Regulation 167 Insertion of regulation 205A (further obligations in respect of pharmacovigilance activities)

After regulation 205 insert—

“Further obligations in respect of pharmacovigilance activities

Further obligations in respect of pharmacovigilance activities

205A.

(1)

Schedule 12A makes further provision as to the obligations of a holder and the licensing authority in respect of the performance of pharmacovigilance activities under this Part.

(2)

The Ministers may by regulations amend Schedule 12A.

(3)

Regulations under paragraph (2) may make provision regarding the performance of pharmacovigilance activities under this Part as to—

(a)

the content and maintenance of the pharmacovigilance system master file kept by the holder;

(b)

the minimum requirements for the quality system for the performance of pharmacovigilance activities by the holder and the licensing authority;

(c)

the use of internationally agreed terminology, formats and standards for the performance of pharmacovigilance activities;

(d)

the minimum requirements for the monitoring of data recorded by the licensing authority pursuant to regulation 185 (recording obligations on the licensing authority) to determine whether there are new risks or whether risks have changed;

(e)

the format and content of electronic transmission of suspected adverse reactions by a holder;

(f)

the format and content of electronic periodic safety reports and risk management plans; and

(g)

the format of protocols, abstracts and final study reports for the post-authorisation safety studies.”.