• Pharmacopoeias Q4 - Q4B

    Code Document Title Previously coded
    • Q4B Annex 6R1Uniformity of Dosage Units General Chapter

      Draft Annex:
      September 2010

      Q4B Annex 6(R1)
      Description:

      This annex has been released for consultation under Step 2 of the ICH process in November 2008.
      This annex is the result of the Q4B process for Uniformity of Dosage General Chapter.

      This annex was revised -R1- to include the Interchangeability Statement from Health Canada on 27 September 2010.

      Consultation:

      Step 3

      EU:

      Transmission to CHMP and Interested Parties in December 2008, issued as CHMP/ICH/645408/08

      http://www.emea.europa.eu/pdfs/human/ich/56117607enfin.pdf

      MHLW:

      Released for consultation, 19 February 2009, PFSB/ELD

      FDA:

      Published in the Federal Register, 17 February 2009, Vol. 74, No. 30

      Frequently Asked Questions

      Finalised Document:
      April 2012

      Q4B FAQs
      Description:

      The Q4B Expert Working Group (EWG) developed a set of Frequently Asked Questions (FAQs) to help users of the Q4B Guideline and Annexes to understand the use and implication of these documents.