1 | 1. Name of pharmacopoeia

French Pharmacopoeia (10th edition) Pharmacopée française ( Ph. fr.10ème édition)

French version (except homeopathy - English version available) 2 | 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

4 | 4. Publication of latest edition

 10th edition since 1982

 11th edition ► in April 2012 ► free on line!

5 | 5. Update frequency

 Annually:

ADDENDUM (“mises à jour”)

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

6 | 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

7 | 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)

8 | 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…

9 | 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…

10 | 9. Publication of harmonized pharmacopoeial texts within the pharmacopoeia

Covered by Ph . Eur

11 | 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..)

12 | 11. Strategy for the future (1/2)

13 | 11. Strategy for the future (2/2)

14 | 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? [email protected] [email protected]

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