Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine related problems. During the first five years of a new; medicine being placed on the market, pharmacovigilance is particularly important, as comparatively little about its safety profile is known until it is exposed to a much larger population. In line with the Medicines Act 2003, and its subsidiary legislation, as well as the European codified Directive 2001/83/EC as amended by the pharmacovigilance Directive 2010/84/EU, pharmaceutical companies and regulatory authorities have specific obligations with regards to pharmacovigilance. The Medicines Authority ensures patient safety by communicating with healthcare professionals and by monitoring the activity of Marketing Authorisation Holders, in order to assess whether they are compliant with pharmacovigilance obligations. The fulfillment of pharmacovigilance obligations by Marketing Authorisation Holders is a condition for maintaining the marketing authorisation of a product.
A well-organised system of pharmacovigilance is essential to ensure the safety of medicinal products. Before recommending the granting of a marketing authorisation the Medicines Authority ensures that a system of pharmacovigilance is in place through scrutiny of the pharmacovigilance system master file. After granting an authorisation the Medicines Authority scrutinises procedures, assesses safety reports and conducts pharmacovigilance inspections.
An appropriately Qualified Person for Pharmacovigilance (QPPV), holds the overall oversight and responsibility of pharmacovigilance. Since this responsibility is extensive, tasks may be delegated to company representatives or affiliates. It is important that the roles, responsibilities and required tasks are clear to all parties. An essential element of any such system is that clear documentation of the company's procedures are in place. The following procedures outline in particular, the roles and responsibilities of pharmaceutical companies for pharmacovigilance:
A Risk Management Plan (RMP) may be defined as a set of pharmacovigilance activities designed to identify, characterise, prevent, or minimise risks related to the medicinal products; to assess the effectiveness of those interventions; and to communicate those risks to health care professionals and patients.
Pharmacovigilance and risk management activities that might be included in an RMP fall into two categories:
Routine pharmacovigilance includes the safety evaluations within clinical trials and the monitoring and reporting of spontaneous adverse events post-authorisation. Routine risk management activities include ensuring that suitable warnings are in all product information and careful labelling/packaging of the medicine.
Additional pharmacovigilance activities may involve:
Additional Risk Minimisation Measures could include: educational materials about the medications and its indications (patient information brochures, visual aids, doctors' prescribing guides/checklists, pharmacist dispensing guides/checklists, direct healthcare professional communication letters), training programs (for patients, pharmacists or doctors) and restricting the use of the medicine for example by restricting access to prescription only. Click here to search for ARCHIVED Risk Minimisation Measures.
Marketing Authorisation Holder should notify Emerging Safety Issues (ESI) in writing to the Medicines Authority via email to firstname.lastname@example.org. The sent document should indicate the points of concern and the actions proposed in relation to the marketing application/authorisation for the concerned medicinal product. ESI should also be analysed in the relevant sections of the periodic safety update report of the authorised medicinal product.
For more detailed information consult the Guidance Notes for Pharmaceutical Companies on Pharmacovigilance Obligations & Adverse Drug Reaction (ADR) Reporting Requirements for Medicinal Products for Human Use.
Enquiries can be made by mail, email, fax or telephone:
Malta Medicines Authority
Sir Temi Żammit Buildings
Malta Life Sciences Park
San Ġwann SĠN 3000
Sir Temi Żammit Buildings,
Malta Life Sciences Park,
San Ġwann SĠN 3000
Telephone: 356 2343 9000 (from 7:30 to 15:45)
Helpline: 356 2343 9111 (from 9:00 to 12:00)
Fax: 356 2343 9161