ANNEX II – Part 1
Reference Number | Substance |
---|---|
1 | N-5 Chlorobenzoxazol-2-ylacetamide |
2 | ß-Acetoxyethy trimethylammonium hydroxide (acetylcholine and its salts) |
3 | DEANOL ACEGLUMATE |
4 | Spironolactone |
5 | [4-(4-HYDROXY-3-IODOPHENOXY)-3,5-DIODOPHENYL] ACETIC ACID AND ITS SALTS |
6 | Methotrexate |
7 | Aminocaproic acid and its salts |
8 | Cinchophen,its salts,derivatives and salts of these derivatives |
9 | Thyropropic acid and its salts |
10 | Trichloroacetic acid |
11 | Aconitum napellus L. (leaves,roots and galenical preparations) |
12 | Aconitine (principal alkaloid of Aconitum napellus L.) and its salts |
13 | Adonis vernalis L. and its preparations |
14 | Epinephrine |
15 | Rauwolfia serpentina alkaloids and their salts |
16 | Alkyne alcohols,their esters,ethers and salts |
17 | Isoprenaline |
18 | Allyl isothiocyanate |
19 | Alloclamide and its salts |
20 | Nalorphine,its salts and ethers |
21 | Sympathomimetic amines acting on the central nervous system: any substance contained in the first list of medicaments w/c are subject to medical Prescription and are referred to in resolution AP(69) 2 of the Council of Europe |
22 | Aniline,its salts and its halogenated and sulphonated derivatives |
23 | Betoxycaine and its salts |
24 | Zoxazolamine |
25 | Procainamide,its salts and derivatives |
26 | Benzidine |
27 | Tuaminoheptane,its isomers and salts |
28 | Octodrine and its salts |
29 | 2-Amino-1,2-bis (4-methoxyphenyl) ethanol and its salts |
30 | 1,3-dimethylpentylamine and its salts |
31 | 4-Aminosalicylic acid and its salts |
32 | TOLUIDINES, THEIR ISOMERS, SALTS AND HALOGENATED AND SULPHONATED DERIVATIVES |
33 | Xylidines, their isomers, salts and halogenated and sulphonated derivatives |
34 | Imperatorin [9-(3-methylbut-2-enyloxy) furo(3,2-g)chromen-7-one] |
35 | Ammi majus and its galenical preparations |
36 | 2,3-Dichloro-2-methylbutane |
37 | Subtances w/ androgenic effect |
38 | Anthrancene oil |
39 | Antibiotics |
40 | Antimony and its compounds |
41 | Apocynum cannabinum L. and its preparations |
42 | Apomorphine (5,6,6a,7-tetrahydro-6-methyl-4H-dibenzo (de, g)- quinoline-10,11- dyhydric alcohol) and its salts |
43 | Arsenic and its compounds |
44 | Atropa belladonna L. and its preparations |
45 | Atropine, its salts and derivatives |
46 | Barium salts with the exception of barrium sulfhate, baruim sulphide under the conditions laid down in ANNEX III, Part 1, and Lakes, salts and pigments prepared from the colouring agents listed with the reference (3) in ANNEX IV, part 1, and ANNEX IV, Part 2 |
47 | Benzene |
48 | Benzimidazol-2(3H)-one |
49 | Benzazepines and benzadiazepines |
50 | 1-Dimethylaminomethyl-1-methylpropyl benzoate (amylocaine) and its salts |
51 | 2,2,6-Trimethyl-4-piperidyl benzoate (benzamine) and its salts |
52 | Isocarboxazide |
53 | Bendroflumethiazide and its derivatives |
54 | Beryllium and its compounds |
55 | Bromine, elemental |
56 | Bretylium tosilate |
57 | Carbromal |
58 | Bromisoval |
59 | Brompheniramine and its salts |
60 | Benzilonium bromide |
61 | Tetrylammonium bromide |
62 | Brucine |
63 | Tetracaine and its salts |
64 | Mofebutazone |
65 | Tolbutamide |
66 | Carbutamide |
67 | Phenylbutazone |
68 | Cadmium and its compounds |
69 | Cantharides, Cantharis vesicatoria |
70 | (1R,2S)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride (cantharidin) |
71 | Phenprobamate |
72 | Nitroderivatives of carbozol |
73 | Carbon disulphide |
74 | Catalase |
75 | Cephaeline and its salts |
76 | Chenopodium ambrosioides (essential oil) |
77 | 2,2,2-Trichloroethane-1,1-diol |
78 | Chlorine |
79 | Chlorpropamide |
80 | Diphenoxylate hydrochloride |
81 | 4-Phenylazophenyiene-1,3-diamine citrate hydrochloride (chrysoidine citrate hydrochloride) |
82 | Chlorzoxazone |
83 | 2-Chloro-6-methylpyrimidin-4-yldimethylamine (crimidine-ISO) |
84 | Chlorprothixene and its salts |
85 | Clofenamide |
86 | N,N-bis (2-chloroethyl) methylamine N-oxide and its salts |
87 | Chlormethine and its salts |
88 | CYCLOPHOSPHAMIDE AND ITS SALTS |
89 | Mannomustine and its salts |
90 | Butanilicaine and its salts |
91 | Chlormezanone |
92 | Triparanol |
93 | 2-[2-(4-Chlorophenyl)-2-phenylacetyl] indan 1,3-dione (chlorophacinone-ISO) |
94 | Chlorphenoxamine |
95 | PHENAGLYCODOL |
96 | Chloroethane |
97 | Chromium; chromic acid and its salts |
98 | Claviceps purpurea Tul., its alkaloids and galenical preparations |
99 | Conium maculatum L.(fruit,powder,galenical preparations) |
100 | Glycyclamide |
101 | Cobalt benzenesulphonate |
102 | Colchicine, its salts and derivatives |
103 | Colchicoside and its derivatives |
104 | Colchicum autumnale L. and its galenical preparations |
105 | Convallatoxin |
106 | Anamirta cocculus L.(fruit) |
107 | Croton tiglium (oil) |
108 | 1-Butyl-3-(N-crotonoylsulphanilyl) urea |
109 | Curare and curarine |
110 | Synthetic curarizants |
111 | Hydrogen cyanide and its salts |
112 | 2-α-Cyclohexylbenz,yl (N,N,N’,N’-tetraethyl) trimethylenediamine (phenetamine) |
113 | Cyclomenol and its salts |
114 | Sodium hexacyclonate |
115 | Hexapropymate |
116 | Dextropropoxyphene |
117 | O,O’-Diacetyl-N-allyl-N-normorphine |
118 | Pipazetate and its salts |
119 | 5-(α-ß- Dibromophenethyl)-5- methylhydantoin |
120 | N,N’-Pentamethylenebis (trimethylammonium) salts,e.g. Pentamethonium bromide |
121 | N,N’-[(Methylimino)diethylene]bis(ethyldimethylammonium) salts,e.g. azamethonium bromide |
122 | Cyclarbamate |
123 | Clofenotane; DDT (ISO) |
124 | Hexamethylenebis (trimethylammonium) salts e.g. hexamethonium bromide* |
125 | Dichloroethanes (ethylene chlorides) |
126 | Dichloroethylenes (acetylene chlorides) |
127 | Lysergide and its salts |
128 | 2-Diethylaminoethyl 3-hydroxy-4-phenylbenzoate and its salts |
129 | Cinchocaine and its salts |
130 | 3-Diethylaminopropyl cinnamate |
131 | O,O’-Diethyl O-4-nitrophenyl phosphorothioate (parathion-ISO) |
132 | (Oxalylbisiminoethylene) bis [(O-chlorobenzyl) diethylammonium] salts, e.g. ambenomium chloride |
133 | Methyprylon and its salts |
134 | Digitaline and all heterosides of Digitalis purpurea L. |
135 | 7-[2-Hydroxy-3-(2-hydroxyethyl)-N-methylamino) propyl]theophylline (xanthinol) |
136 | Dioxethedrin and its salts |
137 | Piprocurarium |
138 | Propyphenazone |
139 | Tetrabenazine and its salts |
140 | Captodiame |
141 | Mefeclorazine and its salts |
142 | Dimethylamine |
143 | 1,1-Bis(dimethylaminomethyl) propyl benzoate (amydricaine,alypine) and its salts |
144 | Methapyrilene and its salts |
145 | Metamfepramone and its salts |
146 | Amitriptyline and its salts |
147 | Metformin and its salts |
148 | Isosorbide dinitrate |
149 | Malononitrile |
150 | Succinonitrile |
151 | Dinitrophenol isomers |
152 | Inproquone |
153 | Dimevamide and its salts |
154 | Diphenylpyraline and its salts |
155 | Sulfinpyrazone |
156 | N-(3-Carbamoyl-3,3-diphenylpropyl)-N,N-diisopropylmethylammonium salts, e.g. isopropamide iodide |
157 | Benactyzine |
158 | Benzatropine and its salts |
159 | Cyclizine and its salts |
160 | 5,5-Diphenyl-4-imidazolidone |
161 | Probenecid |
162 | Disulfiram; thiram (ISO) |
163 | Emetine, its salts and derivatives |
164 | Ephedrine and its salts |
165 | Oxanamide and its derivatives |
166 | Eserine or physostigmine and its salts |
167 | Esters of 4-aminobenzoic acid, with the free amino group,with the exception of That given in Annex VII, Part 2 |
168 | Choline salts and their esters, e.g.choline chloride |
169 | Caramiphen and its salts |
170 | Diethyl 4-nitrophenyl phosphate |
171 | Metethoheptazine and its salts |
172 | Oxpheneridine and its salts |
173 | Ethoheptazine and its salts |
174 | Metheptazine and its salts |
175 | Methylphenidate and its salts |
176 | Doxylamine and its salts |
177 | Tolboxane |
178 | 4-Benzyloxyphenol,4-methoxyphenol and 4-ethoxyphenol |
179 | Parethoxycaine and its salts |
180 | Fenozolone |
181 | Glutethimide and its salts |
182 | Ethylene oxide |
183 | Bemegride and its salts |
184 | Valnoctamide |
185 | Haloperidol |
186 | Paramethasone |
187 | Fluanisone |
188 | Trifluperidol |
189 | Fluoresone |
190 | Fluorouracil |
191 | Hydroflouric acid,its normal salts,its complexes and hydrofluorides with the EXCEPTION OF THOSE GIVEN IN ANNEX III, PART1 |
192 | FURFURYLTRIMETHYLAMMONIUM SALTS, E.G. FURTRETHONIUM IODIDE* |
193 | Galantamine |
194 | Progestogens |
195 | 1,2,3,4,5,6-Hexachlorocyclohexane (BHC-ISO) (lindane) |
196 | (1R,4S,5R,8S)-1,2,3,4,10,10,-Hexachloro-6,7-epoxy-1,4,4a,5,6,7,8,8a-octahydro-1,4:5,8- dimethanonaphtalene (endrin-ISO) |
197 | Hexachloroethane |
198 | (1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4,5,8-dimethanonaphthalene (isodrin-ISO) |
199 | Hydrastine, hydrastanine and their salts |
200 | Hydrazides and their salts |
201 | Hydrazine, its derivatives and their salts |
202 | Octamoxin and its salts |
203 | Warfarin and its salts |
204 | Ethyl bis(4-hydroxy-2-oxo-1-benzopyran-3-yl) acetate and its salts of the acid |
205 | Methocarbamol |
206 | Propatylnitrate |
207 | 4,4′-Dihydroxy-3,3′-(3-methylthiopropylidene) dicoumarin |
208 | Fenadiazole |
209 | Nitroxoline and its salts |
210 | Hyoscyamine,its salts and derivative |
211 | Hycoscyamus niger L. (leaves,seeds,powder and galenical preparations) |
212 | Pemoline and its salts |
213 | Iodine |
214 | Decamethylenebis (trimethylammonium) salts,e.g. decamethonium bromide |
215 | Ipecacuanha (Cephaelis ipecacuanha Brot. And related species) (roots,powder & galenical preparations |
216 | (2-Isopropylpent-4-enoyl) urea (apronalide) |
217 | α-Santonin (( 3S,5aR,9bS)-3,3a,4,5,5a,9b-hexahydro-3,5a,9-trimethyl-naphto(1,2-b)furan-2,8-dione |
218 | Lobelia inflata L. and its galenical preparations |
219 | Lobeline and its salts |
220 | Barbiturates |
221 | Mercury and its compounds except those special cases included in Annex VI, Part 1 |
222 | 3,4,5-Trimethoxyphenethylamine and its salts |
223 | Metaldehyde |
224 | 2-(4-Allyl-2-methoxyphenoxy)-N,N-dietthylacetamide and its salts |
225 | Coumetarol |
226 | Dextromethrophan and its salts |
227 | 2-Methylheptylamine and its salts |
228 | Isometheptene and its salts |
229 | Mecamylamine |
230 | Guaifenesin |
231 | Dicoumarol |
232 | Phenmetrazine,its derivatives and salts |
233 | Thiamazole |
234 | 3,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5H,pyrano(3,2-c)-(1)benzopyran-5-one(cyclocoumarol) |
235 | Carisoprodol |
236 | Meprobamate |
237 | Tefazoline and its salts |
238 | Arecoline |
239 | Poldine methylsulfate |
240 | Hydroxyzine |
241 | 2-NAPHTHOL |
242 | 1-and- 2-Naphthylamines and their salts |
243 | 3-(1-Naphthyl)-4-hydroxycoumarin |
244 | Naphazoline and its salts |
245 | Neostigmine and its salts (e.g. neostigmine bromide) |
246 | Nicotine and its salts |
247 | Amyl nitrites |
248 | Inorganic nitrites, with the exception of sodium nitrite |
249 | Nitrobenzene |
250 | Nitrocresols and their alkali metals salts |
251 | Nitrofurantoin |
252 | Furazolidone |
253 | Propane-1,2,3-triyl trinitrate |
254 | Acenocoumarol |
255 | Alkali pentacyanonitrosylferrate (2-) |
256 | Nitrostilbenes, their homologues and their derivatives |
257 | Noradrenaline and its salts |
258 | Noscapine and its salts |
259 | Guanethidine and its salts |
260 | Oestrogens,with the exception of thosed listed in Annex V |
261 | Oleandrin |
262 | Chlortalidone |
263 | Pelletierine and its salts |
264 | Pentachloroethane |
265 | Pentaerithrityl tetranitrate |
266 | Petrichloral |
267 | Octamylamine and its salts |
268 | Picric acid |
269 | Phenacemide |
270 | Difencloxazine |
271 | 2-Phenylindan-1,3-dione (phenindione) |
272 | Ethylphenacemide |
273 | Phenprocoumon |
274 | Fenyramidol |
275 | Triamterence and its salts |
276 | Tetraethyl pyrophosphate; TEPP (ISO) |
277 | Tritolyl phosphate |
278 | Psilocybine |
279 | Phosphorus and metal phosphides |
280 | Thalidomide and its salts |
281 | Physostigma venenosum Balf |
282 | Picrotoxin |
283 | Pilocarpine and its salts |
284 | α-Piperidin-2-yl benzyl acetate laevorotatory thereoform (Levophacetoperane and its salt) |
285 | Pipradrol and its salts |
286 | Azacyclonol and its salts |
287 | Bietamiverine |
288 | Butopiprine and its salts |
289 | Lead and its compounds,with the exception of that mentioned in ANNEX III, No 55 under the condition stated |
290 | Coniine |
291 | PRUNUS LAUROCERASUS L. (CHERRY LAUREL WATER) |
292 | Metyrapone |
293 | Radioactive substances (1) |
294 | Juniperus sabina L.(leaves,esential oil & galenical preparations) |
295 | Hyoscine, its salts and derivatives |
296 | Gold salts |
297 | Selenium and its compounds with the exception of selenium disulphide under the conditions set out under the reference no 49 in ANNEX III, Part 1 |
298 | Solanum nigrum L. and its galenical preparations |
299 | Sparteine and its salts |
300 | Glucocorticoids |
301 | Datura stramonium L. and its galenical preparatipns |
302 | Strophantines, their aglucones & their respective derivatives |
303 | Strophantus species and their galenical preparations |
304 | Strychnine and its salts |
305 | Strychnos species and their galenical preparations |
306 | Narcotics, natural and synthetic: All substances listed in Table I and II of the Single Convension on narcotic drugs signed in New York on 30 March 1961. |
307 | Sulphonamides (sulphanilamide & its derivatives obtained by substitution of one or more H-atoms of the -NH2 groups) and their salts |
308 | Sultiame |
309 | Neodymium and its salts |
310 | Thiotepa |
311 | Pilocarpus jaborandi Holmes and its galenical preparations |
312 | Tellurium and its compounds |
313 | Xylometazoline and its salts |
314 | Tetrachloroethylene |
315 | Carbon Tetrachloride |
316 | Hexaethyl tetraphosphate |
317 | Thallium and its compounds |
318 | Thevetia neriifolia Juss. Glycoside extract |
319 | ETHIONAMIDE |
320 | Phenothiazine and its compounds |
321 | Thiourea and its derivatives, with exception of the one listed in Annex III,Part 1 |
322 | Mephenesin and its esters |
323 | Vaccine, toxins or serums listed in the Annex to the Second Counsil Directive of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (O J N L 147,9.6.1975,p.13) |
324 | Tranylcypromine and its salts |
325 | Trichloronitromethane (chloropicrine) |
326 | 2,2,2-Tribromoethanol (tribromoethyl alcohol) |
327 | Trichlormethine and its salts |
328 | Tretamine |
329 | Gallamine triethiodide |
330 | Urginea scilla Stern. And its galenical preparations |
331 | Veratrine, its salts and galenical preparations |
332 | Schoenoocaulon officinale Lind.(seeds and galenical preparations) |
333 | Veratrum Spp. And their preparations |
334 | Vinyl chloride monomer |
335 | Ergocalciferol and cholecalciferol (vitamins D2 and D3) |
336 | Salts of O-alkyldithiocarbonic acids |
337 | Yohimbine and its salts |
338 | Dimethyl sulfoxide |
339 | Diphenhydramine and its salts |
340 | 4-tert-Butylphenol |
341 | 4-tert-Butylpyrocatechol |
342 | Dihydrotachysterol |
343 | Dioxane |
344 | Morpholine and its salts |
345 | Pyrethrum album L. and its galenical preparations |
346 | 2-(4-Methoxybenzyl-N-(2-pyridyl)amino)ethyldimethylamine maleate |
347 | Tripelennamine |
348 | Tetrachlorosalicylanilides |
349 | Dichlorosalicylanilides |
350 | TETRABROMOSALICYLANILIDES |
351 | Dibromosalicylanilides |
352 | Bithionol |
353 | Thiuram monosulphides |
354 | Thiuram disulphides |
355 | Dimethylformamide |
356 | 4-Phenylbut-3-en-2-one |
357 | Benzoates of 4-hydroxy-3-methoxycinnamyl alcohol except for normal content in natural essences used |
358 | Furocoumarines (e.g. trioxysalan,8-methoxypsoralen, 5-methoxypsoralen), except for normal content in natural essences used. In Sun protection and in Bronzing products, urocoumarins shall be below 1 mg/kg |
359 | Oil from the seeds of Laurus nobilis L |
360 | Safrole except for normal content in the natural essences used and provided the concentration does not exceed: 100 ppm in the finished product 50 ppm in products for dental and oral hygiene, and provided that Safrole is not present in toothpastes intended specifically for children |
361 | 5,5′-Di-isopropyl-2,2′-dimethylbiphenyl-4,4′-diyl dihypoiodite |
362 | 3′-ethyl-5′,6′,7,8′-tetrahydro-5′,5′,8′,8′,-tetramethyl-2′-acetonaphthone or 7-acetyl- |
6-ethyl-1,1,4,4- tetrametyl-1, 2,3,4-tetrahydronaphtalen | |
363 | o-phenylenediamine and its salts |
364 | 4-Methyl-m-phenylenediamine and its salts |
365 | Aristolochic acid and its salts/;Aristolochia spp. and their preparations |
366 | Chloroform |
367 | 2,3,7,8,-Tetra chlorodibenzo-p-dioxin |
368 | 2,6-Dimethyl-1,3-dioxan-4-yl acetate (Dimethoxane) |
369 | Pyrithione sodium (INNM) |
370 | N-(Trichloromethylthio)-4-cyclohexene-1,2-dicarboximide (Captan) |
371 | 2,2′-Dihydroxy-3,3’5,5′,6,6′-hexachlorodiphenylmethane (Hexachlorophene) |
372 | 6-(Piperidinyl)-2,4-pyrimidinediamine-3-oxide (Minoxidil) and its salts |
373 | 3,4’,5-Tribromosalicylanilide |
374 | Phytolacca Spp. And their preparations |
375 | Tretinoin (retinoic acid and its salts) |
376 | 1-Methoxy-2,4-diaminobenzene (2,4-diaminoanisole-CI 76050) & their salts |
377 | 1-Methoxy-2,4-diamenobenzene (2,5-diaminoanisole) and their salts |
378 | Colouring agent CI 12140 |
379 | Colouring agent CI 26105 |
380 | Colouring agent CI 42555
Colouring agent CI 42555-1 Colouring agent CI 42555-2 |
381 | Amyl 4-dimethylaminobenzoate,mixed isomers (Padimate A (INN) |
382 | Benzoyl peroxide |
383 | 2-Amino-4-nitrophenol |
384 | 2-Amino-5-nitrophenol |
385 | 11α-Hydroxypregn-4-ene-3,20-dione and its esters |
386 | Colouring agent CI 42640 |
387 | Colouring agent CI 13065 |
388 | Colouring agent CI 42535 |
389 | Colouring agent CI 61554 |
390 | Anti-androgens with steroid structure |
391 | Zirconium and its compounds, with the exception of the subtances listed under reference number 50 in ANNEX III,Part One, and the zirconium lakes, pigments or salts of colouring agents listed in ANNEX IV, Part One, with reference number 3 |
392 | Thyrothricine |
393 | Acetonitrile |
394 | Tetrahydrozoline and its salts |
395 | Hydroxy-8-quinoline and its sulphate, except for the uses provided for in no 51 in Annex III, Part 1 |
396 | Dithio-2,2′-bispyridine-dioxide 1,1′ ( additive w/ trihydrated magnesium sulphate)-(pyrithione disulphide + magnesium sulphate) |
397 | Colouring agent CI 12075 and its lakes, pigments and salts |
398 | Colouring agent CI 45170 and CI 45170:1 |
399 | Lidocaine |
450 | 1,2-Epoxybutane |
401 | Colouring agent CI 15585 |
402 | STRONTIUM LACTATE |
403 | Strontium nitrate |
404 | Strontium polycarboxylate |
405 | Pramocaine |
406 | 4-Ethoxy-m-phenylenediamine and its salts |
407 | 2,4-Diaminophenylethanol and its salts |
408 | Cathechol |
409 | Pyrogallol |
410 | Nitrosamines |
411 | Secondary dialkanolamines |
412 | 4-Amino-2-nitrophenol |
413 | 2-Methyl-m-phenylenediamine |
414 | 4-tert-Butyl-3-methoxy-2,6-dinitrotoluene (Musk ambrette) |
416 | Cells,tissues or products of human origin |
417 | 3,3- Bis (4-hydroxyphenyl)phthalide (Phenolphthalein) |
418 | 3-Imidazol-4-ylacrylic acid and its ethyl ester (urocanic acid) |
419 | (a) the skull, including the brain and eyes, tonsil and spinal cord of: -bovine animals aged 12 month -ovine and caprine animals which are aged over 12 months or have a Permanent incisor tooth erupted through the gum;The spleens of ovine and caprine animals and ingredients derived therefrom. However, tallow derivatives may be used provided that the following methods have been used and strictly certified by the producer transesterification or hydrolysis at at least 200ºC and at appropriate corresponding pressure, for 20 minutes (glycerol and fatty acids and esters); saponification with NaOH 12M (glycerol and soap): batch process: 95ºC for 3 hours or continuous process: at 140ºC, 2 bars (2000 hPa) for 8 minutes or equivalent |
420 | Crude and refined coal tars |
421 | 1,1,3,3,5-Pentamethyl-4,6-dinitroindane (moskene) |
422 | 5-tert-Butyl-1,2,3-trimethyl-4,6-dinitrobenzene (musk tibetene) |