How ready are you for the new e-cigarettes legislation?
How ready are you for the new e-cigarettes legislation with the forthcoming implementation of Article 20 of the Tobacco Products Directive 2014/40/EU on 20th May 2016?
Do you have the have all the necessary information to hand to submit your e-liquid product notification to the MHRA?
Do you know what information you need to include in your product notification filing?
Do you know what information you might be missing and where to get it from?
Do you know if your vendors are supplying you with TPD compliant raw materials and packaging materials?
Do you actually know who the primary manufacturers of your raw materials are, or are your suppliers actually a broker?
Will your labelling be compliant with the new directive?
Are your manufacturing processes documented, robust and validated?
Do your products comply with the emissions testing requirements?
Do you have a robust Quality Management System in place with a formal change control system to record and validate any proposed changes to your raw materials and packaging materials to ensure ongoing compliance once you have achieved your product notification?
The consequences of non-compliance could be a batch recall and revocation of your notification.
Do you have a formal recall procedure in place? Have you confirmed that it works?
There are so many questions to find the answers to and time is ticking away, so let Diamond Pharma Services take up the strain and reduce your stress by supporting you with their expertise during these challenging next few months and beyond.
The flow of consultation, guidance and implementation documentation is now starting to be released by the EU Commission and the MHRA who are acting as the UK gatekeeper for product notifications.
- Commission Implementing Decision on TPD notifications
- Commission Implementing Decision on technical standards for the refill mechanism of electronic cigarette
- MLX 390 MHRA Consultation document on e-cigarette fees
- Draft Statutory Instrument on consumer protection: The Tobacco and Related Products Regulations 2016
Diamond Pharma Services can provide you with the following support:
- Generation of product Notifications
- Submission of product Notifications to MHRA/Local HA if not UK
- Updates/amendments to Notifications
- Generation of product labels
- Generation of product leaflets
- Provision of RP
- Generation of Quality Manuals/systems
- Support in setting up manufacturing processes
- Support with product development process
- Vapo-vigilance – the e-liquid equivalence of pharmacovigilance
For further information or to request support, please contact Lena Demetre:
Phone: +44 (0) 7876 664 543