Marketing authorisations environmental risk

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... 

Phase II - studies that might be conducted to investigate environmental hazards and thus eventually lead to risk mitigation measures that could, in the most extreme circumstances, lead to the product being refused a licence, marketing authorisation, approval etc. 

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