In June, Colonis Pharma Limited has obtained marketing authorisation for a licensed version of Melatonin 1mg/ml oral solution sugar free in a pack size of 150ml with a list price of £130 (correct at time of writing). This product is licensed for the short-term treatment of jet-lag in adults and its Summary of Product Characteristics can be accessed here.

For England and Wales, following representation from the PSNC, the Department of Health and Social Care (DHSC) has retrospectively agreed that from July 2019:

  • Melatonin 1mg/1ml oral solution sugar free (150ml) – is added to Part VIIIA of the Drug Tariff as a Category C line based on Colonis Pharma,
  • Melatonin 5mg/5ml oral solution and Melatonin 5mg/5ml oral suspension – are deleted from Part VIIIB.

Payments for July’s prescriptions will reflect this and not as per the published July English and Welsh Drug Tariff.

Community Pharmacy Scotland has confirmed that they are assessing each prescription on a case by case basis until a policy has been agreed for going forward.

No decision has been made yet for prescriptions processed in Northern Ireland.

The Numark Information Team has been asked by many of our members how they will be able to continue to supply the unlicensed product when asked to do so by the prescriber or patient. The Medicines and Healthcare Products Regulatory Agency (MHRA) issued guidance ‘The supply of unlicensed medicinal products (“specials”)’[1] in May 2014, which states:

  • An unlicensed special should not be used where a product available and licensed in the UK could be used to meet a patient’s special need
  • Although MHRA does not recommend "off label" (outside of the licensed indications) use of products, if the UK licensed product can meet the clinical need, even "off-label", it should be used instead of an unlicensed product. Licensed products available in the UK have been assessed for quality safety and efficacy. If used "off-label" some of this assessment may not apply, but much will still be valid. This is better than the use of an un-assessed, unlicensed product. The fact that the intended use is outside of the licensed indications is therefore not a reason to use an unlicensed product. It should be understood that the prescriber’s responsibility and potential liability are increased when prescribing off-label. 
  • Anyone supplying an unlicensed medicinal product, where an equivalent licensed medicinal product is available must be satisfied as to the existence of a special need for the unlicensed medicinal product. MHRA expects that documentary evidence of this special need should be obtained by manufacturers, importers or distributors and that this evidence should be made available on request of the Licensing Authority.  This may take the form of a prescriber’s letter, however an alternative fully documented audit trail through the supply chain confirming special need may be acceptable.

This means that Specials Manufacturers will ask for a letter from the prescriber to confirm the special need for an unlicensed product over a licensed product before a supply of an unlicensed product can be made.

Colonis Pharma has also licensed Melatonin 3mg tablets for the short-term treatment of jet-lag in adults.