A guide to what is a medicinal product

to be medicinal products. Examples of non medicinal procedures include tattoos, and cosmetic
procedures such as semi-permanent makeup.
Weight loss products
Many supplement products which make claims to reduce weight are not medicinal products.
However where the use is for a medical purpose, such as to treat clinical obesity, products can fall
within the definition of a medicinal product if: (a) they make medicinal claims; (b) if they modify
physiological functions by acting pharmacologically, immunologically or metabolically.
It is also possible that some ingested products with claims to be medical treatments and which act
by a physical action, such as by preventing fat being absorbed by the body or as bulking agents
could be classified as medical devices.
Nitrous oxide
Nitrous oxide, also known as ‘laughing gas’ is a substance with a number of legitimate
uses in medicine and catering. It is a medical gas (a medicinal product) and, when mixed
with oxygen, it is used to treat analgesia and as an anaesthetic. Use as a medicinal
product typically involves large cylinders containing the gases which are administered to
the patient using a face mask in a variety of settings such as hospitals, dental surgeries
and by ambulance crews. Nitrous oxide is also an approved food additive (E942) when
used as a propellant for whipped cream. Unless the products used are clearly medicinal
the MHRA nitrous oxide, when used for recreational purposes is not a matter for the
MHRA and the Home Office has issued guidance to enforcement bodies to restrict supply
for recreational purposes which can currently be found at the following link. (Also refer to
information about the Psychoactive Substances Act in Section 13, above.
https://www.gov.uk/government/publications/guidance-on-restricting-the-supply-of-nitrous-oxide-for-recreational-use
What to do if you are still unsure of the status of your product
Classification is carried out on a product by product basis. If you have looked at all the literature in
this Guidance Note and on the website and you are still unsure, complete the advice request form
which is available on the website at
https://www.gov.uk/decide-if-your-product-is-a-medicine-or-a-medical-device
under the sub-heading ‘Getting advice about your product’. When seeking advice from the Agency
it is expected that enquirers have read and taken into account the guidance contained in this
document and also have some knowledge of the use and function of the ingredients contained in
their product.
Marketing authorisations
Guidance on marketing authorisations is provided in the ”Notice to Applicants” (Volume II of the
Rules Governing Medicinal Products in the European Community) and can be obtained using the
link http://ec.europa.eu/health/documents/eudralex/index_en.htm.
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