SCHEDULES
F1SCHEDULE 12AFurther provision as to the performance of pharmacovigilance activities
PART 1Pharmacovigilance system master file
Content of the Annex to the pharmacovigilance system master file3
The pharmacovigilance system master file must have an Annex containing the following documents—
a
a list of medicinal products covered by the pharmacovigilance system master file, including the name of each medicinal product, the international non-proprietary name (INN) of each active substance and the countries other than the United Kingdom in which the products covered are authorised to be marketed;
b
a list of written policies and procedures for the purpose of complying with Part 11 of these Regulations;
c
the list of any sub-contracts falling within paragraph 6(1);
d
a list of the tasks that have been delegated by the qualified person for pharmacovigilance;
e
a list of all scheduled and completed audits;
f
where applicable, a list of the performance indicators that support the quality system for pharmacovigilance specified in paragraph 2(e);
g
where applicable, a list of other pharmacovigilance system master files held by the same holder; and
h
a logbook containing a record of any alteration of the content of the pharmacovigilance system master file made within the preceding 5 year period, except any alteration of the content that is specified in of paragraph 2(a)(ii) to (iv) or this paragraph.
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)