Dear exhibitors and visitors!
Exhibition company DENTALEXPO urges you to pay special attention to the need to comply with the legislation of the Russian Federation when working at the exhibition. Remember that one of the most important tasks of the exhibition is the development of the civilized market, improving the quality of life of patients.
NOTICE: Medical devices not registered at Ministry of Health (in particular - at Rosdravnadzor agency), can be exhibited but are not allowed for sale
In accordance with the Agreement between the Exhibitor (Exhibitor) and the Organizer, as well as the Conditions of participation in the exhibitions, the Exhibitor undertakes to comply with the current legislation of the Russian Federation, including:
1) The exhibitor undertakes to observe the current legislation of the Russian Federation regulating the procedure for the circulation of medical products and medicines, in particular: Federal Law No. 61-FZ of 12.04.2010 "On the circulation of medicinal products", art. 38 of the Federal Law No. 323 of 21.11.2011 "On the fundamentals of protecting the health of citizens in the Russian Federation" and the relevant regulatory legal acts.
2) The exhibitor realizes that the violation of the requirements of the legislation to the procedure for the circulation of medical products and medicines, including the use of unregistered medical devices and medicines, entails the responsibility provided for in Articles 6.28, 6.33, 14.43 of the Code of Administrative Offenses of the Russian Federation, Article 238.1 The Criminal Code of the Russian Federation.
3) The exhibitor realizes that violation of the requirements of the legislation regarding compliance with licensing requirements in the implementation of medical and pharmaceutical activities approved by Federal Law No. 99-FZ of 04.05.2011 "On licensing certain types of activities" entails administrative and criminal liability.
It is recommended to have on the stand copies of registration certificates for medical products that are circulating in the Russian Federation, if the exhibitor is engaged in their sale.
USEFUL INFORMATION
1. Treatment of medical devices
According to Part 3 of Art. 38 of the Federal Law of 21.11.2011 № 323-FZ "On the fundamentals of protecting the health of citizens in the Russian Federation", the concept of "treatment of medical products" includes, among them, their state registration. According to the law, medical devices registered in accordance with the procedure established by the Government of the Russian Federation and authorized by the federal executive authority are allowed on the territory of the Russian Federation. A document certifying the fact of state registration of a medical device is the registration certificate for a medical device. The state registration of medical products in the territory of the Russian Federation is exercised by the Federal Service for Supervision in the Health Care Sector in accordance with the powers vested in it by the Government of the Russian Federation.
Administrative violations in the sphere of medical products circulation can be conditionally divided into several groups:
1. Violations in the sphere of treatment of medical devices: Article 6.28 of the Code of Administrative Violations "Violation of the established rules in the sphere of the circulation of medical devices, if these actions do not contain any signs of a criminal offense";
Article 6.33 of the Code of Administrative Offenses "Treatment of counterfeit, counterfeit, poor-quality and unregistered medicines, medical devices and the turnover of adulterated biologically active additives".
2. Violations of the requirements of technical regulations and product conformity: Article 14.43 of the Administrative Code "Violation by the manufacturer,
(the person performing the functions of a foreign manufacturer), the seller of the requirements of technical regulations ";
Article 14.44 of the Code of Administrative Offenses "Unreliable Declaration of Conformity of Products";
Article 14.46 of the Code of Administrative Offenses "Violation of the order of marking of products subject to mandatory confirmation of conformity".
Article 19.4 of the Code of Administrative Offenses "Disobedience to the lawful order of the official of the body exercising state supervision (control), municipal control";
article 19.4.1. Administrative Code "Obstruction of lawful activity of an official of the body of state control (supervision), body of municipal control";
article 19.5. Administrative Code "Failure to comply with the lawful order (decision, submission, decision) of the body (official) performing state supervision (control), municipal control";
Article 19.7.8 of the Code of Administrative Offenses "Failure to provide information or submission of knowingly unreliable information to the federal executive body that exercises functions of control and supervision in the field of public health";
Article 19.33 of the Code of Administrative Offenses "Failure to meet the requirements for the presentation of product samples, documents or information necessary for the exercise of state control (supervision) in the field of technical regulation".
Since January 23, 2015, criminal liability has been established for violations in the sphere of medical devices, namely:
article 235.1. The Criminal Code of the Russian Federation establishes responsibility for the illegal manufacture of medicines and medical products;
article 238.1. The Criminal Code of the Russian Federation establishes the responsibility for the circulation of falsified, inferior and unregistered medicinal products, medical products and trafficking in falsified biologically active additives;
article 327.2. The Criminal Code of the Russian Federation establishes the responsibility for forgery of documents for medicinal products or medical products, or for the packaging of medicinal products or medical devices.
Also in Art. 38 of Law No. 323-FZ amended Federal Law No. 532-FZ of December 31, 2014 and provides the following definitions:
- falsified medical product - medical product accompanied by false information about its characteristics and (or) the manufacturer (manufacturer);
- a poor-quality medical product - a medical product that does not meet the requirements of the regulatory, technical and (or) operating documentation of the manufacturer (manufacturer) or, in the absence of it, the requirements of other normative documentation;
- Counterfeit medical product - a medical product that is in circulation in violation of civil law.
More details about violations and the liability provided can be read in the source of the above information: Bulletin of Roszdravnadzor №3 for 2015.
2. Counterfeit products
Counterfeit today is becoming an increasingly serious problem, affecting the interests not only of business, but of society. However, the problem is clearly acute, and the damage inflicted on completed criminal cases in the Moscow Region exceeds one billion rubles. (source: MAIN DEPARTMENT OF THE RUSSIAN MINISTRY OF MINISTRY OF THE RUSSIAN FEDERATION FOR THE MOSCOW REGION) Results of the press conference on the topic: "Suppression of offenses related to the illegal use of the trademark" on 29 November 2016)
Methods of protection and protection of intellectual property in the Russian Federation
First of all, it is necessary to indicate what is meant by the objects of intellectual property.
Trademark - a designation that serves to individualize goods and / or services of legal entities and individual entrepreneurs. Can be verbal, pictorial or combined. The law also provides for the possibility of registering other designations as trademarks, for example, volume or sound.
The invention is a technical solution in any field related to a product (device, substance, strain of a microorganism, a plant or animal cell culture) or a method (the process of performing actions on a material object by means of material means).
A Utility model is a technical solution related to the device.
The industrial design is an artistic design solution of a product of industrial or handicraft and craft production, which determines its appearance.
The above objects are subject to mandatory state registration in the territory of each particular country where the right holder intends to obtain legal protection.
Objects of copyright, in particular, computer programs and databases are not subject to compulsory state registration, but the latter is possible at the request of the right holder.
The secret of production or know-how is also understood as an object of intellectual property, but due to the fact that these objects are always protected in the mode of commercial secrecy and information about them is closed to an indefinite circle of persons, violation of exclusive rights in their relation rarely concerns directly to the exhibition activity .
In order to be able to limit the number of persons who have the right to use the object of intellectual property, the right holder must apply to the competent authorities for the state registration of the intellectual property object and, accordingly, the receipt of the title of protection in each country where he intends to obtain legal protection.
Actions taken to protect intellectual property
Judicial bodies - in case of the discovery of the fact of violation of exclusive rights, the rightholder can apply for protection of his rights and interests to the judicial bodies of the Russian Federation with a requirement to prohibit the infringer in the future to use a certain object of intellectual property, as well as to demand monetary compensation.
Customs authorities - in Russia there is the possibility of applying to the customs authorities for the purpose of entering a trademark in the Customs Register of the Russian Federation. This measure is more of a preventive nature and is aimed at suppressing the import of goods marked with identical or similar designations by foreign counterparties. In this case, the customs authorities will notify the right holder about all cases of crossing the goods marked with the same or similar signs with their trademark, if the importation of goods is carried out by unauthorized persons.
The antimonopoly authority - an appeal to the antimonopoly body allows to protect its rights not only to persons who have security documents for any intellectual property objects, but also to those who for certain reasons did not receive the specified documents, but their goods became known to consumers and associated with the latter specific manufacturer.
Useful links:
Non-Profit Partnership "Anti-Counterfeiting International Alliance for Counteracting the Traffic of Counterfeit Products"
The Federal Service for Supervision in the Sphere of Health Care (Roszdravnadzor)