Registration process
Bulgaria vape product registration
Bulgaria adheres to the EU Tobacco Products Directive (2014/40/EU) for the notification of e-cigarettes, refill containers, and nicotine-containing products. The process involves submission through the EU-CEG system, followed by a mandatory six-month notification period before products can be legally placed on the market.
Step 1: Prepare the Submission
Using TPD PRO, prepare your product data in EU-CEG-compliant XML format:
Submitter and Manufacturer setup
Full product Composition including toxicological and emissions data
Presentations intended for the Bulgarian market
Required documentation such as packaging, leaflet, emissions reports, and tox files
Export and validate all XML and supporting files
Step 2: Submit via eTrustEx
Log in to the eTrustEx platform and submit your files in the following order:
Submitter XML
Attachments (PDF format)
Submission XML
Ensure each file receives a "Success" status to confirm proper delivery and validation.
Step 3: Six-Month Notification Period
After a successful submission, Bulgaria requires a six-month waiting period before your product can be legally sold on the market. This aligns with the general EU-TPD timeline and compliance rules.
Step 4: Public Listing
After the six-month period and successful review, approved products are listed on the official website of the Bulgarian Ministry of Economy:
This listing serves as a public confirmation of regulatory approval.
Summary
To register products in Bulgaria:
Prepare and submit via TPD PRO and eTrustEx
Observe the six-month waiting period
Approved products will be published on www.mi.government.bg