Pharmacovigilance Agreement Template

This Pharmacovigilance Agreement (the “Agreement”) dated [Document.CreatedDate] (the “Effective Date”) is by and between [MarketingAuthorizationHolder.Company] (the “MarketingAuthorizationHolder.Company”), and [ThirdPartyRepresentative.Company], (“ThirdParty.Company”), collectively the “Parties” and each a “Party.”

Term of the Agreement

This Agreement will become effective on (Enter the Date) (the “Effective Date”) and will continue in effect until (Enter the day) (the “Initial Term”). This Agreement may be extended beyond the Initial Term by the written agreement of all the involved parties.

Scope of Services

The Scope of Services is set out in Appendix A, attached to this Agreement.

Both Parties acknowledge and agree that each Scope of Services shall be subject to the terms and conditions of this Agreement, in addition to the specific details set forth in the specific Scope of Services. To the extent any terms or provisions of a Scope of Services conflict with the terms and provisions of this Agreement, the terms and provisions of this Agreement shall control, except to the extent that the applicable Scope of Services expressly and specifically states an intent to supersede this Agreement on a specific matter.

Definitions

• “Adverse Event” or “AE” shall mean any untoward medical occurrence in a patient who takes or uses a Product and which does not necessarily have a causal relationship with that Product. An Adverse Event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease, temporally associated with the use of such a Product, whether or not considered related to that Product.

• “Business Day” (another term for Working Day definition) means in respect to any note, any day other than a Saturday, a Sunday, or a day which is not declared to be a holiday or rest day on which the companies of one of the Parties are authorized or required by law or executive order to close or be closed.

• Day 0” (Awareness Date Clock Start Receipt Date): means the date on which a Party first becomes aware of an Adverse Event or a PV Data and, in relation to a third-party Representative of a Party, such as clinical research organizations or distributors, that have contractual and/or regulatory obligations to report Adverse Events or a PV Data to that Party, the date on which such Third Parties first become aware of that Adverse Event or a PV Data. For both Parties, this is considered “Day Zero” for reporting the other party of such information, irrespective of whether the information is received during a weekend or public holiday.

• “Emerging Safety Issue”: means a Product(s) safety issue considered by the MAH to require urgent attention / urgent safety restriction by the regulator related or not to (Product quality complaints/Customer complaints) because of the potential major impact on the risk- benefit balance of the medicinal product and/or on patients’ or public health, and the potential need for prompt regulatory action and communication to patients and healthcare professionals.

• “Incident” (in the context of medical devices) shall mean any malfunction or deterioration in the characteristics or performance of a medical device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect.

• “Pharmacovigilance” or “PV” is taken to include the concepts of Cosmetovigilance, Nutrivigilance, and Device Vigilance as applicable to the Product(s) covered by the General Terms and Conditions and Order.

• “Pharmacovigilance Data (PV Data)” means all safety information relating to known or potential risk to humans, obtained or otherwise received from any available Source of information for the Product (including spontaneous unsolicited and/or other interventional solicited).

PV Data shall include:

1. Any Adverse Event / Experience (Serious or not).

2. Any of the following special situations (with or without Adverse Events): any report of misuse; any report from Lawsuits; any medication error; any off-label use (intentional use outside the labeled indication); any overdose (intentional or not); any drug abuse/dependence/addiction (withdrawal syndrome); any lack of therapeutic efficacy (or disease progression); any drug exposure during pregnancy or child exposure during breastfeeding or conception (whether from the male or female); any occupational exposure (unintentional exposure during work); accidental exposure; any suspected transmission of infectious agents; suspected drug interactions involving active ingredients or their metabolites.

3. Unintended beneficial effects and any other information relevant to the safety of the Product(s) or unexpected therapeutic benefit.

4. Counterfeits with AE (see below Product Technical Complaint or PTC).

5. In addition, PV Data include Adverse Events associated with a suspected or confirmed PTC of falsified Product(s) or with a quality defect of a Product(s). When a Product Technical Complaint arises in conjunction with an AE, such complaints are subject to the reporting obligations applicable to PV Data. Where a PTC arises in conjunction with an AE, such complaints are subject to the reporting obligations applicable to PV Data.

• “Product(s)” shall mean all the products owned and/or manufactured and/or commercialized by CLIENT or any of its Affiliates, including medicinal products, devices, cosmetics, and food supplements. Product Technical Complaint (PTC): refers to any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, efficacy, or performance of a Product, device, its packaging, or any written leaflet or other information provided with such Product or device, after it is released for distribution. Where a PTC is also associated with PV Data, this should be notified to all Parties.

• “Serious Incident” in connection with the medical device shall mean any incident that directly or indirectly led, might have led, or might lead to any of the following: (a) the death of a patient, user, or other person, (b) the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health, (c) a serious public health threat. Serious use in connection with adverse events, reactions, and experiences shall mean any untoward medical occurrence that at any dose results in, or may have resulted in, death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability and/or incapacity or is a congenital anomaly/birth defect.

• Source of Safety Information – PV Data: In service providers’ agreements for Products on the market, available sources of information mean unsolicited, spontaneous reports that arise from the following sources but are not limited to, e.g., healthcare.

Responsibilities of Parties

The Responsibilities of Parties are set out in Appendix B, attached to this Agreement.

Training

​[MarketingAuthorizationHolder.Company] is responsible for training all its employees and agents involved in the performance of Services on PV Data reporting and the requirements set forth above prior to such employee or agent performing Services under the General Terms and Conditions and Order.

Training materials are provided by [ThirdPartyRepresentative.Company] PV at the outset of Services agreed.

​[MarketingAuthorizationHolder.Company] commits to provide annual refresher training going forward as needed. Upon request from [MarketingAuthorizationHolder.Company], [MarketingAuthorizationHolder.Company] shall provide within the best delay any justification and documentation relating to the training that has been performed.

Right to Audit

Upon request and reasonable notice, [MarketingAuthorizationHolder.Company] shall permit [ThirdPartyRepresentative.Company] to audit PV records to confirm compliance with the relevant provisions of this PV Clause and of Applicable Law.

Confidentiality

​[MarketingAuthorizationHolder.Company] shall collect, use, and disclose data governed in compliance with applicable privacy and data protection laws, rules, and regulations.

​[MarketingAuthorizationHolder.Company] shall implement all reasonable physical, technical, and administrative safeguards to protect PV Data information from loss, misuse, and unauthorized access, disclosure, alteration, destruction and to ensure that data privacy legislations are followed. [MarketingAuthorizationHolder.Company] shall notify [ThirdPartyRepresentative.Company] promptly of any suspected breach of this clause on [ThirdPartyRepresentative.Company] ’s Data.

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Retention of Information

For a minimum period of ten (10) years following the completion of the Services,[MarketingAuthorizationHolder.Company] shall retain all PV Data reporting forms, PV training records, audit, and inspection reports and responses, as well as proof that such data and documents were sent to [ThirdPartyRepresentative.Company] in accordance with this Article. During such period, all source data and information shall be made available to [ThirdPartyRepresentative.Company] upon request as soon as possible but, in no event, later than one (1) business day following the request.

Liability

Nothing in this agreement excludes or limits [MarketingAuthorizationHolder.Company] liability to the extent that any applicable law precludes or prohibits any exclusion or limitation of liability. Except in connection with each Party’s indemnification obligations hereunder, neither Party shall be liable to the other Party for any indirect or consequential damages, including, but not limited to, lost time, lost money, lost profits, or good-will, whether in contract, tort, strict liability or otherwise, and whether or not such damages are foreseen or unforeseen.

Appendices

Appendix A – Scope of Services

Appendix B – Responsibilities of Parties

Governing Law

This Agreement shall be subject to the laws of the state of (Enter State).

IN WITNESS WHEREOF, the undersigned have executed this Agreement on the date first written above.