Dedicated to the compliance of
Nicotine Containing Products

Dedicated to the compliance of
Nicotine Containing Products

Dedicated to the compliance of
Nicotine Containing Products

Dedicated to the compliance of
Nicotine Containing Products

Dedicated to the compliance of
Nicotine Containing Products

Dedicated to the compliance of
Nicotine Containing Products

e-liquid pens

Welcome To
Inter Regulatory

Established by experienced individuals to provide a single firm solution to regulatory needs for e-cigarettes, e-liquids and novel medicines. We bring together the skills and expertise needed to provide innovative solutions to regulatory challenges.

three leaves

About us

We are a firm dedicated to bridging the gap between industry and regulators through supporting you through the emerging regulatory landscape for Nicotine Containing Products in a simple, and pragmatic way.

Meet our team

Mark Dignum

Mark has worked with pharmaceutical and medical device products for over 20 years and has been involved in ENDS for 8 years.

Mark was listed as the Quality Expert on the Nicadex / e-voke project and worked on the development, characterisation and registration of the product through to final approval.

Mark has a thorough understanding and appreciation of the regulatory framework for a wide range of products over a wide range of territories.

Mark has worked with regulators on ENDS and has significant experience in quality, characterisation and production standards.

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David Lawson

A biochemist by background, David was responsible for the project management and submission of the worlds first medically regulated electronic cigarette which was approved in 2013 by the medicine regulator in the UK, e-Voke.

David has worked exclusively in the ENDS category for over 7 years and has acquired a wealth of knowledge in all areas of ENDS regulation. He was also the Quality Manager for e-VOKE and responsible for the CE marking of the medical device.

More recently, David has been responsible for establishing a world class consultancy team focusing on ENDs and pharmaceutical product development.

David also sat as a technical expert on 3 working groups contributing to the European Tobacco Products Directive (TPD) as well as sitting on the Technical Committee established for TPD.

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Sarah Lea-Hayes

Sarah is a Biomedical Scientist by background. During her degree Sarah was responsible for clinical trials into COPD and Allergic Broncho-Pulmonary Aspergillosis at the University Hospital of South Manchester and the Medicines Evaluation Unit.

With a strong background in respiratory science, Sarah has also worked on new product development with the Ministry of Defence for decontamination units and respiratory protective devices.

She is currently working towards her MSc in Medicinal Chemistry with an interest in Respiratory disease and inhaled medications.

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Charlie Milford

Charlie has recently graduated in Biochemistry. During his degree, Charlie worked on the differences in gene expression levels between artificially engineered and naturally-occurring tendons.

Having worked within the e-cigarette industry for the past two years, he has gained insight into how the industry operates as well as a strong understanding of the e-cigarette market, and how regulation shapes the ENDS industry.

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Commitment to Quality

Here at Inter Regulatory, we are passionate about Quality. It is at the heart of what we do, and what we offer to you. It is for this reason that we operate under an ISO9001 certified Quality Management System.We are certified by the British Standards Institute for: "the provision of consultancy services to the regulated nicotine products category."

Our commitment to quality extends from the scoping of projects and services to the notification of data to regulators. It is through our approach to quality that we seek to exceed your expectations.

nicotine
science behind nicotine

Our Quality Policy

"Inter Regulatory is committed to both its clients and to its personnel, to strive to be a world class leader in regulatory advice, consultancy and engagement in the Nicotine Containing Products category, and to contribute to the protection of public health from the risks of combustible tobacco.

Inter Regulatory is committed to continually improving its systems and services to achieve the highest level of customer satisfaction while meeting all regulatory, legal and environmental obligations. Inter Regulatory strives to achieve this through its commitment to its Quality Objectives.

In its commitment to its employees, Inter Regulatory is dedicated to engaging all employees in strategic decisions of the company, providing a safe and welcoming workplace and promoting a blame-free culture of work".

Pre-Market Tobacco Applications

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.

We understand that committing your company to attaining a marketing order through the PMTA process is not a decision that should be taken lightly, and will require substantial resource from your company. From our extensive experience of the regulated ENDS category we have developed a road map to guide you on your way through the process. Our aim is to simplify the PMTA process for you and to assist you in every step of the way.

The requirements for compliance with the current guidance for PMTA is onerous and entails satisfying the requirements of a broad number of areas related to product and public health and safety. Formulation of an appropriate strategy, taking a risk-based approach, is fundamental to Inter Regulatory approach to PMTA. Early engagement with the FDA is key in reducing the risk of a rejection to grant a marketing order. The outcome of the PMTA is a dossier of information related to the product which demonstrates that the product is of benefit to public health. There are many ways in which to demonstrate this outcome however the adopted approach must be accepted by the FDA who are the custodian of the market order, the document that will permit you to sell your product on the US market.

The key areas which need to be addressed for each product undergoing scrutiny by the FDA under PMTA are:

  • Chemical, control and manufacture of the product (hardware and liquid)
  • Non-clinical or toxicological impact of the product
  • Human Health Impact evaluation
  • Consumer Perceptions
  • Gateway Use
  • Product Use Patterns
  • Human Factors and Abuse Liability
  • Biomarkers of Harm and Exposure
  • Health Outcome

Initial engagement and establishment of requirements

Review of current product pertfolio and data

Generation of PTMA strategy and briefing document

FDA engagement and refinement of strategy

Commerce analytical testing and toxilogical review of products

Review manufacturing process and control

Compile Human Health Impact Information related to product

Complete Consumer Perceptions analysis of product

Evaluate potential for Gateway use

Determine Product Use Patterns

Evaluate Human Factors and Abuse Liability

Justify biomarkers of harm and exposure

Complete review of PTMA and finalise for submission

Deadlines

Products introduced after 8th August 2016, must submit the ingredient listing 90 days before marketing.

8th November 2019
Submit the quantities of Harmful and Potentially Harmful Constituents (HPHCs).

11th May 2020
Deadline to submit a premarket application for new noncombustible tobacco products.

8th August 2021
Deadline to submit a premarket application for new combustible tobacco products.

FAQs

How Do I Demonstrate that the New Tobacco Product Is Appropriate for the Protection of Public Health?

Premarket Tobacco Applications must provide scientific data to demonstrate that the new tobacco product is beneficial to the population as a whole including users and non-users. This demonstration shall take into account the increased or decreased likelihood that existing tobacco users will stop using such products and the increased or decreased likelihood that those who do not use tobacco products will start using them.

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What information is needed in a Premarket Tobacco Application?

Premarket Tobacco Applications must include the information, as required by Section 910(b)(1) of the FD&C Act:

full reports of all information, published or known to, or which should reasonably be known to, the applicant, concerning investigations that have been made to show the health risks of such tobacco product and whether such tobacco product presents less risk than other tobacco products;

  • a full statement of the tobacco products:
    • components
    • ingredients
    • additives
    • properties
    • principle(s) of operation
  • a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of such tobacco product;
  • an identifying reference to any tobacco product standard, under section 907, which would be applicable to any aspect of such tobacco product, and either adequate information to show that such aspect of such tobacco product fully meets such tobacco product standard or adequate information to justify any deviation from such standard;
  • such samples of such tobacco product and of components thereof as the Secretary may reasonably require;
  • specimens of the labelling proposed to be used for such tobacco product, and such other information relevant to the subject matter of the application as the Secretary may require.
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When should a Premarket Tobacco Application be submitted?

The applicant must obtain an order from FDA authorizing marketing of the new product before it can be introduced or delivered for introduction into interstate commerce as per Section 910(a)(2) of the FD&C Act. To receive a marketing order, a premarket tobacco application must be submitted by the applicant, reviewed by FDA, and determined to be appropriate for the protection of public health.

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What happens after a Premarket Tobacco Application is submitted?

Upon receipt of an application, the FDA will determine if the application can be accepted and then filed for substantive review. FDA has refused to accept procedures for premarket tobacco product submissions.

If the application is accepted, the FDA then will conduct a filing review to determine whether the application is complete, i.e., whether it contains all the items under Section 910(b)(1) of the FD&C Act. If not, the application is incomplete, and we will refuse to file it.

If the application is complete, FDA will file the application and begin substantive review.

As part of its review, the FDA may refer the applications to the Tobacco Product Scientific Advisory Committee(TPSAC). You may also request that FDA refer the application to TPSAC.

After completing its review, the FDA intends to issue an order within 180 days after receipt of the Premarket Tobacco Application that the new product may or may not be introduced or delivered for introduction to consumers.

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What is the deadline for PMTA submission?

Following the July 11th 2019 court ruling the deadline for submission has been brought foward to May 11th 2020. The ruling ordered that:

1. The FDA (Food and Drug Administration) shall require that, for new tobacco products on the market as of the August 8, 2016 effective date of the Deeming rule (“New Products”), applications for marketing orders must be filed within 10 months of the date of this Memorandum Opinion and Order;

2. New Products for which applications have not been filed within this period shall be subject to FDA enforcement actions, in the FDA’s discretion;

3. New Products for which applications have been timely filed may remain on the market without being subject to FDA enforcement actions for a period not to exceed one year from the date of application while FDA considers the application;

4. The FDA shall have the ability to exempt New Products from filing requirements for good cause on a case-by-case basis.

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Tobacco & Related Products Regulations

Since the 20th of May 2017, e-cigarettes and e-liquids containing nicotine in Europe have been subject to the Tobacco Products Directive, but National variation exists from state to state. In the UK, the directive is known as the Tobacco and Related Products Regulations (TRPR). The TRPR contains regulations tailored to the UK, such as a warning that covers 30% of the front and back packaging, and a £150 notification fee payable to the MHRA. A 6 month pre-notification must be submitted prior to products being placed on the market.

Having been involved in TRPR from the onset and subsequently in the standardisation across Europe, Inter Regulatory is your perfect TRPR partner.

Ingredient Disclosure

Aerosol Testing and Analysis

Toxicology Report Generation

Submission of Required Documents

Product Notification

Product Verification

Our services include:

  • Chemical analysis and characterisation
  • Product Toxicology Review
  • Review of Ingredient Toxicology
  • Data Submission to the Common Entry Gateway

Toxicology

Reports detailing the toxicological profiles of chemical ingredients are required for TRPR and TPD. This involves reviewing whether the chemical has any addictive, CMR, emissions, and cardiopulmonary toxicities. Toxicology reports are available for most chemical ingredients, and are available as single reports or batches. Feel free to contact us to discuss any requirements.

Request Toxicological Review on Ingredient

Review Ingredient and Conduct Toxicological Analysis

Report Delivery

Conversion to XML

Add to Notification

Upload to E-TrustEx

FAQs

What is the TRPR?

TRPR stands for Tobacco and Related Products Regulations. The TRPR is derived from an EU directive (the TPD) that came into effect on May 20th 2016. The TRPR introduced new laws for e-cigarettes, vaping devices and e-liquids.

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What does the TRPR involve?

The TRPR states that a notification shall include the following information:

The name and contact details of the manufacturer, a responsible legal or natural person within the Union, and, if applicable, the importer into the Union;

  • A list of all ingredients contained in, and emissions resulting from the use of, the product, by brand name and type, including quantities thereof;
  • Toxicological data regarding the product's ingredients and emissions, including when heated, referring in particular to their effects on the health of consumers when inhaled and taking into account, inter alia, any addictive effect;
  • Information on the nicotine doses and uptake when consumed under normal or reasonably foreseeable conditions;
  • A description of the components of the product; including, where applicable the opening and refill mechanism of the electronic cigarette or refill containers;
  • A description of the production process, including whether it involves series production, and a declaration that the production process ensures conformity with the requirements of this Article.
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What is the EU-CEG?

EU-CEG stands for the European Union Common Entry Gate. It is an online tool designed to ensure uniform reporting of information regarding tobacco products. The information required to complete a notification entry through the EU-CEG is follows from Article 5(5) and 20(13) of the Tobacco Products Directive (2014/40/EU).

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What happens after notification?

  • The notification will be reviewed by the relevant authorities, should there be any information missing from the notification then contact may be made in order to obtain this.
  • Once a notification is completed, Inter Regulatory will continue to provide services to navigate through the post-notification requirements and product development as you expand.
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What is the route from product creation to market?

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News & Updates

FDA are now cracking down on e-liquids that look like foods products

FDA are now cracking down on e-liquids that look like foods products

FDA are now cracking down on e-liquids that look like foods products

Address

10.6 The Matchworks,
Speke,
Liverpool,
L19 2RF

FS 681824 Inter Regulatory. A company registered in England and Wales, Company registration number: 10841512

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