Thanet Labs is developing a Specials manufacturing capability for the production of unlicensed sterile peptide medicines for patients with unmet clinical need. This service is planned, not yet active. It is subject to the grant of a Manufacturer’s Specials Licence (MSL) from the MHRA. Prescribers and dispensing pharmacies with patients requiring unlicensed peptide preparations are invited to register interest ahead of service launch.
Background
A “Special” is an unlicensed medicinal product manufactured or imported to meet the specific clinical needs of an individual patient for whom no licensed equivalent is available or appropriate. The manufacture of Specials in the UK is regulated under Regulation 167 of the Human Medicines Regulations 2012 and requires a Manufacturer’s Specials Licence (MSL) granted by the MHRA.
Specials may only be supplied to a prescribing practitioner or a dispensing pharmacy in response to a bona fide unsolicited order for a named patient. They cannot be marketed, promoted, or supplied to the general public. Thanet Labs is building a Specials manufacturing capability to address the specific gap in UK sterile peptide Specials supply.
Planned Scope
The planned Specials service will cover the manufacture of sterile peptide preparations in liquid and lyophilised presentations for supply to prescribers and dispensing pharmacies in response to named-patient orders. Manufacture will be performed under the same aseptic fill and finish conditions as Thanet Labs’ other sterile manufacturing services, with full batch documentation and certificate of analysis issued for each batch.
Thanet Labs does not perform peptide synthesis. The bulk peptide API is supplied by the prescriber, pharmacy, or their designated API supplier. Thanet Labs provides the downstream sterile manufacturing infrastructure to convert the API into a finished, documented, and labelled preparation ready for dispensing. All supply is subject to MSL requirements and applicable MHRA conditions.
Planned Conditions
Authorisation basis
Manufacturer’s Specials Licence (MSL) — planned
Regulatory basis
Regulation 167 of the Human Medicines Regulations 2012
Supply route
To prescribing practitioners and dispensing pharmacies only
Patient requirement
Unmet clinical need — no licensed equivalent available
Compound types
Sterile peptide preparations, unlicensed liquid and lyophilised vials
Documentation
Certificate of analysis, batch records, prescriber documentation
Labelling
To MSL and UK specials labelling requirements
Shelf life
Confirmed per compound based on stability data
All parameters are indicative and subject to change pending MHRA MSL grant. This service is in development and not yet commercially available. Specials may only be supplied in response to a bona fide unsolicited order for a named patient from a prescribing practitioner or dispensing pharmacy.
Register Interest
If you are a prescribing practitioner or dispensing pharmacy with patients requiring sterile peptide preparations that are not available as licensed medicines, Thanet Labs would welcome an early conversation. Registering interest now helps us understand the clinical need and ensures that our planned Specials service is structured to meet prescriber and pharmacy requirements. We aim to respond to all enquiries within two working days.
