Following the MHRA’s announcement at the end of July that the government will regulate electronic cigarettes and other nicotine containing products (NCPs) as medicines, the MHRA has issued further guidance to the industry.
Whilst this guidance is useful to those with an understanding of medicines and medical devices regulation, it may raise more questions than it answers for companies. One such question is likely to be what is the overall cost and timeframe. Regulis has reviewed the MHRA advice and is producing a paper explaining exactly what steps have to be undertaken to:
- Develop a regulatory strategy for a product or product portfolio
- Describe what data are required and the potential costs of generating this data
- Put the regulatory requirements and timelines in easy-to-understand terms
- Provide an overall cost of registration of an e-cigarette
- Future costs of owning and maintaining a medicines licence.
This paper will be available for a small fee. If you would like to receive the paper or to have a no obligation discussion with us about your products and their potential licencing, please contact us.
Regulis is well placed to work with companies on the licensing of NCPs as medicines since, as well as having extensive experience of working on the registration of medicines and medical devices, Regulis has also worked with smoking cessation products including smokeless cigarettes.