Pharmacovigilance and safety information

PHARMACOVIGILANCE AND SAFETY INFORMATION

ROXALL receives reports of adverse events, adverse drug reactions or other safety information via telephone or electronic contact. In order to protect public health, pharmacovigilance systems exist, which are fundamental to the safety of consumers of medicines and play a major role in collecting and evaluating information on adverse drug reactions. The regulatory authorities in each country are responsible for monitoring, coordinating and implementing national pharmacovigilance systems for medicines for human use, and it is also the responsibility of the marketing authorization holders or local representatives to set up a pharmacovigilance system in order to be able to collect any suspected adverse reactions to medicines in a timely manner, and to keep detailed records of these, for subsequent notification to the regulatory authorities.
In this sense, personal information is processed, from the people for whom safety information has been notified for a given medicine and from those who notify them. The categories of data recorded and processed are as follows:

• Pseudonymized identification (initials of name, gender, date of birth, age, age group);
•  Anthropometric data (weight and height);
• Safety information (description, onset, duration, severity, evolution);
•  Data on the suspected drug: dates of therapy (start and end date), daily dose, route of administration, therapeutic indication, order number, first use, previous reactions to the same drug, reintroduction of the same drug;
• Clinical data, diagnostic tests, allergies, pregnancy, medical history, concomitant medication [dates of therapy (start and end date), daily dose, route of administration, therapeutic indication], and suspected interaction;
• Opinion on the causal relationship.

The following details of the notifiers who transmit the information are also recorded:

•  Name;
•  Contact.

The aforementioned pseudonymized personal data is transmitted to the competent regulatory authorities.

Thus, in treatments for the purpose of pharmacovigilance, data relating to medicinal products that have been granted a marketing authorization are kept by the sponsor, in accordance with Regulation (EU) No. 1235/2010 of the European Parliament and of the Council of 15 December 2010 and Directive 2001/83/EC of the European Parliament and of the Council.1235/2010 of the European Parliament and of the Council of 15 December 2010 and Directive 2001/83/EC of the European Parliament and of the Council, for at least 10 years after the end of the cycle of the medicinal product, i.e. at least 10 years after the last marketing authorization was granted and until no marketing application is pending or planned anywhere in the world.

ROXALL processes the personal data provided to it in the context of pharmacovigilance, based on reasons of important public interest and compliance with legal obligations, and communicates this information to the authorities and partners.

With regard to this personal data, because it is sensitive information, ROXALL pseudonymizes it as a security measure.