Division 5 Identification and assay of excipient components
United Kingdom
Insofar as is necessary, the excipient(s) shall be subject at least to identification tests.
An upper and lower limit test shall be obligatory in respect of preserving agents. An upper limit test for any other excipient components liable to give rise to an adverse reaction shall be obligatory.
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.