A
A
A
Patient / Consumer
Know more about Medicines Regulation Know more about access to medicines which do not have a Marketing Authorisation Report a Side Effect Biological and Biosimilar Medicinal Products How we monitor the safety of medicines Know more about the Medicines Supply Chain Know more about Use of Medicines Information Leaflets on Medicines Search for your Medicines
Industry
Pharmaceutical Activities and Inspections Product Quality Defects Reporting Scientific Advice Advertising Registering a product Pharmacovigilance Fees
Health Care Professionals
Search Authorised Medicines in Malta Adverse Drug Reaction Reporting How we monitor the safety of medicinal products Safety Information Clinical Trials Product Quality Defects Reporting Medicines supply chain and regulation Advertising
Home / Activities / Pharmaceutical Activities and Inspections / Good Pharmacovigilance Practice

Good Pharmacovigilance Practice

 

Introduction

Every Marketing Authorisation Holder (MAH) is obliged to have a system for pharmacovigilance in order to collect, collate and evaluate information about suspected adverse reactions.

Pharmacovigilance inspections of marketing authorisation holders (MAHs) registered in Malta commenced in September 2011. These are carried out by an inspection team led by a Medicines Inspector and which also includes a Pharmacovigilance Assessor.  The inspection team assess the MAH's pharmacovigilance systems, practices and processes in place against legislation and good practice guidelines.

Good Pharmacovigilance Practice Inspections

Good Pharmacovigilance Practice (GVP) inspections can be routine or triggered. Routine inspections are performed following a risk-based approach. The frequency of re-inspection will be based on a quantitative assessment of the risk posed by each individual MAH.

Inspection findings are classified as critical, major or other. A deficiency that adversely affects the rights, safety or well-being of patients or that poses a potential risk to public health or that represents a serious violation of applicable legislation and guidelines is classified as critical. A deficiency that could potentially adversely affect the rights, safety or well-being of patients or that could potentially pose a risk to public health or that represents a violation of applicable legislation and guidelines is classified as major. Other deficiencies are those that would not be expected to adversely affect the rights, safety or well-being of patients. Recommendations for improvement are also provided at the end of the inspection as comments.

The MAH is required to provide firm proposals for addressing critical deficiencies within 7 days and in the case of major and other findings within 28 days. The lead inspector will follow up on this response to assure that pharmacovigilance requirements are subsequently met.

Inspectors carrying out GVP inspections regularly attend meetings and training held at a European level together with their peers from other EU member states in order to keep abreast of the standards, practices and approach being followed in GVP inspections across the EU.

Further Information

For further information please send an email on inspectorate.adm@gov.mt