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News about GMP/cGMP

2010-02-03

Annex 13 EU GMP Guideline published

On February 3, 2010 the European Commission published the revised Annex 6 "Investigational Medicinal Products" of the EU GMP Guideline. Deadline for comming into operation is until July 31, 2010.

 

Changes/ News:

  • Revision to reinforce the principle of independence between production and quality control functions in cases where the number
  • of personnel involved is small.
  • Changes to sections 36 and 37 to supplement, for investigational medicinal products, the guidance for reference and retention samples
  • given in Annex 19.
  • An additional note has been introduced to clarify the meaning of “reconstitution” as referred to in article 9.2 of Directive 2005/28/EC.
  • The content of the Batch Certificate referred to in Art. 13(3) of Directive 2001/20/EC, agreed following a separate public
  • consultation, has been added as an attachment.
Link:

EC/ Annex 13

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