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alle ændringer i gruppen er ændringer af en active substance master file, vaccine antigen master file eller plasma master file.
todas as alterações no grupo são modificações do dossier principal da substância activa, do dossier principal do antigénio da vacina ou do dossier principal do plasma.
6 masterfiler vedrørende plasma (plasma master file (pmf)).
las evaluaciones externas proseguirán hasta finales de 2007.
european drug master file procedure quality of modified release dosage forms for veterinary use
quality of modified release dosage forms for veterinary use
den europæiske fødevaresikkerhedsautoritet: conclusion on the peer review of the pesticide risk assessment of the active substance plant oil/rape seed oil.
autoridad europea de seguridad alimentaria: «conclusion on the peer review of the pesticide risk assessment of the active substance plant oil/rape seed oil» (conclusión sobre la revisión por pares de la evaluación del riesgo de la utilización como plaguicida de la sustancia activa «aceite vegetal/aceite de colza»).
stability testing of existing active substances and related finished products
stability testing of existing active substances and publicada para consulta en diciembre de 1999 related finished products
stability testing of new active substances and medicinal products annex:
stability testing of new active substances and medicinal products annex:
european drug master file declaration of storage conditions for pharmaceutical veterinary medicinal products in the product particulars and active substances:
european drug master file declaration of storage conditions for pharmaceutical veterinary medicinal products in the product particulars and active substances:
annex to note for guidance on stability testing of new active substances and medicinal products.
annex to note for guidance on stability testing of new active substances and medicinal products.
annex to note for guidance on stability testing of existing active substances and related finished products.
annex to note for guidance on stability testing of existing active substances and related finished products.
declaration of storage conditions for pharmaceutical veterinary medicinal products in the product particulars and active substances.
declaration of storage conditions for pharmaceutical veterinary medicinal products in the product particulars and active substances.
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
master filen for forsøget danner grundlag for det tilsyn, der foretages af sponsorens uafhængige tilsynsførende, og for den kompetente myndigheds inspektion.
el expediente permanente del ensayo proporcionará la base para las auditorías que pueda realizar el auditor independiente del promotor y las inspecciones de las autoridades competentes.
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
título del documento 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
stability testing of existing active substances and related finished products summary of requirements for active substances process validation (update) quality aspects of veterinary medicinal products administered via drinking water
stability testing of existing active substances and related finished products summary of requirements for active substances process validation (update) quality aspects of veterinary medicinal products administered via drinking water
med henblik herpå bør begrebet plasma master file (pmf) indføres, især for at samle den nationale ekspertise og for at opnå, at der gennem emea's koordinering kun skal foretages en enkelt bedømmelse.
a tal fin, debería introducirse el concepto de archivo principal sobre plasma (app), en concreto para permitir el agrupamiento de los conocimientos nacionales y la realización de una única evaluación coordinada por la agencia europea para la evaluación de medicamentos (emea).
efsa's videnskabelige rapport (2005) 28, 1-77, conclusion on the peer review of the pesticide risk assessment of the active substance trifluralin (færdigbehandlet 14.3.2005).
informe científico de la efsa (2005) 28, 1-77, conclusion regarding the peer review of the pesticide risk assessment of the active substance trifluralin (fecha de finalización: 14 de marzo de 2005).
note for guidance on non- clinical testing of herbal drug preparations with long- term marketing experience - guidance to facilitate mutual recognition and use of bibliographic data concept paper for a note for guidance on the investigation of biopharmaceutical characterisation and bioavailability/ bioequivalence of herbal drugs/ preparations position paper on the risk associated with the use of herbal products containing estragole position paper on the risk associated with the use of herbal products containing methyleugenol position paper on the risk associated with the use of herbal products containing á - and β- asarone position paper on the use of sassafras albidum as active substance or ingredient in herbal medicinal products concept paper on the levels of scientific evidence required for the authorisation of well- established use and traditional herbal medicinal products core- data on urticae radix core- data on lini semen core- data on rosmarini folium cum flore core- data on primulae radix
concept paper on the levels of scientific evidence required for the authorisation of well-established use and traditional herbal medicinal products core-data on urticae radix core-data on lini semen core-data on rosmarini folium cum flore core-data on primulae radix
