1. name of pharmacopoeia - who · mercosur pharmacopoeia will be included in the argentine...

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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   APIs,   excipients,   dosage forms,   herbal products,   biological products,   medical products,   blood products,   radiopharmaceutical products,   vaccines

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7. Number of texts included in the pharmacopoeia   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

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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