Pharmacovigilance - Revision history

Bara at 16:22, 21 August 2013

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Bara at 16:21, 21 August 2013

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Raquel.gopal at 12:47, 21 August 2013

2013-08-21T12:47:56Z

Raquel.gopal: Created page with "Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related..."

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Created page with "Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related..."

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Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. Veterinary pharmacovigilance involves the surveillance of adverse events occurring in animals and humans after exposure to veterinary medicinal products with the aim of improving the safety of veterinary medicinal products.

An [[Adverse Drug Reactions|adverse event]] (also referred to as a ‘[[Adverse Drug Reactions|suspected adverse reactions]]’ or ‘[[Adverse Drug Reactions]]’ is defined as any observation in animals, whether or not considered to be product-related, that is unfavourable and unintended and that occurs after any use of a veterinary medicinal product (off-label and recommended use). Adverse events also include events related to a suspected lack of expected efficacy or [[Vaccines|vaccine failure]] according to approved labelling; and noxious reactions in humans after being exposed to veterinary medicinal products.
In addition to adverse events, veterinary pharmacovigilance also involves collection of information on investigations of the validity of the withdrawal periods in food producing animals and potential environmental problems following the use of veterinary medicinal products.

'''Adverse event reporting and evaluation'''
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 [1,2] 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].

Adverse event reports are evaluated as part of the ongoing process to ensure the benefit-risk balance of veterinary medicinal products remains favourable and to improve the knowledge of the product. When necessary, the evaluation of adverse events reports may support recommendations to improve the instructions for using the product as well as adding new warnings, adverse effects and precautionary advice.

More information on [http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000190.jsp&mid=WC0b01ac058002d89c/ veterinary pharmacovigilance] in the EU can be found on the [http://www.ema.europa.eu/ema/ European Medicines Agency] and [http://eudravigilance.ema.europa.eu/veterinary/index.html EudraVigilance Veterinary] websites.

'''References'''
# 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)
# 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)

@@ Line 9: / Line 9: @@
 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].

@@ Line 1: / Line 1: @@
-Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.  Veterinary pharmacovigilance involves the surveillance of adverse events occurring in animals and humans after exposure to veterinary medicinal products with the aim of improving the safety of veterinary medicinal products.
+==Introduction==
-An [[Adverse Drug Reactions|adverse event]] (also referred to as a ‘[[Adverse Drug Reactions|suspected adverse reactions]]’ or ‘[[adverse drug reactions]]’ is defined as any observation in animals, whether or not considered to be product-related, that is unfavourable and unintended and that occurs after any use of a veterinary medicinal product (off-label and recommended use). Adverse events also include events related to a suspected lack of expected efficacy or [[Vaccines|vaccine failure]] according to approved labelling; and noxious reactions in humans after being exposed to veterinary medicinal products.
+An [[Adverse Drug Reactions|adverse event]] (also referred to as a ‘[[Adverse Drug Reactions|suspected adverse reactions]]’ or ‘[[Adverse Drug Reactions|adverse drug reactions]]’ is defined as any observation in animals, whether or not considered to be product-related, that is '''unfavourable''' and '''unintended''' and that occurs after any use of a veterinary medicinal product (off-label and recommended use). Adverse events also include events related to a suspected lack of expected efficacy or '''[[Vaccines#Vaccine Failure|vaccine failure]]''' according to approved labelling; and noxious reactions in humans after being exposed to veterinary medicinal products.
 In addition to adverse events, veterinary pharmacovigilance also involves collection of information on investigations of the validity of the withdrawal periods in food producing animals and potential environmental problems following the use of veterinary medicinal products.
-'''Adverse event reporting and evaluation'''
+==Adverse event reporting and evaluation==
 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 [1,2] 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].
@@ Line 14: / Line 17: @@
 More information on [http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000190.jsp&mid=WC0b01ac058002d89c/ veterinary pharmacovigilance] in the EU can be found on the [http://www.ema.europa.eu/ema/ European Medicines Agency] and [http://eudravigilance.ema.europa.eu/veterinary/index.html EudraVigilance Veterinary] websites.
-'''References'''
+==References==
-# 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)
-# 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)
+<references />