PHARMACOVIGILANCE INSPECTIONS REGULATIONS

PHARMACOVIGILANCE INSPECTIONS

SUBSIDIARY LEGISLATION 458.57

PHARMACOVIGILANCE INSPECTIONS

REGULATIONS

30th October, 2012

LEGAL NOTICE 374 of 2012.

(1) The title of these regulations is the Pharmacovigilance

Inspections Regulations.

(2) These regulations shall apply to authorised medicinal

products for human use, their marketing authorisation holder and

any pharmacovigilance activity connected therewith.

(3) These regulations implement the provisions of Directive

2010/84/EU of the European Parliament and of the Council of 15

December 2010 amending, as regards pharmacovigilance

inspections, Directive 2001/83/EC on the Community code relating

to medicinal products for human use.

For the purpose of these regulations

"the Authority" means the Medicines Authority set up in terms of

article 4 of the Medicines Act;

"Pharmacovigilance system" means a system used by the

marketing authorisation holder and by Member States to fulfil the

tasks and responsibilities listed in these regulations and designed to

monitor the safety of authorised medicinal products and detect any

change to their risk-benefit balance;

"Pharmacovigilance system master file" means a detailed

description of the pharmacovigilance system used by the marketing

authorisation holder with respect to one or more authorised

medicinal products.

(1) The Authority shall have a right to inspect the

premises, records, documents and pharmacovigilance system

master files of the marketing authorisation holder or any firms

employed by the marketing authorisation holder to perform the

activities described in Title IX of Directive 2001/83/EC.

(2) After every inspection, the Authority shall report on

whether the inspected entity complies with the requirements laid

down in Title IX of Directive 2001/83/EC. The Authority shall

communicate the content of the report to the inspected entity.

Before adopting the report, the Authority shall give the inspected

entity concerned the opportunity to submit comments.

(3) If the outcome of the inspection is that the marketing

authorisation holder does not comply with the pharmacovigilance

system as described in the pharmacovigilance system master file

and with Title IX of Directive 2001/83/EC, then the Authority shall

also inform other EU Member States, the European Medicines

Agency and the European Commission with that outcome.