Medicinal products, environmental risk

EMEA (1998) Note for Guidance environmental risk assessment for veterinary medicinal products other than GM-containing and immunological products. EMEA/CVMP/ 055/96. European Agency for the Evaluation of Medicinal Products, London... 

EMEA CHMP (2006) Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use. 

EMEA (2003) Note for guidance on environmental risk assessment of medicinal products for human use. DRAFT. CPMP/SWP/4447/00 draft corr. The European Agency for the Evaluation of Medical Products... 

Abstract Active pharmaceutical ingredients (APIs) represent a group of emerging environmental contaminants. Albeit in trace amounts, they are of great concern since given their continuous introduction into the environment, their impact on ecosystems and human health is of great importance. As a result, the environmental risk assessment (ERA) of medicinal products has to be evaluated and appropriate legislation has been issued in the European Union (EU). 

In September 2010, the European Parliament adopted amendments to the pharmacovigilance legislation (Directive 2001/83/EC and Regulation EC No 726/ 2004 [12, 18]) in order to broaden its concept to environmental concerns. The concept paper was under public consultation, until 7 November 2011, to consider measures to monitor and evaluate the risk of environmental effects of medicinal products [19]. 

The EU Directive 92/18/EEC [122] introduced for the first time the requirement for an ERA, as a prerequisite to obtain marketing authorization for veterinary pharmaceuticals. For this purpose, the European Agency for the Evaluation of Medicinal Products (EMEA) published a Note for Guidance where guidelines to assess the environmental risk of veterinary medicinal products are established [123]. 

Guideline on Risk Assessment of Medicinal Products on Human Reproductive and Development Toxicides from Data to Labelling 1. Guideline on Environmental Risk Assessments... 

An environmental risk assessment may also be required, particularly for Genetically Modified Organism (GMO) medicinal products. The following should be considered genetic structure and stability, the possibility to disseminate and survive in the environment, the ability of the vaccine to transfer potential pathogenicity or virulent factors to other microorganisms, and its ability to stably convert to a toxicogenic phenotype.1920... 

EMEA Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use CHMP/SWP/4447/00, The European Agency for the Evaluation of Medicinal Products, 2006. http //www.emea.eu.int/pdfs/human/swp/444700en.pdf... 

Environmental Risk assessments (ERA), Directive 2001/83/EC — Community code relating to medicinal products for human use and Guideline on the ERA... 

Environmental risk-assessment of medicinal products for human and veterinary use is the process through which the European Medicines Agency ensures that the potential... 

Potential to bioaccumulate in aquatic organisms Certain pharmaceuticals are exempted from classification as for various reasons they are considered not to cause any environmental effect. This is in line with the EU s environmental risk assessment guidelines for medicinal products (see Sect. 38.2.2.2). 

An approach that tries to solve the problem more at the source is the so-called green pharmacy. In order to stimulate the development of more easily degradable medicines, both for human as well as for veterinary medicines, European guidelines are formulated. At the application stage to get a marketing authorisation the manufacturer has to give information about the effects of the medicine on the environment as well as an evaluation of those effects and measurements which have to be taken to prevent or reduce these effects [33-35]. When veterinary products are concerned, authorities can even deny the registration if the environmental risk is considered too big. Market authorisation can... 

The European Medicines Agency (EMA, formerly EMEA ) guidelines on the environmental risk assessment of medicinal products for human use states an action limit of 0.01 pg L , and the guidelines of the US FDA give a predicted environmental concentration (PEC) of 1.0 pg L . However, drugs with endocrine activity are exempted from this limit in the EMA guideline instead, a tailored environmental risk assessment has to be carried out each time. 

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