Who is responsible for safety data exchange agreement?
Who is responsible for safety data exchange agreement?
Companies must have safety exchange agreements in place in order to remain in full regulatory compliance. It is the prime responsibility of the marketing authorization holder to have an SDEA in place to control and guarantee that no safety data falls through any “gaps”.
What is a safety data exchange agreement?
Safety Data Exchange Agreement means that agreement between the Parties regarding receipt, investigation and reporting of product complaints, adverse events, product recalls, and any other information related to the safety of the Licensed Products as set forth in Section 10.03 (Adverse Drug Events).
What is a pharmacovigilance agreement?
Pharmacovigilance Agreement means an agreement entered into by the Parties to set forth the protocols and procedures for reporting adverse events and complying with reporting requirements set forth by Regulatory Authorities.
What is the expiry timeframe for safety data sheets?
Because SDS expire every five years and they are frequently revised, it is common for employers and chemical users to outsource third-party systems to maintain up-to-date SDS for their range of chemicals.
What are the three elements of an agreement?
A: In order to have a valid and binding legal contract, three elements are required: an offer, acceptance of that offer and consideration.
Is the PSMF to be submitted to authorities?
The PSMF may be requested and assessed by any national competent authorities or by the Agency (EMA), during marketing authorisation application(s) or post-authorisation.
Are safety data sheets updated annually?
A Safety Data Sheet shall be reviewed at least every 3 years. Records of SDS updates such as content, date, and version revision, shall be kept for 3 years.
Safety Data Exchange Agreements are legal written contracts ensuring that all safety data regarding a licensed product makes its way quickly and reliably back to the marketing authorisation holder so that they may fulfil their legal obligations to aggregate safety data and to submit safety reports in a timely manner.
What is an SDEA and why do you need one?
It is the prime responsibility of the marketing authorization holder to have an SDEA in place to control and guarantee that no safety data falls through any “gaps”. It is imperative that all the data gets through and there is a system of acknowledgement of receipt and reconciliation of data sent and received.
Is SDEA mandatory in a trail contract?
SDE clauses in these instances are usually part of trail contract and plan. Hence separate SDEA is not mandated and also would not be against any regulation if someone opts to have. For those opting, they would be having SDEA as per clauses similar to type of service provider scenario.
What types of data and activities are governed by SDEAS?
The types of data and activities governed by SDEAs differ from company to company and from product to product. All of the SDEAs must be part of the MAH’s quality management system and the writing, approval and documentation of each SDEA and each type of SDEA must follow company SOPs and be auditable.
