By submitting this request, I agree to the following declarations:
Compliance
I have requested, in accordance with the laws in my country, and all applicable regulatory authorities, supply of the product which is not yet registered in my country (the “Product”) for a patient or group of patients, whose strictly necessary information for the processing of this request is provided in this form (the “Patient”).
Confidentiality
I agree that all information disclosed to me within the context of or relating to the request is the confidential information of Sanofi (“Confidential Information”). I will use such Confidential Information for the sole purpose of treating the patient. I will not publish, disclose, or make available any Confidential Information to any party other than Sanofi. If required by a governmental authority or by a court order to disclose any Confidential Information, I will promptly give Sanofi written notice of such order and will cooperate with Sanofi if it wants to seek a protective order.
Patient Level Data
I agree that I will not publish any Patient-Level Data obtained as part of the Pre-Registration Import License (PRIL) in any media, including, but not limited to, patient baseline characteristics, safety and efficacy outcomes, or patient-reported outcomes. I will not make any scientific publication applications to an external publisher, whether a journal, an event, or a congress.
Processing of Physician Personal Data
I agree that Sanofi may collect certain personal/professional data from me to handle my request, including my name, address and place(s) of work, work telephone number, and email address.
I ensure that all individuals (treating physicians) listed in the request letter also agree with communicating their personal information to Sanofi and are aware of the laws and regulations that are applied to the processing of such information.
I agree that Sanofi may disclose/transfer my personal data to:
- its/their affiliates (as necessary), business partners, service providers, subcontractors and agencies and they may contact me in relation to the request (as relevant)
- governmental, tax or regulatory authorities and other persons as required or permitted by law, and I understand that some of those recipients may be located in countries or territories outside the United States of America ("U.S.A") and/or the European Economic Area (“EEA”) which may not offer the same level of data protection as in my country and appropriate steps will be taken to protect my personal data.
For EEA residents: your personal data may be transferred to the U.S.A., where your personal data may not benefit from the same level of protection as in your country, despite the safeguards implemented by Sanofi (such as the Privacy Shield or the EU Standard Contractual Clauses). In particular and in accordance with local US laws, governmental and judicial authorities may request access to or communication of your personal data for public security, defense and state security purposes. Notwithstanding the preceding, Sanofi complies with recommendations of relevant Data Protection Authorities to protect of your personal data.
I, a EEA resident, understand that my personal data may be transferred to the U.S.A, where judicial and administrative authorities may be entitled to access my personal data, as described above.
For more information on protection mechanisms implemented, I can contact Sanofi, using this Form.
I acknowledge that I have been informed of my right to access, rectify, object to the processing of my personal data and to obtain erasure of my personal data, as well as the right to data portability and the right to request restriction of the processing pursuant to the General Data Protection Regulation (GDPR). For the exercise of the abovementioned rights, I can contact Sanofi, using this Form.
By submitting this request, I give my explicit consent to my personal data being used, disclosed and transferred as described above.
Supply
I will inform the Patient that the Product is not currently registered in my country. I acknowledge that the Patient should be informed that she/he/they is/are being treated with a product that is not yet registered in the country.
I agree that the requested supply of Product is only for the Patient and will not be used for other purposes. Any unused or expired Product will be destroyed according to local requirements and the written instructions of Sanofi.
I agree to adhere to Sanofi requirements regarding drug supply including specific storage and administration requirements for the Product.
Reporting of Pharmacovigilance Data
I agree to report to Sanofi all PV Data of which I become aware during the period of Pre-Registration Import Licenses (“PRIL”). In case of a Serious Adverse Event (SAE), I agree to report this within 24 hours, and in case of a non-Serious AE or any other PV Data with no AE, I agree to report this within 30 days. Where required, I agree to report any Adverse Drug Reactions (ADR) directly to the Regulatory Authorities. . I shall complete the PV Data Reporting Form provided by Sanofi, and shall provide at least the following information: patient identifiers (including the patient’s age or age group and sex), reporter name and contact information), Sanofi suspect product (name of the product, dose, route of administration, date of administration and batch number), country of incidence and description of the PV Data, by email to the appropriate generic email addresses on the list made available by Sanofi at the outset of the Services, according to the country of origin of the relevant PV Data.
I will cooperate in good faith with Sanofi or other Sanofi business partners, service providers, subcontractors, and agencies, in connection with any further investigation of the safety information as requested by Sanofi. When applicable, I understand it is my responsibility to report any such information while the Patient is being treated with the Product to applicable the appropriate local authorities in accordance with local requirements.
Definitions
"Adverse Event" or “AE” shall mean any untoward medical occurrence in a patient administered 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.
“Pharmacovigilance Data” or “PV Data” shall mean any Adverse Event (Serious or not), any incident, or any of the following special situations (with or without Adverse Events): any report of misuse; any medication error; any off-label use (intentional use outside the labelled indication); any overdose (intentional or not); any drug abuse, dependence, addiction, (withdrawal syndrome); any lack of efficacy; 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; unexpected therapeutic benefit; any suspected transmission of infectious agents; and / or suspected drug interactions involving active ingredients or their metabolites. Where a Product Technical Complaint arises in conjunction with an AE, such complaints are also subject to the reporting obligations applicable to PV Data. Where a Product Technical Complaint is not associated to an AE, such complaints are subject to Quality reporting obligations and must be communicated to the respective Country Quality Management (or representative).
"Serious" used in connection with 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 or birth defect.