The following monographs are under development and comments are welcomed.
Proposals for the modification of limits need to be supported by appropriate, and relevant, batch and stability data obtained from a significant number of batches. Further information can be found in BP Supplementary Chapter III C. Monograph Development: Guidance to Manufacturers.
Manufacturers may propose revisions to published monographs by submitting draft proposals, supporting validation data and samples. Summary guidance for the information that is required to support a proposed revision can be found here.
Revision requests may be submitted by email to BPCOM@mhra.gsi.gov.uk or the Customer Feedback Form in the BP publication.
Comments on the draft monographs may be sent to BPCOM@mhra.gsi.gov.uk or to the email contacts given at the head of the draft text.
The links listed here open PDF versions which can be viewed using the Adobe Acrobat Reader plugin for your web browser (external link).You must be logged in to your account and have a valid subscription to access the Revised Monographs. Please login to your account.