1-20 of 25 results for subject:Melatonin
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- subject_t:Melatonin OR subject_t:Circadin OR subject_ses:457812
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To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the effectiveness of the regulatory classification of melatonin in the UK compared with other countries.
To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the effectiveness of the regulatory classification of melatonin in the UK compared with other countries.
The Department has not undertaken a formal assessment comparing the United Kingdom’s prescription-only classification of melatonin with its status in other countries. In the UK, melatonin is regulated as a prescription only medicine. Decisions on how medicines are classified are made by the Medicines and Healthcare products Regulatory Agency (MHRA) upon receipt of an application from a company, in accordance with the Human Medicines Regulations 2012. This process considers each medicine’s safety profile, effectiveness, and whether it can be used without medical supervision.
Other countries may allow melatonin to be sold over-the-counter or as a supplement, for example in the United States. Such differences reflect varying regulatory frameworks and healthcare contexts internationally.
The UK remains responsive to new evidence, and the MHRA will continue to consider any well-founded applications to reclassify melatonin or similar products, ensuring that patient safety and clinical benefit remain paramount.
To ask the Secretary of State for Health and Social Care, what steps he is taking to raise awareness of the potential long term effects of melatonin usage.
To ask the Secretary of State for Health and Social Care, what steps he is taking to raise awareness of the potential long term effects of melatonin usage.
In the United Kingdom, melatonin must be prescribed by a healthcare professional. Melatonin is authorised for a number of indications which specify short term use. For indications that may require longer term use, such as insomnia in children and adolescents aged six to 17 years old with attention deficit hyperactivity disorder, where sleep hygiene measures have been insufficient, there is advice to regularly review treatment, at least every six months, and that during treatment, especially if the treatment effect is uncertain, treatment should be interrupted, stopped briefly, once per year to check whether the treatment is still needed.
The product information provides information to support the use of melatonin, including warnings about possible interactions with other medication as well as details of possible side effects.
The Medicines and Healthcare products Regulatory Agency continuously monitors the safety of all medicines on the UK market, including melatonin, and will take appropriate regulatory action if new safety issues are identified.
To ask the Secretary of State for Health and Social Care, whether there are license applications for melatonin gummy products being processed as of 23 November 2023.
To ask the Secretary of State for Health and Social Care, whether there are license applications for melatonin gummy products being processed as of 23 November 2023.
The Medicines and Healthcare products Regulatory Agency can confirm that there are currently no licensed melatonin gummy products. However, we are unable to confirm or deny whether we have received or are progressing a Marketing Authorisation Application for melatonin gummies as this information is commercially sensitive.
To ask the Secretary of State for Health and Social Care, whether melatonin gummies are licensed for use on the NHS.
To ask the Secretary of State for Health and Social Care, whether melatonin gummies are licensed for use on the NHS.
There are no melatonin gummy products licensed in the United Kingdom. Therefore, there is currently no prescribing of these products reimbursable by the National Health Service. While no recent discussions between the Medicines and Healthcare products Regulatory Agency (MHRA) and my Rt hon. Friend, the Secretary of State for Health and Social Care, on the potential use of melatonin gummies by the NHS have occurred, the MHRA are looking at the reclassification of the products where melatonin may feature as a section of the Primary Care Recovery Plan.
To ask the Secretary of State for Health and Social Care, whether he has had recent discussions with the MHRA on the potential use of melatonin gummies by the NHS.
To ask the Secretary of State for Health and Social Care, whether he has had recent discussions with the MHRA on the potential use of melatonin gummies by the NHS.
There are no melatonin gummy products licensed in the United Kingdom. Therefore, there is currently no prescribing of these products reimbursable by the National Health Service. While no recent discussions between the Medicines and Healthcare products Regulatory Agency (MHRA) and my Rt hon. Friend, the Secretary of State for Health and Social Care, on the potential use of melatonin gummies by the NHS have occurred, the MHRA are looking at the reclassification of the products where melatonin may feature as a section of the Primary Care Recovery Plan.
To ask the Secretary of State for Health and Social Care, whether melatonin gummies have been prescribed for children on the NHS; and if he will make a statement.
To ask the Secretary of State for Health and Social Care, whether melatonin gummies have been prescribed for children on the NHS; and if he will make a statement.
There currently are no melatonin gummy products licensed in the United Kingdom. Therefore, there will be no prescribing of these products for children reimbursable by the National Health Service. That said, the Medicines and Healthcare products Regulatory Agency (MHRA) is reviewing the reclassification of products where melatonin may feature as a section of the Primary Care Recovery Plan.
To ask the Secretary of State for Health and Social Care, if he will make an assessment of the potential merits of prescribing melatonin gummies for sleep disorders in children.
To ask the Secretary of State for Health and Social Care, if he will make an assessment of the potential merits of prescribing melatonin gummies for sleep disorders in children.
There currently are no melatonin gummy products licensed in the United Kingdom. The Medicines and Healthcare products Regulatory Agency (MHRA) will review and advise on the benefits and risks for a given medicine when marketing authorisation applications are received for specific products with the appropriate clinical data. Currently there are no products submitted and since the MHRA’s remit does not extend to soliciting such applications, it cannot make an assessment of the potential merits of prescribing melatonin gummies for sleep disorders in children.
To ask the Secretary of State for Health and Social Care, if his Department will make an assessment of the merits of licensing melatonin for over 18s in the UK who are diagnosed with autism and related sleep disorders.
To ask the Secretary of State for Health and Social Care, if his Department will make an assessment of the merits of licensing melatonin for over 18s in the UK who are diagnosed with autism and related sleep disorders.
The National Institute for Health and Care Excellence has published guidance for the use of melatonin in the United Kingdom which is available at the following link:
https://cks.nice.org.uk/topics/insomnia/prescribing-information/melatonin/
Currently, the Medicines and Healthcare products Regulatory Agency has made no specific assessment of licensing melatonin for over 18s in the UK who are diagnosed with autism and related sleep disorders. Clinicians make prescribing decisions for patients, taking into account best prescribing practice, appropriate guidance and the local commissioning decisions of integrated care boards. The clinician works with the patient to decide on the course of treatment, with the provision of the most clinically appropriate care being the primary consideration.
To ask the Secretary of State for Health and Social Care, if he will make an assessment of the potential implications for his policies of the recommendations of the use of melatonin by children with (a) autism and (b) ADHD who have a sleep disorder.
To ask the Secretary of State for Health and Social Care, if he will make an assessment of the potential implications for his policies of the recommendations of the use of melatonin by children with (a) autism and (b) ADHD who have a sleep disorder.
We have made no specific assessment. Clinicians make prescribing decisions for patients, taking into account best prescribing practice, appropriate guidance and the local commissioning decisions of integrated care boards. The clinician works with the patient to decide on the course of treatment, with the provision of the most clinically appropriate care being the primary consideration.
To ask the Secretary of State for Health and Social Care, for what reasons Circadin is available in Scotland for the treatment of insomnia caused as a result of dementia but not in England.
To ask the Secretary of State for Health and Social Care, for what reasons Circadin is available in Scotland for the treatment of insomnia caused as a result of dementia but not in England.
The availability of treatments in Scotland is a matter for the devolved administration.
In England, the National Institute for Health and Care Excellence (NICE) is the independent body that develops authoritative, evidence-based guidance on best practice in health and social care. NICE’s guideline on the assessment, management and support for people living with dementia and their carers, published in 2018, recommends that Circadin (melatonin) should not be offered to manage insomnia in people living with Alzheimer's disease, and that a personalised multicomponent sleep management approach that includes sleep hygiene education, exposure to daylight, exercise and personalised activities should be considered for people living with dementia who have sleep problems.
Further information about the evidence underpinning NICE’s guideline is available at the following link:
https://www.nice.org.uk/guidance/ng97/evidence/full-guideline-pdf-4852695709
NICE does not make recommendations on the use of melatonin in the treatment of patients living with other types of dementia who have sleep problems.
To ask the Secretary of State for Health and Social Care, what plans he has to make Circadin available in England to people suffering from insomnia caused by dementia.
To ask the Secretary of State for Health and Social Care, what plans he has to make Circadin available in England to people suffering from insomnia caused by dementia.
The availability of treatments in Scotland is a matter for the devolved administration.
In England, the National Institute for Health and Care Excellence (NICE) is the independent body that develops authoritative, evidence-based guidance on best practice in health and social care. NICE’s guideline on the assessment, management and support for people living with dementia and their carers, published in 2018, recommends that Circadin (melatonin) should not be offered to manage insomnia in people living with Alzheimer's disease, and that a personalised multicomponent sleep management approach that includes sleep hygiene education, exposure to daylight, exercise and personalised activities should be considered for people living with dementia who have sleep problems.
Further information about the evidence underpinning NICE’s guideline is available at the following link:
https://www.nice.org.uk/guidance/ng97/evidence/full-guideline-pdf-4852695709
NICE does not make recommendations on the use of melatonin in the treatment of patients living with other types of dementia who have sleep problems.
When and for what reasons it was made illegal to offer kava kava for sale in the United Kingdom; and what assessment they have made of (a). the implications for public health of this decision; and (b) the legality of the continued marketing of products containing kava kava for sale...
When and for what reasons it was made illegal to offer kava kava for sale in the United Kingdom; and what assessment they have made of (a). the implications for public health of this decision; and (b) the legality of the continued marketing of products containing kava kava for sale...
When and for what reasons it was made illegal to offer melatonin for sale in the United Kingdom; and what assessment they have made of (a). the implications for public health of this decision; and (b) the legality of the continued marketing of products containing melatonin for sale to United...
When and for what reasons it was made illegal to offer melatonin for sale in the United Kingdom; and what assessment they have made of (a). the implications for public health of this decision; and (b) the legality of the continued marketing of products containing melatonin for sale to United...
asked Her Majesty's Government:How many complaints about food supplements and herbal remedies being marketed in the United Kingdom with illegal health claims by companies based in the Channel Islands have been referred by the Medicines and Healthcare Products Regulatory Agency to the appropriate agencies in Guernsey and Jersey in the...
asked Her Majesty's Government:How many complaints about food supplements and herbal remedies being marketed in the United Kingdom with illegal health claims by companies based in the Channel Islands have been referred by the Medicines and Healthcare Products Regulatory Agency to the appropriate agencies in Guernsey and Jersey in the...
What assessment they have made of the claims that Beres Drops cure cancer by the Healthy for Life company of the Channel Islands in its direct marketing to United Kingdom consumers; and
What assessment they have made of the claims that Beres Drops cure cancer by the Healthy for Life company of the Channel Islands in its direct marketing to United Kingdom consumers; and
What powers are available to the Medicines and Healthcare products Regulatory Agency to prevent the marketing to United Kingdom mainland consumers of unlicensed medicinal products by companies based in the Channel Islands; and what steps they will take to address this issue.
What powers are available to the Medicines and Healthcare products Regulatory Agency to prevent the marketing to United Kingdom mainland consumers of unlicensed medicinal products by companies based in the Channel Islands; and what steps they will take to address this issue.
What steps they propose to take to prevent direct-mail advertising from the Channel Islands offering products banned in the United Kingdom and products for which promotional health claims are made that would be illegal in the United Kingdom and the European Union; and
What steps they propose to take to prevent direct-mail advertising from the Channel Islands offering products banned in the United Kingdom and products for which promotional health claims are made that would be illegal in the United Kingdom and the European Union; and
Further to the Written Answers by Baroness Hayman on 4 November (44-5WA), whether the Court of Appeal judgment to which they refer was the recent case involving melatonin which is licensed as a medicine in most other European Union member states; and why, if so, they deem this case relevant...
Further to the Written Answers by Baroness Hayman on 4 November (44-5WA), whether the Court of Appeal judgment to which they refer was the recent case involving melatonin which is licensed as a medicine in most other European Union member states; and why, if so, they deem this case relevant...
What steps he is taking to stop the sale of naturally-occurring melatonin in health food shops; what representations he has received calling for chemical equivalents to be available on prescription; and what assessment he has made of the differences between the two products; and what proposals DH has for making...
What steps he is taking to stop the sale of naturally-occurring melatonin in health food shops; what representations he has received calling for chemical equivalents to be available on prescription; and what assessment he has made of the differences between the two products; and what proposals DH has for making...
What is his Department's policy towards foods containing melatonin.
What is his Department's policy towards foods containing melatonin.