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Part 2 Pharmaceutical (physico-chemical, biological or microbiological information (quality))

United Kingdom

Original text. Later amendments are not shown.

  1. Basic principles and requirements
  2. AQUALITATIVE AND QUANTITATIVE PARTICULARS OF THE CONSTITUENTS
  3. BDESCRIPTION OF THE MANUFACTURING METHOD
  4. CCONTROL OF STARTING MATERIALS
  5. DCONTROL TESTS CARRIED OUT AT INTERMEDIATE STAGES OF THE MANUFACTURING PROCESS
  6. ETESTS ON THE FINISHED PRODUCT
  7. FSTABILITY TEST
  8. GOTHER INFORMATION

Notes on Annex II

Footnotes

f1

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.