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Where, when and how to register PASS? Which PASS are to be registered?

A MAH is obliged to notify regulatory authorities of performing the safety study  to notify the start and end of the study, to submit the protocol (no less than 60 days before the starting day of the study) and to present the final report (within 12 months from the end of the data collection). This shall apply to all PASS. All PASS carried out by the MAH are to be entered in the EU PAS register, PASS performed in the CZ shall also be reported to SÚKL.

Entry in the EU PAS register

  • The time schedule for reporting a study or submitting a protocol has not been specified, but with respect to studies imposed as an obligation subject to Art. 21a/22a a study cannot be initiated without the approval of PRAC/SÚKL
  • The specific EMA register has not been established yet, the MAH should make study information available in the EU electronic register maintained by the Agency and accessible by the ENCePP register.

Link to the public ENCePP register: http://www.encepp.eu/encepp_studies/indexRegister.shtml

A step by step guide of how to register a study in the EU PAS register: http://www.encepp.eu/publications/documents/EUPASRegisterGuide.pdf

Entry in the SÚKL register

  • To be performed in the same way as up till now – a web form on SÚKL website will be adjusted in accordance to the requirements of the amended implementing legal regulation
  • Studies imposed as an obligation subject to Section 31a or Section 32a of the Amendment to AoP  shall be governed by Section 93k, a study cannot be initiated without the written consent of SÚKL
  • A guideline PHV-3 ver.3