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New regulations of the EEU in respect of the classification of medical products and medicines


On 22 December and 29 December 2015 respectively, the Board of the Eurasian Economic Commission of the Eurasian Economic Union (hereinafter – “EEU”) has approved the “Rules for the classification of medical products depending on the potential risk of their use” and the “Rules for determining non-prescription and prescription categories of medicines”.

Rules for classification of medical products depending on the potential risk of their use (hereinafter – the “Rules 1”)

Under the Rules 1 the medical products are divided into 4 classes (1, 2a, 2b, 3) depending on the degree of the potential usage risk. When classifying a medical product in accordance with GOST R 51609-2000  following criteria are taken into account: its purpose, usage conditions, duration of use, invasiveness, availability of contact with the human body, method of its introducing into the human body, use of a medical product for the vital organs and systems, use of energy sources. Classification is performed according to Appendix No. 1 to the Rules 1. Moreover, the particular medical product can be assigned only to one class.

The Rules 1 set forth general safety and efficiency requirements of the medical products, as well as:

  • procedures and criteria for assigning each of the medical products to one of the classes (class 1 – medical products of low risk, class 2a - of moderate risk, class 2b – of high risk, class 3 – products having the highest risk degree);
  • particularities of classification of active medical products;
  • peculiarities of classification of certain medical products, in particular medical products, containing substances, which may be considered as medicines, or as products derived from human blood or plasma, when are used independently;
  • classification of medical products for invitro diagnostics, depending on the risk of potential use and algorithm for this classification.

The Rules 1  shall enter into force upon expiration of 30 calendar days from the date of entry into force of the Agreement on Common Principles and Rules for the Treatment of medical products (products of medical purpose and medical equipment) within the EEU, or from the date of entry into force of the Protocol on the jointing of the Republic of Armenia the Agreement on common principles and rules for circulation of medical products (products of medical purpose and medical equipment) within the EEU, depending on whichever  date is the latest.

The rules for determining non-prescription and prescription categories of medicines (hereinafter –  the “Rules 2”)

The Rules 2 define the procedures and criteria for classifying medicines into the non-prescription or prescription category, as well as requirements to the information provided by the holders of the registration certificates for amending of the registration dossier in the category of medicine.

The Rules 2 state that assigning of the medicine to one of the above categories is done at the stage of state registration of the medicine. At the same time, the authorized bodies observe specific ranking of prescription medicines in determining its category:

  • with general dispense rules;
  • subject to special dispense order;
  • subject to a limited dispensing on a specific request or for specific purposes.

The Rules 2 also introduce eligibility criteria for medicines to specific sub-categories of prescription medicines (specific prescription and limited dispense orders):

  • presence in the medical product of substances, classified as narcotic or psychotropic;
  • presence of a high abuse risk, emergence of addiction, use for illegal purposes;
  • presence of active substances that fall under the above categories.

A specific prescription procedure involves dispensing of a medicine to a patient only upon provision of a prescription issued under a special form and formalized under a specific manner.

Medicines are classified as prescription medicines if they:

  • may induce direct or indirect harm to human health, even when used properly, but without medical supervision;
  • are often used improperly, and therefore can induce direct or indirect harm to human health;
  • contain substances, compounds, action of which is poorly researched or side effects of which are not sufficiently researched;
  • are injected parenterally.

When determining damage to human health the following criteria are taken into account:

  • direct harm of the medicine (high risk of toxicity, side effects);
  • indirect harm of the medicine (symptomatic therapy masks the underlying disease, increase of resistance to the medicine due to the widespread use);
  • ability of the patient to perform self-assessment of his condition;
  • risk of improper use of the medicine and consequences of such use;
  • information on medicine available to the patient.

The lists of prescription and non-prescription medicines are to be updated by authorized bodies not less than once a year. It should be noted that the procedure for amending the lists of prescription and non- prescription medicines is not defined by the Rules 2.

The Rules 2  shall enter into force upon expiration of 30 calendar days from the date of entry into force of the Agreement on Common Principles and Rules for the Circulation of medicines within the EEC, or from the date of entry into force of the Protocol on joining of the Republic of Armenia to the Agreement on common principles and rules for circulation of medicines within the EEC, depending on whichever date is the latest.

_____

2GOST R 51609-2000 “Medical devices. Classification depending on the potential usage risk”



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