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Follow on Google News |  Spectrum advises manufacturers on UK eCigarette Regulatory Requirements for 2016 complianceElectronic cigarettes (eCigarettes) are set to be regulated as medicinal products under the Tobacco Products Directive when it is transcribed into UK law, which is expected to be in 2016.
Once the legislation is enacted, manufacturers of eCigarettes will require the following before they can market (or continue to market) their products in the UK: • A Marketing Authorisation (http://www.spectrumrs.com/ • Registration as a Class IIa medical device (http://www.spectrumrs.com/ • CE marking (http://www.spectrumrs.com/ Electronic Cigarettes to be Regulated as Medicines In line with the draft Tobacco Directive, the Commission on Human Medicines, the advisory body of the MHRA, has judged that eCigarettes are largely used to reduce the harm associated with tobacco smoking and should therefore be classed as a medicinal product. The UK government has therefore announced that the MHRA will regulate eCigarettes and other Nicotine Containing Products (NCPs) as medicinal products. The primary purpose of this regulatory change is to ensure the quality and safety of NCPs. As a result of these changes, companies in the UK are being encouraged to make early applications to the MHRA for medicines licenses for nicotine containing products, especially eCigarettes. Compliance Required By 2016 It is expected that the EU Tobacco Directive will be adopted in 2014, and will be transcribed into UK law by 2016. However, in line with government policy, the MHRA is already accepting MAAs for companies who wish to ensure early compliance with the up-coming law, and to ensure uninterrupted supply of eCigarettes in the UK market. Companies submitting an early MAA are likely to have a competitive advantage when the Tobacco Directive becomes UK law. Start Early In order to submit a MAA eCigarette manufacturers will be required to first conduct a series of analytical studies to demonstrate that the components of the eCigarette vapour are below permissible safety thresholds. In addition, they will need to conduct a Phase I clinical study in healthy volunteer smokers. This study, which typically involves about 25 individuals, is required to show that the amount of nicotine absorbed into the bloodstream from the eCigarette is bioequivalent to that from the Nicorette Inhaler. This clinical study is required to support the medicinal claim for the product (e.g. aids smoking cessation and/or reduces harm). Companies are advised to seek Scientific Advice from the MHRA before starting a development programme to ensure that regulatory expectations are met. In addition, if a CE mark for the electronic component of the eCigarette has not already been obtained, the studies required in support of an application to a Notified Body for the CE mark will need to be completed. “Spectrum can help our clients conduct these studies and prepare the regulatory documentation as well as help prepare the MAA and Technical File, if required” said Dr Angela Gisby, Managing Director. Following submission to the MHRA, a Complex Abridged MAA should be approved within 100 days (plus any days during the ‘clock stop’ when the Applicant is responding to regulatory questions). The time from an initial development programme for the eCigarette to final MHRA / Notified Body approval could be 12 months depending on if there are any safety concerns associated with the product. As well as competitive advantage, an additional advantage of seeking an early Marketing Authorisation from the MHRA is the possibility of benefiting from some flexibility in the application of the regulations. Currently MHRA is offering free scientific advice to early adopters. About Spectrum Spectrum Regulatory Solutions was established in 2005 and provides a full-service consultancy to the healthcare industry, working with some of the largest pharmaceutical and medical device companies in the world. Uniquely, this comprises a suite of services which support manufacturers both during the run-up to obtaining marketing approval, and in post-marketing activities. These services include regulatory affairs, medical writing, safety and vigilance, market access, readability, quality assurance and compliance. Spectrum recently successfully obtained ISO 9001:2008 certification, the highest standard of business quality management. Spectrum is part of the Zaicom International group of companies, established in 1998. Contact Ellie Coutts – Marketing Executive ecoutts@zaicom.com +44 (0)1403 320220 www.spectrumrs.com Follow Twitter: @SpectrumRS Google+: Spectrum Regulatory Solutions LinkedIn: Spectrum Regulatory Solutions End
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