Changes

Adverse events may be reported by anyone e.g. veterinarians, farmers, animal handlers or animal owners etc. [http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000176.jsp&mid=WC0b01ac058002ddcb/ European Union (EU) reporting forms] have been developed for veterinarians to report adverse events. These forms are available in each EU language on the [http://www.ema.europa.eu/ema/ European Medicines Agency] website and include the contact details of the competent authority where the report should be sent.  

Adverse events may be reported by anyone e.g. veterinarians, farmers, animal handlers or animal owners etc. [http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000176.jsp&mid=WC0b01ac058002ddcb/ European Union (EU) reporting forms] have been developed for veterinarians to report adverse events. These forms are available in each EU language on the [http://www.ema.europa.eu/ema/ European Medicines Agency] website and include the contact details of the competent authority where the report should be sent.  

In the European Union (EU), there is a legal obligation <ref>Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (Official Journal L 311, 28/11/2001 p. 1 - 66)(consolidated version : 18/7/2009);(available via the following website: http://ec.europa.eu/health/documents/eudralex/vol-5/index_en.htm; accessed on 21 August 2013)</ref><ref>Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (available via the following website: http://ec.europa.eu/health/documents/eudralex/vol-5/index_en.htm; accessed on 21 August 2013)</ref> to collect and evaluate reports of adverse events to occurring in animals and humans following use of a veterinary medicinal product (see also [[Drug Legislation]]). This is undertaken by the marketing authorisation holders (the companies responsible for the products) and the national competent authorities in each EU Member State, Norway, Iceland and Liechtenstein and the European Commission (as the competent authority for medicinal products authorised centrally for the whole EU and [http://www.ema.europa.eu/ema/ European Medicines Agency]).

In the European Union (EU), there is a legal obligation <ref>Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (Official Journal L 311, 28/11/2001 p. 1 - 66) (consolidated version : 18/7/2009); (available via the following website: http://ec.europa.eu/health/documents/eudralex/vol-5/index_en.htm; accessed on 21 August 2013)</ref><ref>Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (available via the following website: http://ec.europa.eu/health/documents/eudralex/vol-5/index_en.htm; accessed on 21 August 2013)</ref> to collect and evaluate reports of adverse events to occurring in animals and humans following use of a veterinary medicinal product (see also [[Drug Legislation]]). This is undertaken by the marketing authorisation holders (the companies responsible for the products) and the national competent authorities in each EU Member State, Norway, Iceland and Liechtenstein and the European Commission (as the competent authority for medicinal products authorised centrally for the whole EU and [http://www.ema.europa.eu/ema/ European Medicines Agency]).

   

   

The European data-processing network and database management system established for the exchange, processing and evaluation of adverse events related to veterinary medicinal products authorised in the EU, Norway, Iceland and Liechtenstein is called [http://eudravigilance.ema.europa.eu/veterinary/index.html EudraVigilance Veterinary].  

The European data-processing network and database management system established for the exchange, processing and evaluation of adverse events related to veterinary medicinal products authorised in the EU, Norway, Iceland and Liechtenstein is called [http://eudravigilance.ema.europa.eu/veterinary/index.html EudraVigilance Veterinary].