SC V A. Monograph Selection: Unlicensed Medicines

This section provides an outline of the criteria by which monographs for unlicensed products that are produced to meet particular patient needs are selected for inclusion in the British Pharmacopoeia. Such products are manufactured under a Manufacturer’s ‘Specials’ Licence or prepared extemporaneously under the supervision of a pharmacist.

The British Pharmacopoeia Commission will consider a monograph for inclusion in the British Pharmacopoeia in the following circumstances:

1. The formulation is widely used (for example: products in the top 100 list of items used in hospitals; products identified by members of the Expert Advisory Group on Unlicensed Medicines).

2. There is a particular need based on the therapeutic category and/or the importance of the material concerned; the latter being particularly relevant to small patient populations.

3. A request is received from the Competent Authority [Medicines and Healthcare products Regulatory Agency (MHRA)].

4. A request is received from a Specials manufacturer for one of their own products.

5. A request is received from official bodies [such as the World Health Organization (WHO)].

6. Other circumstances considered on a case-by-case basis.

It should be noted that compliance with any of the above criteria will not necessarily mean that a monograph will be included in the British Pharmacopoeia. The British Pharmacopoeia Commission may decide not to elaborate a monograph for a number of reasons, including resource limitations or other circumstances, decided on a case-by-case basis.