Pharmacovigilance Regulations, 2004

L.N. 22 of 2004

MEDICINES ACT, 2003

(ACT NO. III OF 2003)

Pharmacovigilance Regulations, 2004

IN exercise of the powers conferred by article 106 of the Medicines

Act, 2003, the Minister of Health, has made the following regulations>-

(1) The title of these regulations is the Pharmacovigilance Title and

commencement.

Regulations, 2004.

(2) These regulations shall come into force on the 1st May,

2004.

These regulations shall apply to authorised medicinal products Scope.

for human use and any pharmacovigilance activity connected therewith.

For the purposes of these regulations -

Interpretation.

“abuse of medicinal products” means a persistent or sporadic,

intentional excessive use of medicinal products which is

accompanied by harmful physical or psychological effects<

“the Act” means the Medicines Act, 2003<

“adverse reaction” refers to a response to a medicinal product

which is noxious and unintended and which occurs at doses

normally used in man for the prophylaxis, diagnosis or therapy of

disease or for the restoration, correction or modification of a

physiological function<

“the Agency” means the European Agency for the Evaluation

of Medicinal Products established by Regulation (EEC) No 2309#93<

“the Authority” means the Licensing Authority set up in terms

of article 3 of the Act<

“the Commission” means the Commission in accordance with

Council Decision 1999#468#EC of the 28th June, 1999<

“the Community” means the European Community and the

European Economic Area<

“Member State” means a State which is a member of the

European Union and shall also include Iceland, Norway and

Lichenstein<

“serious adverse reaction” refers to an adverse reaction which

results in death or is life-threatening, or requires in-patient

hospitalisation or the prolongation of existing hospitalisation, or

which results in persistent or significant disability or incapacity,

or is a congenital anomaly or birth defect<

“Periodic Safety Update Report” refers to the periodical

reports containing the records referred to in regulation 6 of these

regulations<

“post-authorisation

safety

study”

means

a

pharmacoepidemiological study or a clinical trial carried out in

accordance with the terms of the marketing authorisation,

conducted with the aim of identifying or quantifying a safety hazard

relating to an authorised medicinal product.

“unexpected adverse reaction” refers to an adverse reaction,

the nature, severity or outcome of which is not consistent with the

summary of product characteristics.

(a) The Authority shall set up a pharmacovigilance system

which shall be used to collect information which is useful in the

surveillance of medicinal products, with particular reference to adverse

reactions in human beings, to evaluate scientifically such information

and to take into account any available information on the misuse and

the abuse of medicinal products which may have an impact on the

evaluation of their benefits and risks.

(b) It shall be the duty of doctors and other healthcare

professionals to report to the Authority any suspected serious or

unexpected adverse reaction to a medicinal product.

(c) Such information shall be collated together with data

on the consumption of medicinal products.

(1) It shall be the duty of the marketing authorisation holder

to have permanently and continuously at his disposal an appropriately

qualified person responsible for pharmacovigilance.

(2) Such qualified person shall be responsible>

(a) for the establishment and maintenance of a

pharmacovigilance system to ensure that any information about

suspected adverse reactions which has been reported to the personnel

of the company and to medical representatives, is collected and collated

to be made available to the Authority<

(b) for the drawing up of the necessary reports in accordance

with Volume 9 of the Rules Governing Medicinal Products in the

European Community<

(c) to reply fully and promptly to any request made by the

Authority, including the provision of information about the volume of

sales or prescriptions of the medicinal product concerned<

(d) to provide any information to the Authority in relation

to the evaluation of the benefits and risks afforded by a medicinal

product, including appropriate information on post-authorisation safety

studies.

(1) The marketing authorisation holder shall maintain Detailed documents.

detailed records of any suspected adverse reaction to any medicinal

product marketed by him.

(2) (a) The marketing authorisation holder shall also

immediately record and report to the Authority all suspected adverse

reactions occurring in Malta and in no case later than 15 calendar days

from receiving the information.

(b) The marketing authorisation holder shall also

immediately record and report all suspected serious adverse reactions

occurring in the territory of other Member States to the competent

authority of the Member State in whose territory the adverse reaction

occurred and in no case later than 15 calendar days from receiving the

information.

(c) The marketing authorisation holder shall also

immediately record and report all suspected serious and unexpected

adverse reactions occurring in the territory of a third country to the

Authority and in no case later than 15 calendar days from receiving the

information.

.

(3) In the case of medicinal products which have benefited

from the procedures of mutual recognition, the marketing authorisation

holder shall inform the reference member state of any suspected serious

adverse reactions which have occurred within the Community.

(4) Unless otherwise required by the marketing

authorisation, or indicated by the The Rules Governing Medicinal

Products in the European Community, records of all adverse reactions,

including a scientific evaluation of the benefit and risks afforded by the

medicinal products, shall be submitted to the Authority in the form of a

periodic safety update report, either immediately upon request or

periodically after the granting of the marketing authorisation as follows>

(a)

six monthly for the first two years,

(b) annually for the subsequent two years,

(c)

at the time of the first renewal

(5) After the periods mentioned in sub-regulation (4) hereof,

the Periodic Safety Update Reports shall be submitted at five-yearly

intervals together with an application for the renewal of the authorisation>

Provided that the marketing authorisation holder may request

a change in the periods above mentioned.

The Authority shall ensure that reports of suspected serious

adverse reactions that have taken place on its territory are immediately

made available to the marketing authorisation holder, the Commission,

the Agency and Member States within 15 calendar days of their

notification.

(1) The Authority shall suspend, withdraw or vary a

marketing authorisation whenever such action results necessary

following an evaluation of pharmacovigilance data. Such decision shall

be communicated to the Agency, to the Member States and to the

marketing authorisation holder.

(2) In any case of urgency, the Authority may suspend the

marketing authorisation of a medicinal product, provided that the

Agency, the Commission and the Member States are informed thereof

at the latest on the following working day.

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press