MHRA

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    [post_date] => 2017-07-19 10:55:22
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    [post_content] => The regulation of homeopathic remedies

The manufacture of homeopathic remedies is regulated by the Medicines and Healthcare products Regulatory Agency (MHRA), which operates a system to register and license medicines.

Explanation of the categories of homeopathic remedies.

This article explains in more details the situation regarding different ‘categories’ of homeopathic remedies and their availability.

Licensed remedies

A relatively small number of homeopathic remedies are ‘licensed’, either through the MHRA’s ‘Homeopathic Registrations’ (HR) scheme or through the more recent ‘National Rules Marketing Authorisations’ (NR) scheme, introduced in 2006.

Homeopathic Registrations (HR)

While a fairly wide range of the more common remedies have been registered with the MHRA, under their Homeopathic Registrations scheme, so far only a few of them are actually available as licensed remedies and these are mostly in 6c or 30c potencies.

This is largely for practical and economic reasons: for the production of a specific remedy and potency to be viable, the manufacturer might need to make a batch of around 1,000 bottles of pills. While this might be feasible for the most commonly used remedies, eg Arnica 6c or Sulphur 30c, a manufacturer is less likely to be able to sell that many bottles of Calcarea iodata 10M,

Remedies licensed and manufactured under the HR scheme will be in a container with an HR number. Unopened containers of these remedies may be bought and sold in chemists, health food shops and clinics, and by practitioners. However, any guidance as to their use needs to be provided separately.

National Rules Marketing Authorisations (NR) 

So far, only a very small number of remedies have been produced under the NR scheme. Some of these are single remedies, eg Nelsons’ Sulphur 30c, and some are combinations.

Remedies in this category have been licensed with specific indications for their use, which are only in relation to self-limiting conditions, and may be sold with these indications. As an example, Nelsons’ Sulphur 30 is licensed for use ‘in the homeopathic tradition’, with the specification ‘for the symptomatic relief of pimples and spots, of mild acne, that are not infected or inflamed and skin prone to eczema, irritation and itching.’
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The regulation of homeopathic remedies

The manufacture of homeopathic remedies is regulated by the Medicines and Healthcare products Regulatory Agency (MHRA), which operates a system to register and license medicines.

Explanation of the categories of homeopathic remedies.

This article explains in more details the situation regarding different ‘categories’ of homeopathic remedies and their availability.

Licensed remedies

A relatively small number of homeopathic remedies are ‘licensed’, either through the MHRA’s ‘Homeopathic Registrations’ (HR) scheme or through the more recent ‘National Rules Marketing Authorisations’ (NR) scheme, introduced in 2006.

Homeopathic Registrations (HR)

While a fairly wide range of the more common remedies have been registered with the MHRA, under their Homeopathic Registrations scheme, so far only a few of them are actually available as licensed remedies and these are mostly in 6c or 30c potencies.

This is largely for practical and economic reasons: for the production of a specific remedy and potency to be viable, the manufacturer might need to make a batch of around 1,000 bottles of pills. While this might be feasible for the most commonly used remedies, eg Arnica 6c or Sulphur 30c, a manufacturer is less likely to be able to sell that many bottles of Calcarea iodata 10M,

Remedies licensed and manufactured under the HR scheme will be in a container with an HR number. Unopened containers of these remedies may be bought and sold in chemists, health food shops and clinics, and by practitioners. However, any guidance as to their use needs to be provided separately.

National Rules Marketing Authorisations (NR) 

So far, only a very small number of remedies have been produced under the NR scheme. Some of these are single remedies, eg Nelsons’ Sulphur 30c, and some are combinations.

Remedies in this category have been licensed with specific indications for their use, which are only in relation to self-limiting conditions, and may be sold with these indications. As an example, Nelsons’ Sulphur 30 is licensed for use ‘in the homeopathic tradition’, with the specification ‘for the symptomatic relief of pimples and spots, of mild acne, that are not infected or inflamed and skin prone to eczema, irritation and itching.’

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