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The European Medicines Agency and the world

European Medicines Agency. Annual report of the European Medicines Agency 2008

European Medicines Agency. Annual report of the European Medicines Agency 2008

... the European medicines network, it was by no means a ‘dull’ year for the ...of medicines move increasingly beyond the traditional spheres of Europe and North America, regulators are becoming more ...

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European Medicines Agency. Annual report of the European Medicines Agency 2006

European Medicines Agency. Annual report of the European Medicines Agency 2006

... anti-infective medicines, microbiocides, pandemic influenza, good manufacturing practice and quality issues, good clinical practice, international non- proprietary names, and a number of areas relating to ...

134

European Medicines Evaluation Agency

European Medicines Evaluation Agency

... the world leading pharmaceutical agent that the ...the european medicines and ...the european union or limit the stems of a ...the european medicines agency has a remedy ...

5

European Medicines Agency. Annual report 2012

European Medicines Agency. Annual report 2012

... What needs to be done to reverse the trend? Actions are needed on various fronts. First, the use of antibiotics needs to be rational, to preserve as much as possible the effectiveness of the current arsenal. Despite ...

52

European Medicines Agency. Highlights 2008. Summary of the European Medicines Agency's annual report for 2008

European Medicines Agency. Highlights 2008. Summary of the European Medicines Agency's annual report for 2008

... of medicines move increasingly beyond the traditional spheres of Europe and North America, regulators are becoming more keenly aware of the need for international cooperation on ensuring that safe and ethical ...

17

One-year report on human medicines pharmacovigilance tasks of the European Medicines Agency

One-year report on human medicines pharmacovigilance tasks of the European Medicines Agency

... the European Union (EU), the European Medicines Agency plays a key role in the ongoing pharmacovigilance ...the World Health Organization (WHO), is - the science and activities relating ...

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European Medicines Agency. Annual report highlights 2009

European Medicines Agency. Annual report highlights 2009

... the World Health Organization and the strain of the virus had been identified, in June, pharmaceutical companies were in a position to begin submitting data on H1N1 vaccines to the ...

7

European Medicines Agency. Annexes of the annual report 2011

European Medicines Agency. Annexes of the annual report 2011

... E-mail: smeoffice@ema.europa.eu Certificates of a medicinal product The EMA issues certificates of a medicinal product in conformity with the arrangements laid down bythe World Health Organisation. These certify ...

117

European Medicines Agency. Annexes of the annual report 2010

European Medicines Agency. Annexes of the annual report 2010

... Certificates of a medicinal product The EMA issues certificates of a medicinal product in conformity with the arrangements laid down bythe World Health Organisation. These certify the marketing authorisation and ...

107

European Medicines Agency. Annual report of the European Medicines Agency 2007

European Medicines Agency. Annual report of the European Medicines Agency 2007

... the Agency and national competent ...the European regulatory network to the problem of the lack of availability of veterinary ...the Agency, in particular with respect to avian influenza and ...

138

European Medicines Agency. Annual report of the European Medicines Agency 2005

European Medicines Agency. Annual report of the European Medicines Agency 2005

... the European system: ! The centralised procedure is compulsory for all medicinal products for human and animal use derived from biotechnology ...human medicines intended for the treatment of HIV/AIDS, ...

112

European Medicines Agency

European Medicines Agency

... The objective of this guideline is to provide broad guidance on appropriate standards for the derivation of human and animal cell lines and microbial cells to be used to p[r] ...

13

European Medicines Agency

European Medicines Agency

... The expression construct of the production cells should be analysed once for the MCB as described in Section III.B, except that the protein coding sequence of the expression construct [r] ...

5

The European regulatory system for medicines and the European Medicines Agency

The European regulatory system for medicines and the European Medicines Agency

... of medicines in the EU must be licensed before they can carry out this ...includes medicines produced solely for ...publicly-available European database operated by the ...

6

European Medicines Agency. Tenth annual report of the European Medicines Agency 2004

European Medicines Agency. Tenth annual report of the European Medicines Agency 2004

... the Agency has developed a strategy that will help to stimulate innovation and research in the EU pharmaceutical, biotechnology and healthcare industries for the development of medicinal ...innovative ...

130

European Medicines Agency. Summary of the annual report of the European Medicines Agency 2005

European Medicines Agency. Summary of the annual report of the European Medicines Agency 2005

... the European system: The centralised procedure is compulsory for all medicinal products for human and animal use derived from biotechnology ...human medicines intended for the treatment of HIV/AIDS, cancer, ...

23

The European Medicines Agency: A public Health European Agency?

The European Medicines Agency: A public Health European Agency?

... For more information on this procedure, see the European Commission's website, Public health, The Decentralized Procedure: http://ec.europa.eu/health/authorisation-procedur[r] ...

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European Medicines Agency decision

European Medicines Agency decision

... Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question ...

9

European Medicines Agency decision

European Medicines Agency decision

... The European Medicines Agency, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1901/2006 of the European Parliament and of the ...

8

European Medicines Agency decision

European Medicines Agency decision

... 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 ...

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