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802. 1x@ title: tab tab containing general ui settings

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the use of herbal products containing aristolochia species note for guidance on quality of herbal
note for guidance on quality of herbal medicinal products

spc for antimicrobial products demonstration of efficacy for veterinary medicinal products containing antimicrobial subsatnces
spc for antimicrobial products demonstration of efficacy for veterinary medicinal products containing antimicrobial subsatnces

note for guidance on comparability of medicinal products containing biotechnology- derived proteins as drug substance
note for guidance on comparability of medicinal products containing biotechnology- derived proteins as drug substance

points to consider on quality aspects of medicinal products containing active substances produced by stable transgene experession in higher plants
points to consider on quality aspects of medicinal products containing active substances produced by stable transgene experession in higher plants

points to consider on xenogeneic cell therapy note for guidance on the production and quality control of animal immunoglobulins and immunosera for human use note for guidance on comparability of medicinal products containing
note for guidance on the production and quality control of animal immunoglobulins and immunosera for human use

dokumenttitel note for guidance on the use of bovine serum in the manufacture of human biological medicinal products points to consider on quality aspects of medicinal products containing active substances produced by stable transgene expression in higher plants revision of note for guidance on minimising the risks of tse transmission via medicinal products points to consider on the development of live attenuated influenza vaccines
titel på dokumentet note for guidance on the use of bovine serum in the manufacture of human biological medicinal products points to consider on quality aspects of medicinal products containing active substances produced by stable transgene expression in higher plants revision of note for guidance on minimising the risks of tse transmission via medicinal products points to consider on the development of live attenuated influenza vaccines

9. den tjeckiska myndigheten motiverar sin begäran med att hänvisa till följande punkter slutsatserna i riskbedömningsrapporten study to assess risks to the environment and health resulting from the use of phosphate fertilisers containing cadmium, som bygger på erm:s riskbedömningsmetod [3]. enligt denna rapport visar tillgängliga uppgifter att pec-värdet (predicted environmental concentration) för kadmium i mineralgödselmedel i tjeckien uppgår till 0,93% av pnec-värdet (predicted no effect concentration) i gödselmedel med en kadmiumhalt på 50 mg cd/kg p2o5 (det nationella gränsvärdet före anslutningen till eu). ett värde över 50 mg skulle utgöra en miljörisk. det är nödvändigt att ha en övre gräns på 50 mg cd/kg p2o5 för att förhindra ansamling av kadmium i marken till en nivå där det utgör en risk för miljön och människors hälsa via livsmedelskedjan.
9. de tjekkiske myndigheder begrunder deres anmodning ved at henvise til konklusionerne i risikovurderingsrapporten "study to assess risks to the environment and health resulting from the use of phosphate fertilisers containing cadmium", der er baseret på erm-metoden [3]. ifølge denne undersøgelse viser de foreliggende data, at pec-værdien (predicted environmental concentration) for cadmium i mineralgødninger i tjekkiet når op på 0,93 af pnec-værdien (predicted no effect concentration) for en gødning med et cadmiumindhold på 50 mg cd/kg p2o5 (den nationale grænseværdi forud for tiltrædelsen af eu). en værdi over 50 mg ville udgøre en risiko for miljøet. endvidere er det nødvendigt med en øvre grænse på 50 mg cd/kg p2o5 for at forhindre, at akkumuleringen af cadmium i jord når et niveau, der udgør en risiko for miljøet og menneskers sundhed via fødekæden.