How to notify SÚKL/EMA of performing PASS

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2. How to notify SÚKL/EMA of performing PASS
In force from:
11.01.2016

PLEASE NOTE THAT: TO NOTIFY SÚKL OF PASS (INITATION, COMPLETION) VALID CZECH ELECTRONIC SIGNATURE IS NECESSARY TO SUBMIT THE WEB FORM!

A. How to notify SÚKL of studies performed voluntarily by the MAH

The extent of information and method of notifying SÚKL of performing voluntary PASS is based on legal requirements – see related regulations. The MAH is obliged to notify SÚKL electronically of an intention to conduct PASS at least 60 days before commencement of the study while providing the following information:

  • Company name (MAH/CRO) or name of the organization performing the study, address
  • Identification of the product in the study, SÚKL code that is assigned to the product
  • Title of the study
  • Identification number of the study according to MAH´s documents
  • Date of start of data collection, expected date of end of data collection, expected date of end of data analysis and expected date of the final study report submission
  • Study protocol

The MAH is obliged to notify SÚKL electronically of the completion of a non-interventional postauthorisation safety study. The marketing authorisation holder shall submit the final study report to SÚKL within 12 months of the end of data collection.

The marketing authorisation holder shall use the appropriate interactive form available on the SÚKL website to inform SÚKL about the start/end of the study. https://www.sukl.eu/modules/nps/index.php?lang=2

The marketing authorisation holder shall evaluate whether the study results have an impact on the marketing authorisation. If necessary, the MAH shall submit an application to vary the marketing authorisation – within 12 months of the end of data collection together with the final study report. The MAH shall monitor the data generated while the study is being conducted and consider their implications for the benefit/risk balance of the medicinal product concerned.

All non-interventional PASS shall be described in the Risk Management Plan for a medicinal product (RMP) in accordance with GVP Module V-RMP. All relevant sections/modules of the RMP should be amended to document the conduct of the study, including the safety specification, the pharmacovigilance plan, the risk minimisation plan and the summary of activities, as appropriate. A copy of the study protocol approved by the competent authority should be provided in annex 6 of the RMP. When a RMP does not exist, a new RMP should be developed referring to the PASS.

The results of all non-interventional PASS (even negative results) shall be provided in the PSUR (Periodic Safety Update Report) in the relevant section (III-8 “Findings from non-interventional studies”). A list of non-interventional studies in the relevant period (see GVP Module VII) shall be annexed to the PSUR. B) How to notify SÚKL of studies requested by a regulatory authority The marketing authorisation holder conducting a non-interventional post-authorisation safety study based on the conditions and obligations imposed under Article 31a or 32a AoP only in the Czech Republic, shall submit a draft protocol to SÚKL at least 60 days before its commencement.

B) How to notify SÚKL of studies requested by a regulatory authority

The marketing authorisation holder conducting a non-interventional post-authorisation safety study based on the conditions and obligations imposed under Article 31a or 32a AoP only in the Czech Republic, shall submit a draft protocol to SÚKL at least 60 days before its commencement. Within 60 days from the submission of the draft protocol, SÚKL issues one of the following:

  • a) a letter endorsing the draft protocol;
  • b) a letter of objection that shall set out in detail the grounds for the objection in any of the following cases:
    • it is considered that the conduct of the study promotes the use of a medicinal product;
    • it is considered that the design of the study does not fulfil the study objectives; or
  • c) a letter notifying the MAH that the study is a clinical trial falling under the scope of Directive 2001/20/EC.

If the study is conducted in multiple Member States, the marketing authorisation holder shall submit the draft protocol to the Pharmacovigilance Risk Assessment Committee (PRAC) and to the Agency.

The imposed study may commence only when the written endorsement from SÚKL or the PRAC, as appropriate, has been issued. When a letter of endorsement has been issued by the PRAC, the marketing authorisation holder shall notify SÚKL electronically of performing PASS. In situation when notification to SÚKL has to be made before an approved protocol (by SÚKL or PRAC) is available, MAH shall submit draft version of protocol with the notification. The final version of protocol is submitted after approval (by SÚKL or PRAC).

After the protocol is approved by the relevant authority (or 60 days at the latest before the study commencement, depending on which situation comes first), the MAH shall electronically notify SÚKL about the commencement of the study by providing the following information:

  • Company name (MAH/CRO) or name of the organization performing the study, address
  • Identification of the product in the study, SÚKL code that is assigned to the product
  • Title of the study
  • Identification number of the study according to MAH´s documents
  • Date of start of data collection, expected date of end of data collection, expected date of end of data analysis and expected date of the final study report submission
  • (Approved) study protocol

The MAH is obliged to notify SÚKL electronically of the completion of a non-interventional postauthorisation safety study. The marketing authorisation holder shall submit the final study report to SÚKL within 12 months of the end of data collection. The marketing authorisation holder shall use the appropriate interactive form available on the SÚKL website to inform SÚKL about the start/end of the study.

https://www.sukl.eu/modules/nps/index.php?lang=2

The marketing authorisation holder shall evaluate whether the study results have an impact on the marketing authorisation. If necessary, the MAH shall submit an application to vary the marketing authorisation – within 12 months of the end of data collection together with the final study report. The MAH shall monitor the data generated while the study is being conducted and consider their implications for the benefit/risk balance of the medicinal product concerned.

All non-interventional PASS shall be described in the Risk Management Plan for a medicinal product (RMP) in accordance with GVP Module V-RMP. All relevant sections/modules of the RMP should be amended to document the conduct of the study, including the safety specification, the pharmacovigilance plan, the risk minimisation plan and the summary of activities, as appropriate. A copy of the study protocol approved by the competent authority should be provided in annex 6 of the RMP. When a RMP does not exist, a new RMP should be developed referring to the PASS.

The results of all non-interventional PASS (even negative results) shall be provided in the PSUR (Periodic Safety Update Report) in the relevant section (III-8 “Findings from non-interventional studies”).A list of non-interventional studies in the relevant period (see GVP Module VII) shall be annexed to the PSUR.

C) How to notify EMA of performing a non-interventional PASS

According to GVP, in order to support transparency, it is strictly recommended to notify EMA on all safety studies conducted by the marketing authorisation holder (non-interventional PASS conducted voluntarily or pursuant an obligation). The marketing authorisation holder should make study information available in the EU electronic register of post-authorisation studies (EU PAS Register) maintained by the Agency and accessible through the European medicines web-portal. The study protocol should be entered in the register before the start of data collection. The EU PAS Register is publicly available. So far, EU PAS can be found here: https://www.encepp.eu/encepp/studiesDatabase.jsp

SÚKL recommends MAHs to enter study information regarding all conducted studies in the EU PAS Register.