A marketing authorisation (MA) is the regulatory gateway to the market for medicinal products. A pharmaceutical company must have an MA – sometimes referred to as a licence – before it can advertise and sell a new medicinal product, for example a medicine or vaccine.
The MA will state the illnesses or conditions and age of patients the product is intended for and will specify the dosage and how it should be administered (e.g. tablet or cream). This will appear on the patient information that comes with the product.
Obtaining an MA – originator products
In order to obtain an MA, the pharmaceutical company must provide evidence to the licensing authority both that the product is safe and that it is effective to treat (or in the case of a vaccine, for example, to prevent) the relevant illness or condition. In the case of new medicines and vaccines, this will usually involve evidence of tests and clinical trials carried out by the originator company. Once the MA has been granted, the MA holder will have a period of data exclusivity during which others cannot rely on that evidence to obtain an MA for the same drug. In practice, the result is usually that competitors cannot sell copycat drugs during this period, even if the product is not protected by a patent. Read more about data exclusivity in our previous article here.
Obtaining an MA – generics
If the medicine has been successful, it is common for generic companies to enter the market after both the data exclusivity period and the period of any patent protection has run out. Generics can obtain an MA through an abridged procedure by demonstrating that their product is the same as the original product, so avoiding the need to repeat trials on animals and humans unnecessarily and allowing generics a quick entry to the market.
Off-label medicines
A medicinal product cannot be sold or promoted for a particular use without an MA relating to that use. In some instances, however, medical opinion indicates that a drug is effective for a different use and a doctor may prescribe that drug "off-label" for that use. A controversial instance of this arose in relation to Avastin (which is licensed for cancer treatment) for treating wet age-related macular degeneration, use of which became widespread, not because there were no alternative licensed treatments, but because those treatments were more expensive.
Applications
MAs are generally country-specific – they are obtained by applying to the relevant medical health authority. Applications for MAs for the UK are made to the UK Medical and Healthcare products Regulatory Agency (MHRA).
Effect of Brexit
Following the end of the Brexit transition period on 31 December 2020 new applications for UK MAs can no longer be made through EU procedures. However, under the Northern Ireland Protocol, Northern Ireland is treated differently and is still subject to EU requirements governing medicinal products. An MA for Northern Ireland can, therefore, still be obtained via the centralised, decentralised or mutual recognition procedures operating in the EU. In addition, an MA covering Northern Ireland may be obtained through an application to the MHRA.
UK businesses are still able to use the EU procedures to obtain MAs in the EU Member States, Iceland, Liechtenstein and Norway.
Charlotte Tillett