Paragraph 11 Compliance managementF1
Specific quality system procedures and processes must be 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 holder;
the scientific evaluation by the holder of all information on the risks of medicinal products, as referred to in regulation 182(4)(a);
the submission of accurate and verifiable data on serious and non-serious adverse reactions to the licensing authority within the time limits provided for in regulation 188(1)(a) or (b);
the quality, integrity and completeness of the information submitted on the risks of medicinal products, including processes to avoid duplicate submissions;
effective communication by the holder with the licensing authority, including communication on—
new risks or changed risks,
the pharmacovigilance system master file,
risk management systems,
risk minimisation measures,
periodic safety update reports,
corrective and preventive actions, and
post-authorisation studies;
the update of product information by the holder in the light of scientific knowledge, including the assessments and recommendations made public via the UK web-portal, and on the basis of a continuous monitoring by the holder of information published on that web-portal; and
appropriate communication by the holder of relevant safety information to healthcare professionals and patients.
Where a holder has subcontracted some of its pharmacovigilance tasks, it must retain responsibility for ensuring that an effective quality system is applied in relation to those tasks.
Annotations
Textual amendments
- F1
Sch. 12A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 6 (as amended by S.I. 2019/1385, reg. 1, Sch. 1 para. 9 and S.I. 2020/1488, reg. 1, Sch. 2 para. 192); 2020 c. 1, Sch. 5 para. 1(1)