. In this webinar we will provide a brief overview of section 905 of the Federal Food, Drug and Cosmetic Act. Fdc Act, establishment, registration and product listing requirements for Tobacco Product manufacturers, and we will show our viewers, the new Tobacco Registration Product, Listing Module Next Generation.. Let s go ahead and get started. Section 905 of the FDC Act covers the annual registration and product listing requirements. 1.. Section 905a1 defines the term manufacture, preparation, compounding or processing as including repackaging or otherwise changing the container wrapper or labeling of any tobacco product package. In furtherance of the distribution of the tobacco product from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user., 2., Section 905b requires owners and operators of establishments in any U.S. state territory or D.C. engaged in the Manufacturing, preparing compounding or processing of a tobacco product to register on or before December 31st of each year, 3., Section 905i3 requires that any changes in the product list be submitted biannually once during June and once during December. Next, we will review the Tobacco Registration Product Listing Module Next Generation also referred to as TRLM NG. The Center for Tobacco Products or CTP introduced TRLM NG. In August 2020., TRLM NG replaced the FDA, Unified Registration, Listing System Tobacco Registration, Product Listing Module, FURLS TRLM. TRLM NG has been modernized to streamline the process for registering and updating, registered establishment and product listings.. The TRLM NG landing page gives tobacco industry users access to TRLM NG so that they can create an account and register their establishments and list their products.

. Additionally, TRLM NG allows users to provide information about registration and product listing updates.. If the users experience an issue, there is a Need: Help weblink on the top right hand, corner of the landing page that contains downloadable resources such as TRLM NG user guides, training, videos, industry training, videos and TRLM NG FAQs.. Next, we will highlight the benefits to using the new TRLM NG system.. The new TRLM NG site allows industry users to Review guidance on FDA registration and product listing requirements for establishments, Register establishments, products and material files with FDA, Update registration, information annually and product listing changes. Biannually to comply with statutory requirements., You can access TRLM NG at httpstrlm ng industry.fda.gov.. Next, we will cover who should register their establishment and submit product listing information. Every person who owns or operates any domestic establishment engaged in manufacturing, preparing compounding or processing regulated tobacco products must register under section 905b of the FDC Act, and every registrant must file a list Of its regulated tobacco products, in accordance with section 905i of the FDC Act., An owner or operator, may authorize a third party agent to register their establishment and submit product listing information on its behalf., An importer who does not own or operate. Such an establishment is not subject to the requirements of section 905b or section 905i of the FDC Act.. Currently, foreign establishments are not required to register and list until FDA issues, regulations establishing such requirements. In accordance with section 905h of the FDC Act.

. We will now review registration and when to update an establishment s, registration and product listing in TRLM NG., When an establishment first engages in the manufacturing of a tobacco product in any domestic establishment, the owner or operator, shall immediately register.. We request firms update their registration when the establishment no longer engages in the manufacturing, preparing compounding or processing of any tobacco product, including repackaging and relabeling of tobacco products.. Additionally, it can vary based on each business s situation., For example. We request that you inactivate your establishment registration if the establishment has closed if it has become solely a retail establishment and no longer engages in manufacturing practices, if you are solely an importer or a brand owner who is not conducting manufacturing activities outlined in 905a1.. As a reminder for establishments, we will review what types of updates should be included in biannual product list updates.. If you have introduced a tobacco product into commercial distribution and have not included that product in a previous submission, then you are required to provide the complete product listing information If you have discontinued manufacturing a product for commercial distribution. Since the last report, you are required to provide notice that the product has been discontinued along with the date of the discontinuance. If you a had a product listing that was marked as discontinued in a previous report and you have since resumed manufacturing for commercial distribution, then you are required to provide notice of the resumption the date of the resumption and complete current product listing information and Any material Change in any information previously submitted.

, We will now review how establishments may report updates and changes. FDA recommends that you submit your registration and product listing updates online using FDA s, Tobacco Registration and Listing Module Next Generation, TRLM NG. Industry users can use TRLM NG to streamline The data entry process for multiple establishments., The hyperlink to TRLM NG, is on this slide.. Although electronic submissions are not required, FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data, submission and management.. Alternatively, establishments can use FDA Forms 3741 and 3741a to submit registration and product listing information to FDA.. Please note that you don t have to wait until June or December of each year to update registration or product listings.. You can do so at any time once your business operation changes.. The main goal of this webinar is to remind and encourage industry to comply with registration and product listing requirements., Who must register their establishments when and how to update an establishment s, registration and product list. In TRLM, NG and types of updates to include in biannual Updates 905i. Included on this slide are some helpful resources.. You can download the slides accompanying this webinar, which will include the links to these resources.. Additionally, if users need further assistance, users can use the contact. The FDA feature on the Need: help page. The Need help page also has helpful resources to guide you through the registration and listing process, including the TRLM NG User Guide, TRLM, NG Training, Videos and a frequently asked questions.

Section.. If you have any TRLM NG questions, you can call us at 1, 877, CTP, 1373 or email us at AskCTPfda.hhs.gov. For other questions, technical assistance or guidance. Finding the right resources. You can contact the Office of Small Business Assistance by e mail phone or mail using the contact information listed on the screen..

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