1. name of pharmacopoeia - · pdf file2 | 1. name of pharmacopoeia french pharmacopoeia (10th...

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1. Name of pharmacopoeia

French Pharmacopoeia (10th edition)

Pharmacopée française ( Ph. fr.10ème édition)

French version

(except homeopathy - English version available)

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2. Pharmacopoeia referred to national/regional legislations

► National legislation (Code de la santé publique: Art. L. 5112-1)

Pharmacopoeia consists of the texts of the European Pharmacopoeia and of the French Pharmacopoeia, including the “overseas” Pharmacopoeia.

►Ph Eur Convention + EU regulation

► Mandatory

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3. National/regional legislation includes reference to other

 National pharmacopoeia(s) : no

European Pharmacopoeia (French version texts, no longer published in Ph. fr since 1997)

 Regional pharmacopoeia(s) : yes

“overseas” traditional pharmacopeia subject to regulatory conformities (departments- Caribbean, Guyana, Reunion Island -and territories -French Polynesia, Caledonia-)

  international pharmacopoeia(s) : no

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4. Publication of latest edition

 10th edition since 1982

 11th edition

► in April 2012

► free on line!

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5. Update frequency

 Annually:

ADDENDUM (“mises à jour”)

 Other: new procedure for 11th edition (2/year)

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6. For which products does the pharmacopoeia provide specifications?

 APIs  Herbal products  Homeopathic products  Biologicals  Small scale preparations (National Formulary),  Materials used for containers  Analytical methods  Reagents

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7. Number of texts included in the pharmacopoeia Ph. fr. 11 th ed

  53 APIs   Dosage forms cross-referred to Ph Eur (except 4

monographs)

  115 herbal products (including essential oils) Specific work program traditional use - on overseas traditional use - Traditional Chinese Medicines (Ph Eur work program or national priorities like clinical trials)

  320 Homeopathic stocks

  5 Biologicals (4 monographs on allergenic products, 1 immunoserum)

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7. Number of texts included in the pharmacopoeia Ph. fr. 11 th ed (continued)

  3 general chapters (analytical , antiseptics and pharmacotechnical)

  List of medicinal plants under pharmaceutical monopoly

  31 pharmaceutical preparations described in National Formulary

  Approx 500 Dénominations Communes Françaises = DCF (No INNs republished)

  + 41 SCR fr…

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8. Collaboration with and/or being part of a (different) national/regional pharmacopoeia

 Work sharing and exchanges on practices and national policies with NPAs members of the Ph Eur Commission or specific agreement (MHRA; EDQM)

 Cooperation agreement: China, Brazil

 Collaboration : Vietnam, Algeria, Morocco, Tunisia…

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9. Publication of harmonized pharmacopoeial texts within the pharmacopoeia

Covered by Ph . Eur

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10. Interaction with stakeholders, including regulators

 Producers (chemicals, herbals, excipients…)

 Hospital or community pharmacists

 Pharmaceutical industry (MA holders)

 Professional societies

 Licensing, Inspectorate, OMCLs

 Other institutions or ministries (Customs, Food..)

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11. Strategy for the future (1/2)

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11. Strategy for the future (2/2)

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Warning

  Link of interest: employee of Afssaps (State operator).

  This speech is made under strict compliance with the independence and impartiality of Afssaps as regards other speakers.

  Any further use of this material must be submitted to Afssaps for prior approval.

 Any questions? Pharmacopeefrancaise@afssaps.sante.fr an.le@afssaps.sante.fr