The Tobacco Products Directive (2014/40/EU) or TPD, is the European Directive governing the manufacture, importation and sale of tobacco products with the European Union. The Directive covers various product types such as cigarettes, oral tobacco, novel tobacco products and e-cigarettes & e-liquids (ENDS). The Directive came into legal effect in May 2016 and places a certain responsibility on the manufacturer or importer of covered products.
In May 2016, the Food and Drug Administration finalised its “deeming” rule, subjecting nicotine products to scrutiny under the Federal Food, Drug, and Cosmetic Act as amended by the Family Smoking Prevention and Tobacco Control Act. Products marketed after February 2007 must submit a Premarket Tobacco Product Application (PMTA) before the product can be sold in the US.
Pharmaceuticals and medical devices are highly regulated with comprehensive requirements to ensure patient safety and product quality and efficacy. Inter Regulatory brings all the required skills together to offer our clients state-of-the-art knowledge to decrease the regulatory burdon.