Hdl Handle:
http://hdl.handle.net/10147/337487
Title:
National Drugs Advisory Board annual report 1975
Authors:
National Drugs Advisory Board (NDAB)
Citation:
National Drugs Advisory Board. 1975. National Drugs Advisory Board annual report 1975. Dublin: National Drugs Advisory Board (NDAB)
Publisher:
National Drugs Advisory Board (NDAB)
Issue Date:
1975
URI:
http://hdl.handle.net/10147/337487
Item Type:
Report
Language:
en
Description:
By the end of 1975. the National Drugs Advisory Board had 15 months of experience in the management of mandatory licensing systems for medicinal products and for manufacturers of pharmaceuticals in Ireland. With few exceptions. most applicants now have an appreciation of the intentions of these systems and are providing the type of data which the Board requires. During 1976 the Board will be commencing a review of established drugs. Although the information required for assessment is less comprehensive than that needed for a new drug substance. the Board is seeking and must receive sufficient information to ensure acceptability of pharmaceutical quality availability of the active ingredient for effect (bioavailability) and reasonable safety and efficacy in use. In some cases the information is self-evident. in others this may· not be so. With the implementation of the licensing systems for manufacturers and wholesalers. the first legal steps were taken toward the assurance of compliance with international standards of good practice by establishing a regular system of inspection. The increasing availability of established laboratory facilities for the analvsis of samples of pharmaceutical products will augment the overall coverage of marketed products. The visit of the EFTA Committee of Officials during 1975 was a welcome confirmation that the surveillance system established here is up to international standards and that it will form a sound base for continued improvement.
Keywords:
HEALTH BOARD; DRUG; PHARMACEUTICAL SERVICE

Full metadata record

DC FieldValue Language
dc.contributor.authorNational Drugs Advisory Board (NDAB)en_GB
dc.date.accessioned2014-12-22T14:32:27Z-
dc.date.available2014-12-22T14:32:27Z-
dc.date.issued1975-
dc.identifier.citationNational Drugs Advisory Board. 1975. National Drugs Advisory Board annual report 1975. Dublin: National Drugs Advisory Board (NDAB)en_GB
dc.identifier.urihttp://hdl.handle.net/10147/337487-
dc.descriptionBy the end of 1975. the National Drugs Advisory Board had 15 months of experience in the management of mandatory licensing systems for medicinal products and for manufacturers of pharmaceuticals in Ireland. With few exceptions. most applicants now have an appreciation of the intentions of these systems and are providing the type of data which the Board requires. During 1976 the Board will be commencing a review of established drugs. Although the information required for assessment is less comprehensive than that needed for a new drug substance. the Board is seeking and must receive sufficient information to ensure acceptability of pharmaceutical quality availability of the active ingredient for effect (bioavailability) and reasonable safety and efficacy in use. In some cases the information is self-evident. in others this may· not be so. With the implementation of the licensing systems for manufacturers and wholesalers. the first legal steps were taken toward the assurance of compliance with international standards of good practice by establishing a regular system of inspection. The increasing availability of established laboratory facilities for the analvsis of samples of pharmaceutical products will augment the overall coverage of marketed products. The visit of the EFTA Committee of Officials during 1975 was a welcome confirmation that the surveillance system established here is up to international standards and that it will form a sound base for continued improvement.en_GB
dc.language.isoenen
dc.publisherNational Drugs Advisory Board (NDAB)en_GB
dc.subjectHEALTH BOARDen_GB
dc.subjectDRUGen_GB
dc.subjectPHARMACEUTICAL SERVICEen_GB
dc.titleNational Drugs Advisory Board annual report 1975en_GB
dc.typeReporten
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