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Documents for advertising in regulated fields in Romania

The official checklist of approvals, notifications, licences and proof required before advertising regulated products and services in Romania.

advertising documents regulated products romaniaPublished · updated · 9 min read

“Documents for online advertising” hides very different files, set by the exact category of the product and by the claims in the text. Before publication, send the final material, the sender's identity, the sectoral authorisations or approvals and the proof for every verifiable claim. A commercial name is not enough to classify the material.

Fact check: 23 August 2026. This guide explains the publication's intake file. It does not establish the legality of an individual case and does not replace a professional's analysis. The laws cited are Romanian; they bind the publication, whatever the client's country.

Why do we ask for the documents before publication?

The documents come before writing because some material has to be published in the approved form, and some cannot be accepted for the general public at all. A late check can change the headline, the claims or even the classification of the product. The publication has to know what it is promoting before proposing a format.

Romanian Law 363/2007, Article 11 obliges the trader to be able to provide evidence of the accuracy of its claims. If the documents are not submitted within the deadline set by the authority, or are insufficient, the claims are deemed inaccurate. The current text does not set a universal seven-day deadline here.

The intake file has three possible outcomes:

  • complete: the category, the sender, the form and the proof can be verified;
  • needs clarification: a document is missing or the classification of the product is ambiguous;
  • unpublishable in the form sent: the request falls under a prohibition that cannot be repaired by rewording.

What do you send for an over-the-counter medicine?

For a medicine dispensed without prescription, send the approved material, the number and date of the ANMDMR (the Romanian medicines agency) approval, plus the product's data and the marketing authorisation holder's data. Do not send a version “adapted for the press” if it differs from the approved form. A prescription medicine does not enter this route.

The rules consolidated through Ministry of Health Order 194/2015 show that advertising aimed at the general public is subject to ANMDMR approval and has to display the approval number and the date it was granted. The official ANMDMR advertising page publishes the procedure and current notices.

Intake checklist:

  • the final form that received the approval;
  • the approval number and the date it was granted;
  • the product's name and the sender's data;
  • confirmation that the product is dispensed without prescription;
  • all mandatory mentions already included in the approved form.

A request that publicly names a prescription medicine is unpublishable as advertising for the general public. For an over-the-counter product, the absence of the approval means “needs clarification”, not an invitation to rewrite the text outside the procedure.

Which documents accompany the advertising of a supplement?

For a supplement, send proof of the product's notification, the approval of the advertising content and the exact list of claims used. The product's notification and the approval of the advert are different legal checks, with distinct documents. Neither allows therapeutic claims or wordings that go beyond the authorised claims.

The rules annexed to Ministry of Health Order 1069/2007 provide for approval of the advertising content and exclude references to treatments, prevention or diseases. The Ministry of Health publishes the lists of notified supplements, but appearing in a register does not replace the approval of the material.

The file has to contain:

  • the certificate or notification form applicable to the product;
  • the approval for the content of the material sent;
  • the text and the visuals in the approved version;
  • the wording and the source of the nutritional or health claims;
  • identification of the operator placing the product on the market.

If the text attributes to the product therapeutic properties against a disease, the outcome is “unpublishable in the form sent”. The publication does not turn a forbidden claim into an acceptable one through synonyms.

What do you check for medical devices and services?

For a medical device, send the EU declaration of conformity or the documents supporting the CE marking, the intended purpose and the relevant instructions. For a medical service, send the unit's authorisation and the proof for the qualifications or equipment mentioned. Patient cases and images require a separate check of consent.

Regulation (EU) 2017/745, Article 7 forbids attributing non-existent functions and promoting uses outside the intended purpose. The CE marking alone does not prove every claim the sender wishes to add.

For medical units, the Statute of the Romanian College of Physicians assigns to the ethics committee the setting of advertising conditions and the approval of the content of material. That is why the file is also checked against the professional rules applicable to the issuer, without assuming the same list applies to all medical professions.

The outcome is “needs clarification” if the document does not allow the claim in the text to be tied to the intended purpose, to the unit's authorisation or to the cited source. The publication does not decide in place of the authority which new use would be permitted.

What must credit advertising contain?

If the credit advert uses an interest rate or another cost figure, send the complete representative example, in the form in which it will appear in the material. The elements required by the applicable act are needed, not just the APR isolated in a footnote.

Government Emergency Ordinance 50/2010, Article 9 requires the standard information to be presented through a representative example. It includes the interest rate and the costs, the total amount of credit, the APR, the duration and, where applicable, the total amount payable, the instalments and the mandatory ancillary services.

Send:

  • the representative example approved for the offer;
  • the assumptions and the period in which the offer is valid;
  • the identity of the creditor and, where applicable, of the intermediary;
  • the source document for every comparison or cost claim;
  • the visual form that keeps the information in the same field.

Material with a promotional figure but without the rest of the required example needs completion. The publication does not calculate the APR and does not reconstruct the financial offer from fragments.

What proof do you send for gambling?

For promoting gambling, send the series and number of the organiser's licence, the operator's data and confirmation of validity for the promoted activity. The number has to appear visibly in the material; it is not enough for it to exist in an internal email or an inaccessible footer.

Government Emergency Ordinance 77/2009, Article 1^2 requires the series and number of the licence to be displayed on promotional material. The consolidated form also includes obligations regarding advertising contracts and the promotion tax, which belong to the operator and have to be clarified before ordering.

A missing licence produces the outcome “needs clarification”. If the operator or the activity is not authorised for the targeted market, the material is unpublishable. The editorial team does not infer validity from a logo, a screenshot or the fact that the client's site is accessible.

How do you support comparisons and commercial figures?

For any comparison, percentage, ranking or leadership claim, send the source, the year, the method and the criterion measured under comparable conditions. The document has to support exactly the sentence published. An internal presentation without methodology, or a screenshot without origin, is not sufficient proof.

Law 158/2008, Article 6 allows comparison only if the legal conditions are cumulatively met, including objective comparison of essential, relevant, verifiable and representative characteristics.

Examples of a correct match between claim and document:

  • “compatible with standard X” → the report or certificate indicating exactly that standard;
  • “leader by criterion Y” → the full study, the period, the sample and the definition of the market;
  • “reduces the time of the operation” → the test method, the product version and the measured results;
  • “cheaper than offer Z” → the comparable offers, the date and the same contractual conditions.

If the source supports only part of the claim, the text is narrowed to the part proven. A comparison that cannot be verified is not published as fact.

How do you send the file for verification?

Send a single file with the final material, the exact category, the sender and clearly named documents. Tie every sensitive claim to the file that supports it. The editorial team can confirm whether the file is complete for evaluation, but it does not issue approvals and does not give individual legal opinions.

Use the service pages for advertorials and SEO articles to choose the format. After classification, the team indicates a single relevant commercial pillar; you do not need to request all formats at once.

For verification, write to redactie@comunicate.top and attach:

  1. the final text and visuals;
  2. the sender's complete identity;
  3. the declared legal category of the product or service;
  4. the applicable approval, notification, licence or representative example;
  5. the table claim → document → page or section;
  6. the person authorised to answer clarifications.

For medical services, what you can and cannot claim in a paid text, with the health publications in the catalogue, is on healthcare advertorials for clinics, doctors and pharmacies.

Frequently asked questions

Is a self-declaration enough?

No, if the applicable act requires an approval, a licence, a notification or an approved form. The declaration can explain the origin of the documents, but it does not replace the document issued or required by the competent authority.

Can the editorial team obtain the approval on the client's behalf?

No. The sender or the responsible holder obtains the documents required for the product and the material. The publication checks the file received before deciding whether it can continue the evaluation.

Is the CE marking enough for any claim?

No. The claim has to stay within the intended purpose and the device's documentation. The marking does not automatically authorise uses or properties that do not appear there.

Does publication confirm the legality of the product?

No. Publication shows that the material passed the editorial filter applied to the file received. It is not an authorisation, a certification or a legal opinion on the sender's activity.

When does the check have to be redone?

When the text, visuals, offer, documents or applicable framework change. A new version must not be assumed covered by the approval of a previous version.