Manufacturers of electronic cigarettes are advised by Spectrum Regulatory Solutions on how they can comply with ecig regulations that will be implemented in the UK starting 2016. Once the Tobacco Products Directive is approved, ecigs will be regulated as medicines.
If Law Is Enacted
Once approved and enacted, UK law will require ecigarette manufacturers several requisites in order to continue marketing their products in the UK. The need a marketing authorization, Class IIa medical device registration, and ecig components CE marking.
UK’s Commission on Human Medicine judged that ecigs are widely used as THR and thus, need to be categorized as medicinal products. Uk government announced therefore that MHRA will regulate ecigarettes along with other nicotine containing products as medicines. Compliance to this law is required come 2016.
MHRA welcomes companies that like to comply early in order to get ahead of the Tobacco Directive being passed as law. The process for certification is taxing and complex.
Managing Director of Spectrum, Dr. Angela Gisby, said that they can help ecig companies in meeting the requirements of ecig regulations from conducting studies to documentation, etc.
Spectrum has been around since 2005 and offers a complete service consultancy to the industry of healthcare. It has been working with several biggest companies in the medical and pharmaceutical companies worldwide.
It offers a collection of services that can support ecig manufacturers during run up for obtaining approval to market products and even during post marketing activities. Spectrum offers solution in regulatory affairs, in medical writing, in vigilance and safety, in readability, market access, compliance and quality assurance.
In the light of looming regulations, electronic cigarette manufacturers and companies will need the help offered by Spectrum so they can comply the best possible way with the rules and policies that the law would set for them. To be considered as a medicinal product is a rather distinctive avenue that ecig products must face if ever the Tobacco Directive will be made into law.