaceutical industry and to other stakeholders such as licensed health service provider, an independent research institution or a professional organisation of doctors.

SAM provides advice in writing accompanied with face to face/virtual meetings when found necessary. Advice may be requested at any stage of development of a medicinal product/ therapeutic concept and irrespective of subsequent choice of procedure for approval. The advice is given in the light of the current scientific knowledge, effective guidelines and legislation, responding to specific questions posed by the medicine developer and based on the documentation and proposals provided by the Applicant.

Scientific advice focuses on development strategies and it means that pre-evaluation of data to support a marketing-authorisation application is not provided. The advice given is not legally binding upon the parties.

Request for advice

To request the national scientific advice please complete and submit the application form to the SAM to [email protected].

Click the following link to download the Application Form: 

Relevant background documentation can either be attached to the application or sent separately by Eudralink or NextCloud. Instructions on the use of these channels can be obtained from SAM at the aforementioned e-mail address. A briefing document giving an introduction to the medicine under development, together with 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 be included.

From receiving the request for advice, the procedure is as follows:

  1. SAM will send the confirmation to the Applicant within two weeks from receipt of the advice request (i.e. validation of the application). A reference number will be provided for each case which should be used in all future communications concerning the specific advice.
  2. SAM will send the written advice to the applicant within two months from receipt of relevant documentation.

Out of scope of the scientific advice:

General regulatory advice regarding e.g. administrative data, manufacturing authorisation, pharmacovigilance and product information.

Please note that SAM reserves the right to assess the nature of enquiries and whether they fall under this scope or not. The parties will be notified accordingly.

Scientific advice is liable for fee*, please refer to:

*Advice to a licensed health service provider, an independent research institution or a professional organisation of doctors (if the sponsor does not receive any financial or other remuneration from the manufacturer of the investigational medicinal product or its representative) shall be free of charge.

For more information on the scientific advice procedure, please contact [email protected]

Last updated: 15.03.2024