Argentine Pharmacopoeia pdf, 1.35Mb

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1. Name of pharmacopoeia
FARMACOPEA ARGENTINA
ARGENTINE PHARMACOPOEIA
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2. Pharmacopoeia referred to in national/
regional legislations
LEY N° 16.463/64 Art. 3° - Los productos comprendidos
en la presente ley deberán reunir las condiciones establecidas en la
Farmacopea Argentina y,
en caso de no figurar en ella, las que surgen de los patrones
internacionales y de los textos de reconocido valor científico.
Ordinance 21.886/56 Creates the Argentine Pharmacopoeia Permanent
Commission depending directly of the Health Ministry
Health Ministry Resolution N° 297/96 entrust the integration and reactivation
of the Argentine Pharmacopoeia Permanent Commission to ANMAT
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National/regional legislation includes
reference to other
Brazilian Pharmacopoeia and internationally recognised
Pharmacopoeias (Disp. 5743/2009)
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4. Publication of latest edition
2003 – SEVENTH EDITION VOLUME 1
(Decreto 202/02)
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5. Update frequency
UNDETERMINED, INTENDED BIANUALLY AFTER
THE APPROVAL OF THE EIGHTH EDITION
(on its way to be sent to Parliament for approval by law)
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6. For which products does the pharmacopoeia
provide specifications?
Eighth Edition
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APIs,
excipients,
dosage forms,
herbal products,
biological products,
medical products,
blood products,
radiopharmaceutical products,
vaccines
7. Number of texts included in the pharmacopoeia
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 monographs for APIs and excipients: 496
 monographs for finished dosage forms: 254
 monographs for biologicals: 18
 monographs for herbal products: 29
 monographs for medical products: 5
 monographs for blood products: 12
 monographs for radiopharmaceutical products: 18
 monographs for vaccines: 21
 general monographs: 92
 supplementary texts: 18
8. Collaboration with and/or being part of a (different)
national/regional pharmacopoeia
 Mercosur Pharmacopoeia
 European Pharmacopoeia Observers
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9. Publication of harmonized pharmacopoeial
texts within the pharmacopoeia
All those documents harmonized in the context of
MERCOSUR Pharmacopoeia will be included in the
Argentine Pharmacopoeia
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10. Interaction with stakeholders,
including regulators
Composition of the Sub commissions
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11. Strategy for the future
Strengthen regional harmonization through the
conjunct development of Reference Standards,
harmonization of general methods and
monographs in order to establish similar quality
standards within the region
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