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Drug procurement advice: Restrictions on the import of unlicensed Melatonin products following the grant of a marketing authorisation for Circadin® 2mg tablets

Drug procurement advice
Advice to clinicians, pharmacists and procurement staff
For distribution within 5 days

Date: 15 August 2008 EL(08)A/11 Our Ref: MDR 13-08/08

Dear Healthcare Professional,

Restrictions on the import of unlicensed Melatonin products following the grant of a marketing authorisation for Circadin ® 2mg tablets 

At the beginning of June 2008, a licensed modified release melatonin product, Circadin ® (Lundbeck), became available in the UK.

Before June 2008, melatonin was only available in the UK in unlicensed medicinal products, many of which were non-pharmaceutical grade products imported from the United States of America, where melatonin products are classed as supplements, not medicines. These products are not required to be manufactured to the standards of Good Manufacturing Practice normal for pharmaceuticals. It is therefore important to ensure that the licensed product available in the UK is used wherever possible. This includes off-label use of the licensed product , if deemed suitable by the clinician.

It is recognised, however, that there may be individual patients for whom the UK product cannot meet their clinical needs. In particular, there may be some need for alternative dosage forms, or strengths, or for an immediate release product.

Importation of unlicensed melatonin products remains possible under the MHRA scheme for the import of unlicensed medicines. Details of the scheme are available in our Importing unlicensed medicines section.

Prescribers will need to provide written details of the special clinical need to the importer for submission to the MHRA. Details have to be provided with every order and not just the first occasion.

Patient identification is not required in letters from clinicians in order to maintain patient confidentiality.

The MHRA does not provide template letters for clinicians. Importers are familiar with the MHRA requirements for letters concerning special clinical need. For questions on this area we would ask any newly affected parties to contact their proposed importer in the first instance. For all other enquiries on this notice, please contact Ms Raia Stoyanova on 0207 084 2625.

Primary Care Trusts are requested to forward this letter to General Practitioners and Retail Pharmacies. NHS QC recipients are requested to forward this to Purchasing Pharmacists and Clinicians.

Yours faithfully

Ian Holloway

MHRA distribution:
Regional Contacts for NHS Trusts and Provider Units
Chief Pharmacists: England, Scotland, Wales, Northern Ireland
Prison Health Policy Unit (DH)
Chief Pharmacists: Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Special Hospitals
Healthcare Commission for distribution to Independent Health Care Establishments
Primary Care Trusts ( England)

Page last modified: 15 August 2008