Quote from VigiServe Admin on December 15, 2020, 3:07 PM

Definition:

Safety Data Exchange Agreements (SDEA) are legal contracts meant for ensuring prompt exchange of safety data with the business partner, that will ensure fulfilment of legal obligations by the marketing authorization holder (MAH).

An SDEA may be executed between a MAH and:

• Service Provider

• Affiliate/ Subsidiary, or even across business functions

• Batch Release Site

• Distributor

• Exploitant (France)

• Local QPPV

• Co-Licensor

• Innovator/RLD Owner (common in Para IV applications in the US)

• M&A Partner (acquirer or acquiree)

In rare situations, the MAH may act as a distributor and commercialize a product that pertains to its partner, which is now the MAH.

Constituents of an SDEA

• Timelines and mechanism for Exchanging safety data

• Products and Territory

• Language (and/or translation)

• Responsibility matrix, including Case handling, follow-up,Medical information, Signal Management, Safety Database ownership, Inspections, local QPPV, local literature search, Aggregate Reports, and coordination with a local regulatory agency

• Safety-related recalls (global)

• Reconciliation processes

• Data Privacy & BCP

• Validity and Revision timelines

• Termination

• Signatures

• Contact Details

Types of SDEA - Based on number of Parties

• Bipartite SDEA: This is the commonest arrangement, where an SDEA is executed between two partners.

• Tripartite SDEA: When there are three parties involved in a business arrangement. E.g., When a company (MAH) wants to outsource pharmacovigilance operations in France, and there is an Exploitant involved. A tripartite agreement may even be required when a distributor is incapable of fulfilling Pharmacovigilance obligations, where a local service provider may need to get involved.

• Quadrapartite SDEA: This is a rare scenario where four parties are involved in executing an SDEA. E.g., when there is a MAH, distributor, service provider and a local QPPV.

Who can Sign-off the SDEA?

The Pharmacovigilance head/ designee can sign off an SDEA only if he/she has been authorized by means of a board resolution. If not, then the execution can be performed by any other authorized designee. In such cases, the designee may exercise caution and get the agreement vetted by the legal, before sign off.

Is SDEA required for Tender Supplies?

The answer is Yes, but there are some nuances that one need to consider.

If the MAH has an affiliate office in the Tender country, and if the company personnel are involved in the tender process, then an SDEA may not be required.

However, if there is an agent involved, or if the tender is direct with the regulatory agency / Government, then some documentation (preferably SDEA) needs to be considered.

One may even consider literature monitoring for the respective country, and this may continue until the shelf life of the product.

At times, reconciliation may be a challenge, unless the local agent agrees to reconcile.

At times, tenders are recurring ones, and the MAH may or may not win all of them, depending on competition or exclusivity of the product.

 

Does the Company need to hold an MA, for Tender Participation?

The company may or may not hold an MA in the tender country. E.g., if the company holds an MA in the UK/US, the local regulatory agency may allow the supply of the UK/US product. Again, literature monitoring will still be required. The cases arising from the tender country will still be considered as foreign (and NOT domestic) in UK/US.