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 a 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 recently 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 only are made under the so-called "national procedure" to the UK Medical and Healthcare products Regulatory Agency (MHRA). The EU "mutual recognition" procedure can be used where an MA has already been obtained in a European Economic Area (EEA) member state[i] and authorisation is required in further such states. The EU "decentralised" procedure can be used where there is not yet an MA in any EEA member state. In that case the applicant must choose an EEA member state to act as a "reference member state" and authorisations in other such states will be based on the assessment in that state. Alternatively, in many cases an authorisation covering the whole of the EU can be obtained through the EU "centralised" procedure, and this can be extended to the EEA states.
The effect of Brexit
During the transitional period, the UK has no longer been able to act as the reference member state in relation approvals of MAs, but UK authorisation has continued to be available through the mutual recognition and decentralised procedures. Similarly, the UK has still been treated as part of the EU for the purposes of the centralised procedure. After the end of the transition period on 31 December 2020, the UK will no longer be treated as part of the EU for the purposes of the centralised procedure and UK authorisation will no longer be available through the mutual recognition and decentralised procedures. UK businesses will, however, still be able to use these procedures to obtain MAs in the EU27, Norway, Lichtenstein and Iceland. Where an existing authorisation under the centralised procedure covers the UK at the end of the transition period, this will automatically be converted into a UK MA.
[i] The EU Member States plus Iceland, Lichtenstein and Norway.
Charlotte Tillett