When to apply for Scientific Advice?
The Institute provides Scientific Advice on marketing authorisation of medicinal products both in terms of procedural-regulatory issues and scientific issues concerning the requirements for pharmaceutical, pre-clinical, and clinical documentation and safety requirements for medicinal products.
The applicant for Scientific Advice may be a pharmaceutical company, a sponsor of clinical studies or another entity involved in the marketing authorisation of medicinal products.
Examples of relevant applications for Scientific Advice are as follows:
- selection of the procedure type;
- selection of a suitable legal basis for marketing authorisation of the medicinal product;
- changes in the product information (Summary of the Product Characteristics, SmPC; Patient Information Leaflet, PIL);
- changes in the legal status for supply;
- pharmaceutical aspects (e.g., physical, chemical, pharmaceutical, and biological tests performed to evidence the quality of the medicinal product);
- non-clinical aspects (e.g., toxicological and pharmacological tests to evidence the safety of the medicinal product);
- clinical aspects (e.g., endpoints of clinical studies, target populations, selection of a suitable comparator);
- risk management plans;
- preliminary assessment of the acceptability of the product name and graphic layout of medicinal product packaging.
Topics beyond the scope of procedural-regulatory and scientific areas (as mentioned above) are not relevant and should not be the subject of an application for Scientific Advice (e.g., recommendations on suitable indication of the medicinal product, preliminary assessment of documentation prior to the submission of the marketing authorisation application). Furthermore, the Institute does not provide Scientific Advice in the course of pending administrative procedures where the subject-matter of the Scientific Advice is to be the respective administrative procedure.
Scientific Advice is provided on the basis of currently effective regulatory requirements and state-of-the-art scientific knowledge. The responses of the Institute are based on the questions submitted by the applicant and the submitted documentation and they need not reflect any future changes in scientific progress and regulatory requirements. The applicant acknowledges that the Scientific Advice is provided regardless of any marketing authorisation documentation submitted in the future and any details documented therein for the purposes of the marketing authorisation of the product in question and regardless of the intellectual property of third parties.
How to submit an application for Scientific Advice
The Institute provides oral as well as written Scientific Advice. Oral Scientific Advice may be provided in person, via a teleconference or in hybrid manner. In their application for Scientific Advice, the applicant must always submit a list of clear and specific questions, with duly justified proposals for their solution. The Institute also recommends to indicate the time duration and proposed date of the Advice.
The applicant shall complete the required data in the relevant REG-94 form and shall submit it electronically along with the annexes either via e-mail to posta@suklcz or to the Institute’s data mailbox. Thereafter, the applicant shall be contacted by the respective employee assigned to handle the Scientific Advice (hereinafter referred to as the “contact person”). The contact person shall arrange for the date of the meeting and, on the basis of the submitted questions, shall advice the applicant of the amount to be paid for the Scientific Advice.
It is necessary to complete any known information in the REG-94 form; columns marked with an asterisk are mandatory only for previously authorised products.
In the annexes, the applicant may insert e.g., the following information:
- introduction to the issue;
- summary of the requirements;
- study protocols;
- results of other Scientific Advice, if previously given on the issue;
- relevant legislative background.
The scope of the attached documentation must be limited solely to the information necessary for the Scientific Advice.
The application for Scientific Advice should be submitted to the Institute sufficiently in advance (at least 1 month) of the proposed date of the Advice.
Scientific Advice process
Oral Scientific Advice
In the case of oral Scientific Advice, a meeting between the applicant and the respective Institute’s employees will take place (in the Institute’s premises; via a teleconference, or in a hybrid manner) on the date previously agreed by the attendees.
As a standard, the duration of Scientific Advice is 60 minutes.
The applicant may prepare a presentation, which should not be longer than 15 minutes, to allow for sufficient time to discuss the relevant issues.
After the meeting, the applicant shall draft minutes from the Scientific Advice and send it to the contact person within 5 working days. If necessary, the Institute shall amend the minutes and return the final version to the applicant within 15 working days.
The aforementioned timelines for drafting the minutes may be agreed otherwise during the Scientific Advice, if necessary. If the Institute does not receive the draft minutes by the standard or otherwise agreed timeline, the meeting will be concluded as Scientific Advice in respect of which the Institute did not issue any opinion.
Written Scientific Advice
In the case of written Scientific Advice, the Institute shall send its written answers to the questions submitted by the applicant by means of the completed REG-94 form within the previously agreed timeline.
The payment for the Advice must be made 1 day prior to the Scientific Advice at the latest. The proof of the payment shall be sent by the applicant to the Institute electronically.
The contact person shall send the confirmation of acceptance of the reimbursement of the cost of expert activities to the applicant via e-mail or, if appropriate, shall hand it over to the applicant personally at the time of the Scientific Advice.
Various types of Scientific Advice and respective amounts of reimbursement of costs of expert activities have been determined with a view to the issue to be consulted. Applicants may find the required information on the payment, types of Scientific Advice, and fee amounts in Guideline UST-29.
Payment code O-001 corresponds to procedural-regulatory SA, code O-003 to more scientific SA and code O-002 for SA regarding assessment of the acceptability of the product name.
On the basis of the scope of questions submitted by the applicant in the REG-94 form, the contact person shall determine the amount and code of reimbursement of costs of the Scientific Advice and shall advise the applicant thereof.
Before the payment is made, it is necessary to complete the interactive form for the payment of reimbursement of costs of expert activities, which will generate a specific variable symbol under which the payment must be sent.
It is necessary to complete all of the mandatory items in this form and thereafter, submit the form.
Reimbursement of costs is not required for Scientific Advice in cases for which the payment was waived pursuant to Guideline UST-24.
Meetings with the representatives of regulated entities to which the representatives were invited by the Institute within the scope of ongoing administrative procedures shall not be considered as Scientific Advice.
Marketing Authorisation Section
Updated on 25th May 2022