GROUP COM (EUROPEAN PHARMACOPOEIA COMMISSION / COMMISSION EUROPEENNE DE PHARMACOPEE)

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1 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 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 Strasbourg (France)

2 PA/PH/SG (16) 110 ii EUROPEAN PHARMACOPOEIA COMMISSION COMMISSION EUROPEENNE DE PHARMACOPEE Summary of Decisions of the 156 th Session November 2016 Résumé des décisions de la 156 e Session 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 Aceclofenac / Acéclofénac (1281) Alverine citrate / Alvérine (citrate d') (2156) Azithromycin / Azithromycine (1649) Bacterial endotoxins / Essai des endotoxines bactériennes (20614) Ceftazidime pentahydrate / Ceftazidime pentahydratée (1405) Ceftazidime pentahydrate with sodium carbonate for injection / Ceftazidime pentahydratée avec du carbonate de sodium pour préparations injectable (2344) Cell substrates for the production of vaccines for human use/substrates cellulaires utilises pour la production de vaccins pour usage humain (50203) Chlorhexidine diacetate / Chlorhexidine (diacétate de) (0657) Chlorhexidine digluconate solution / Chlorhexidine (digluconate de), solution de (0658) Chlorhexidine dihydrochloride / Chlorhexidine (dichlorhydrate de) (0659) Determination of metal catalyst or metal reagent residues ( ) / Dosage des résidus de catalyseurs ou de réactifs métalliques ( ) Gefitinib / Géfitinib (2866) Human coagulation factor IX (rdna) concentrated solution / Facteur IX de coagulation humain (ADNr), solution concentrée de (2522) Lactose / Lactose (1061) Lactose monohydrate / Lactose monohydraté (0187) Lactulose/Lactulose (1230) Metal catalyst or metal reagent residues / Résidus de catalyseurs ou de réactifs métalliques (5.20.) Naloxone hydrochloride dihydrate / Naloxone (chlorhydrate de) dihydraté (0729) ALL

3 iii PA/PH/SG (16) 110 I.1.1 Minor revisions / Révisions mineures Names of herbal drugs used in traditional Chinese medicine / Noms des drogues végétales utilisées en médecine traditionnelle chinoise (5.22.) Pentetate sodium calcium for radiopharmaceutical preparations / Pentétate (calcium) de sodium pour préparations radiopharmaceutiques (2353) Pharmacopoeial harmonisation (5.8.) / Harmonisation des pharmacopées (5.8.) Test for anticomplementary activity of immunoglobulin / Essai d activité anticomplémentaire de l immunoglobuline (20617) Test for Fc function of immunoglobulin / Essai de la fonction Fc de l immunoglobuline (20709) Uncaria stem with hooks / Uncaria rhynchophylla (rameau d ) avec épines (2729) Veterinary liquid preparations for cutaneous application / Préparations vétérinaires liquides pour application cutanée (1808) Vitamin A concentrate (oily form), synthetic / Vitamine A synthétique (concentrat de), forme huileuse (0219) Vitamin A concentrate (powder form), synthetic / Vitamine A synthétique (concentrat de), forme pulvérulente (0218) Vitamin A concentrate (solubilisate/emulsion), synthetic / Vitamine A synthétique (concentrat de), solubilisat/émulsion (0220) I.1.2 Revisions / Révisions Aluminium magnesium silicate / Aluminium (silicate d') et de magnésium (1388) -> Group 9 will continue working on this Angelica dahurica root / Angelica dahurica (racine d') (2556) Angelica pubescens root / Angelica pubescens (racine d') (2557) Aspartic acid / Aspartique (acide) (0797) Barbary wolfberry fruit / Lyciet de Barbarie (fruit de) (2612) Betamethasone dipropionate / Bétaméthasone (dipropionate de) (0809) Capsules / Capsules (0016) Chewing gums, medicated / Gommes à mâcher médicamenteuses (1239) Clematis armandii stem / Clematis armandii (tige de) (2463) Clindamycin hydrochloride / Clindamycine (chlorhydrate de) (0582) Deferoxamine mesilate / Déféroxamine (mésilate de) (0896)

4 PA/PH/SG (16) 110 iv I.1.2 Revisions / Révisions 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) Gas detector tubes / Tubes détecteurs de gaz (2.1.6.) Heparin calcium / héparine calcique (0332) Heparin sodium / héparine sodique (0333) Hydroxyethylcellulose / Hydroxyéthylcellulose (0336) Intraruminal devices / Dispositifs intraruminaux (1228) Liquid preparations for oral use / Préparations liquides pour usage oral (0672) Magnesium aspartate dihydrate / Magnésium (aspartate de) dihydraté (1445) Nortriptyline hydrochloride / Nortriptyline (chlorhydrate de) (0941) Olive oil, refined / Olive (huile d') raffinée (1456) Olive oil, virgin / Olive (huile d') vierge (0518) Oromucosal preparations / Préparations buccales (1807) Pharmaceutical preparations / Préparations pharmaceutiques (2619) Prednisone / Prednisone (0354) Soya-bean oil, refined / Soja (huile de) raffinée (1473) Sticks / Bâtons (1154) Substances for pharmaceutical use / Substances pour usage pharmaceutique (2034) Tablets / Comprimés (0478) Tests for extraneous agents in viral vaccines for human use / Essai des agents étrangeres dans les vaccins viraux pour usage humain (20616) Tiotropium bromide monohydrate / Tiotropium (bromure de) monohydraté (2420) Tylosin for veterinary use / Tylosine pour usage vétérinaire (1273) Tylosin phosphate bulk solution for veterinary use / Tylosine (phosphate de) pour usage vétérinaire, solution en vrac de (1661) Tylosin tartrate for veterinary use / Tylosine (tartrate de) pour usage vétérinaire (1274) Vindesine sulfate / Vindésine (sulfate de) (1276) X-Ray fluorescence spectrometry ( ) / Spectrométrie de fluorescence-x ( )

5 v PA/PH/SG (16) I.1.2 New texts adopted / Nouveaux textes adoptés Acetylene intermix (1 per cent in nitrogen) / Acétylène intermix (1 pour cent dans le nitrogène) (2903) Ammonium carbonate for homoeopathic preparations / Ammonium (carbonate d') pour préparations homéopathiques (2916) Carbon monoxide intermix (5 per cent in nitrogen) / Monoxyde de carbone intermix (5 pour cent dans le nitrogène) (2904) Chemical imaging / Imagerie chimique (5.24.) Etanercept / Étanercept (2895) Human coagulation factor IX (rdna) powder for solution for injection / Facteur IX de coagulation humain (ADNr) (poudre pour solution injectable de) (2994) 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) Magnolia biondii flower bud / Magnolia biondii (bouton floral de) (2742) Methane intermix (2 per cent) in nitrogen / Méthane intermix (2 pour cent) dans l'azote (2905) Nicardipine hydrochloride / Nicardipine (chlorhydrate de) (2776) Rupatadine fumarate / Rupatadine (fumarate de) (2888) Sodium pertechnetate (99mTc) injection (accelerator-produced) / Sodium (pertechnétate (99mTc) de, produit dans un accélérateur ) solution injectable de (2891) Tacrolimus / Tacrolimus (2244) 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

6 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

7 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

8 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

9 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

10 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 Guide for the elaboration of monographs on vaccines for veterinary use. / Guide pour l'élaboration des monographies de vaccins pour usage vétérinaire 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 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 Acetylene intermix (1 per cent) in nitrogen / Acétylène à 1 pour cent dans l'azote (mélange intermédiaire d') (2903) -> Group 9G Aciclovir / Aciclovir (0968) -> Group 10C Allergen products / Produits allergènes (1063) -> ALG WP Aprotinin / Aprotinine (0580) -> Group Aprotinin concentrated solution / Aprotinine (solution concentrée d ) (0579) -> Group Assay of pertussis vaccine (acellular) / Titrage de l'activité du vaccin coquelucheux acellulaire (20716) -> Group 15

11 xi PA/PH/SG (16) 110 IV.1 Approved by the Commission Aujeszky's disease vaccine (inactivated) for pigs / Vaccin inactivé de la maladie d'aujeszky pour le porc (0744) -> Group 15V Benserazide hydrochloride / Bensérazide (chlorhydrate de) (1173) -> Group 10A Calf cornavirus diarrhoea vaccine (inactivated) / Vaccin inactivé des diarrhées à coronavirus des veaux (1953) -> Group 15V Calf rotavirus diarrhoea vaccine (inactivated) / Vaccin inactivé des diarrhées à rotavirus des veaux (1954) -> Group 15V Carbon monoxide intermix (5 per cent) in nitrogen / Carbone (monoxyde de) à 5 pour cent dans l'azote (mélange intermédiaire de) (2904) -> Group 9G Castor oil, refined / Ricin (huile de) raffinée (2367) -> Group 13H Cetyl palmitate / Cétyle (palmitate de) (1906) -> Group 13H Cholecalciferol concentrate (oily form) / Cholécalciférol (concentrat de), forme huileuse (0575) > VIT WP Cilastatin sodium / Cilastatine sodique (1408) -> Group 10C Composition of fatty acids in oils rich in omega-3 acids / Composition en acides gras des huiles riches en acides oméga-3 ( ) -> Group 13H Diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed) / Vaccin DTC (acellulaire, multicomposé), adsorbé (1931) -> Group Diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed, reduced antigen(s) content) / vaccin DTC adsorbé, à teneur réduite en antigène(s) (2764) -> Group 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 Diphtheria, tetanus, pertussis (acellular, component) and hepatitis b (rdna) vaccine (adsorbed) / Vaccin diphtérique, tétanique, coquelucheux et de l hépatite B (1933) -> Group Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed)/ Vaccin diphtérique, tétanique, coquelucheux et poliomyélitique (1934) -> Group 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 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

12 PA/PH/SG (16) 110 xii IV.1 Approved by the Commission 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 Disodium phosphate dodecahydrate / Phosphate disodique dodécahydraté (0118) -> Group Ear preparations / Préparations auriculaires (0652) -> Group Entecavir monohydrate / Entécavir monohydraté (2815) -> Group P Eye preparations / Préparations ophtalmiques (1163) -> Group Falling ball and automatic rolling ball viscometer methods / Méthodes du viscosimètre à chute de bille et du viscosimètre automatique à bille roulante ( ) -> CEL WP Fosinopril sodium / Fosinopril sodique (1751) -> Group 10C Fresh bilberry fruit dry extract, refined and standardised / Myrtille (fruit frais de), extrait sec purifié et titré de (2394) -> Group 13A Griseofulvin / Griséofulvine (0182) -> Group Hard fat / Glycérides hémisynthétiques solides (0462) -> Group 13H Hard fat with additives / Glycérides hémisynthétiques solides avec additifs (2731) -> Group 13H Homoeopathic preparations / Préparations homéopathiques (1038) -> HMM WP Indigo plant leaf / Renouée des teinturiers (feuille de) (2727) -> TCM WP Influenza vaccine (split virion, inactivated) / Vaccin grippal inactivé à virion fragmenté (0158) -> Group Influenza vaccine (surface antigen, inactivated) /Influenza vaccine (surface antigen, inactivated) (0869) -> Group Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) /Vaccin grippal inactivé (antigène de surface, sur cultures cellulaires) (2149) -> Group Influenza vaccine (surface antigen, inactivated, virosome) / Vaccin grippal inactivé (antigène de surface, virosomal) (2053) -> Group Influenza vaccine (whole virion, inactivated)/ Vaccin grippal inactivé à virion entier (0159) -> Group Influenza vaccine (whole virion, inactivated, prepared in cell cultures) /Vaccin grippal inactivé à virion entier préparé sur cultures cellulaires (2308) -> Group Lauromacrogol 400 / Lauromacrogol 400 (2046) -> Group 13H

13 xiii PA/PH/SG (16) 110 IV.1 Approved by the Commission Liquid preparations for oral use / Préparations liquides pour usage oral (0672) -> Group Methane intermix (2 per cent) in nitrogen / Méthane à 2 pour cent dans l'azote (mélange intermédiaire de) (2905) -> Group 9G Microbiological examination of non-sterile products: test for specified micro-or / Contrôle microbiologique des produits non stériles : recherche de microorganisme (20613) -> Group Myxomatosis vaccine (live) for rabbits / Vaccin vivant de la myxomatose pour le lapin (1943) -> Group 15V Nasal preparations / Préparations nasals (0676)-> Group Nystatin /Nystatine (0517) -> Group Patches, transdermal / Dispositifs transdermiques (1011) -> Group Pertussis vaccine (acellular, component, adsorbed) / Vaccin coquelucheux (adsorbé, multicomposé, acellulaire) (1356) -> Group Pertussis vaccine (acellular, co-purified, adsorbed)/ Vaccin coquelucheux (adsorbé, copurifié, acellulaire) (1595) -> Group Phenytoin / Phénytoïne (1253) -> Group 10A Porcine parvovirosis vaccine (inactivated) / Vaccin inactivé de la parvovirose porcine (0965) -> Group 15V Prednisone / Prednisone (0354) -> Group 10B Protamine sulfate / Protamine (sulfate de) (0569) -> Group Saw palmetto extract / Palmier de Floride (extrait de) (2579) -> Group 13A Semi-solid preparations for cutaneous application / préparations semi-solides pour application cutanée (0132) -> Group Senna leaf dry extract, standardised / Séné (feuille de), extrait sec titré de (1261) -> Group 13A Sets for the transfusion of blood and blood components / Nécessaires pour la transfusion du sang et des produits du sang (30206) -> Group Smallpox vaccine (live) / Vaccin vivant de la variole (0164) -> Group Sodium molybdate dihydrate / Sodium (molybdate de) dihydraté (1565) -> Group Sterile single-use plastic syringes / Seringues en matière plastique non réutilisables, stériles (30208) -> Group Streptokinase concentrated solution / Streptokinase (solution concentrée de) (0356) -> Group 6

14 PA/PH/SG (16) 110 xiv IV.1 Approved by the Commission Technetium (99mTc) bicisate injection / Technétium (99mTc) (bicisate-), solution injectable de (2123) > Group Technetium ( 99m Tc) colloidal rhenium sulfide injection / Technétium (99mTc) (sulfure de rhénium colloïdal et de), solution injectable de (0126) > Group Technetium ( 99m Tc) colloidal sulfur injection / Technétium (99mTc) (soufre colloïdal et de), solution injectable de (0131) > Group Technetium ( 99m Tc) colloidal tin injection / Technétium (99mTc) (étain colloïdal et de), solution injectable d (0689) > Group Technetium ( 99m Tc) etifenin injection / Technétium (99mTc) (étifénine-), solution injectable d (585) > Group Technetium ( 99m Tc) exametazime injection / Technétium (99mTc) (examétazime-), solution injectable d (1925) > Group Technetium ( 99m Tc) gluconate injection / Technétium (99mTc) (gluconate-), solution injectable de (1047) > Group Technetium ( 99m Tc) human albumin injection / Technétium (99mTc) (albumine humaine-), solution injectable d (640) > Group Technetium ( 99m Tc) macrosalb injection / Technétium (99mTc) (macrosalb-), suspension injectable de (296) > Group Technetium ( 99m Tc) mebrofenin injection / Technétium (99mTc) (mébrofénine-), solution injectable de (2393) > Group Technetium ( 99m Tc) medronate injection / Technétium (99mTc) (médronate-), solution injectable de (641) > Group Technetium ( 99m Tc) mertiatide injection / Technétium (99mTc) (mertiatide-), solution injectable de (1372) > Group Technetium ( 99m Tc) microspheres injection / Technétium (99mTc) (microsphères-), suspension injectable de (570) > Group Technetium ( 99m Tc) oxidronate injection / Technétium (99mTc) (oxidronate-), solution injectable d (2376) > Group Technetium ( 99m Tc) pentetate injection / Technétium (99mTc) (pentétate-), solution injectable de (642) > Group Technetium ( 99m Tc) sestamibi injection / Technétium (99mTc) (sestamibi-), solution injectable de (1926) > Group Technetium ( 99m Tc) succimer injection / Technétium (99mTc) (succimère-), solution injectable de (643) > Group Technetium ( 99m Tc) tin pyrophosphate injection / Technétium (99mTc) (pyrophosphate d étain et de), solution injectable de (129) -> Group 14

15 xv PA/PH/SG (16) 110 IV.1 Approved by the Commission Tetracosactide / Tétracosactide (0644) -> Group Tramadol hydrochloride / Tramadol (chlorhydrate de) (1681) -> Group 10D Tylosin for veterinary use / Tylosine pour usage vétérinaire (1273) -> Group Tylosin phosphate bulk solution for veterinary use / Tylosine (phosphate de) pour usage vétérinaire, solution en vrac de (1661) -- > Group Tylosin phosphate for veterinary use / Tylosine (phosphate de) pour usage vétérinaire (2802) -> Group Tylosin tartrate for veterinary use / Tylosine (tartrate de) pour usage vétérinaire (1274) -> Group Typhoid vaccine / Vaccin typhoïdique (0156) -> Group Uniformity of mass of delivered doses from multidose containers / Uniformité de masse de la dose délivrée par les récipients multidoses ( ) -> Group 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 Atosiban (3054) Group Cabazitaxel acetone (3060) Group P4 8.3 Cabazitaxel concentrate for solution for infusion (3061) - Group P4 8.3 Glatiramer (3057) Group Hexyl aminolevulinate hydrochloride (3062) Group 10D 8.3 Infectious pancreatic necrosis vaccine (inactivated) for Salmonids (3063) Group 15V 8.3 Lanreotide (3056) Group Melatonin (3059) Group 10C 8.3 Meningococcal conjugate vaccine (A,C, Y, W135) (3066) Group Posaconazole (3058) Group 10B 8.3 Triptorelin (3055) Group Winter ulcer vaccine (inactivated) for Salmonids (3064) Group 15V

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

17 xvii PA/PH/SG (16) 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 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 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 March June November