For studies carried out voluntarily by the MAH – from the effective date of the Amendment to AoP (Apr. 2, 2013), for studies imposed as an obligation in accordance with Section 31a or Section 32a of the Amendment to AoP – from the effective date of the Amendment to AoP, for studies imposed as an obligation by other authorities including the EMA (Art. 21a and 22a of Dir.2010/84/EC) – applicable from Jul. 2, 2012.On Sep. 1, 2013 the amendment to the Decree on Marketing Authorisation came into force. The new Sub-section of Section 17a, which was inserted in the amended Decree, governs all the safety studies (carried out pursuant to Section 93j of the Act on Pharmaceuticals).
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
As from Jan. 10, 2013 the format was unified in accordance with the recommendation of the EMA Guidance on GVP – in the CZ it applies for all safety studies initiated after the effective date of the Amendment to AoP. On the basis of this recommendation an ENCePP checklist should be attached to the protocol. It is recommended to state all the chapters in accordance to EMA Guidance (and indicate N/A for parts which are not applicable to the specific study) and the order/numbers of the chapters pursuant to the GVP. The protocol should include the EU PAS register number of the study or be stated as “the study not registered in the EU PAS”.
In order to ensure compliance of the MAH with its pharmacovigilance obligations, the QPPV or his/her delegate should be involved in the review and sign-off of study protocols conducted in the EU. When applicable, the MAH´s pharmacovigilance contact person at national level should be informed of any study sponsored or conducted by the MAH in the Czech Republic and have access to the protocol. A copy of the protocol signed by the QPPV is to be archived for the reason of audits and inspections..
The reduced format of the protocol/abstract/final study report is also available at: COMMISSION IMPLEMENTING REGULATION (EU) No 520/2012 - Annex III
As from Jan. 10, 2013 the format was unified in accordance with the recommendation of the EMA Guidance – in the CZ it applies for all safety studies initiated after the effective date of the Amendment to AoP. The final study report must be signed by the principal investigator and a copy of the report is to be archived for the reason of audits and inspections by the QPPV. The final study report shall contain the date of the study registration in the EU PAS register. It is recommended to state all the chapters in accordance to EMA Guidance (and indicate N/A for parts which are not applicable to the specific study) and the order/numbers of the chapters pursuant to the GVP.
The most frequent safety studies conducted in the Czech Republic: PASS initiated, managed or financed by the MAH voluntarily – summary of obligations:
Concerning SÚKL – pursuant to the Amendment to AoP
- Obligation to notify the start and end of the safety study to SÚKL - electronically via a web form (see PHV-3 Guideline)
- Submission of a study protocol (pursuant to Decree No. 228/2008 Coll.), submission of a final report as soon as possible within 12 months of the end of the data collection
- PASS shall not be performed where the act of conducting of study promotes the use of a medicinal product
- Payments to healthcare professionals for participating shall be restricted to compensation for time and expenses incurred
- The MAH shall systematically monitor and evaluate the data generated while the study is being conducted and consider their impact on the B/R profile of the medicinal product concerned
Concerning EU PAS – subject to Dir. 2010/84/EC and GVP
- Registration of the study in the EU PAS register (this obligation applies from Jul. 2, 2012), it is recommended to enter the protocol abstract in English (or the entire protocol), to enter the final report abstract in English after the study completion
- Keep the templates of protocols/abstracts/final study reports pursuant to the EMA
For more details see PHV-3 Guideline.