FOI release
Medicinal Products
Case reference FOI2025/00945
Received 2 September 2025
Published 9 October 2025
Request
We do have a couple of follow up questions to clarify your statement. The first question relates to the statement: However, we do not currently consider vitamins and minerals administered intravenously or by injection to have pharmacological, immunological or metabolic action and therefore, provided that no medicinal claims are made, injectable products administered for a nonmedicinal purpose can be regarded to fall outside the definition of a medicinal product and outside the remit of the MHRA. We highlighted that, at the current time, an approved establishment WDA 49864 is able to promote and sell on their website an 8g/50ml ascorbic acid parenteral preparation as a supplement. Our product is a 7.5g/50ml ascorbic acid parenteral preparation which is licensed accordingly: PL 14369/0009. Clearly the licensed product is not inert, has active ingredients, and has pharmacological properties – hence its required licensed status, so is it therefore logical to extrapolate and assume that a bioequivalent product also has the same pharmacological properties and therefore cannot be deemed a supplement? Also, the primary intended purpose of the product and the manner in which it would be used requires consideration. By the very nature of a parenteral preparation there is associated pharmacovigilance with a relative greater risk of adverse events (including infection; extravasation; degradation of product) that may arise as a result of its design, formulation and mode of administration that surely would require oversight by the MHRA? Indeed, The Human Medicines Regulations 2012 state within https://www.legislation.gov.uk/uksi/2012/1916/schedule/1/part/1 The following medicinal products shall be available only on prescription— a product for parenteral administration Please can we have an explanation as how two products that are effectively bioequivalent can be seen as either a supplement or a licensed product respectively? The second question relates to the statement on medical claims. Could you clarify where you determine a medical claim to be made – eg for example but not limited to a manufacturer in its packaging leaflets (if it’s not supplied to a patient), an advert, a prescriber to a customer etc. This would be really useful in determining what and where a claim is in or outside of MHRA rules.
Response
See attached
Documents
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