All new texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 32.3 is 30 September 2020.
Users and interested parties are welcome to comment on these drafts. It should be noted that:
- although draft monographs must not be regarded as official standards, they will, once adopted by the European Pharmacopoeia (Ph. Eur.) Commission at a later date, become applicable and legally binding standards for the products concerned in all Ph. Eur. member states;
- if general texts are not legally binding per se, they become mandatory when referred to in a monograph. Changes to general texts may therefore impact monographs.
It is therefore extremely important that users provide feedback on such drafts.
Comments made after adoption of the text and/or publication in the Ph. Eur. will be too late to be considered. Users may then be in a position where their product is not compliant with the Ph. Eur. monograph, which is a legal standard in Europe. This could ultimately lead to a situation where a product can no longer be marketed in Europe.
So don’t miss this opportunity to provide your comments. The 48 drafts published in Pharmeuropa 32.3 are:
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Drafts published in Pharmeuropa 32.3 (end of commenting period: 30 September 2020) |
Group |
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1 |
2.2.48. Raman spectroscopy Reference number: PA/PH/Exp. SDA/T (20) 1 ANP Text number: 20248 |
SDA |
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2 |
2.4.35. Extractable elements in plastic materials for pharmaceutical use Reference number: PA/PH/Exp. 16/T (19) 22 ANP Text number: 20435 |
16 |
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3 |
3.1.16. Cyclo-olefin polymers Reference number: PA/PH/Exp. 16/T (16) 15 ANP Text number: 30116 |
16 |
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4 |
3.1.17. Cyclo-olefin copolymers Reference number: PA/PH/Exp. 16/T (19) 17 ANP Text number: 30117 |
16 |
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5 |
Arnica flower Reference number: PA/PH/Exp. 13A/T (19) 80 ANP Text number: 1391 |
13A |
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6 |
Arnica tincture Reference number: PA/PH/Exp. 13A/T (19) 81 ANP Text number: 1809 |
13A |
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7 |
Atorvastatin calcium Reference number: PA/PH/Exp. 10A/T (13) 59 ANP R3 Text number: 2191 |
10A |
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8 |
Atorvastatin magnesium trihydrate Reference number: PA/PH/Exp. 10A/T (17) 86 ANP Text number: 2755 |
10A |
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9 |
Botulinum toxin type A for injection Reference number: PA/PH/Exp. 15/T (19) 70 ANP Text number: 2113 |
BOT |
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10 |
Carmellose sodium Reference number: PA/PH/Exp. CEL/T (20) 7 ANP Text number: 0472 |
CEL |
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11 |
Chlortalidone Reference number: PA/PH/Exp. 10B/T (20) 13 ANP Text number: 0546 |
10B |
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12 |
Clostridium novyi (type B) vaccine for veterinary use Reference number: PA/PH/Exp. 15V/T (19) 25 ANP Text number: 0362 |
15V |
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13 |
Clostridium perfringens vaccine for veterinary use Reference number: PA/PH/Exp. 15V/T (19) 26 ANP Text number: 0363 |
15V |
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14 |
Clostridium septicum vaccine for veterinary use Reference number: PA/PH/Exp. 15V/T (15) 28 ANP Text number: 0364 |
15V |
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15 |
Cod-liver oil Reference number: PA/PH/Exp. 13H/T (20) 30 ANP Text number: 1192 |
13H |
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16 |
Diphtheria and tetanus vaccine (adsorbed) Reference number: PA/PH/Exp. 15/T (20) 12 ANP Text number: 0444 |
15 |
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17 |
Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s) content) Reference number: PA/PH/Exp. 15/T (20) 15 ANP Text number: 0647 |
15 |
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18 |
Diphtheria vaccine (adsorbed) Reference number: PA/PH/Exp. 15/T (20) 11 ANP Text number: 0443 |
15 |
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19 |
Diphtheria vaccine (adsorbed, reduced antigen content) Reference number: PA/PH/Exp. 15/T (20) 14 ANP Text number: 0646 |
15 |
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20 |
Diphtheria, tetanus and hepatitis B (rDNA) vaccine (adsorbed) Reference number: PA/PH/Exp. 15/T (20) 21 ANP Text number: 2062 |
15 |
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21 |
Diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed) Reference number: PA/PH/Exp. 15/T (20) 16 ANP Text number: 1931 |
15 |
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22 |
Diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed, reduced antigen(s) content) Reference number: PA/PH/Exp. 15/T (20) 27 ANP Text number: 2764 |
15 |
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23 |
Diphtheria, tetanus and pertussis (whole cell) vaccine (adsorbed) Reference number: PA/PH/Exp. 15/T (20) 13 ANP Text number: 0445 |
15 |
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24 |
Diphtheria, tetanus and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content) Reference number: PA/PH/Exp. 15/T (20) 25 ANP Text number: 2328 |
15 |
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25 |
Diphtheria, tetanus, pertussis (acellular, component) and haemophilus type b conjugate vaccine (adsorbed) Reference number: PA/PH/Exp. 15/T (20) 17 ANP Text number: 1932 |
15 |
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26 |
Diphtheria, tetanus, pertussis (acellular, component) and hepatitis B (rDNA) vaccine (adsorbed) Reference number: PA/PH/Exp. 15/T (20) 18 ANP Text number: 1933 |
15 |
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27 |
Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed) Reference number: PA/PH/Exp. 15/T (20) 19 ANP Text number: 1934 |
15 |
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28 |
Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content) Reference number: PA/PH/Exp. 15/T (20) 26 ANP Text number: 2329 |
15 |
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29 |
Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) Reference number: PA/PH/Exp. 15/T (20) 24 ANP Text number: 2067 |
15 |
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30 |
Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) Reference number: PA/PH/Exp. 15/T (20) 22 ANP Text number: 2065 |
15 |
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31 |
Diphtheria, tetanus, pertussis (whole cell) and poliomyelitis (inactivated) vaccine (adsorbed) Reference number: PA/PH/Exp. 15/T (20) 20 ANP Text number: 2061 |
15 |
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32 |
Diphtheria, tetanus, pertussis (whole cell), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) Reference number: PA/PH/Exp. 15/T (20) 23 Text number: 2066 |
15 |
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33 |
Domperidone Reference number: PA/PH/Exp. 10B/T (19) 153 ANP Text number: 1009 |
10B |
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34 |
Domperidone maleate Reference number: PA/PH/Exp. 10B/T (19) 152 ANP Text number: 1008 |
10B |
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35 |
Ezetimibe Reference number: PA/PH/Exp. 10D/T (13) 54 ANP Text number: 2767 |
10D |
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36 |
Formoterol fumarate dihydrate Reference number: PA/PH/Exp. 10B/T (20) 27 ANP Text number: 1724 |
10B |
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37 |
Human anti-D immunoglobulin Reference number: PA/PH/Exp. 6B/T (20) 3 ANP Text number: 0557 |
6B |
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38 |
Human anti-D immunoglobulin for intravenous administration Reference number: PA/PH/Exp. 6B/T (20) 4 ANP Text number: 1527 |
6B |
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39 |
Hydrochloric acid, concentrated Reference number: PA/PH/Exp. 9/T (20) 22 ANP Text number: 0002 |
9 |
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40 |
Hydrochloric acid, dilute Reference number: PA/PH/Exp. 9/T (20) 23 ANP Text number: 0003 |
9 |
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41 |
Methods of preparation of homoeopathic stocks and potentisation Reference number: PA/PH/Exp. HMM/T (20) 3 ANP Text number: 2371 |
HMM |
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42 |
Nebivolol hydrochloride Reference number: PA/PH/Exp. 10A/T (18) 11 ANP Text number: 2775 |
10A |
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43 |
Notopterygium root Reference number: PA/PH/Exp. TCM/T (10) 37 ANP R3 Text number: 2662 |
TCM |
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44 |
Paraffin, white soft Reference number: PA/PH/Exp. 13H/T (09) 11 ANP R3 Text number: 1799 |
13H |
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45 |
Paraffin, yellow soft Reference number: PA/PH/Exp. 13H/T (09) 8 ANP R3 Text number: 1554 |
13H |
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46 |
Propylene glycol monocaprylate Reference number: PA/PH/Exp. 13H/T (20) 29 ANP Text number: 2799 |
13H |
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47 |
Stearic acid Reference number: PA/PH/Exp. 13H/T (20) 32 ANP Text number: 1474 |
13H |
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48 |
Tetracaine hydrochloride Reference number: PA/PH/Exp. 10A/T (18) 206 ANP Text number: 0057 |
10A |