Under the Presentational Limb, the Medicines and Healthcare products Regulatory Agency (MHRA)  will consider the validity of assertions, characteristics and claims being made for it as a whole, and whether it is being presented as a medicinal product.

Under the Functional Limb, the MHRA will consider its actual function and its intended use, and whether it is to be administered with a view to achieving a medical purpose.

Placing a Medicinal Product on the Market

The sale of medicinal products is tightly regulated given the clear risk to public health without tight parameters. In the UK, a licence is required to sell or supply medicinal products.[1] (a marketing authorisation), which is issued by the MHRA (for UK). Once granted, the medicinal product can be sold or supplied in the UK under the terms of that licence, the HMR and other laws and regulations which ensure the safety, quality, and adverse events are tightly monitored and any claims made about the product are fair, balanced, can be substantiated and do not give false hope (amongst other things). 

The parameters of the marketing authorisation will include details as to the indication for which it can be used, (e.g., in the case of Viagra® (sildenafil), erectile dysfunction “ED”) along with its conditions of sale, such as whether the product is ‘POM’, ‘P-Meds’ or ‘general sale’.[2]

Factors that influence the MHRA’s determination include the maximum single dose, the maximum daily dose, the strength of the product, its pharmaceutical form, its packaging, and any other circumstances related to the product that the MHRA considers relevant.[3] The licence runs for a period of 5 years, after which it can be renewed indefinitely.[4]

Changes to the Marketing Authorisation

Initially, Viagra® (sildenafil) was classified as a POM. However, in 2017, the MHRA recommended that it should be made available as a P-Meds and after a public consultation the MHRA relaxed its status.  In making its decision the MHRA decided that the benefits of permitting Viagra® (sildenafil) to be sold without a prescription outweighed potential risks, particularly given the rise in counterfeiting of the little blue pill.   

We hope you found this brief article interesting.  The procedure for placing a medicinal product on the market is intricate this article does not constitute legal advice.  There are many areas which need to be addressed before placing a HMP on the market, some of which we will consider in later articles. 

Please do feel free to reach out to Wendy Lloyd-Goodwin (wendy@lslawservices.com ) at Life Science Law with any queries.

© Life Science Law 14th February 2021.

[1] The Human Medicines Regulations 2012, s 46.

[2] The Human Medicines Regulations 2012, s 62.

[3] Ibid.

[4] The Human Medicines Regulations 2012, s 65-66.