Pharmaceutical advertising regulation and medical device advertising in Romania

• Law no. 148/2000 on advertising;
• Audiovisual Law no. 504/2002;
• Law no. 95/2006 on the healthcare reform;
• Ministry of Health Order no. 194/2015 approving the Norms for the valuation and approval of advertising of medicinal products for human use;
• National Audio-visual Council Decision no. 220/2011
• Government Emergency Ordinance no. 46/2021.

There are several industry associations in Romania, that have their internal codes of conduct, binding on their members.

In relation to medicines, the most relevant association is the Romanian Association of International Medicines Manufacturers (ARPIM) (member of EFPIA).

In relation to medical devices, the most active associations in Romania are the Romanian Association of the Self-Care Industry (RASCI) and the Association of Suppliers of Medical Products (AFPM) (the latter, a member of MedTech Europe).

3.1 Medicines

• The advertising materials for over-the-counter medicinal products (“OTC”), as well as the educational materials, destined for the general public/patients, must be approved by the National Agency for Medicines and Medical Devices in Romania (“ANMDMR”) before they are placed on the market. This obligation is born by the marketing authorisation holder. The fee is calculated based on a specific formula.  1 For advertising materials – RON 550 (approx. EUR 120) X the number of marketing authorizations included in the material X the number of the communication channels X 1 (for 6 months) or 2 (for 12 months). For educational materials – RON 350 (approx. EUR 70) X the number of marketing authorizations included in the material X the number of the communication channels X 1 (for 6 months) or 2 (for 12 months).footnote
• It is prohibited to advertise to the general public (among others) prescription-only-medicines (“POM”), and medicines prescribed and released in the health insurance system.
• The advertising materials for POMs or OTCs destined for the healthcare professionals do not need prior approval from ANMDMR. They will be verified randomly or upon notification by ANMDMR after they are placed on the market.

3.2 Medical devices

• Romanian law regulates an advertising approval for medical devices in all cases where the advertising is intended for the general public.
• Advertising intended for healthcare professionals (“HCPs”) is not subject to approval. However, when the product for which the advertising is intended for HCPs is part of the category of medical devices with a high degree of risk for the health of the population, such advertising must be notified, as an emergency, in advance, to ANMDMR.  

Yes, as detailed in response to question 3 above.

5.1 Medicines

• It is prohibited to advertise medicines to the general public:
  • if such medicines do not hold a valid marketing authorisation in Romania;
  • without the approval of ANMDMR (where such approval is required);
  • if such medicines are POMs or they contain narcotic or psychotropic substances (with the exception of vaccination campaigns performed by the pharmaceutical industry and approved by the Ministry of Health);
  • if such medicines are prescribed and released in the health insurance system.
• In addition, the advertising materials must not include information:
  • suggesting that proper medical consultation or surgical intervention is not necessary, especially by offering certain suggestions for diagnosis or long-distance treatment;
  • suggesting that the medicinal product has a guaranteed effect or it does not cause adverse reactions;
  • suggesting that the patient’s health condition cannot be improved unless he/she uses the advertised medicinal product;
  • suggesting that the patient’s health condition may worsen unless he/she uses the advertised medicinal product; − aimed exclusively or mainly at children;
  • emphasising a certain recommendation from healthcare professionals whose celebrity could encourage the consumption of such medicinal products;
  • suggesting that the medicine is a food, cosmetic or other consumer product;
  • suggesting that the medicine’s safety or efficacy is due to the fact that it is a natural substance;
  • that may constitute, through a detailed description or representation of a case, an incentive to an incorrect self-diagnosis;
  • offering assurances regarding healing, in inappropriate or misleading terms;
  • that improperly, impressively or deceptively uses visual representations of alterations of the human body due to UK-634770444.14 101 illness or injury, or of the action of a medicine on the human body or on a part thereof;
  • falsely stating that there is a marketing authorisation in force for a particular product; − presenting violence (even stylized);
  • using diminutives or other words (expressions) meant to trigger an emotional response from the users’ side;
  • presenting messages, images from campaigns of other types of products (cosmetics, food supplements, medical devices etc.).

5.2 Medical devices

• Advertising for medical device:
  • Must encourage the rational use of the medical device, by presenting it objectively and without exaggerating its properties;
  • Must not be misleading;
  • Must contain correct, up-to-date, verifiable and sufficiently complete information to allow the general public to understand how to use the medical device, and the HCPs to appreciate the characteristics and performance of the medical device (as the case may be).
  • Advertising for a medical device whose way of achieving the proposed goal cannot be supported by clinical evidence is prohibited.
  • All information contained in the advertising material for a medical device must correspond to the information found in the instructions/user manual of the product.
  • It is forbidden to advertise medical devices with special purposes, which are used only according to a medical recommendation, to the general public.
  • Advertising intended for the general public is allowed only for those medical devices which, by purpose, are intended to be used without the intervention of qualified medical personnel for the purpose of establishing the diagnosis, their recommendation or for monitoring the treatment, being sufficient, if necessary, the advice of pharmacists.
• Advertising for medical devices intended for the general public must not contain any information:
  • to suggest the impression that a medical consultation or a surgical intervention is not necessary;
  • to suggest that the diagnosis, the result of the determination established with a medical device is guaranteed, or cannot be accompanied by errors or that the effect of the treatment with a medical device is guaranteed, or that it is not accompanied by adverse reactions or that the effect is better or equivalent to that of another treatment with another medical device or medicine;
  • to suggest that the health of the relevant person may be affected if the medical device is not used;
  • to be addressed exclusively to children;
  • to refer to a recommendation of scientists, HCPs or people who are not part of these categories, but whose celebrity may encourage the use of the medical device;
  • to suggest that the medical device is a cosmetic or relaxation product or other consumer product;
  • to suggest that the safety or effectiveness of the medical device is due to the fact that it is natural;
  • which can, through a detailed description or representation of a case, lead to an erroneous self-diagnosis;
  • to offer, in inadequate, alarming or misleading terms, assurances regarding healing through the use of the respective medical device;
  • to use, in inappropriate, alarming or misleading terms, visual representations of changes in the human body caused by diseases or injuries or actions of medical devices on the human body or a part thereof.
• In addition, under Romanian law, there are certain rules and restrictions in case of radio and TV advertisement of medical devices. In brief, it is prohibited to:
  • advertise a medical device released based on medical prescription;
  • broadcast advertising materials where healthcare professionals, medical associations or pharmacists recommend the use of medical devices;
  • broadcast advertising materials in TV shows for children or during the commercial breaks preceding or subsequent to the broadcast of such shows.

6.1 Medicines

• The following restrictions apply in case of advertising medicines to healthcare professionals:
  • it is prohibited to advertise a medicinal product prior to the issuance of the marketing authorization, as well as to advertise a medicinal product outside its approved therapeutic indication;
  • it is prohibited to state that a medicinal product has no adverse reactions, toxicity or dependence risks, except as documented in the summary of a product characteristics;
  • it is prohibited to promise and receive gifts, benefits in cash or in kind for the purpose of prescribing or to release medication;
  • it is prohibited to advertise a medicinal product by misleading health professionals through statements that one drug is better or safer than another unless there is scientific support for this statement;
  • it is prohibited to present messages in the printed advertising materials stating or only suggesting that the use of the medicinal product does not bear any risks, except for cases documented in the summary of product characteristics;
  • it is prohibited to leave advertising materials in places accessible to the general public, as are, but are not UK-634770444.14 102 limited to, pharmacies, waiting rooms of medical offices, hospitals and clinics etc.

6.2 Medical devices

See question 5 above.

7.1 Medicines

• Advertisements, regardless of whether referring to POMs or OTCs, must contain at least the following mandatory information:
  • name of the medicinal product and the active substance (INN = International Non-proprietary Name);
  • pharmaceutical form and formulation;
  • doses for each administration mode / route and for each therapeutic indication, as the case may be;
  • the date of the first marketing authorisation or of the authorisation’s renewal;
  • the other essential information in the summary of product characteristics;
  • date of revision of the text (for summary of product characteristics);
  • the statement: "This promotional material is intended for health professionals”;
  • how the medicine is dispensed and the type of prescription on which it is dispensed;
  • the information from the summary of product characteristics shall be printed using the minimum font size of 10, regardless of the font used.

7.2 Medical devices

• See question 5 above.
• In addition, advertising for medical devices intended for HCPs In addition, advertising for medical devices intended for HCPs must be tailored to the recipients and must contain the following information:
  • to specify that it is intended exclusively for HCPs;
  • the name of the medical device, the name of the manufacturer or its representative;
  • the clear definition of the purpose proposed for use by the manufacturer, of the characteristics and performances of the medical device, for which the advertisement is made;
  • medical device class;
  • the essential information for the use of the medical device;
• Note, the local industry associations’ codes of practice may include specific requirements on the matter, applicable to their members.

8.1 Medicines

• Advertisements of OTCs and vaccination campaigns performed by the pharmaceutical industry and approved by the Ministry of Health, must contain at least the following mandatory information:
  • the name of the medicinal product, as well as the international non-proprietary name (if the medicinal product contains a single active substance);
  • the information necessary for the correct use of the medicinal product (therapeutic indication, UK-634770444.14 103 recommended dose in accordance with the therapeutic indication);
  • an explicit and readable invitation to carefully read the instructions in the package leaflet or on the outer packaging, formulated in accordance with the provisions in force;
  • "reminder" type materials must include the name of the medicinal product and the invitation to read the instructions on the package leaflet or on the outer packaging, as the case may be.

8.2 Medical devices

See question 6 and 7 above.

See question 6 and 7 above.

In addition, any quotation, table and other illustrative material taken from medical publications or other scientific work, that are destined for usage in advertisement directed to healthcare professionals, must be reproduced faithfully and with the exact indication of the source (references).

Also, all illustrations from the promotional materials, including graphs, various images, photos and tables, taken from published studies must meet the following conditions:

• they must clearly indicate the exact source(s) of the illustrations;
• they must be faithfully reproduced, unless adaptation or modification is necessary, in which case one must clearly state that the illustrations have been adapted and/or modified;
• they must not to mislead in any way in relation to the information about the medicine.

There are specific legal provisions for comparative advertisement in relation to medicines, as detailed below.

Comparative advertisement of medicines directed to the general public is prohibited.

By contrast, comparative advertisement of medicines (whether POMs or OTCs) directed to the healthcare professionals is permitted unless:

• the comparison is misleading;
• the brand name of a competitor is used; only international non-proprietary names may be mentioned;
• one compares drugs that have different therapeutic indications or different pharmaceutical forms;
• one does not objectively compare one or more essential, relevant, verifiable and representative characteristics of certain medicinal products, including the price;
• one creates confusion on the market between the entity that advertises and a competitor or between different brands, international non-proprietary names or other distinctive signs UK-634770444.14 104 of the entity that advertises and those belonging to a competitor;
• one discredits or denigrates the trademark, international non-proprietary name, other distinctive signs, activities or any other characteristics of a competitor;
• one incorrectly takes advantage of the reputation of a trademark, the international non-proprietary name, the distinctive signs of a competitor or any other characteristics of a competitor without having evidence in support of those stated.

With regard to medical devices, the local industry associations’ codes of practice may include specific requirements on the matter, applicable to their members.

There are specific legal provisions for advertisement of medicines on the internet, as detailed below.

Advertisement of medicines on the internet includes: webpages, emails, forums, blogs or any other form of electronic support, except for social networks or Android, iOS or any other mobile application.

The advertisement on the internet, irrespective of the form in which it is made, must be valuated and approved by ANMDMR.

Every webpage must comprise at least information about:

• the identity and address (both physical and electronic) of webpage’s sponsor;
• complete references regarding the source(s) of all medical information included on the webpage;
• the target audience of the webpage;
• the number of the advertising visa and date of issuance;
• relevant information for investors, media and the general public, including financial data, descriptions of research and development programs, list of products in the portfolio, discussions on regulations affecting the company and its products, information for potential future employees;
• non-promotional information on health education, characteristics of diseases, prevention methods, screening and treatment, as well as other information with the intention of promoting public health;
• relevant aspects of therapeutic alternatives, including, where appropriate, surgery, diet, behavioural change and other interventions that do not require the use of medicines;
• the latest approved information, package leaflet and summary of product characteristics of the advertised medicines;
• non-promotional aspects for patients and the general public regarding the OTC portfolio of the pharmaceutical company;
• links to a complete, unmodified copy of any public assessment report issued by the Committee for Medicinal UK-634770444.14 105 Products for Human Use (CHMP) of the European Medicines Agency (EMA) or by a relevant national competent authority;
• the recommendation for visitors to consult a health professional for more information.

It is prohibited to advertise medicines through email, mobile phones (SMS) or social networks.

The advertisement of POMs on the internet to healthcare professionals is permitted under the following conditions:

• the marketing authorisation holder must prove that access to such information is restricted to persons other than health professionals through a valid and verifiable password system; the information provided must contain the full summary of product characteristics;
• website providers must ensure that the materials posted on the website do not contain information inconsistent with applicable national and international regulations

With regard to medical devices, the local industry associations’ codes of practice may include specific requirements on the matter, applicable to their members.

ANMDMR is the body that monitors compliance with the requirements of the law on advertising medicines (whether POMs or OTCs) and medical devices. 

In case of non-compliance with the requirements of the law on advertising medicines (POMs and OTCs), ANMDMR can apply a fine ranging between RON 10,000 (approx. EUR 2,000) and RON 30,000 (approx. EUR 6,000). This fine can be applied to the manufacturer, importer, wholesale distributor, marketing authorization holder or the representative of the marketing authorization holder. For non-compliance with the requirements of the law on advertising medical devices, the fines may be up to RON 20,000 (approx. EUR 4,000), per instance of breach.

The National Consumer Protection Agency, the Ministry of Finance, the Romanian Audiovisual Council are the bodies that monitor compliance with the general advertisement provisions. They can apply various fines and sanctions for non-compliance with the advertisement provisions, depending on the type of infringement. These sanctions include the suspension, withdrawal or cancellation of certain authorisations, and the withdrawal of certain products from the market.  

 We could not identify future developments envisaged.