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.
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