LEGAL SERVICES

Analysis of labeling, instructions, advertising and promotional materials for compliance with the requirements of legislation

The market of health products (medical devices, medicines, cosmetics, nutritional supplements, etc.) is among the most regulated markets.

The inconsistency of labeling, packaging and promotional materials with the current legislation of Ukraine increases the risk of sanctions from state regulatory and anti-monopoly authorities.

The selling companies do not always take into account that product labeling and promotional materials, among other subject matters, should contain obligatory information and consider certain restrictions.

Obligatory information shall include (depending on the product category):

  • serial numbers and dates of issuing of the documents that confirm the right to sell products on the market;
  • obligatory symbols and conformity marks;
  • specification of the objects of intellectual property rights;
  • date of manufacture or best before date;
  • information on authorized representatives and importers.

Restrictions and requirements may be applicable to (depending on the product category)

  • indications for usage of the product;
  • sizes of: fonts, symbols, and signs;
  • local language requirements;
  • units of measure;
  • comparative characteristics with competitive products;
  • warning information for the consumer.

An incorrect indication or statement may entail undesirable consequences for the advertiser.

Example:

The most common reason for the sanctions of market authorities for medical devices circulation supervision is not the quality of the product itself, but inconsistence of product labeling with technical regulations and industry standards.

The most common form of unfair advertising in the field of health products circulation is dissemination of misleading information.

The Law of Ukraine dated June 07,1996, № 236/96-ВР “On Protection from Unfair Competition” in its art. 15-1 stipulates that dissemination of misleading information is informing by a business entity, directly or through another person, to one, several persons or an indefinite number of persons, including but not limited to in the advertising, of incomplete, inaccurate, false information, in particular due to the chosen way of its presentation, understatement of separate facts or vagueness of the language that influenced or may influence the intentions of these persons as to the purchase (order) or realization (sale, delivery, usage, provision) of goods, works, services of this enterprise.

At the same time, the laws and regulations on health products advertising do not provide:

  • clear criteria for assessment of information in misleading advertising;
  • criteria for assessing inaccuracy, uncertainty, ambiguity of information in advertising;
  • unified rules of professional ethics (code) in the pharmaceutical and medical market.

The upper mentioned shortcomings of the Ukrainian legislation lead to the sanctions of the Antimonopoly Committee of Ukraine (AMCU) while handling inspections of the companies that function in the market in respect of the correctness of dissemination of information (advertising) by the business entities, and the dissemination of misleading information. And with consideration of the lack of regulations that define uniform and clear criteria for evaluating advertising information, it is extremely difficult for business entities to avoid sanctions from the AMCU.

With the aim to reduce the risks of violating the rights of third parties and subsequent sanctions from state regulators, when developing advertising and promotional materials, the specialists of “Archimedes” Company carry out legal analysis for compliance with the requirements of:

  • the Law of Ukraine “On Advertising”;
  • the Law of Ukraine “On Protection of Consumers’ Rights”;
  • the Law of Ukraine “On Protection from Unfair Competition”;
  • the Law of Ukraine “On Market Supervision”;
  • the Law of Ukraine “On Medicines”;
  • the Law of Ukraine “On the General Safety of Non-Food Products”
  • the Law of Ukraine “On Basic Principles and Requirements for Food Safety and Quality”
  • Technical regulations for medical devices

and other related regulatory acts.

The aim of this service is to protect the interests of our customers, as advertisers, from responsibility stipulated by law for inappropriate and unfair advertising information in advertising and promotional materials.

“Archimed” Company has necessary competencies and considerable experience in supporting both the process of creating advertising and its usage.

Likewise, we will eagerly assist you in:

  • analysis and support of contracts with media, advertising and creative agencies
  • organizing of participation in specialized exhibitions;
  • development of programs for creating/enhancing loyalty of recommending experts (doctors, pharmacists, opinion leaders);
  • carrying out promotions in pharmacies, sampling, merchandising, educational and information programs for pharmacists;
  • organization of professional events for doctors, pharmacists, cosmetologists and other stakeholders;
  • holding of seminars and trainings for employees of distributing companies (distributors).

 

Get more detailed consultation by sending us a brief request or calling the number below.