1. Name of pharmacopoeia - · PDF file2 | 1. Name of pharmacopoeia French Pharmacopoeia (10th edition) Pharmacopée française ( Ph. fr.10ème édition) French version...
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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
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