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harmonisation
harmonisation
Last Update: 2011-10-23
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"harmonisation of animal clinic pathology testing in toxicity and safety studies", fundam.
"harmonisation of animal clinic pathology testing in toxicity and safety studies", fundam.
Last Update: 2014-11-21
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estimation of predicted environmental concentrations, including harmonisation of default values and development of a harmonised computer model toxicity of substances to dung fauna degradation of substances in manure
estimation of predicted environmental concentrations, including harmonisation of default values and development of a harmonised computer model
Last Update: 2008-03-04
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this enhanced community involvement will also increase harmonisation of national approaches and tap into potential synergies by including experts from other member states in in-depth monitoring visits .
this enhanced community involvement will also increase harmonisation of national approaches and tap into potential synergies by including experts from other member states in in-depth monitoring visits .
Last Update: 2011-10-23
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oecd, (1996) final report of the oecd workshop on harmonisation of validation and acceptance criteria for alternative toxicological test methods, p. 62
oecd, (1996) final report of the oecd workshop on harmonisation of validation and acceptance criteria for alternative toxicological test methods, p. 62.
Last Update: 2014-11-21
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note for guidance on cell culture inactivated influenza vaccines – annex to note for guidance on harmonisation of requirements for influenza vaccines cpmp/ bwp/ 214/ 96
note for guidance on cell culture inactivated influenza vaccines – annex to note for guidance on harmonisation of requirements for influenza vaccines cpmp/bwp/214/96
Last Update: 2011-10-23
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os dados provenientes de ensaios clínicos realizados fora da união só podem ser tomados em consideração na avaliação de um pedido de autorização de introdução no mercado se esses ensaios tiverem sido concebidos, executados e comunicados em conformidade com as normas estabelecidas pelas orientações internacionais em matéria de boas práticas clínicas da international cooperation on harmonisation of technical requirements for registration of veterinary medicinal products.
data stemming from clinical trials conducted outside the union may be taken into consideration for the assessment of an application for a marketing authorisation only if those trials were designed, implemented and reported in accordance with the standards set by the international guidelines on good clinical practice of the international cooperation on harmonisation of technical requirements for registration of veterinary medicinal products.
Last Update: 2017-04-06
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note for guidance on cell culture inactivated influenza vaccines annex to nfg on harmonisation of requirements for influenza vaccines (cpmp/ bwp/ 214/ 96)
note for guidance on cell culture inactivated influenza vaccines annex to nfg on harmonisation of requirements for influenza vaccines (cpmp/bwp/214/96)
Last Update: 2011-10-23
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no âmbito da conferência internacional sobre a harmonização [international conference on harmonisation (ich)] chegou-se a um consenso em 2000 sobre a criação de um formato e de uma terminologia harmonizados para um documento técnico comum que permita obter uma organização e apresentação homogéneas de um dossier de pedido de autorização de introdução no mercado de medicamentos para uso humano.
within the framework of the international conference on harmonisation (ich) a consensus was reached in 2000 to provide a harmonised format and terminology for a common technical document through which a homogeneous organisation and presentation of a marketing authorisation application dossier for human medicinal products could be achieved.