Importing or manufacturing a regulated product comes with a great deal of responsibility and often involves complex systems and processes to be in place to ensure compliance, including the requirement of a Quality Management System.
Inter Regulatory is uniquely positioned to assist in 360° of the product life-cycle process. We can help with as many or a few stages of the life-cycle as are required. Whether supporting our clients to implement processes and procedures through in-house consultancy or managing their regulatory processes on their behalf, we aim to create innovative solutions for theirs and their product needs.
The Tobacco Products Directive (2014/40/EU) is the European Directive governing the manufacture, importation and sale of tobacco products with the European Union. The Directive covers cigarettes, oral tobacco, novel tobacco products and e-cigarettes & e-liquids (ENDS). The Directive came into legal effect in May 2016.
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.
Since January 2019, CBD products have been regulated as Novel Food Products in the European Union following the decision by the European Commission. CBD manufacturers, trade bodies and suppliers are required to apply for authorisation with a deadline of March 31, 2021 set for all applications for products on the market.
Pharmaceuticals and medical devices are highly regulated with comprehensive requirements to ensure patient safety and product quality and efficacy. Inter Science brings all the required skills together to offer our clients state-of-the-art knowledge to decrease the regulatory burden.