Marketing, Manufacturing, Packaging & Labeling, Advertising
Marketing, manufacturing, packaging & labeling, advertising in Romanian Pharma – a comprehensive legal overview. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 75.
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products?
In order to be placed on the Romanian market, a medicinal product needs a marketing authorization, which can be issued by NAMMD at local level (under the national evaluation procedure or under the mutual recognition or decentralized procedures) or by the European Medicines Agency (EMA) at the centralized EU level.
For the new, innovative medicines, the marketing authorization application dossier contains various information regarding the product in question, its manufacturer, the characteristics of the active substance, the therapeutic indications and adverse reactions, including the results of the pharmaceutical tests, the pre-clinical tests and of the clinical trials, the risk management plan and the pharmacovigilance system to be implemented by the marketing authorization holder.
The marketing authorization is issued by NAMMD, under the national procedure, within a maximum of 210 days of submitting the complete application dossier. In case of the mutual recognition or decentralized procedures, where Romanian acts as interested member state, NAMMD should issue the marketing authorization within maximum 120 days from receiving the evaluation report from the reference member state.
In the case of medical devices, it is required: (a) at EU level, to obtain the CE trade mark and (b) at local level, to register certain medical devices in the National Medical Devices Database, by submitting an application dossier with NAMMD. The registration certificate for the National Medical Devices Database shall be issued within 60 days from the filing of the notification form and of the related documents with NAMMD.
2. What is the authorization process for the marketing of generic versions of these products?
The authorization process for generics is similar. The main difference is that if the applicant proves that the product is a generic version of a reference (innovative) medicinal product which has been authorized either in Romania, in another EU Member state or in the EU at centralized level for at least 8 (eight) years, it is not necessary to submit the results of the preclinical tests and of the clinical trials. Another difference is that, in practice, the marketing authorization for generic products may be issued faster than 210 days.
By law, the generic medicine authorized based on the results of pre-clinical tests and clinical trials of an innovative product cannot be placed on the market until 10 years have elapsed from the initial authorization of the latter (the “data exclusivity period”).
3. What are the typical fees for marketing approval?
When submitting the marketing authorization dossier for a medicinal product, the applicant should pay an administrative fee of EUR 5,000.
The administrative fee for the evaluation of the marketing authorization dossier ranges between EUR 900 and EUR 9,500 depending on the type of product, the relevant procedure and the applicable circumstances.
The fees are expressly provided by an order issued by the Ministry of Health. For example, the law provides for a fee of EUR 9,500 for the authorization of an innovative product under the national procedure, EUR 5,700 for the authorization of a generic product under the national procedure and EUR 6,650 for the authorization of a biosimilar under the national procedure.
4. What is the period of authorization and the renewal process?
The marketing authorization granted by NAMMD is valid for an initial period of 5 (five) years, at the end of which it can be renewed for an unlimited period. In justified cases, NAMMD can approve the renewal of the marketing authorization for a limited period of 5 (five) years.
The renewal procedure requires the marketing authorization holder to file, not later than 9 (nine) months before the expiry date, an application together with certain relevant information regarding the product, including a consolidated version of the marketing authorization dossier on the quality, safety and efficacy of the medicinal product, the evaluation of the data in the reports on suspected adverse reactions and the periodic updated safety reports and relevant data regarding the variations occurred after the marketing authorization.
5. What are the requirements, if any, for post-approval pharmacovigilance?
As a rule, marketing authorization holders should submit to the European Medicines Agency periodic updated safety reports containing (a) summaries of the relevant data on the benefits and risks of the medicine, including the results of the related studies, (b) a scientific assessment of the risk-benefit report and (c) relevant data on the sales and the prescription of the respective medicine. Such reports have to be provided in electronic format, in accordance with the timeframe set by the marketing authorization.
The periodic updated safety reports should be submitted with NAMMD:
- before placing the product on the market, every 6 (six) months as of the marketing authorization date;
- after placing the product on the market, (a) every 6 (six) months during the first 2 (two) years; (b) once a year, for the 3rd and 4th year after its placing on the market; and afterwards, (c) every 3 (three) years.
NAMMD assesses the periodic updated safety reports to determine potential new risks, changes in the risks already known or changes in the risk-benefit balance and, as the case may be, adequate measures concerning the terms of the marketing authorization. Based on such assessment, NAMMD could maintain, modify, suspend or withdraw the marketing authorization.
6. Are foreign marketing authorizations recognized?
The marketing authorization issued at centralized level by the European Medicines Agency (EMA) is valid in Romania. Before placing on the Romanian market a product authorized under the centralized procedure, the marketing authorization holder should submit certain information with NAMMD concerning the product’s classification.
The marketing authorization issued for a medicinal product in another EU member state can be used for obtaining the marketing authorization in Romania from NAMMD, pursuant to the mutual recognition procedure.
By way of exception, the medicines which are donated to Romanian healthcare units can be authorized for marketing in the European Economic Area or in the United States of America. All medicines donations need to be approved by NAMMD.
7. Are parallel imports of medicines or devices allowed?
Parallel imports of products from EU member States are allowed and supported by EU and Romanian legislation, as a tool for achieving and maintaining a Single Internal Market, based on the principle of free movement of goods. Parallel imports from non-EU Member States are not covered by this legal regime and hence they are subject to general import rules.
As a general principle, the hindering of parallel imports from EU Member States is subject to sanctions based on competition legislation and EU single market rules.
Pharma Regulatory perspective
The parallel imports of medicines, intended as cross-border sales of goods by independent distributors outside the manufacturer’s or its licensed distributors’ formal channels, must be carried out with the observance of specific regulatory conditions, particularly:
- the product concerned by the import to be identical or very similar to a product already authorized for sale in Romania and
- the distributor to hold a parallel import license from NAMMD (except for medicines authorized through a centralized procedure).
NAMMD issues parallel import authorizations when the following conditions are met:
- the existence of a market authorization issued by the NAMMD for the primary directly distributed medicinal product;
- the parallel imported medicine should be (a) imported from an EU member State or from the EEA; (b) subject to a market authorization in force in the country of export; (c) sufficiently similar to the primary distributed medicinal product, even though some differences regarding the excipients may exist; and
- the applicant should provide data or arguments that make it at least plausible that the efficacy and safety of the primary directly distributed medicinal product apply also to the parallel imported medicine.
The parallel import authorization is issued by NAMMD within 45 days from the submission of the relevant complete file. The authorization is issued for each medicinal product and is valid for five years, with the possibility of renewal.
The parallel importer must:
- hold a wholesale distribution authorization;
- hold a manufacturing authorization, if the importer intends to amend the labelling or outer packaging;
- comply with the rules on good distribution practice and, where applicable, the rules on good manufacturing practice.
The restriction of parallel trade of products, including medicines, qualifies as hardcore restriction of competition, which infringes both Article 5 of the Romanian competition law no. 21/1996 (the “Competition Law”) and Article 101 of the Treaty on the Functioning of the European Union (“TFEU”). Parallel trade restrictions cannot benefit of category exemption under European Commission Regulation 330/2010 and are very unlikely to benefit of individual exemption under Article 101 (3) TFEU or Article 5 (2) of the Competition Law. Such restrictions may be sanctioned by the Romanian Competition Council with fines ranging between 0.5% of the total revenues obtained by the relevant company on the Romanian territory and 10% of the worldwide turnover of the relevant company, where both the revenues and the turnover considered are achieved in the year prior to the issuance of the sanctioning decision.
Parallel trade restriction carried out through unilateral conduct of a company in a dominant position on the market, may raise competition risks as well, especially in cases of refusal to supply. Under relevant case law, although it is accepted that manufacturers should have the option of taking reasonable measures to protect their commercial interests, they may not refuse orders of a customary nature in an attempt to prevent parallel exports, as this may amount to an abuse of the dominant position in violation of article 6 of the Competition Law and Article 102 of the TFEU. These restrictions may also be sanctioned by the Romanian Competition Council with fines ranging between 0.5% of the total revenues obtained by the relevant company on the Romanian territory and 10% of the worldwide turnover of the relevant company. The revenues and the turnover considered are those achieved in the year prior to the issuance of the sanctioning decision. However, a Member State of destination of the import can legally stop or restrict parallel imports of certain products, if the restrictive measure aims at the protection of human health and life or the protection of industrial and commercial property (e.g. trademarks, patents).
The parallel importer is personally liable for legal issues resulting from the infringements of the brand or industrial property rights related to the imported product. Therefore, if a parallel importer breaches certain IP rights (e.g. in relation to registered trademarks), the holder of the relevant IP rights can request the parallel importer to solve the issues and/or pay damages.
8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?
The Health Law, the Advertising Guidelines approved by the Ministry of Health’s Order no. 194/2015 and the industry codes provide for various limitations concerning gifts and sponsorships which can be granted to healthcare professionals and healthcare organization, as well as rules on the services and consultancy agreements that may be concluded with them.
According to the Health Law, healthcare professionals are prohibited to be supplied with, offered or promised any gifts, pecuniary advantages or benefits in order to prescribe, purchase, supply, trade or administer medicines. The breach of these provisions can also fall under the umbrella of the anti – bribery legislation.
Promotional materials may be granted to healthcare professionals only if their value is not higher than RON 150 (roughly EUR 30), including VAT, and if they are relevant to the medicinal or pharmaceutical practice.
Physicians can receive sponsorships for certain medical, educational and/or scientific activities, including but without limitation for the participation to promotional and scientific events. Pursuant to the Health Law, the sponsorship can cover relevant expenses such as travel and accommodation costs, while the payment for entertainment is forbidden.
Non-profit organizations (NGOs) acting in the healthcare field can receive sponsorships for their activities in the medical, educational, scientific and humanitarian field, and in certain other fields provided for by the Sponsorship Law.
Similar to the Sunshine Act from the USA, the Romanian legislation expressly requires pharmaceutical and medical devices companies, and the wholesale and retail distributors, to declare to NAMMD and the Ministry of Health all sponsorships granted to healthcare professionals and to healthcare organizations, as well as the agreements concluded with such persons and entities. This information is published on the authorities’ website.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
The manufacturing of medicinal products in Romania, including the partial manufacturing activities such as re-packaging and re-labelling, can only be performed by the entities holding a manufacturing authorization issued by NAMMD.
In order to obtain the manufacturing authorization, one should submit with NAMMD an application dossier containing various information regarding:
- the personnel involved in the manufacturing activities, including the qualified person which should be specialized in one of the following fields: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical technology and biology;
- the manufacturing premises and the technical equipment;
- the system implemented for supervising the manufacturing process; and
- the medicines and pharmaceutical forms which are produced or imported.
According to the Health Law, NAMMD should inspect the premises, to verify the accuracy of the information provided by the applicant, and should issue the authorization within 90 days of submitting the necessary documentation.
NAMMD is the competent authority also in the medical devices field, and in this capacity it issues the authorizations for the trade, repair, maintenance and installation of medical devices. The law does not expressly regulate the procedure for obtaining an authorization for the manufacturing of medical devices in Romania.
10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the U.S. Food & Drug Administration and/or the European Medicines Agency?
The Romanian legislation on medicines manufacturing is compatible with the Good Manufacturing Practices approved by the European Medicines Agency, since Directive no. 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use was transposed into the Romanian legislation.
According to the local legislation, the issuance of the manufacturing authorization and of the good manufacturing practices certificate by NAMMD is carried out in accordance with the principles and rules set forth by the European Guidelines on Good Manufacturing Practices. In this respect, NAMMD should:
- verify the observance of the principles and guidelines on Good Manufacturing Practices for medicinal products issued by the European Commission; and
- comply with the procedures approved at the level of the European Union regarding the manufacturing inspections and the information exchange;
- register the certificates on good manufacturing practices in the European Union database, which is managed by the European Medicines Agency.
In 2017, the Scientific Council of NAMMD issued the updated guidelines on good manufacturing practices, in accordance with the latest updates in the European legislation on medicines manufacturing.
11. What is the inspection regime for manufacturing facilities?
NAMMD carries out periodic and sometimes unannounced inspections at the premises of manufacturing entities to determine if the latter comply with the guidelines on good manufacturing practices and the other applicable requirements, aiming to ensure the protection of the public health at a level at least equivalent to that of the European Union.
NAMMD’s inspectors are empowered to control the activities performed by the manufacturing units, including to take samples of medicinal products for independent laboratory tests, as the case may be. The findings from the inspection and the required measures shall be comprised in the inspection report, which shall be communicated by NAMMD to the holder of the manufacturing authorization.
By law, the inspections carried out by NAMMD should comply with the inspection procedures issued by the European Commission and with the local guidelines transposing into the local legislation the EU enactments on inspection procedures.
In addition to inspections carried out by NAMMD, the manufacturers should ensure compliance with the requirements set forth in the GMPs guidelines by implementing a self-inspection system for the manufacturing facilities. The conclusions of any such inspection should be included in a report, along with the relevant proposals on corrective measures, as the case may be.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
According to the Health Law, the inspections concerning the manufacturing facilities are carried out by NAMMD’s inspectors. The law provides for various rules on the collaboration with the European Medicines Agency and other competent authorities, amongst which:
- NAMMD cooperates with the European Medicines Agency and exchanges information with the latter concerning the inspections, to ensure that legal requirements on medicinal products are observed;
- the inspections can be carried out either in Romania or in a third country, or in another EU Member State, based on the request of NAMMD, of another Member State, of the European Commission or of the European Medicines Agency;
- NAMMD should communicate to the European Commission and the European Medicines Agency the relevant conclusions of the inspection.
Consequently, the European Medicines Agency is entitled to request the performance of the inspection and to cooperate with NAMMD during the inspection, however the inspection activities shall be carried out by NAMMD. The law does not expressly provide for the possibility of foreign inspectors to carry out the inspection.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
According to the applicable legislation and guidelines, medicinal products must be stored separately from other products, with the purpose of avoiding alteration and protecting them from the harmful effects of light, humidity, temperature, as well as other external factors. In addition, storage facilities must be adequately illuminated and have a solid structure and sufficient capacity as to ensure a safe storage and handling.
The access to medicinal products must be limited to authorized personnel. Inside the storage areas, the presence of food supply, beverages, and articles for smokers and medicinal products for personal use is strictly forbidden.
The handling and/or transportation activities should be performed using special vehicles and equipment, in a manner that prevents any leakage, rupture, contamination and mixing of substances. Moreover, it is mandatory to plan the transport based on a risk assessment approach. Regardless of the means of transportation, the distributor should be able to prove that the products have not been exposed to conditions that might compromise their quality and integrity.
In respect of the packaging requirements envisaged by the law, the mandatory information should be mentioned on the label in Romanian language (solely or with other language). The law provides for certain exceptions to this rule (i.e., for certain orphan medicines). Also, the inclusion of a package leaflet in the package of all medicinal products is mandatory, unless all the information to be mentioned thereto is written on the secondary or primary packaging.
By law, in order to be traded in Romania, the medical devices must be designed, manufactured and packaged in such a way that their characteristics and performance during use are not affected by transport and storage, in accordance with the instructions and information provided by the manufacturer. Also, it is necessary to minimize the risk of contaminants and residues to persons involved in their transport and storage as well as to users of the devices, taking into account the intended purpose of the product. Special attention should be paid to exposed tissues, duration and frequency of exposure.
The devices delivered in a sterile condition must be designed, manufactured and packaged in disposable packages and/or in a way that ensures that they are sterile when placed on the market, during storage and transport under conditions specified by the manufacturer, and that they remain sterile until damage or opening of the protective packaging.
In respect of packaging medicinal products, the CE marking is mandatory, provided in a conspicuous, clearly legible and indelible manner, either on the device or on its sterile package, as well as included in the instructions for use. Custom-made medical devices and medical devices intended for clinical investigation are exempt from compliance with this condition.
The package and/or the label of the medical device must allow the differentiation between identical or similar traded products, in both sterile and non-sterile form. As well as in the case of medicines, the label should be in Romanian language (solely or with other language).
14. What information must be included in medicine and device labeling?
The information on the label of medicinal products, provided on the primary and on the secondary packaging, includes:
- the name of the medicinal product followed by its strength and pharmaceutical form;
- the active substances, expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a particular volume or weight;
- excipients list;
- route of administration;
- special warning that the product must be kept out of the reach and sight of children;
- date of expiry (month and year);
- special storage requirements;
- special precautions related to the disposal of unused medicinal products and waste materials;
- name and address of the marketing authorization holder and its local representative, as the case may be;
- marketing authorization number;
- manufacture batch number;
- instructions for use, for OTC medicinal products;
- safety precautions, where applicable.
The label of the medical devices should mention:
- the name/trade name and address of the manufacturer; for the devices imported in the European Union in view of trade, the name and address of the authorized representative of the non EU-manufacturer should be mentioned on the label;
- CE mark-up;
- the details strictly necessary for the user to identify the medical device and the content of the package;
- the claim “sterile”, if the case;
- the batch code, preceded by the word „lot” or the serial number, as the case may be;
- an indication of the date (year and month) by which the device could be safely used, as the case may be;
- an indication that the device is for single use, as the case may be;
- the claim „custom-made device”, in case of custom-made devices;
- the claim „exclusively for clinical investigations”, if the device is intended for clinical investigations;
- special storage and/or handling conditions;
- special instructions for use;
- safety precautions, as the case may be;
- year of manufacture, for active devices;
- sterilization method, if the case;
- statement that the device contains a derivative of human blood, if the case.
15. What additional information may be included in labeling and packaging?
The primary and the secondary package of medicinal products may provide for the following additional information:
- graphic symbols and icons designed to clarify certain information included in the labeling and patient information leaflet;
- other specifications compatible with the summary of product characteristics, which might prove useful to the patient, provided that any advertising intended element is excluded;
- a translation in one or more languages besides Romanian, bearing in mind that the information provided must be identical in all the languages used.
In certain cases, the information provided by the manufacturer can be in the form of symbols. Any such symbol or identification color used shall be in compliance with the European harmonized standards. Where there are no such standards, the symbols and colors used shall be described in the documentation provided for the medical device.
Also, if the intended purpose of the device is not obvious to the user, the manufacturer must clearly mention it on the label, as well as in the instructions for use.
16. What items may not be included in labeling and packaging?
By law, the information included on the labeling and packaging of the medicinal product shall not include elements which entail an advertising purpose. Also, the restrictions regarding misleading and comparative advertising, unfair practices and consumer protection should apply accordingly.
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
As a general rule, the information provided for advertising purposes must be in accordance with the summary of product characteristics and, as a general rule, shall not be comparative or misleading. The competent authority in this fields is NAMMD.
By law, the advertisement for a medicinal product:
- should be accurate, balanced, equitable, objective and complete to enable those to whom it is addressed to form their own opinion on the therapeutic value of the medicinal product in question;
- should be based on an up-to-date assessment of all relevant evidences and clearly reflect such evidences;
- should encourage the rational use of the medicinal product, without exaggerating its therapeutic properties;
- should not encourage self-medication or the unreasonable use of the medicine;
- should not be misleading, subliminal or misleading by distortion, exaggeration, unjustified accentuation, omission or any other way;
- should not suggest that a medicinal product or an active ingredient has any merit, quality or special property if this cannot be scientifically documented;
- should not prejudice respect for human dignity;
- should not include discrimination based on race, gender, language, origin,
social origin, ethnicity or nationality;
- should not harm the image, honor, dignity and private life of individuals.
In addition to the above mentioned requirements, the Advertising Norms provide certain restrictions for the advertising addressed to the general public, such as the prohibition to advertise medicinal products:
- without marketing authorization in Romania;
- without the approval of NAMMD, where such is required;
- released only based on medical prescription;
- containing narcotic or psychotropic substances;
- prescribed and released in the health insurance system, with the exception of vaccination campaigns performed by the pharmaceutical industry and approved by the Ministry of Health.
It is also prohibited to include in the advertisement information suggesting, inter alia, that:
- proper medical consultation or surgical intervention is not necessary, especially by offering diagnosis or long distance treatment suggestions;
- the medicinal product has a guaranteed effect and is not likely to cause adverse reactions;
- the patient’s overall health can be improved only by using the advertised medicinal product;
- emphasizes a certain recommendation from healthcare professionals whose celebrity could encourage the consumption of such medicinal products.
The applicable legislation does not regulate a specific procedure for the authorization by the competent authorities of the advertising for medical devices, but it provides for certain rules and limitations. In case of radio and TV advertisements, it is prohibited:
- to advertise a medical device released based on medical prescription;
- to broadcast advertising materials where healthcare professionals, medical associations or pharmacists recommend the use of such products;
- to broadcast advertising materials in TV shows for children or during the commercial breaks preceding or subsequent to the broadcast of such shows.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
As a rule, medicinal products are sold and released to the patients by the open circuit (community) pharmacies or by the closed circuit pharmacies, at the authorized premises of such pharmacies. In order to supply medicines to the patients, the pharmacy needs to be authorized by the Ministry of Health.
According to the Pharmacy Law no. 266/2008, as republished and further amended, certain community pharmacies could be authorized to sell OTC medicinal products online, based on a special authorization to be issued by the Ministry of Health. The secondary legislation issued by the Ministry of Health in 2019 lays down the procedure and the requirements for setting up and operating online pharmacies. Currently, there are several online pharmacies authorized and functioning in Romania.
Medical devices can be sold via various distribution channels, meaning that they can be acquired in pharmacies, in hospitals and on the internet, from the entities authorized to supply such products. The delivery via post is possible, provided that the transportation ensures the observance of the applicable distribution requirements (e.g., handling, storage, temperature), as the case may be.
19. What are the restrictions and requirements for electronic marketing and advertising via email, by Internet, social media, and other channels?
Internet advertising for medicinal products includes webpages, e-mails, forums, blogs or any other form of electronic support (except for social networks or Android, iOS or any other mobile application).
Activities which entail using internet as a platform for advertising medicinal products to the public require the prior approval of NAMMD. The concerned webpages should contain, amongst others, the following information:
- identity and address of the owner of the webpage;
- complete references on the source of every medical information within the webpage;
- the target audience of the webpage;
- the number of the advertising visa and date of issuance;
- relevant information for investors, media and general public, including financial data, descriptions of research and development programs, a list of all available products;
- non-promotional information on health education, characteristics of the diseases concerned, prevention, screening and treatment methods, as well as other information aimed at promoting public health;
- relevant aspects of therapeutic alternatives, including, where appropriate, surgery, diet, behavioral modification and other interventions that do not require the use of medicines;
- the latest approved information, package leaflet and summary of product characteristics (SmPC) of the advertised medicines;
- non-promotional aspects for patients and for the general public with regard to the OTC portfolio of the pharmaceutical company;
- ink the public assessment report(s) issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use or by a competent national competent authority;
- recommendation to consult a healthcare professional for further information.
It is prohibited to advertise medicinal products through e-mail, mobile phones (SMS), mobile apps (for example, Android or iOS) or social networks.
Advertising of prescription based medicines via internet to healthcare professionals is permitted provided that:
- • the marketing authorization holder proves 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 SmPC;
- • website providers must ensure that the materials posted on the website do not contain information inconsistent with applicable national and international regulations.
There are no specific regulations on using internet as a platform for advertising medical devices.
The audiovisual regulations provide for certain limitations on the advertisement of medical devices on TV and on radio. Amongst others, it is forbidden:
- to advertise a medical device released based on medical prescription;
- to broadcast advertising materials where healthcare professionals, medical associations or pharmacists recommend the use of such products;
- to broadcast advertising materials in TV shows for children or during the commercial breaks preceding or subsequent to the broadcast of such shows.
20. May medicines and devices be advertised or sold directly to consumers?
OTC medicinal products may be advertised to the public, subject to certain restrictions, as mentioned at Chapter 3 Question 17 above.
Medical devices can be advertised and sold directly to consumers, by observing the applicable legal requirements referred to in the sections above.
In all cases, both for medicines and for medical devices, it is prohibited to use misleading or comparative claims, as well as unfair commercial practices.
21. How is compliance monitored?
NAMMD is the main authority in Romania monitoring and ensuring compliance with the regulatory provisions on medicines and medical devices.
Thus, NAMMD is competent to monitor compliance with the legal requirements set for the marketing, manufacturing, packaging and labeling, as well as advertising and promotion of medicinal products and medical devices.
In this respect, NAMMD, among others, carries out inspections, issues authorizations and approvals for the purpose of manufacturing, marketing, labeling and advertising for such products, issues guidelines, norms and decisions, supervises and controls the quality of medicinal products and medical devices, applies sanctions in case of breach.
22. What are the potential penalties for noncompliance?
Depending on the type of infringement, NAMMD, National Consumer Protection Agency, the Ministry of Finance, the Romanian Audiovisual Council can apply various fines and sanctions, including the suspension, withdrawal or cancellation of certain authorizations, and the withdrawal from the market of certain products.
By way of example, the non-compliance with the requirements of the law on advertising medicinal products constitutes a minor offence which can trigger an administrative fine ranging between RON 10,000 (roughly EUR 2,100) and RON 30,000 (roughly EUR 6,300). This fine can be applied to the manufacturer, importer, wholesale or retail distributor.
According to Government Ordinance no. 2/2001, the following additional (complementary) sanctions might be applied by the competent authorities in case of offenses: (a) the suspension or, as the case may be, cancellation of the approval/endorsement/authorization for carrying out the activity; (b) the closing of the unit; (c) the blocking of the bank account; (d) the suspension of the activity of the relevant entity; (e) the withdrawal as a temporary or final measure of the license or approval for certain operations; (f) seizure of the goods designated, used or resulting from the contravention. As a rule, the sanctions provided by GO no. 2/2001 could be applied depending the gravity of the offense and by taking into account the circumstances of the deed, the means and the purposes of the offense, the consequences, as well as the background of the relevant offender.