Pharmacovigilance services

I agree to the processing of my personal data (PD) for the purpose of providing consultations, ensuring pharmacovigilance and monitoring the safety of medicinal products (MP), in accordance with Federal Law No. 152-FZ "On Personal Data" (hereinafter referred to as 152-FZ), No. 61-FZ "On the Circulation of Medicines" and the EAEU GVP Rules.
Volume of PD: General PD (full name, date of birth/age, gender, place of residence/region); contact information (phone number, email address, postal address); special categories of PD (information on health status: diagnosis, description of adverse reactions (ARs), concomitant diseases, drugs taken, case outcome; Secondary data (call recordings, IP address, browser data). The volume is the minimum required for verification and follow-up of reports of adverse reactions (Clause 2.1 of Agreement No. 414461/1).
Operations with PD: Collection, recording (including audio recording of hotline conversations), systematization, accumulation, storage, clarification (updating, modification), retrieval, use, transfer (provision, access), depersonalization, blocking, deletion, destruction. Processing — automated/mixed, without distribution to third parties (except those specified below) (Clause 2.2 of Agreement No. 414461/1).
Recipients of PD: Call center (OOO WEST-CALL LTD, INN 7725707850, address: Moscow, Bolshaya Polyanka St., 51A/9; Agreement No. 414461/1 dated 11.04.2017) for receiving calls via the hotline (8-800-777-8604), audio recordings and transfer to the Operator within 24 hours;
To the Marketing Authorization Holder (MAH) for benefit-risk assessment and reporting (PPB/PUR); to regulatory authorities (Roszdravnadzor via AIS) without additional consent, based on paragraph 2 of part 2 of article 10 of Federal Law No. 152 (paragraph 2.3 of Agreement No. 414461/1).
Security measures: Personal data is stored exclusively in the Russian Federation; segregation, access control, and encryption are ensured; a responsible person has been appointed; employees are trained in Federal Law No. 152 and the GVP. In the event of an incident (leak), notification is required within 12 hours (clauses 3.1–3.3, 6.1–6.3 of Agreement No. 414461/1).
Terms: Processing — until full fulfillment of obligations under the contract; storage — no longer than 10 years after the expiration of the medicinal product’s RU.
Yandex.Metrica cookies: Technical (necessary for operation, e.g. _ym_required_info — session) — without consent (clause 7, part 1, article 6, Federal Law No. 152); analytical (for statistics: _ym_uid — identifier, valid for 1 year; _ym_visorc — Webvisor, 30 min; ym_landing — login page, session) — only with opt-in via banner. Revocation — data deletion and data collection deactivation.
I have read and agree with Privacy Policy,
Disclaimer. I agree to the processing of personal data, as well as my rights under Article 14 of Federal Law 152: access to personal data, their correction/clarification, withdrawal of consent (in writing) email: info@drugsafety.ru), Blocking, deletion, or appeal to Roskomnadzor. Revocation will not affect prior legal actions. An audit is possible upon request (clauses 4.3 and 7.3 of Agreement No. 414461/1).