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LINKS

 

BACKGROUND INFORMATION ON THE TOPIC

 

Pharmaceuticals in Drinking-water, World Health Organization Technical Report, 2011

In 2009, a WHO working group of experts was assembled to undertake a review of the state of the science of pharmaceuticals in drinking-water, and provide practical guidance and recommendations for managing this emerging concern, taking into consideration the evidence collected in a literature review. This report contains their key findings and recommendations.

 

Pharmaceuticals in the environment: Results of an EEA workshop, EEA Technical Report, 2010

This report summarises the results of a workshop held at the European Environment Agency in January 2009. The experts described the current situation and drew up proposals for actions concerning pharmaceuticals in the environment (PIE).

 

Knowledge and Need Assessment on Pharmaceutical Products in Environmental Waters, 2007

One of the main aims of the EU KNAPPE project was to bundle and extend research on the occurrence of PPs in the aquatic environment, as well as on the environmental and health impacts related to PPs. On this basis, the project aimed to identify the relevant priority actions to be taken in the framework of sustainable development, in terms of lowering the presence, impacts and risk of PPs.

 

RELEVANT EU LEGISLATION

 

Directive 2001/83/EC: Community Code Relating to Medicinal Products for Human Use (Consolidated version: 05/10/2009).   

This Directive establishes a Community code which brings together, in a single instrument, all the provisions in force governing the placing on the market, production, labelling, classification, distribution and advertising of medicinal products for human use.

 

Two relevant developments regarding Directive 2001/83/EC are:  

 

Guideline for the Environmental Risk Assessment of Medicinal Products for Human Use

This document provides guidance on how to perform the Environmental Risk Assessment (ERA) that shall accompany an application for a marketing authorisation for a medicinal product for human use. An ERA is required for all new marketing authorisation applications. The guideline (EMEA/CHMP/SWP/4447/00) came into effect on 1 December 2006.

 

Directive 2004/27/EC

This directive requires Member States to ensure that appropriate collection systems are in place for human medicinal products that are unused or have expired.  Reference to these collection systems is to be made on the labelling or package leaflet.

 

ORGANISATIONS

 

European Medicines Agency (EMEA)

The EMEA is the European Union body responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products. The Agency provides advice on questions relating to the evaluation of the quality, safety and efficacy of medicinal products for human or veterinary use.

 

Environmental Protection Agency Pharmaceutical and Personal Care Products (EPA PPCP)

The United States EPA PPCP offers on its website a resources and information for the general public (e.g. FAQs) as well as researchers (e.g. literature, research needs and gaps) on the topic of pharmaceuticals and personal care products. 

 

European Federation of Pharmaceutical Industries and Associations (EFPIA)

The EFPIA represents the pharmaceutical industry operating in Europe. Its mission is to promote pharmaceutical research and development in Europe.

 

 

RELATED PROJECTS

 

Cytothreat

This FP7 project addresses the need to assess the risks of pharmaceuticals released in the environment. The occurrence, distribution and fate of selected widely used cytostatics in different aquatic matrices, their acute and chronic toxicity and impact on the stability of the genetic material in a variety of aquatic organisms is addressed to provide data sets necessary for scientifically based risk assessment. Special emphasis is put on the combined effects of environmentally relevant mixtures.

 

KNAPPE

One of the main aims of this EU FP6 project is to bundle and extend research on the occurrence of PPs in the aquatic environment as well as on the environmental and health impacts related to PPs. On this basis, the project aims to identify the relevant priority actions to be taken in the framework of sustainable development, in terms of lowering the presence, impacts and risk of PPs.

 

NORMAN

The Network of reference laboratories for monitoring of emerging environmental pollutants is established since 2009 as a permanent network of reference laboratories, research centres and related organisations for the monitoring and biomonitoring of emerging environmental substances.

Knowledge and Need Assessment on Pharmaceutical Products in Environmental Waters, 2007

The EU project KNAPPE aims to identify relevant priority actions to be taken in order to reduce the occurrence, impacts and risk of pharmaceutical products in the aquatic environment.