Revised Monographs
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 using the Request for Revision form on this website (see menu to left) or the Customer Feedback Form in the BP publication.
Comments on the draft monographs may be sent to BPmonographs@mhra.gsi.gov.uk.
The links listed here open PDF versions which can be viewed using the Adobe Acrobat Reader plugin for your web browser (external link).
- Amiodarone Infusion
- Betahistine Dihydrochloride Tablets
- Deltamethrin (Vet)
- Dipyridamole Tablets
- Disopyramide Phosphate Capsules
- Gastro-resistant Bisacodyl Tablets
- Gastro-resistant Mesalazine Tablets
- Hydroxychloroquine Sulfate
- Hydroxychloroquine Tablets
- Mesalazine Suppositories
- Meslazine Enema
- Metformin Oral Solution
- Nimodipine Tablets
- Phentolamine Injection
- Prolonged-release Mesalazine Granules
- Prolonged-release Mesalazine Tablets
- Prolonged-release Salbutamol Capsules
- Prolonged-release Salbutamol Tablets
- Prolonged-release Tamsulosin Capsules
- Prolonged-release Verapamil Capsules