EUROPEAN PHARMACOPOEIA COMMISSION

CV/lake

Working document, with no legally binding status, intended exclusively for the addressees and their associates, under the responsibility of the addressees (listed opposite). Level 4

BILINGUE

GROUP COM

PA/PH/SG (16) 110

Strasbourg, December 2016

(EUROPEAN PHARMACOPOEIA COMMISSION / COMMISSION EUROPEENNE DE PHARMACOPEE)

Summary of Decisions taken at the 156th Session of the Commission

Résumé des décisions prises lors de la 156è Session de la Commission

22-23 November 2016

Distribution

For action:

COM European Pharmacopoeia Commission

For information:

ANP National Pharmacopoeia Authorities COM 156 COM 156th

PRES Praesidium

This document will not be redistributed in sessions. Ce document ne sera pas redistribué lors des sessions.

EDQM address: 7 allée Kastner, CS 30026, FR-67081 Strasbourg (France)

PA/PH/SG (16) 110 ii

EUROPEAN PHARMACOPOEIA COMMISSION COMMISSION EUROPEENNE DE PHARMACOPEE

Summary of Decisions of the 156th Session

22-23 November 2016 Résumé des décisions de la 156e Session

22-23 novembre 2016 Deadline for confirmation / Date de confirmation: 16 December 2016

Item I. ADOPTED TEXTS Subject to Confirmation

I.1 Monographs and chapters/Monographies et chapitres

I.1.1 Minor revisions / Révisions mineures

18.3.1 Aceclofenac / Acéclofénac (1281)

20.3.1 Alverine citrate / Alvérine (citrate d') (2156)

15.3.1 Azithromycin / Azithromycine (1649)

33.3.1 Bacterial endotoxins / Essai des endotoxines bactériennes (20614)

15.3.2 Ceftazidime pentahydrate / Ceftazidime pentahydratée (1405)

15.3.3 Ceftazidime pentahydrate with sodium carbonate for injection / Ceftazidime pentahydratée avec du carbonate de sodium pour préparations injectable (2344)

28.3.1 Cell substrates for the production of vaccines for human use/Substrates cellulaires utilises pour la production de vaccins pour usage humain (50203)

19.3.1 Chlorhexidine diacetate / Chlorhexidine (diacétate de) (0657)

19.3.2 Chlorhexidine digluconate solution / Chlorhexidine (digluconate de), solution de (0658)

19.3.3 Chlorhexidine dihydrochloride / Chlorhexidine (dichlorhydrate de) (0659)

11.1.1.4 Determination of metal catalyst or metal reagent residues (2.4.20.) / Dosage des résidus de catalyseurs ou de réactifs métalliques (2.4.20.)

31.3.1 Gefitinib / Géfitinib (2866)

55.3.1 Human coagulation factor IX (rDNA) concentrated solution / Facteur IX de coagulation humain (ADNr), solution concentrée de (2522)

11.2.3 Lactose / Lactose (1061)

11.2.4 Lactose monohydrate / Lactose monohydraté (0187)

38.3.1 Lactulose/Lactulose (1230)

11.1.1.3 Metal catalyst or metal reagent residues / Résidus de catalyseurs ou de réactifs métalliques (5.20.)

ALL

22.3.1 Naloxone hydrochloride dihydrate / Naloxone (chlorhydrate de) dihydraté (0729)

iii PA/PH/SG (16) 110 I.1.1 Minor revisions / Révisions mineures

65.3.2 Names of herbal drugs used in traditional Chinese medicine / Noms des drogues végétales utilisées en médecine traditionnelle chinoise (5.22.)

59.3.1 Pentetate sodium calcium for radiopharmaceutical preparations / Pentétate (calcium) de sodium pour préparations radiopharmaceutiques (2353)

11.2.2 Pharmacopoeial harmonisation (5.8.) / Harmonisation des pharmacopées (5.8.)

14.3.2 Test for anticomplementary activity of immunoglobulin / Essai d’activité anticomplémentaire de l’immunoglobuline (20617)

14.3.1 Test for Fc function of immunoglobulin / Essai de la fonction Fc de l’immunoglobuline (20709)

65.3.1 Uncaria stem with hooks / Uncaria rhynchophylla (rameau d’) avec épines (2729)

23.3.2 Veterinary liquid preparations for cutaneous application / Préparations vétérinaires liquides pour application cutanée (1808)

66.3.2 Vitamin A concentrate (oily form), synthetic / Vitamine A synthétique (concentrat de), forme huileuse (0219)

66.3.1 Vitamin A concentrate (powder form), synthetic / Vitamine A synthétique (concentrat de), forme pulvérulente (0218)

66.3.3 Vitamin A concentrate (solubilisate/emulsion), synthetic / Vitamine A synthétique (concentrat de), solubilisat/émulsion (0220)

I.1.2 Revisions / Révisions

16.2.1 Aluminium magnesium silicate / Aluminium (silicate d') et de magnésium (1388) -> Group 9 will continue working on this

65.2.1 Angelica dahurica root / Angelica dahurica (racine d') (2556)

65.2.2 Angelica pubescens root / Angelica pubescens (racine d') (2557)

21.2.2 Aspartic acid / Aspartique (acide) (0797)

65.2.4 Barbary wolfberry fruit / Lyciet de Barbarie (fruit de) (2612)

19.2.1 Betamethasone dipropionate / Bétaméthasone (dipropionate de) (0809)

23.2.1 Capsules / Capsules (0016)

23.2.2 Chewing gums, medicated / Gommes à mâcher médicamenteuses (1239)

65.2.3 Clematis armandii stem / Clematis armandii (tige de) (2463)

15.2.1 Clindamycin hydrochloride / Clindamycine (chlorhydrate de) (0582)

21.2.1 Deferoxamine mesilate / Déféroxamine (mésilate de) (0896)

PA/PH/SG (16) 110 iv

I.1.2 Revisions / Révisions

35.2.1 Falling ball and automatic rolling ball viscometer methods (2.2.49.) / Méthodes du viscosimètre à chute de bille et du viscosimètre automatique à bille roulante (2.2.49)

17.2.1 Gas detector tubes / Tubes détecteurs de gaz (2.1.6.)

13.2.1 Heparin calcium / héparine calcique (0332)

13.2.2 Heparin sodium / héparine sodique (0333)

11.2.1 Hydroxyethylcellulose / Hydroxyéthylcellulose (0336)

23.2.3 Intraruminal devices / Dispositifs intraruminaux (1228)

23.2.4 Liquid preparations for oral use / Préparations liquides pour usage oral (0672)

21.2.3 Magnesium aspartate dihydrate / Magnésium (aspartate de) dihydraté (1445)

18.2.1 Nortriptyline hydrochloride / Nortriptyline (chlorhydrate de) (0941)

26.2.1 Olive oil, refined / Olive (huile d') raffinée (1456)

26.2.2 Olive oil, virgin / Olive (huile d') vierge (0518)

23.2.5 Oromucosal preparations / Préparations buccales (1807)

11.1.1.2 Pharmaceutical preparations / Préparations pharmaceutiques (2619)

19.2.2 Prednisone / Prednisone (0354)

26.2.3 Soya-bean oil, refined / Soja (huile de) raffinée (1473)

23.2.6 Sticks / Bâtons (1154)

11.1.1.1 Substances for pharmaceutical use / Substances pour usage pharmaceutique (2034)

23.2.7 Tablets / Comprimés (0478)

28.2.1 Tests for extraneous agents in viral vaccines for human use / Essai des agents étrangeres dans les vaccins viraux pour usage humain (20616)

22.2.2 Tiotropium bromide monohydrate / Tiotropium (bromure de) monohydraté (2420)

15.2.2 Tylosin for veterinary use / Tylosine pour usage vétérinaire (1273)

15.2.4 Tylosin phosphate bulk solution for veterinary use / Tylosine (phosphate de) pour usage vétérinaire, solution en vrac de (1661)

15.2.3 Tylosin tartrate for veterinary use / Tylosine (tartrate de) pour usage vétérinaire (1274)

22.2.1 Vindesine sulfate / Vindésine (sulfate de) (1276)

53.2.1 X-Ray fluorescence spectrometry (2.2.37.) / Spectrométrie de fluorescence-X (2.2.37.)

v PA/PH/SG (16) 110 I.1.2 New texts adopted / Nouveaux textes adoptés

17.1.3 Acetylene intermix (1 per cent in nitrogen) / Acétylène intermix (1 pour cent dans le nitrogène) (2903)

48.1.1 Ammonium carbonate for homoeopathic preparations / Ammonium (carbonate d') pour préparations homéopathiques (2916)

17.1.1 Carbon monoxide intermix (5 per cent in nitrogen) / Monoxyde de carbone intermix (5 pour cent dans le nitrogène) (2904)

67.1.1 Chemical imaging / Imagerie chimique (5.24.)

55.1.2 Etanercept / Étanercept (2895)

55.1.1 Human coagulation factor IX (rDNA) powder for solution for injection / Facteur IX de coagulation humain (ADNr) (poudre pour solution injectable de) (2994)

28.1.1 In vivo assay substitution with in vitro methods for quality control of vaccines/ Remplacement de méthode(s) in vivo de contrôle de la qualité des vaccins par une ou plusieurs méthodes in vitro (50214)

65.1.2 Magnolia biondii flower bud / Magnolia biondii (bouton floral de) (2742)

17.1.2 Methane intermix (2 per cent) in nitrogen / Méthane intermix (2 pour cent) dans l'azote (2905)

21.1.1 Nicardipine hydrochloride / Nicardipine (chlorhydrate de) (2776)

31.1.1 Rupatadine fumarate / Rupatadine (fumarate de) (2888)

27.1.1 Sodium pertechnetate (99mTc) injection (accelerator-produced) / Sodium (pertechnétate (99mTc) de, produit dans un accélérateur ) solution injectable de (2891)

15.1.1 Tacrolimus / Tacrolimus (2244)

15.1.2 Tylosin phosphate for veterinary use / Tylosine (phosphate de) (2802)

I-2 CRS/BRP SCR/PBR

New substances

Aescin for LC assay HRS 1

Alfuzosin for peak identification CRS 1

Alfuzosin for system suitability A CRS 1

Andrographis herb HRS 1

Andrographolide CRS 1

Aprepitant CRS 1

Aprepitant for system suitability CRS 1

Bacitracin for system suitability CRS 1

Benzylpenicillin for system suitability CRS 1

PA/PH/SG (16) 110 vi

Cape jasmine fruit SST HRS 1

Chloramphenicol for peak identification CRS 1

Clopidogrel besilate CRS 1

Clopidogrel hydrochloride CRS 1

Dicycloverine for system suitability CRS 1

Emodin CRS 1

Ergotamine for system suitability CRS 1

Erythromycin ethylsuccinate for impurity P identification CRS 1

Erythromycin for impurity M identification CRS 1

Erythromycin for system suitability CRS 1

Erythromycin lactobionate CRS 1

Erythromycin stearate for impurity S identification CRS 1

Escitalopram CRS 1

Geniposide CRS 1

Hydroxychloroquine for system suitability CRS 1

Hydroxychloroquine sulfate CRS 1

Indapamide impurity C CRS 1

Irinotecan for peak identification CRS 1

Irinotecan for system suitability 1 CRS 1

Irinotecan for system suitability 2 CRS 1

Irinotecan hydrochloride trihydrate CRS 1

Isopropyl isostearate CRS 1

Isorhynchophylline CRS 1

Oxytetracycline for system suitability CRS 1

Paeoniflorin CRS 1

Phenoxymethylpenicillin for system suitability CRS 1

Pholcodine for impurity G identification CRS 1

Polydatin CRS 1

Polygonum orientale fruit for system suitability HRS 1

Proguanil hydrochloride CRS 1

Pyrantel impurity D CRS 1

Remifentanil impurity mixture CRS 1

Sildenafil for peak identification CRS 1

Tacalcitol for system suitability CRS 1

Tacalcitol impurity A CRS 1

Tacalcitol monohydrate CRS 1

Taxifolin CRS 1

vii PA/PH/SG (16) 110 Timolol impurity F CRS 1

Triamcinolone hexacetonide for system suitability CRS 1

Uncaria stem with hooks dry extract for system suitability HRS 1

Replacement batches

1,1’-ethylidenebistryptophan CRS 6

Acarbose for peak identification CRS 4

Acarbose for peak identification CRS 5

Acetylcysteine impurity D CRS 7

Allopurinol impurity A CRS 3

Alverine impurity C CRS 2

Amoxicillin trihydrate for performance verification CRS 2

Anhydrotetracycline hydrochloride CRS 5

Anhydrous paroxetine hydrochloride impurity C CRS 2

Aripiprazole CRS 2

Aspartam impurity A CRS 5

Atorvastatin impurity A CRS 3

Atorvastatin impurity B CRS 4

Atorvastatin impurity C CRS 3

Atorvastatin impurity D CRS 4

Atorvastatin impurity E CRS 4

Atovaquone for system suitability CRS 2

Azelastine impurity B CRS 2

Benazepril for system suitability CRS 2

Betamethasome 17-valerate CRS 4

Betamethasome 21-valerate CRS 4

Betamethasome valerate for system suitability CRS 2

Bromhexine hydrochloride CRS 4

Budesonide CRS 5

Busulfan CRS 3

Calcium glucoheptonate CRS 2

Captopril impurity D CRS2

Captopril impurity J CRS 2

Carbidopa impurity mixture CRS 2

Carbocisteine CRS 3

Carvedilol CRS 2

Cefixime CRS 4

PA/PH/SG (16) 110 viii

Cefprozil for peak identification CRS 2

Cefprozil impurity mixture CRS 2

Cetyl palmitate 15 CRS 2

Cetyl palmitate 95 CRS 2

Chlorhexidine CRS 5

Chlorhexidine for system suitability CRS 2

Ciclopirox CRS 2

Ciclopirox impurity A CRS 4

Cisplatin impurity A CRS 2

Clindamycin hydrochloride CRS 5

Crospovidone CRS 2

Cyclopentolate hydrochlorideCRS 3

Dexamethasone acetate CRS 4

Dimenhydrinate for peak identification CRS 2

Entecavir impurity F CRS 2

Erythromycin A CRS 4

Erythromycin ethylsuccinate for impurity P identification CRS 2

Estriol CRS 3

Flucloxacillin sodium CRS 8

Fluphenazine sulfoxide CRS 2

Fosinopril impurity I CRS 2

Gentamicin sulfate CRS 14

Glibenclamide impurity A CRS 4

Glycerol mono-oleate CRS 3

Haloperidol for peak identification CRS 3

Haloperidol for system suitability CRS 2

Hydrastine hydrochloride CRS 2

Ibuprofen for peak identification CRS 7

Imatinib mesilate CRS 2

Iobenguane sulfate CRS 3

Isosorbide dinitrate CRS 4

Isosorbide dinitrate CRS 4

Ketoprofen impurity C CRS 4

Levetiracetam CRS 3

Levodopa CRS 3

Levodropropizine CRS 2

Lithium clavulanate CRS 8

ix PA/PH/SG (16) 110 Lovastatin CRS 4

Megestrol acetate for system suitability CRS 2

Methyldopa CRS 3

Methyldopa for system suitability CRS 2

Methylprednisolone hydrogen succinate for performance test CRS 2

Methyltestosterone CRS 2

Metoclopramide hydrochloride CRS 3

Metoclopramide impurity E CRS 2

Nadroparin clacium CRS 3

Naftidrofuryl impurity A CRS 2

Naloxone for peak identification CRS 3

Naloxone hydrochloride dihydrate CRS 3

Neomycin sulfate for microbiological assay CRS 6

Neomycin sulfate for microbiological assay CRS 5

Nikethamide CRS 2

Noradrenaline tartrate CRS 7

Orciprenaline sulfate CRS 3

Oseltamivir impurity A CRS 2

Oxytetracycline CRS 8

Paroxetine impurity E CRS 2

Pheniramine maleate CRS 3

Plastic additive 12 CRS 4

Plastic additive 23 CRS 3

Prednisolone for peak identification CRS 2

Pregabalin CRS 2

Pregabalin impurity B CRS 2

Racecadotril CRS 2

Ranitidine impurity J CRS 7

Riboflavin for peak identification CRS 4

Saccharin sodium CRS 2

Salbutamol impurity F CRS 6

Salvianolic acid B CRS 2

Sertraline for peak identification CRS 5

Sucralose impurity B CRS 3

Tacalcitol - reference spectrum

Thiamazole impurity C CRS 4

PA/PH/SG (16) 110 x

Ticarcillin monosodium CRS 3

Tiotropium impurity F CRS 3

Triamcinolone hexacetonide CRS 3

Tricaprylin CRS 2

Trometamol CRS 4

Vinpocetine impurity A CRS 2

Vinpocetine impurity B CRS 2

Vinpocetine impurity D CRS 2

Xylazine impurity C CRS 3

Xylometazoline impurity A CRS 3

II. GENERAL TEXTS APPROVED / TEXTES GENERAUX APPROUVÉS

29.5.2 Guide for the elaboration of monographs on vaccines for veterinary use. / Guide pour l'élaboration des monographies de vaccins pour usage vétérinaire

29.5.3 Technical guide for the elaboration and use of monographs for vaccines and IVMPs / Guide technique pour l'élaboration et l'utilisation des monographies de vaccins et MIV

61.1 Rules of Procedure of the Ph. Eur. Commission

61.2 Guide for work of the Ph. Eur.

61.3 Code of Practice for the work of the Ph. Eur

III. ITEMS DEFERRED – SCHEDULED FOR A FUTURE SESSION/ SUJETS REPORTES – A INSCRIRE A UNE PROCHAINE SESSION

IV. REQUESTS FOR REVISION / DEMANDES DE REVISION

IV.1 Approved by the Commission

17.4.1 Acetylene intermix (1 per cent) in nitrogen / Acétylène à 1 pour cent dans l'azote (mélange intermédiaire d') (2903) -> Group 9G

20.4.1 Aciclovir / Aciclovir (0968) -> Group 10C

32.4.1 Allergen products / Produits allergènes (1063) -> ALG WP

13.4.1 Aprotinin / Aprotinine (0580) -> Group 6

13.4.1 Aprotinin concentrated solution / Aprotinine (solution concentrée d’) (0579) -> Group 6

28.4.2 Assay of pertussis vaccine (acellular) / Titrage de l'activité du vaccin coquelucheux acellulaire (20716) -> Group 15

xi PA/PH/SG (16) 110 IV.1 Approved by the Commission

29.4.1 Aujeszky's disease vaccine (inactivated) for pigs / Vaccin inactivé de la maladie d'Aujeszky pour le porc (0744) -> Group 15V

18.4.3 Benserazide hydrochloride / Bensérazide (chlorhydrate de) (1173) -> Group 10A

29.4.1 Calf cornavirus diarrhoea vaccine (inactivated) / Vaccin inactivé des diarrhées à coronavirus des veaux (1953) -> Group 15V

29.4.1 Calf rotavirus diarrhoea vaccine (inactivated) / Vaccin inactivé des diarrhées à rotavirus des veaux (1954) -> Group 15V

17.4.1 Carbon monoxide intermix (5 per cent) in nitrogen / Carbone (monoxyde de) à 5 pour cent dans l'azote (mélange intermédiaire de) (2904) -> Group 9G

26.4.5 Castor oil, refined / Ricin (huile de) raffinée (2367) -> Group 13H

26.4.4 Cetyl palmitate / Cétyle (palmitate de) (1906) -> Group 13H

66.4.1 Cholecalciferol concentrate (oily form) / Cholécalciférol (concentrat de), forme huileuse (0575) –> VIT WP

20.4.2 Cilastatin sodium / Cilastatine sodique (1408) -> Group 10C

26.4.6 Composition of fatty acids in oils rich in omega-3 acids / Composition en acides gras des huiles riches en acides oméga-3 (2.4.29.) -> Group 13H

28.4.2 Diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed) / Vaccin DTC (acellulaire, multicomposé), adsorbé (1931) -> Group 15

28.4.2 Diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed, reduced antigen(s) content) / vaccin DTC adsorbé, à teneur réduite en antigène(s) (2764) -> Group 15

28.4.2 Diphtheria, tetanus, pertussis (acellular, component) and haemophilus type b conjugate vaccine (adsorbed) / Vaccin diphtérique, tétanique, coquelucheux (acellulaire, multicomposé) et conjugué de l’haemophilus type b, adsorbé (1932) -> Group 15

28.4.2 Diphtheria, tetanus, pertussis (acellular, component) and hepatitis b (rdna) vaccine (adsorbed) / Vaccin diphtérique, tétanique, coquelucheux et de l’hépatite B (1933) -> Group 15

28.4.2 Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed)/ Vaccin diphtérique, tétanique, coquelucheux et poliomyélitique (1934) -> Group 15

28.4.2 Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content) / vaccin DTCP adsorbé, à teneur réduite en antigène(s) (2329) -> Group 15

28.4.2 Diphtheria, tetanus, pertussis (acellular, component), hepatitis b (rdna), poliomyelitis (inactivated) and haemophilus Type b conjugate vaccine (adsorbed) / Vaccin DTCP, du VHB et de l’haemophilus type b (2067) -> Group 15

PA/PH/SG (16) 110 xii

IV.1 Approved by the Commission

28.4.2 Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) / Vaccin DTC (acellulaire, multicomposé), polio et de l’haemophilus type b (2065) -> Group 15

16.4.2 Disodium phosphate dodecahydrate / Phosphate disodique dodécahydraté (0118) -> Group 9

23.4.2 Ear preparations / Préparations auriculaires (0652) -> Group 12

31.4.1 Entecavir monohydrate / Entécavir monohydraté (2815) -> Group P4

23.4.2 Eye preparations / Préparations ophtalmiques (1163) -> Group 12

35.4.1 Falling ball and automatic rolling ball viscometer methods / Méthodes du viscosimètre à chute de bille et du viscosimètre automatique à bille roulante (2.2.49.) -> CEL WP

20.4.3 Fosinopril sodium / Fosinopril sodique (1751) -> Group 10C

24.4.3 Fresh bilberry fruit dry extract, refined and standardised / Myrtille (fruit frais de), extrait sec purifié et titré de (2394) -> Group 13A

15.4.1 Griseofulvin / Griséofulvine (0182) -> Group 7

26.4.2 Hard fat / Glycérides hémisynthétiques solides (0462) -> Group 13H

26.4.3 Hard fat with additives / Glycérides hémisynthétiques solides avec additifs (2731) -> Group 13H

47.4.1 Homoeopathic preparations / Préparations homéopathiques (1038) -> HMM WP

65.4.1 Indigo plant leaf / Renouée des teinturiers (feuille de) (2727) -> TCM WP

28.4.1 Influenza vaccine (split virion, inactivated) / Vaccin grippal inactivé à virion fragmenté (0158) -> Group 15

28.4.1 Influenza vaccine (surface antigen, inactivated) /Influenza vaccine (surface antigen, inactivated) (0869) -> Group 15

28.4.1 Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) /Vaccin grippal inactivé (antigène de surface, sur cultures cellulaires) (2149) -> Group 15

28.4.1 Influenza vaccine (surface antigen, inactivated, virosome) / Vaccin grippal inactivé (antigène de surface, virosomal) (2053) -> Group 15

28.4.1 Influenza vaccine (whole virion, inactivated)/ Vaccin grippal inactivé à virion entier (0159) -> Group 15

28.4.1 Influenza vaccine (whole virion, inactivated, prepared in cell cultures) /Vaccin grippal inactivé à virion entier préparé sur cultures cellulaires (2308) -> Group 15

26.4.1 Lauromacrogol 400 / Lauromacrogol 400 (2046) -> Group 13H

xiii PA/PH/SG (16) 110 IV.1 Approved by the Commission

23.4.3 Liquid preparations for oral use / Préparations liquides pour usage oral (0672) -> Group 12

17.4.1 Methane intermix (2 per cent) in nitrogen / Méthane à 2 pour cent dans l'azote (mélange intermédiaire de) (2905) -> Group 9G

12.4.1 Microbiological examination of non-sterile products: test for specified micro-or / Contrôle microbiologique des produits non stériles : recherche de microorganisme (20613) -> Group 1

29.4.1 Myxomatosis vaccine (live) for rabbits / Vaccin vivant de la myxomatose pour le lapin (1943) -> Group 15V

23.4.2 Nasal preparations / Préparations nasals (0676)-> Group 12

15.4.1 Nystatin /Nystatine (0517) -> Group 7

23.4.4. Patches, transdermal / Dispositifs transdermiques (1011) -> Group 12

28.4.2 Pertussis vaccine (acellular, component, adsorbed) / Vaccin coquelucheux (adsorbé, multicomposé, acellulaire) (1356) -> Group 15

28.4.2 Pertussis vaccine (acellular, co-purified, adsorbed)/ Vaccin coquelucheux (adsorbé, copurifié, acellulaire) (1595) -> Group 15

18.4.2 Phenytoin / Phénytoïne (1253) -> Group 10A

29.4.1 Porcine parvovirosis vaccine (inactivated) / Vaccin inactivé de la parvovirose porcine (0965) -> Group 15V

19.4.1 Prednisone / Prednisone (0354) -> Group 10B

13.4.1 Protamine sulfate / Protamine (sulfate de) (0569) -> Group 6

24.4.1 Saw palmetto extract / Palmier de Floride (extrait de) (2579) -> Group 13A

23.4.4. Semi-solid preparations for cutaneous application / préparations semi-solides pour application cutanée (0132) -> Group 12

24.4.2 Senna leaf dry extract, standardised / Séné (feuille de), extrait sec titré de (1261) -> Group 13A

30.4.1 Sets for the transfusion of blood and blood components / Nécessaires pour la transfusion du sang et des produits du sang (30206) -> Group 16

28.4.3 Smallpox vaccine (live) / Vaccin vivant de la variole (0164) -> Group 15

16.4.1 Sodium molybdate dihydrate / Sodium (molybdate de) dihydraté (1565) -> Group 9

30.4.2 Sterile single-use plastic syringes / Seringues en matière plastique non réutilisables, stériles (30208) -> Group 16

13.4.1 Streptokinase concentrated solution / Streptokinase (solution concentrée de) (0356) -> Group 6

PA/PH/SG (16) 110 xiv

IV.1 Approved by the Commission

27.4.1 Technetium (99mTc) bicisate injection / Technétium (99mTc) (bicisate-), solution injectable de (2123) –> Group 14

27.4.1 Technetium (99mTc) colloidal rhenium sulfide injection / Technétium (99mTc) (sulfure de rhénium colloïdal et de), solution injectable de (0126) –> Group 14

27.4.1 Technetium (99mTc) colloidal sulfur injection / Technétium (99mTc) (soufre colloïdal et de), solution injectable de (0131) –> Group 14

27.4.1 Technetium (99mTc) colloidal tin injection / Technétium (99mTc) (étain colloïdal et de), solution injectable d’ (0689) –> Group 14

27.4.1 Technetium (99mTc) etifenin injection / Technétium (99mTc) (étifénine-), solution injectable d’ (585) –> Group 14

27.4.1 Technetium (99mTc) exametazime injection / Technétium (99mTc) (examétazime-), solution injectable d’ (1925) –> Group 14

27.4.1 Technetium (99mTc) gluconate injection / Technétium (99mTc) (gluconate-), solution injectable de (1047) –> Group 14

27.4.1 Technetium (99mTc) human albumin injection / Technétium (99mTc) (albumine humaine-), solution injectable d’ (640) –> Group 14

27.4.1 Technetium (99mTc) macrosalb injection / Technétium (99mTc) (macrosalb-), suspension injectable de (296) –> Group 14

27.4.1 Technetium (99mTc) mebrofenin injection / Technétium (99mTc) (mébrofénine-), solution injectable de (2393) –> Group 14

27.4.1 Technetium (99mTc) medronate injection / Technétium (99mTc) (médronate-), solution injectable de (641) –> Group 14

27.4.1 Technetium (99mTc) mertiatide injection / Technétium (99mTc) (mertiatide-), solution injectable de (1372) –> Group 14

27.4.1 Technetium (99mTc) microspheres injection / Technétium (99mTc) (microsphères-), suspension injectable de (570) –> Group 14

27.4.1 Technetium (99mTc) oxidronate injection / Technétium (99mTc) (oxidronate-), solution injectable d’ (2376) –> Group 14

27.4.1 Technetium (99mTc) pentetate injection / Technétium (99mTc) (pentétate-), solution injectable de (642) –> Group 14

27.4.1 Technetium (99mTc) sestamibi injection / Technétium (99mTc) (sestamibi-), solution injectable de (1926) –> Group 14

27.4.1 Technetium (99mTc) succimer injection / Technétium (99mTc) (succimère-), solution injectable de (643) –> Group 14

27.4.1 Technetium (99mTc) tin pyrophosphate injection / Technétium (99mTc) (pyrophosphate d’étain et de), solution injectable de (129) -> Group 14

xv PA/PH/SG (16) 110 IV.1 Approved by the Commission

13.4.2 Tetracosactide / Tétracosactide (0644) -> Group 6

22.1.4 Tramadol hydrochloride / Tramadol (chlorhydrate de) (1681) -> Group 10D

15.4.2 Tylosin for veterinary use / Tylosine pour usage vétérinaire (1273) -> Group 7

15.4.2 Tylosin phosphate bulk solution for veterinary use / Tylosine (phosphate de) pour usage vétérinaire, solution en vrac de (1661) -- > Group 7

15.4.2 Tylosin phosphate for veterinary use / Tylosine (phosphate de) pour usage vétérinaire (2802) -> Group 7

15.4.2 Tylosin tartrate for veterinary use / Tylosine (tartrate de) pour usage vétérinaire (1274) -> Group 7

28.4.4 Typhoid vaccine / Vaccin typhoïdique (0156) -> Group 15

23.4.1 Uniformity of mass of delivered doses from multidose containers / Uniformité de masse de la dose délivrée par les récipients multidoses (2.9.27.) -> Group 12

29.4.2 Yersiniosis vaccine (inactivated) for salmonids / Vaccin inactivé de la yersiniose pour salmonidés (1950) -> Group 15V

8.3 V ADDITIONS TO THE WORK PROGRAMME / PROGRAMME DE TRAVAIL (NEW ITEMS)

8.3 Aluminium phosphate, hydrated, for adsorption (3065) – Group 9

8.3 Atosiban (3054) – Group 6

8.3 Cabazitaxel acetone (3060) – Group P4

8.3 Cabazitaxel concentrate for solution for infusion (3061) - – Group P4

8.3 Glatiramer (3057) – Group 6

8.3 Hexyl aminolevulinate hydrochloride (3062) – Group 10D

8.3 Infectious pancreatic necrosis vaccine (inactivated) for Salmonids (3063) – Group 15V

8.3 Lanreotide (3056) – Group 6

8.3 Melatonin (3059) – Group 10C

8.3 Meningococcal conjugate vaccine (A,C, Y , W135) (3066) – Group 15

8.3 Posaconazole (3058) – Group 10B

8.3 Triptorelin (3055) – Group 6

8.3 Winter ulcer vaccine (inactivated) for Salmonids (3064) – Group 15V

PA/PH/SG (16) 110 xvi

8.3 VI. DELETION FROM THE WORK PROGRAMME. / RETRAIT DU PROGRAMME DE TRAVAIL.

8.3 Calamus rhizome for decoction used in TCM (2456)

8.3 Ephedra distachya for homoeopathic preparations (2837)

8.3 Intrauterine preparations for vet. Use (1806)

8.3 Nelarabine (2643)

8.3 Tablets (0478)

8.3 Yarrow (1382)

8.3 VII. SUPPRESSIONS FROM THE PH. EUR. / SUPPRESSIONS DE LA PH. EUR.

8.3 Cholera vaccine / Vaccin cholérique (0154)

8.3 Cholera vaccine (freeze dried) / Vaccin cholérique cryodesséché (0155)

8.3 Typhoid vaccine (freeze dried) / Vaccin typhoïdique cryodesséché (0157)

VIII.1 PROCEDURES AND QUESTIONS OF PRINCIPLE/ PROCEDURES ET QUESTIONS DE PRINCIPE

7.1 Request for Observer Status from the Indian Pharmacopoeia Commission

7.2 Request for Observer Status from Japan: awaiting confirmation from EU Commission

11.3.1 Legal status of Ph. Eur. texts on containers used in/as medical devices -> Secretariat to send out an enquiry

11.3.2 Assays in monographs on herbal drugs: Alternative approaches for quality control. Proposal for pilot studies -> to be carried out on 3 TCM monographs:

● Chinese motherwort (Leonuri herba, 2785)

● Thunberg fritillary bulb (Fritillaria thunbergii, 2588)

● Corydalis rhizome (Corydalis rhizome, 2976)

23.5.1 Semi-solid preparations for cutaneous application (0132); Patches, transdermal (1011) and new dosage form monograph 3032 Commission approved that Group 12 combine cutaneous and transdermal patches into one monograph and separate medicated plasters (impact on monograph on Semi-solid preparations for cutaneous application 0132)

xvii PA/PH/SG (16) 110

23.5.2 Eye preparations / Préparations ophtalmiques (1163) Commission approved:

- To elaborate a new test method (2.9.xx) to provide limits for sub-visible particulates. The Secretariat will launch an official enquiry to formalise the approval of the Commission.

- To include Eye Preparations in the reflection concerning ‘practically free from particles’.

- the addition of a Dissolution test in the Production section in the absence of a specific test method

- The sending of a survey to collect the opinion of specialists on whether a limit for BET should be included in this dosage form monograph

48.5.1 Toxicodendron quercifolium for homoeopathic preparations / Rhus toxicodendron pour préparations homéopathiques (2519) – delegations to confirm the following approach: 1. to include of a limit test specifically for urushiols based on the HPLC method already available. This would cover the safety aspects. 2. regarding the assay, since the active substance was not known, to recommend not to include an assay in the monograph and to inform the users by an introductory statement such as “It is not possible to include an assay due to the high instability of the urushiols, which prevents to set a lower assay limit. The safety aspects are therefore covered by a limit test.”

55.5.1 Proposal from the working party to conclude the P4Bio pilot phase: the Commission agreed the end of the pilot phase and P4BIO would now be considered as a “classic” Working Party

2 Priorities for the 3 coming years ALL

IX. DATES OF FUTURE SESSIONS/DATE DE LA PROCHAINE SESSION DE LA COMMISSION

Dates for 2017 - 21-22 March - 20-21 June - 21-22 November