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dette skal følge cpmp guideline for risk management systems for medicinal products for human use and skal indsendes inden 30 dage efter commission decision.
esto debe estar en línea con la guideline del chmp titulada risk management systems for medicinal products for human use, debiendo presentarla en los 30 días siguientes tras la publicación de la decisión de la comisión.
ministry for economic affairs & labour, division for dual-use and wassenaar arrangement (c2/3)
ministry for economic affairs & labour, division for dual-use and wassenaar arrangement (c2/3)
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
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