Transcription of RADIOPHARMACEUTICALS - Europa
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RADIOPHARMACEUTICALS - Europa
175_____3AQ20a nRADIOPHARMACEUTICALSG uideline TitleRadiopharmaceuticalsLegislative basisDirectives 65/65/EEC, 75/318/EEC as amended, Directive89/343/EECDate of first adoptionDecember 1990 Date of entry intoforceJune 1991 StatusLast revised December 1990 Previous titles/otherreferencesNone/III/3936/89 Additional NotesThis note for guidance concerns the application toradiopharmaceuticals of Directive 65/65/EEC and of parts2, 3 and 4 of the Annex to Directive 75/318/EEC asamended, with a view to the granting of a marketingauthorisation for a , BIOLOGICAL OR MICROBIOLOGICAL TESTS OFMEDICINAL AND PHARMACOLOGICAL AND PACKAGING177_____3AQ20a for marketing authorisation in respect of RADIOPHARMACEUTICALS should beaccompanied, as in the case of all medicinal products, by the particulars and documentsreferred to in Directives 65/65/EEC and 75/319/EEC, as amended, and in the Annex ofDirective 75/318/EEC as amended.
radiopharmaceutical and radiation hygiene aspects and radiation dosimetry in addition to general parameters. Radiopharmaceuticals have changing composition with time, associated with the radioactive ... The contents in many final preparations (e.g. kit preparations) may be so small that is may
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Preparations, Radiopharmaceutical preparations, Particulate Matter in Injections, Particulate Matter in Injec-tions, RADIOPHARMACEUTICALS, World Health Organization, Radiopharmaceutical, Radiopharmaceutical Materials Policy, Non-hazardous sterile preparations, MODEL STANDARDS FOR PHARMACY COMPOUNDING OF