Licensing issues

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Chapter: Hospital pharmacy : Technical services

With the exception of a limited number of lines produced by specialist hos-pital manufacturing units, medicines produced by hospital technical services departments are unlicensed and have no product licence (PL) or marketing authorisation.


Licensing issues

 

With the exception of a limited number of lines produced by specialist hos-pital manufacturing units, medicines produced by hospital technical services departments are unlicensed and have no product licence (PL) or marketing authorisation. If the production of an unlicensed medicine is conducted under the supervision of a pharmacist, and the batch size and frequency of prepar-ation are within MHRA-defined limits, section 10 of the 1968 Medicines Act provides exemption from the requirement to hold a manufacturer’s licence. (At the time of writing, the Medicines Act is under review.) In addition to the above restrictions, manufacture under section 10 exemption does not permit the supply of the product outside the NHS trust in which it was made and imposes limits on the maximum shelf-life which may be assigned to certain product types.

 

For the production of larger batches, and in the case of medicines sold outside the production unit’s trust, a manufacturer’s specials licence is required. The specials licence is regulated by the MHRA and permits the manufacture of products that are not subject to a PL. The licence specifies the type of manufacture permitted (that is, non-sterile, aseptic manufacture, and so on) and the product categories to which the licence applies (large-volume IVs, antibiotics, cytotoxics, biologicals). Hospitals holding a specials licence are subjected to regular audits by the MHRA, including an inspection of facilities and a full audit of good pharmaceutical manufacturing practice, QA and QC systems. Advertising of products manufactured under a specials licence is not permitted, although it is permissible to advertise a specials manufacturing service.

 

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