The Human Medicines Regulations 2012

[F1Compliance managementU.K.

This section has no associated Explanatory Memorandum

15.  The licensing authority must establish specific procedures and processes in order to achieve the following objectives—

(a)ensuring the evaluation of the quality, including completeness, of pharmacovigilance data submitted;

(b)ensuring the assessment of pharmacovigilance data and its processing within the timelines provided for in Part 11 of these Regulations;

(c)ensuring independence in the performance of pharmacovigilance activities;

(d)ensuring effective communication among regulatory bodies in countries other than the United Kingdom who have the same or similar functions as the licensing authority, as well as with patients, healthcare professionals, marketing authorisation holders and the general public; and

(e)conducting inspections, including pre-authorisation inspections.]

Textual Amendments