Authorisation of Electronic Cigarettes and Vapes in Romania

Electronic cigarettes and related products, such as refill containers and vaporisers, have gained popularity in recent years, both among smokers looking for alternatives and among young people. However, the strict rules imposed by Romanian law and by European Union legislation set out clear requirements for placing such products on the market. Failure to comply with these requirements may attract serious penalties.

This article is intended to assist entrepreneurs, importers and manufacturers who wish to understand the legal steps required to launch such products on the market in accordance with Legea nr. 201/2016 (Law no. 201/2016).

What does the law say about electronic cigarettes?

Under current legislation, it is prohibited to place on the market electronic cigarettes and refill containers that do not meet the requirements laid down by Legea nr. 201/2016 and by the applicable European rules. The only exception concerns products authorised as medicinal products or medical devices under Legea 95/2006 (Law no. 95/2006) or Hotărârea Guvernului nr. 54/2009 (Government Decision no. 54/2009).

In short, if a nicotine-containing product is intended to be promoted for the treatment of addiction, it must be authorised as a medicinal product. In all other cases, it falls under the law referred to above and is treated as a tobacco or related product.

What must manufacturers and importers do?

Any manufacturer or importer wishing to place electronic cigarettes or refill containers on the market is required to notify the Ministry of Health. That notification must be submitted at least 6 months before the product is launched. Moreover, if the product undergoes substantial changes, the notification must be renewed.

The information to be submitted is complex and includes:

The composition of the product, its ingredients and the resulting emissions
Toxicological data on the ingredients and their effects on health
The nicotine level and the amount absorbed under normal conditions of use
A description of the components and of the manner in which the product operates
Declarations regarding the safety and quality of the product
The production process and compliance with applicable standards

It is essential that the information provided be accurate and complete. Where the Ministry of Health considers it insufficient, it may request additional information within a period set by order.

Strict technical requirements for placing on the market

Electronic cigarettes and refill containers must meet a series of technical requirements at the time they are placed on the market, such as:

Refill containers may not hold more than 10 ml of nicotine-containing liquid
The nicotine level may not exceed 20 mg/ml
Products must not contain hazardous additives or ingredients carrying a major risk potential
They must be protected against leakage and include a safe refilling mechanism
Labels must carry health warnings and clear instructions for use

Prohibitions on advertising and promotion

The legislation expressly prohibits the advertising and promotion of electronic cigarettes and refill containers in the mass media, the print press, online, on the radio or on billboards. Publications intended for professionals and those printed in third countries are exempt, provided they are not directly aimed at the EU market.

At the same time, the sponsorship of events and programmes that may have a cross-border impact is prohibited, particularly where these involve young people or a vulnerable audience.

Ongoing obligations after placing on the market

Obligations do not cease once the product has been authorised and placed on the market. Manufacturers and importers are required to:

Monitor adverse reactions and report any identified risk to the Ministry of Health and to ANPC
Provide annual data on sales volumes, consumer preferences and market research
Collect and retain information on product safety
Respond to requests from the authorities within a maximum of 6 months

If a product no longer meets safety requirements, it must be withdrawn from the market or recalled, and the relevant institutions must be informed.

Control mechanisms and penalties

The Ministry of Health has the power to verify the compliance of products and to take measures, including the temporary or permanent prohibition of the sale of certain types of products where there are indications that they may pose a serious risk to public health.

The information provided by economic operators may be made available to the European Commission and to other Member States, subject to confidentiality in justified cases.

How can a specialist lawyer help you?

The authorisation and distribution of electronic cigarettes involve a multitude of national and European rules. A lawyer experienced in commercial law and public health law can provide:

Legal advice on the notification file
A review of the product's compliance with legal requirements
Representation before the authorities in the event of inspections or penalties
Assistance in the event of recalls or safety investigations

Involving a specialist at the authorisation stage reduces compliance risks and significantly improves the chances of a successful market launch.

Conclusion

The authorisation of electronic cigarettes and refill containers is not a mere formality. It is a rigorous, closely regulated process that calls for legal and strategic attention. Both manufacturers and importers must understand that a simple error in the documentation or labelling can result in the product being banned.