Scientific Advice provided by the Marketing Authorization branch

The Marketing Authorization branch of the State Institute for Drug Control (hereinafter the “Institute”) provides Scientific Advice upon request concerning procedural-regulatory issues and scientific requirements related in particular to applications for marketing authorization, variation  applications and marketing authorisation renewal applications. Scientific Advice is a paid service of the Institute and is provided only outside the ongoing administrative proceedings (e.g. before submission of a marketing authorization application in the phase of “medicinal product development”, before submission of a marketing authorisation variation or renewal application).  

When apply for Scientific Advice?

The Institute provides consulting for both the procedural-regulatory issues as well as for scientific issues concerning requirements for pharmaceutical, pre-clinical and clinical documentation and safety requirements for medicinal products.

The applicant may be a pharmaceutical company, sponsor of clinical studies or other entity involved in the marketing authorization 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 authorization of the medicinal product,
  • changes in the Product information (SmPC, PIL),
  • changes in the legal status,
  • pharmaceutical aspects (e.g. chemical, pharmaceutical and biological tests performed to prove the quality of the medicinal product),
  • pre-clinical aspects (e.g. toxicological and pharmaceutical tests to prove the safety of the medicinal product),
  • clinical aspects (e.g. endpoints of clinical studies, target populations, selection of a suitable comparator),
  • risk management plans.

Topics outside of the procedural-regulatory and scientific areas (see above) are not relevant and should not be the subject of the Scientific Advice (e.g. recommendation of suitable indication of the medicinal product, preliminary assessment of documentation before submitting a marketing authorization application).

The Scientific Advice is provided on the basis of currently valid regulatory requirements and scientific knowledge. The responses of the Institute are based on the queries submitted by the applicant and the submitted documentation and they need not reflect any future changes in scientific progress and regulatory requirements. The applicant takes into account that this consultation is provided regardless of any future submitted registration documentation and contained substantiated details for purposes of marketing authorisation of the product in question and regardless of the intellectual property of third parties.

How to submit an application for consulting

The Institute provides oral and written Scientific Advice. Within the application form 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 date of the Advice.

The applicant completes the required data in the relevant form REG-94 and sends it electronically together with the annexes either via e-mail to posta@sukl_cz or to the Institute’s data box. The applicant will then be contacted by the respective department (i.e. consultant) responsible for the Advice, and will confirm the suggested date or propose a different meeting date (in the case of oral Advice) or date for submitting the written answers (in the case of written Advice).

In the form REG-94, it is necessary to indicate all known information; columns marked with an asterisk are mandatory only for products already authorized.

The applicant may add the following information to the annexes:

  • introduction to the issue,
  • summary of the requirements,
  • study protocols,
  • results of other Scientific Advice, if there have been any concerning the issue,
  • relevant legislative materials.

The scope of attached documentation must be limited to the information required for the Scientific Advice.

The application for the Scientific Advice should be submitted to the Institute sufficiently in advance (at least 1 month) before the proposed date of the Advice.

Course of consulting

Oral consulting

In the case of oral consulting, a meeting will take place (in the Institute’s premises) between the applicant and respective Institute’s employee on the date previously mutually agreed.

The time of consulting is stipulated by standard at 60 minutes.

The applicant may prepare a presentation, which should not be longer than 15 minutes, to leave enough time to discuss the relevant issues.

After the meeting, the applicant will compile minutes from the Advice. The applicant’s contact person will send these minutes to the consultant within 5 business days. If necessary, the consultant will amend the minutes, confirm the final version and send it back to the applicant within 5 business days.

The deadlines for drafting the minutes may be agreed otherwise during the Advice, if necessary. If the consultant does not receive the draft minutes by the given or otherwise agreed deadline, the meeting will be concluded as consulting in which the Institute did not give an opinion.

Written consulting

In the case of written Scientific Advice, the Institute will send its written answers to the questions sent by the applicant by means of the completed form REG-94 within the previously agreed deadline.

Payment

The payment for the Advice must be made either before consulting or on the date of consulting at the latest. The proof of the payment needs to be sent to the Institute via email.

In case of prepayment the consultant will send to the applicant the confirmation of acceptance of payment related to covering expenditures for expert activities via e-mail; in case of payment at the day of the Scientific Advice, confirmation of acceptance of payment related to covering expenditures for expert activities is submitted to the applicant at the meeting.

Based on the consulted issue, various types of Advice and respective payments related to covering expenditures for expert activities are stipulated. The applicant will find the required information for payment, types of Advice and appropriate fees in Guideline UST-29.

If the applicant is unsure as to which type of Advice to choose for the purpose of the payment, the Institute, based on the scope of questions sent by the applicant in the form REG-94, will confirm the fee to covering expenditures for the Advice and the code.

Before providing the payment, it is necessary to complete the interactive form for payment related to covering expenditures for expert activities, which will generate a specific variable symbol under which the payment must be sent.

It is necessary to complete all the mandatory items in this form and then send the form.

Payment related to covering expenditures is not required for consulting in cases the payment was waived according to Guideline UST-24.

Meetings with the representatives of regulated entities to which the representatives were invited by the Institute within the framework of ongoing administrative proceedings are not considered as the Scientific Advice.