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for vacciner og sera er forsøgspopulationens immunologiske status og alder og den lokale epidemiologi af kritisk betydning og skal kontrolleres under forsøget og beskrives fuldt ud.
for vaccines and serums, the immunological status and age of the trial population and the local epidemiology are of critical importance and shall be monitored during the trial and fully described.
for så vidt angår fremstilling af immunologiske veterinærlægemidler, som består af sera, skal de producerende dyrs oprindelse, almindelige sundhedstilstand og immunologiske status meddeles;
for the production of immunological veterinary medicinal products consisting of serums, the origin, general health and immunological status of the producing animals shall be indicated;
for så vidt angår fremstilling af immunologiske veterinærlægemidler, som består af sera, skal de producerende dyrs oprindelse, almindelige sundhedstilstand og immunologiske status angives, og udgangsmaterialet skal komme fra definerede pools.
for the production of immunological veterinary medicinal products consisting of serums, the origin, general health and immunological status of the producing animals shall be indicated and defined pools of source materials shall be used.