I.B.9. Specific quality system procedures and processes

I.B.9.1. Compliance management by marketing authorisation holders

For the purpose of compliance management, marketing authorisation holders shall have specific quality system procedures and processes in place in order to ensure the following:

• the continuous monitoring of pharmacovigilance data, the examination of options for risk minimisation and prevention and that appropriate measures are taken by the marketing authorisation holder [IR Art 11(1)(a)] (see Modules IX and XII);
• the scientific evaluation of all information on the risks of medicinal products as regards patients’ or public health, in particular as regards adverse reactions in human beings arising from use of the product within or outside the terms of its marketing authorisation or associated with occupational exposure [IR Art 11(1)(b)] (see Modules VI, VII, VIII, IX);
• the submission of accurate and verifiable data on serious and non-serious adverse reactions to the competent authorities within the legally required time-limits [IR Art 11(1)(c)] (see Modules VI and IX);
• the quality, integrity and completeness of the information submitted on the risks of medicinal products, including processes to avoid duplicate submissions and to validate signals [IR Art 11(1)(d)] (see Modules V, VI, VII, VIII and IX);
• effective communication by the marketing authorisation holder with competent authorities, including communication on new or changed risks (see Module XII and XV), the pharmacovigilance system master file (see Module II), risk management systems (see Module V), risk minimisations measures (see Modules V and XVI), periodic safety update reports (see Module VII), corrective and preventive actions (see Modules II, III and IV) and post-authorisation safety studies (see Module VIII) [IR Art 11(1)(e)];
• the update of product information by the marketing authorisation holder in the light of scientific knowledge [IR Art 11(1)(f)] (see Module XII);
• appropriate communication of relevant safety information to healthcare professionals and patients (see Module XII and XV) [IR Art 11(1)(g)].

I.B.9.2. Compliance management by competent authorities

For the purpose of compliance management, competent authorities shall establish specific quality system procedures and processes in order to achieve all of the following objectives:

• ensuring the evaluation of the quality, including completeness, of pharmacovigilance data submitted [IR Art 15(1)(a)];
• ensuring the assessment of pharmacovigilance data and its processing in accordance with the legal timelines [IR Art 15(1)(b)];
• ensuring independence in the performance of pharmacovigilance activities [IR Art 15(1)(c)];
• ensuring effective communication with patients, healthcare professionals, marketing authorisation holders and the general public [IR Art 15(1)(d)];
• conducting inspections, including pre-authorisation inspections [IR Art 15(1)(f)].

Independence in the performance of pharmacovigilance activities is interpreted in the sense that all regulatory decisions on medicinal products should be taken in the sole interest of patients’ and public health.