Pharmacovigilance Regulations, 2006

L.N. 61 of 2006

MEDICINES ACT, 2003

(ACT NO. III OF 2003)

Pharmacovigilance Regulations, 2006

IN exercise of the powers conferred by article106 of the Medicines

Act, 2003, the Minister of Health, the Elderly and Community Care has

made the following regulations>

The title of these regulations is the Pharmacovigilance Title and

commencement.

Regulations, 2006.

These regulations shall apply to authorised medicinal products Scope.

for human use and any pharmacovigilance activity connected therewith.

These regulations shall also apply to homeopathic medicinal products,

with the exception of those referred to in paragraph (a), (b) and (c) of

regulation 10(3) of the Medicines (Marketing Authorisation)

Regulations, 2005.

For the purposes of these regulations

Interpretation.

“abuse of medicinal products” means 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

physiological function<

“the Agency” means the European Medicines Agency

established by Regulation (EC) No 726#2004<

“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 Union and the

European Economic Area<

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

Community<

“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<

“Risk-benefit balance” means an evaluation of the positive

therapeutic effects of the medicinal product in relation to any risk

relating to the quality, safety or efficacy of the medicinal product

as regards patients’ health or public health<

“unexpected adverse reaction” refers to an adverse reaction,

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

summary of product characteristics.

(1) (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) The suitable information collected within this

system shall be communicated by the Authority to the other Member

States and the Agency. The information shall be recorded in the database

referred to in point (l) of the second subparagraph of Article 57(1) of

Regulation (EC) No 726#2004 and shall be permanently accessible to

all Member States and without delay to the public.

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

professionals to immediately report to the Authority any suspected

serious or unexpected adverse reaction to a medicinal product in Malta.

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

marketing

to have permanently and continuously at his disposal an appropriately authorization

holder.

qualified person responsible for pharmacovigilance.

(2) Such qualified person shall reside in the Community

and shall be responsible for the following>

(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 Union<

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

Authority for the provision of additional information necessary

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

product, 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 risk-benefit balance of a medicinal product,

including appropriate information on post-authorisation safety

studies.

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

detailed records of all suspected adverse reactions occurring either in

the Community or in a third country to any medicinal product marketed

by him. Save in exceptional circumstances, these reactions shall be

communicated electronically in the form of a report in accordance with

Volume 9 of the Rules Governing Medicinal Products in the European

Union.

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

immediately record and report electronically to the Authority all

suspected serious adverse reactions occurring in Malta which are brought

to his attention by a healthcare professional 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 and which are brought

to his attention by a healthcare professional to the competent authority

of the Member State in whose territory the adverse reaction occurred

and in no case later than 15 calendar days following the receipt of the

information.

(c) The marketing authorisation holder shall record and

report all other suspected serious adverse reactions which meet the

notification criteria in accordance with the guidelines published in

Volume 9 of The Rules governing Medicinal Products in the European

Union, of which he can reasonably be expected to have knowledge,

promptly to the competent authority of the Member State in whose

territory the incident occurred, and no later than 15 calendar days

following the receipt of the information.

(d) The marketing authorisation holder shall ensure that

all suspected serious unexpected adverse reactions and any suspected

transmission via a medicinal product of any infectious agent occurring

in the territory of a third country are reported promptly in accordance

with the guidelines referred to in the preceding paragraph, so that the

Agency and the competent authorities of the Member States in which

the medicinal product is authorized are informed of them and no later

than 15 calendar days following the receipt of the information.

(e) For medicinal products which are covered by

Directive 87#22#EC or which have qualified for the procedures laid down

in Articles 28 and 29 of Directive 2001#83#EC as amended by Directive

2004#27#EC, or which have been the subject of the procedures under

Articles 32,33 and 34 of Directive 2001#83#EC as amended by Directive

2004#27#EC, the provisions of paragraphs (b), (c) and (d) above shall

not apply and the marketing authorisation holder shall ensure that all

suspected serious adverse reactions occurring in the Community are

reported in such a way as to be accessible to the reference Member

State or to any competent authority acting as reference Member State.

If Malta is the reference Member State, the Authority shall assume the

responsibility of analysing and monitoring such adverse reactions.

(3) (a) Unless other requirements have been laid down as

a condition for the granting of the marketing authorisation, or

subsequently as indicated in the guidelines referred to above, reports of

all adverse reactions shall be submitted to the competent authorities in

the form of a periodic safety update report, immediately upon request

or at least every six months after authorisation and until the placing on

the market.

(b) Periodic safety update reports shall also be

submitted immediately upon request and periodically after the initial

placing on the market as follows>

(i) every six months during the first two years<

(ii) annually for the subsequent two years.

Thereafter, the reports shall be submitted at three-yearly

intervals, or immediately upon request.

(c) The periodic safety update reports shall include a

scientific evaluation of the risk-benefit balance of the medicinal product.

(4) Following the granting of a marketing authorisation, the

marketing authorisation holder may request the amendment of the

periods referred to above in accordance with the procedure laid down

by Commission Regulation (EC) No. 1084#2003.

(5) In accordance with Volume 9 of The Rules Governing

Medicinal Products in the European Union, marketing authorisation

holders shall use internationally agreed medical terminology for the

reporting of adverse reactions.

(6) The marketing authorization holder may not

communicate information relating to pharmacovigilance concerns to

the general public in relation to its authorised medicinal product without

giving prior notification to the Authority>

Provided that the marketing authorization holder may

communicate the information in the first paragraph to the general public

if the Authority does not oppose the communication within 24 hours of

receipt of the marketing authorization holder’s notification>

Provided further that in any case, the marketing authorisation

holder shall ensure that such information is presented objectively and

is not misleading.

By making use of the network referred to in Article 105 of Availability through

network system.

Directive 2001#83#EC as amended by Directive 2004#27, 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 Agency and other Member States

within 15 days after their notification at the latest.

(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) Where urgent action to protect public health is necessary,

the Authority may suspend the marketing authorisation of a medicinal

product, provided that the Agency, the Commission and the Member

States are informed no later than the following working day.

The Pharmacovigilance Regulations, 2004 are hereby being

2004. repealed.

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