Pharmacovigilance Inspections Regulations, 2012

L.N. 374 of 2012

MEDICINES ACT

(CAP. 458)

Pharmacovigilance Inspections Regulations, 2012

IN exercise of the powers conferred by article 106 of the

Medicines Act, the Minister of Health, the Elderly and Community

Care, after consultation with the Licensing Authority, has made the

following regulations:-

(1) The title of these regulations

is

the Citation and

scope.

Pharmacovigilance Inspections Regulations, 2012.

(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

Interpretation.

"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 Inspection.

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.

€0.18