Home | Databases | WorldLII | Search | Feedback Maltese Laws

Medicines Act, 2003 (Act No. Iii Of 2003) Pharmacovigilance Regulations, 2004 (L.N. 22 Of 2004 )

MEDICINES ACT, 2003 (ACT NO. III OF 2003)
B 131
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. (1) The title of these regulations is the Pharmacovigilance
Regulations, 2004.
(2) These regulations shall come into force on the 1st May,

Title and commencement.

2004.
2. These regulations shall apply to authorised medicinal products for human use and any pharmacovigilance activity connected therewith.
3. For the purposes of these regulations -
“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<

Scope.

Interpretation.

B 132

Setting up of pharmacovigilance system.

Duty of the marketing authorisation holder.

“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.
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.
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.
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 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.

.

B 133

Detailed documents.

(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.
B 134

Report by the

Authority.

Suspension, withdrawal, variation.

(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.
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 15 calendar days of their notification.
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.

Ippubblikat mid-Dipartiment ta’ l-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta

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

Prezz 16ç – Price 16c