X.A. Introduction

Pharmacovigilance is a vital public health function with the aim of rapidly detecting and responding to potential safety hazards associated with the use of medicinal products.

A medicinal product is authorised on the basis that, its benefit-risk balance is considered to be positive at that time for a specified target population within its approved indication (s). However, not all risks can be identified at the time of initial authorisation and some of the risks associated with the use of a medicinal product emerge or are further characterised in the post-authorisation phase of the product’s lifecycle. . To strengthen the safety monitoring of medicinal products, the 2010 EU Pharmacovigilance legislation, further amended in 2012, has introduced a framework for enhanced risk proportionate post-authorisation data collection for medicinal products, including the concept of additional monitoring for certain medicinal products.

As defined in Article 23 of Regulation (EC) No 726/2004 (REG) and Article 11 of Directive 2001/83/EC (DIR), the Agency shall, in collaboration with the Member States, set up, maintain and make public a list of medicinal products that are subject to additional monitoring (hereafter referred to as “the list”). These medicinal products will be readily identifiable by an inverted equilateral black triangle ▼as stipulated in the Implementing Regulation (EU) No 198/2013. That triangle will be followed by an explanatory statement in the summary of product characteristics (SmPC) as follows:

“This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.”

A similar statement will also be included in the package leaflet. This explanatory statement should encourage healthcare professionals and patients to report all suspected adverse reactions.

The pharmacovigilance provisions of Regulation (EC) No 726/2004 and of Directive 2001/83/EC have been recently amended by Regulation (EU) No 1027/2012 and Directive 2012/26/EU respectively. These amendments have impacted on the content and the scope of Article 23 of the REG and will be applicable for centrally authorised products on 5 June 2013. This GVP takes into account the new provisions relating to the list of products which require additional monitoring.

Post-authorisation spontaneous Adverse Drug Reactions (ADR) reports remain a cornerstone of pharmacovigilance. Data from ADR reports is a key source of information for signal detection activities (see Module IX). Increasing the awareness of healthcare professionals and patients of the need to report suspected adverse drug reactions and encouraging their reporting is therefore an important means of monitoring the safety profile of a medicinal product.

The concept of additional monitoring originates primarily from the need to enhance the ADR reporting rates for newly authorised products for which the safety profile might not be fully characterised or for products with newly emerging safety concerns that also need to be better characterised. The main goals are to collect additional information as early as possible to further elucidate the risk profile of products when used in clinical practice and thereby informing the safe and effective use of medicinal products.

This Module is divided in two sections:

• X.B. provides general principles for assigning additional monitoring status to medicinal products and on communication and transparency aspects.
• X.C. describes the operation of the EU network regarding the supervision of additional monitoring status, the communication strategy and the impact on pharmacovigilance activities.