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+40 (744) 368 368office@bsa.roStr. Belgrad 10, Sector 1, 011804Buju, Stanciu & Asociații face parte din Interlegal și din Legal Network International

Drept comercial

By Buju, Stanciu & Asociații

How to Legally Introduce Vaping Products and E-Cigarettes on the Romanian Market

In recent years, vaping and e-cigarettes have become increasingly popular alternatives to traditional tobacco products. However, for manufacturers and importers looking to bring these products to the Romanian market, understanding and complying with the relevant regulations is essential. Romania has adopted strict rules aligned with European Union directives, particularly Law no. 201/2016, which governs the manufacturing, presentation, and sale of tobacco products and related products, including e-cigarettes and refill containers.

This article provides a comprehensive overview of what businesses must do to ensure their products are legally introduced and maintained on the Romanian market.

1. Is Vaping Regulated in Romania?

Yes. E-cigarettes and vape liquids fall under strict regulation in Romania. Products that do not comply with Romanian and EU standards cannot be introduced or sold on the market. There are two main pathways for legal entry:

  • Complying with Law no. 201/2016 (the general rule for e-cigarettes).
  • Or being authorized as a medicine or medical device, if the product is intended for therapeutic use, based on Law no. 95/2006.

2. Notification Requirement

Before launching any vaping product in Romania, the manufacturer or importer must notify the Ministry of Health at least 6 months prior to the intended launch date. This also applies if:

  • The product is already on the market and being updated.
  • Substantial modifications are made to an existing product.
  • A new refill bottle or e-cigarette device is introduced.

3. Information Required for Notification

The notification must include detailed information such as:

  • Producer and importer contact details, including a responsible entity within the EU.
  • A full list of ingredients and emissions by product type and brand.
  • Toxicological data related to inhalation risks and nicotine dependence.
  • Nicotine dosage and absorption under normal usage.
  • A complete description of the product components and refilling mechanisms.
  • Manufacturing process and quality assurance.
  • A declaration that the product meets all legal safety requirements.

If any of this information is incomplete, the Ministry of Health can request additional data within a legally defined timeframe.

4. Packaging and Product Safety Requirements

E-cigarettes and refill containers must meet strict packaging and safety criteria, including:

  • Nicotine-containing liquids must not exceed 20 mg/ml.
  • Refill containers are limited to 10 ml capacity; cartridges and tanks must not exceed 2 ml.
  • Child-resistant and tamper-proof packaging.
  • Leak-proof refill mechanisms.
  • A health warning stating: “This product contains nicotine. Nicotine is a highly addictive substance.”
  • A leaflet with usage instructions, contraindications, side effects, and manufacturer contact details.

5. Restrictions on Advertising and Promotion

Romanian law prohibits all advertising and sponsorship for e-cigarettes and vape products through:

  • Online media and printed press.
  • Radio and audiovisual services.
  • Public events or venues with transnational impact.
  • Outdoor billboards or public display structures.

Only trade professionals and publications outside the EU may be targeted under specific conditions.

6. Ongoing Compliance and Market Surveillance

Manufacturers and importers must submit annual reports to the Ministry of Health by November 20th, including:

  • Sales data by product type and brand.
  • Consumer demographics and usage trends (especially among youth and non-smokers).
  • Research summaries and marketing strategies.

They must also monitor and report any suspected adverse effects on human health and immediately act if a product is found unsafe.

In serious cases, the Ministry may suspend or ban certain products and notify EU institutions accordingly.

Introducing vaping products in Romania involves more than just developing a product - it requires full legal compliance, continuous reporting, and a solid understanding of national and EU health regulations. Missing a single requirement can result in product withdrawal or fines, and may damage your brand reputation.

This is where legal professionals with experience in product compliance and health law can make the difference. A legal partner can support your business from the initial notification to ongoing compliance monitoring, so you can focus on innovation and growth.