PHARMACOVIGILANCE g S.L.458.35 1
SUBSIDIARY LEGISLATION 458.35
PHARMACOVIGILANCE REGULATIONS
1st May, 2004
LEGAL NOTICE 22 of 2004.
Citation.
Regulations.
Scope.
products for human use and any pharmacovigilance activity
connected therewith.
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;
Cap. 458.
''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;
''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
2 g S.L.458.35 PHARMACOVIGILANCE
nature, severity or outcome of which is not consistent with the
summary of product characteristics.
Setting up of 
pharmacovigilance 
system.
4. ( 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.
Duty of the 
marketing 
authorisation 
holder.
5. (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.
Detailed 
documents.
6. (1) The marketing authorisation holder shall maintain
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 fifteen 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
PHARMACOVIGILANCE g S.L.458.35 3
Member States to the competent authority of the
Member State in whose territory the adverse reaction
occurred and in no case later than fifteen 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 fifteen 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 subregulation (4), 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.
Report by the 
Authority.
7. 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 fifteen
calendar days of their notification.
Suspension, 
withdrawal, 
variation.
8. (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.
