1. Controller / Company
Primex Pharmaceuticals Oy and its affiliates Primex Pharmaceuticals AG and Giovanni Ogna e Figli S.r.l.,
Eteläesplanadi 24 A
(Primex Pharmaceuticals Oy and its affiliates Primex Pharmaceuticals AG and Giovanni Ogna e Figli S.r.l., hereinafter also “Primex”)
2. Contact person
Eteläesplanadi 24 A
3. Name of register
Adverse Event Register
4. The purpose for use of the data file and the related processing of personal data
The purpose of the Adverse Event Register is to collect information for the fulfilment of Primex’s legal pharmacovigilance responsibilities in relation to drug safety reporting and monitoring of the safety profiles of Primex’s products (based on inter alia the Finnish Medicines Act 395/87 Section 30e and 30f, as well as Directives 2001/83/EC and 2010/84/EC).
The data file and the information contained therein is processed by Primex and its pharmacovigilance subcontractor Biocodex Oy.
5. Content of the register
The following data may be collected:
- Regarding the patient: gender, age, initials, height and weight, medical condition, description of adverse event, relevant concomitant medication, pregnancy information when relevant.
- Regarding the reporter: name, status as a health professional, contact details such as e-mail, phone number, address, institute or organization.
The collecting of the aforementioned personal data relating to the foregoing data subject groups is a statutory requirement.
6. Regular sources of information
Adverse events are reported by patients themselves or medical professionals through the online form on Primex’s website (www.primexpharma.com), by phone / e-mail to Primex or its partners or through reporting by regulatory authorities.
7. Disclosure to third parties
Primex has partially outsourced the processing of personal data to Biocodex Oy. Personal data is not transferred or disclosed to any third parties except for Primex’s pharmacovigilance subcontractor Biocodex Oy or where so provided by the applicable legislation to which Primex is subject.
Based on the provisions of the applicable legislation, information recorded to the Adverse Event Register may have to be disclosed to third parties inter alia a competent supervisory authority such as the Finnish Medicines Agency Fimea (‘Fimea’), which maintains national Adverse Reaction Register to the extent necessary to fulfil our drug safety related obligations. The national Adverse Reaction Register and information recorded in it is subject to statutory processing requirements, and the information may only be used for monitoring and reporting of adverse reactions, scientific research or for analysing the safety and risk-benefit ratio of drugs. The recorded data may not be used when making decisions concerning the data subject.
8. Data protection principles
A. Manual register
The manual register is stored in an area with restricted access, available only for authorized persons.
B. Electronic register
The access to the electronic data register is encrypted through SSL-technology and the data is available only for authorized persons.
9. Retention of personal data
Based on the provisions of compelling legislation, Primex has to retain the information recorded to Adverse Event Register for a period of maximum of 50 years from the expiry of the medical selling permit or the effectiveness of the registration. Thereafter, Primex will destroy the data within a year, unless otherwise instructed by the competent supervisory authority.
10. Data subject rights
Everyone shall have the right to access the personal data regarding himself/herself recorded to the register and to request correction, completion or deletion of incorrect personal data related to them contained in the register.