Regulatory Pharmacovigilance & HCC

The Regulatory Affairs Department was established over a decade ago with Malta’s accession into the European Union with the aim of ensuring that all the company’s activities related to importation, storage and distribution are in line with established national and European legislation.

The company has established quality systems that are the backbone of all its activities ensuring processes, procedures and documentation are in line with the latest Guidelines of Good Distribution Practices and Good Pharmacovigilance Practices.

The regulatory office coordinates all the activities ensuring Good Distribution Practices and Good Storage Practices (such as temperature mapping and monitoring, cleaning, maintenance, transportation, pest control, Stock rotation and stock management systems, stock disposal, documentation, cold-chain maintenance and record keeping etc.). It is also responsible for ensuring quality systems are maintained by regular yearly training of employees, training evaluation, internal audits, review of corrective actions and quality assurance procedures that ensure quality of products and procedures is monitored, maintained and where necessary, improved.

The regulatory office also provides support for Pharmacovigilance activities such as reporting of Adverse Drug Reactions, Product Quality Complaints, Service complaints, batch recalls, literature review, monitoring of local legislation and guidelines, signal detection, Implementation of Risk Management Plans, distribution of Dear Healthcare Professional Communications etc.

It also supports Marketing Authorisation Holders’ (MAH) regulatory offices for the provision of product exposure data and submissions of various documents such as application forms, Periodic Safety Update Reports etc and also serves as an efficient link between the local national health authority and the MAH to ensure any queries on both sides are addressed in a timely and professional manner. The office also offers translation service agreements for the outsourcing of translations of product documents as well as translation reviews before submission to the authority and post-reviewing support during the Quality Review of Documents.

Further to this, the regulatory office provides internal consultation services and regulatory support for the supply and distribution of Food Supplements, Medical Devices, Hospital Equipment and Infant Formula. It also supports the regulatory needs of all the Group of Companies within A.M. Mangion Ltd.