Examples of State Institute for Drug Control in a sentence
Sponsor shall be responsible, before the commencement of the Study, for obtaining an appropriate permission from the State Institute for Drug Control and a concurring opinion of the relevant Ethical Commission, as stipulated by the Act on Pharmaceuticals.
The Sponsor shall, within 90 days of the study completion, inform the State Institute for Drug Control and relevant Ethics Committees on completion of the study.
Institution hereby undertakes to ensure that the Study Drug be stored separately from other medication in the pharmacy, and its preparation, inspecting, preserving and dispensing (hereinafter only “Study Drug Handling”) be performed in compliance with Protocol and Study Instructions, and the Applicable Law, as well as the terms and conditions stipulated by LEK-12 Directive issued by State Institute for Drug Control.
In furtherance of the foregoing obligations, AbbVie shall ensure that the State Institute for Drug Control (“SUKL“) and an Ethics Committee (“EC”) established and constituted in accordance with applicable Laws approves and oversees the conduct of the Study.
Principal Investigator shall be obliged to immediately inform Sponsor, the State Institute for Drug Control and the competent Ethical Commission if he interrupts or terminates performance of the Study before completion of all acts determined by Protocol without a previous Sponsor’s approval; he shall submit a detailed written explanation to Sponsor and the competent Ethical Commission.
If performance of the Study is interrupted or terminated ahead of schedule by Sponsor or the State Institute for Drug Control, Principal Investigator shall immediately inform about such situation the competent Ethical Commission, and Principal Investigator shall submit a detailed written explanation to this Ethical Commission.
In accordance with the legislation of the Czech Republic, the Clinical Trial description shall be published on the internet site of State Institute for Drug Control xxx.xxxx.xx and will also be available on the website xxxxx://xxx.xxxxxxxxxxxxxxxxxxxxxx.xx/index.html and xxx.XxxxxxxxXxxxxx.xxx, as required by the legislation of the EU and the USA.
Before the Study is initiated, CRO will obtain or will procure a third party to obtain approval of the Study and informed consent document by the State Institute for Drug Control (“SUKL”) and the Ethics Committee.
The permission of the State Institute for Drug Control and the concurring opinions of Multicentric and Local Ethical Commissions are attached as Apendix C to this Agreeement.
Bodies having the power to regulate, including authorities that review submitted clinical data and those that conduct inspections, including, but not limited to State Institute for Drug Control.