Scientific advice

Advice may be requested for all medical products, irrespective of choice of procedure for approval.

Request for advice

Submit the application form with well specified questions to RIC@lakemedelsverket.se or by regular mail.

Swedish Medical Products Agency
Box 26
SE-751 03 Uppsala
Sweden

When the Swedish MPA has registered the application form, a confirmation email will be sent to the applicant.

The documentation must be submitted electronically three weeks before scheduled meeting to RIC@lakemedelsverket.se

The documentation must contain:

• Briefing book, maximum 100 pages
• List of questions (Word‍-‍format)
• List of participants including nationalities and email address  (Word‍-‍format)
• Other relevant documentation such as references, Investigator’s Brochure, etcetera.

Scientific advice expert areas

The scientific advice may concern the following areas:

• Non-clinical
• Clinical
• Statistics
• Pharmacokinetics
• Quality – Chemistry
• Quality – Biotechnology
• Regulatory combined with scientific questions

The scientific advice does not concern the following areas:

• Regulatory advice such as choice of procedure, labelling etc. (not liable to a fee)
• Advice with reference to assessments in progress (not liable to a fee)

Scope

The purpose of the scientific advice meeting is to facilitate an open dialogue concerning the development work. Advice may concern applications for marketing authorization or for clinical testing.

The questions put by the applicant may be prospective and concern the future development of a medical product but may also involve a discussion of results of investigations carried out. However, the Swedish MPA does not supply a prior assessment of the documentation with respect to the approval of a medical product for sale.

The scientific advice given is based on present opinion and is not binding for the Swedish MPA nor for the applicant.

Forms of scientific advice

• Face-to-face meeting
  At the Swedish MPA premises. Maximum 6 participants present.

• Digital MS Teams meeting. Maximum 12 participants.

• Hybrid meeting. Maximum 6 participants present at the Swedish MPA premises and 6 participants via MS Teams.

• Written advice
  Swedish MPA will send the response within two months from receipt of relevant documentation.

• Pre-submission meeting
  The company may request a pre‍-‍submission meeting if the MPA is appointed rapporteur or co‍-‍rapporteur. A pre‍-‍submission meeting is an opportunity for the company to present its product and to discuss regulatory matters. These meetings should not contain any scientific questions. The pre‍-‍submission meeting is free of charge. The same application form as for scientific advice should be used for pre‍-‍submission meetings.

The applicant may request for any form of scientific advice but the Swedish MPA will determine the form depending on the nature of the questions. The length of the meeting is 90 minutes. The applicant may submit their meeting minutes within a month to the Swedish MPA. The Swedish MPA will acknowledge receipt of the minutes and may comment on the content. The minutes cannot be interpreted as a document issued by the Swedish MPA, or as an official position of the Agency.

Summer holiday

The Swedish MPA is unable to offer scientific advice meetings in July and August due to the summer holiday period. It is possible, though, to submit applications during the summer. However, the administration time may be longer than usual.

Fees

The fee for scientific advice is currently SEK 65,000.

An invoice will be sent to the applicant after the scientific advice has taken place.

Ordinance (Swedish)

Fee reduction for scientific advice

The Swedish MPA may grant a reduction of fee if there are exceptional reasons. If the applicant would like to apply for a reduction of the fee, the grounds for such a reduction would have to be justified and should be clearly stated in an attachment to the application form.

No advance notices regarding whether the fee may be reduced or not will be given by the Swedish MPA, the applications will be assessed on a case by case basis.

The applicant should be aware that the scientific advice will be conducted regardless of whether the reduction of fee is granted or not and presuppose that the entire fee should be paid when the advice has been performed.

Simultaneous National Advice

Since February 2020, the EU Innovation Network (EU-IN) has been running a pilot project for simultaneous national scientific advice (SNSA) from national competent authorities (NCAs). SNSA helps applicants get advice from multiple NCAs at the same time, useful for clinical trials in multiple countries or marketing authorization applications.

After a positive evaluation in January 2025, the HMA has decided to continue the SNSA project. The SNSA Working Group will improve the procedure based on pilot learnings. Applicants can continue to submit SNSA requests via snsa@fagg-afmps.be according to current guidelines.

More information: