Pharmacovigilance (Amendment) Regulations, 2013

L.N. 352 of 2013

MEDICINES ACT

(CAP. 458)

Pharmacovigilance (Amendment) Regulations, 2013

IN exercise of the powers conferred by article 106 of the

Medicines Act, the Minister for Health, after consultation with the

Licensing Authority, has made the following regulations:-

(1) The title of these regulations is the

Pharmacovigilance (Amendment) Regulations, 2013, and these

regulations shall be read and construed as one with the

Pharmacovigilance Regulations, hereinafter referred to as "the

principal regulations".

(2) The scope of these regulations is to transpose amendments

to Directive 2001/83/EC on the Community code relating to

medicinal products for human use, brought about by Directive 2012/

26/EU, as regards pharmacovigilance.

(3) These regulations shall be deemed to have come into force

on the 28th October, 2013.

Regulation 57 of the principal regulations shall be

amended as follows

(a)

for sub-regulation (1) thereof, there shall be

substituted the following

"(1) (a) The Authority or the Commission, as

appropriate, shall, on the basis of concerns resulting from

the evaluation of data from pharmacovigilance activities,

initiate the procedure provided for in this regulation by

informing the other Member States, the Agency and the

Commission where

(i) it considers suspending or revoking a

marketing authorisation;

(ii) it considers prohibiting the supply of a

medicinal product;

(iii) it considers refusing the renewal of a

marketing authorisation; or

(iv) it is informed by the marketing

authorisation holder that, on the basis of safety

concerns, the holder has interrupted the placing on

the market of a medicinal product or has taken

action to have a marketing authorisation

withdrawn, or intends to take such action or has

not applied for the renewal of a marketing

authorisation.

(b) The Authority or the Commission, as

appropriate, shall, on the basis of concerns resulting from

the evaluation of data from pharmacovigilance activities,

inform the other Member States, the Agency and the

Commission where it considers that a new contra-

indication, a reduction in the recommended dose or a

restriction to the indications of a medicinal product is

necessary. The information shall outline the action

considered and the reasons therefor.

The Authority or the Commission, as appropriate,

shall, when urgent action is considered necessary, initiate

the procedure provided for in this sub-regulation in any of

the cases referred to in this regulation.

Where the procedure provided for in this regulation

is not initiated, for medicinal products authorised in

accordance with the procedures laid down in Chapter 4 of

Title III of Directive 2001/83/EC, the case shall be brought

to the attention of the coordination group.

Article 31 of Directive 2001/83/EC shall be

applicable where the interests of the European Union are

involved.

(c) Where the procedure provided for in this

regulation is initiated, the Agency shall verify whether the

safety concern relates to medicinal products other than the

one covered by the information, or whether it is common

to all products belonging to the same range or therapeutic

class."; and

(b) for sub-regulation (2) thereof, there shall be

substituted the following

"(2) Where the medicinal product involved is

authorised in more than one Member State, the Agency

shall without undue delay inform the initiator of the

procedure of the outcome of this verification, and the

procedures laid down in Articles 107j and 107k of

Directive 2001/83/EC shall apply. Otherwise, the safety

concern shall be addressed by the Member State

concerned. The Agency or the Authority, as applicable,

shall make the information that the procedure has been

initiated available to marketing authorisation holders.".

€0.27