Division 2.2 Starting materials of non-biological origin
United Kingdom
The description shall be given in the form of a monograph under the following headings:
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the name of the starting material meeting the requirements of point 2 of Section A shall be supplemented by any trade or scientific synonyms,
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the description of the starting material, set down in a form similar to that used in a descriptive item in the European Pharmacopoeia,
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the function of the starting material,
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methods of identification,
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any special precautions which may be necessary during storage of the starting material and, if necessary, its storage life shall be given.
Notes on Annex II
Footnotes
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This Annex will be amended by the Commission in accordance with Articles 146 and 153. All references to Articles or to ‘this Directive’ in this Annex, unless otherwise specified, are to be understood as references to Directive 2001/82/EC.