REGULATORY AUTHORITY INTERACTION Clause Samples
The Regulatory Authority Interaction clause outlines the procedures and responsibilities for engaging with government or regulatory bodies relevant to the agreement. It typically specifies how parties must notify each other of communications with regulators, coordinate responses, and share information or documentation as required by law. This clause ensures that both parties remain compliant with applicable regulations and are aligned in their dealings with authorities, thereby reducing the risk of non-compliance or conflicting actions.
REGULATORY AUTHORITY INTERACTION. 1Expedited Reporting Responsibilities
REGULATORY AUTHORITY INTERACTION. 10.1 Expedited reporting responsibilities The Party holding the Regulatory Authority Authorisation for clinical trials in a country shall be responsible for submitting expedited SAE reports to the Regulatory Authority in that country according to the current applicable laws, regulations and guidelines, regardless of whether the report originated from that Party or not. According to the agreements governing the transaction to which this Pharmacovigilance Agreement relates, for the telbivudine project this will be Idenix or its designee in the USA, Canada and the rest of the world apart from certain countries in SE Asia, for which Novartis shall hold the Regulatory Authority Authorisation and be responsible (see Appendix 2).
REGULATORY AUTHORITY INTERACTION. Salix for assessing whether individual reports meet the criteria set out in applicable legislation and guidance relating to safety reporting and require a submission to a relevant Regulatory Authority. Salix will be responsible for reporting all qualifying reports for the Product to the relevant Regulatory Authorities.
REGULATORY AUTHORITY INTERACTION