Notification regarding tobacco products and related products

This service is intended for manufacturers and importers who plan to place the following on the market of the Republic of Moldova:

tobacco products,
related products (such as liquids for electronic cigarettes),
devices and accessories intended for the use, refilling, or heating of such products.

In accordance with national legislation, any new product or one with a modified composition must be notified in advance to the National Agency for Public Health (ANSP).

The purpose of the notification process is to protect public health, by ensuring that the products comply with legal requirements and do not pose unjustified risks to consumers.

Notification must be submitted at least 90 calendar days prior to the planned date of placing the product on the market.

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Submission of the application
To submit the application electronically, access the platform and click the “Request” button.
Fill out the application form, carefully following all the indicated steps, and make sure that the information provided is accurate and complete.
The application form goes through the following steps:
- Step 1: Completion of the economic agent’s identification data;
- Step 2: Entry of all necessary information and attachment of the mandatory documents;
- Step 3: Selection of the preferred method for receiving the response;
- Step 4: Confirmation of the accuracy of the entered data;
- Step 5: Payment of the applicable fee;
- Step 6: Completion.
Alternatively, the application can be submitted directly at the counter of the National Agency for Public Health, following the same steps.
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Step 2. Processing the request.
After the application is submitted, it is taken over by a responsible specialist who opens the case and examines the content of the application along with the attached documents.
If it is found that some mandatory documents or information, explicitly required by the applicable regulatory framework, are missing, the specialist will suspend the application review period and immediately inform the applicant.
The notification will include: the legal basis for the suspension; a precise description of the missing documents or information; the actions required to remedy the situation and resume the examination process.
The examination of the application will resume only after the file is completed with all the necessary elements.
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Step 3. Responding to the notification
After reviewing the submitted documents, the responsible officer within the National Agency for Public Health (ANSP) prepares a document entitled:
"Response to the notification on the placing on the market of a tobacco product, related product and/or devices and accessories for their use, refilling or heating."
The document will include the decision to accept or reject the notification.
In the event of a rejection, the response will indicate:
- The legal grounds for the rejection
- Recommendations for addressing the identified issues
The response will be delivered in accordance with the method of receipt selected by the applicant during the submission process.

Notification request
The notification request must be fully completed, following all fields as per the available template.
Confirmation letter regarding warnings and labeling
Where applicable, the confirmation letter from the National Public Health Agency regarding the coordination of health warnings and labeling information, as well as the placement method of these on unit packs and the outer packaging of tobacco products and related products, or their simultaneous submission for coordination.
Market studies on consumer preferences
Document certifying the available studies and market research regarding the preferences of different consumer groups, including young people.
Sworn statement regarding the truthfulness of the data
A free-form sworn statement confirming that the data provided in this application and its annexes are true, accurate, and compliant with the legal provisions applicable to the requested type of activity.
Detailed description of the product, device, or accessory
A free-form document that fully presents the technical and functional characteristics of the product, device, or accessory intended for use, recharging, or heating of tobacco products or related products.
Report on the ingredients used and the emission levels
Document detailing all ingredients used in the manufacture of tobacco products and related products, as well as the level of emissions generated by them, in accordance with the available template.
Raport toxicologic privind ingredientele produsului
Document care conține informații privind potențialele riscuri toxice ale ingredientelor utilizate în fabricarea produselor, furnizat de producător sau importator, conform template-ului disponibil.
Study on toxicity, addictiveness, and attractiveness
Document certifying the available scientific studies on the product's toxicity, addiction potential, and attractiveness, especially with regard to its ingredients and emissions.
Copy of the legal activity license
Document certifying the legal right of the economic agent to produce, import, or market tobacco products and related products, in accordance with the legislation.
Safety data sheet for the ingredients
It is a technical document, prepared in accordance with international and national regulations regarding chemical substances, which provides detailed information about the physicochemical, toxicological, and ecotoxicological properties of an ingredient or mixture of substances, as well as the prevention and protection measures necessary for their safe handling.
Information for the public regarding the ingredients and emission levels
Document regarding the format for presenting information related to the ingredients used in the manufacturing process of tobacco products and related products, as well as emission levels, intended for public information, according to the available template.
Declaration of conformity regarding the ingredients
The manufacturer’s or importer’s sworn statement regarding the compliance of the ingredients used in the manufacturing process of tobacco products and related products, according to the available template.
Emission level testing report for cigarettes
In the case of cigarettes, the results of the emission level testing for nicotine, tar, and carbon monoxide per cigarette will be attached/presented.
Graphic design of unit packs with health warnings
Graphic presentation of unit packs regarding the coordination of health warnings, for the approval of the Health Regulation related to health warnings and labeling of tobacco products, roll-your-own tobacco, and related products.
Identification data of the manufacturer or importer
Identification data of the manufacturer or importer of tobacco products and related products, according to the available template.

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