DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of September 27, 2023 No. 108

About marking of medicines means of identification

According to item 4 of article 7 of the Agreement on marking of goods means of identification in the Eurasian Economic Union of February 2, 2018, and also Item 3 of basic technological organizational model of system of marking of goods means of the identification in the Eurasian Economic Union approved by the Decision of Council of the Eurasian economic commission of March 5, 2021 No. 19 (further - basic model), Council of the Eurasian economic commission solved:

1. State members of the Eurasian Economic Union (further respectively - state members, the Union) independently determine the list of the medicines which are subject to marking by means of identification (further - marking), Date of Introduction and procedure for marking in the territory according to this Decision and notify on it the Eurasian economic commission (further - the Commission) not later than 6 months before Date of Introduction of marking.

2. Determine that:

a) the medicines including specified in the inventory, subject to marking by means of identification, approved by this Decision are subject to marking:

the Rules of registration and the examinations of medicines for medical application approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 78 and (or) according to the legislation of state members; registered according to

not being subject to state registration, or the unregistered medicines if marking of such medicines is stipulated by the legislation state members;

b) marking of the medicines made in the territory of the Union is performed by producer of such medicines, and in case of import to customs area of the Union - the holder or the owner of the registration certificate of medicine or other participant of turnover of goods determined by the legislation of state member, way of drawing the means of identification corresponding to the characteristics approved by this Decision or the material carriers containing such means of identification on secondary (consumer) package or on primary package (in case of lack of secondary (consumer) package), taking into account the subitem "k" of this Item.

For separate medicines by the legislation of state members features of drawing means of identification on them or the material carrier containing means of identification can be established. At the same time state members inform the Commission on such medicines and the above-stated features before entry into force of the regulatory legal act establishing these features;

c) secondary (consumer) package - packaging in which medicine in primary package for realization to the consumer is located;

d) primary package - the packaging which is directly adjoining to medicine;

e) marking of remaining balance of medicines is not performed, such remaining balance is stored, transported and implemented before the expiration of their period of validity;

e) marking does not extend to the veterinary medicines, medicines made for conduct of clinical trials, the medicines which are not subject to state registration, medicines which are intended for use in the conditions of military operations, emergency situations, the prevention of emergency situations, prevention and treatment of the diseases constituting danger to the people around, diseases and defeats received as a result of impact of adverse chemical, biological, radiation factors, radio pharmaceutical medicines, bloodsuckers medical and gases medical if other is not stipulated by the legislation state members;

g) state members for the purpose of ensuring functioning of information system of marking of goods determine national operators (administrators) of national components of information system of marking of goods;

h) interaction of state members is performed according to the procedure, provided by basic model, except for Chapter III provisions. Interaction within cross-border trade between state member in the territory of which marking is entered and state member in the territory of which marking is not entered is performed according to the procedure, established by the legislation of state member in the territory of which marking, and this Decision is entered;

i) state members in case of introduction of marking in the territory according to this Decision provide cryptographic protection of means of identification according to the Decision of Council of the Eurasian economic commission of April 23, 2021 to No. 41;

j) the requirements to means of identification other than the requirements established by this Decision can be determined by the legislation of the Kyrgyz Republic. The medicines marked by such means of identification are not subject to turnover in the territory of state members which entered marking of medicines in the territory according to this Decision, without observance of requirements of this Decision. At the same time the Kyrgyz Republic provides recognition of the means of identification conforming to the requirements approved by this Decision, and applied on the medicines imported from the territory of state members which entered marking of medicines according to this Decision;

k) from Date of Introduction of marking in the territory two and more state members according to this Decision, except for the case provided by the subitem "k" of this Item them provide mutual recognition of the means of identification in case of cross-border trade applied on medicines and corresponding to the characteristics approved by this Decision taking into account the term of the direction of the notification specified in Item 1 of this Decision and under condition:

drawings means of identification by the producer, holder or owner of the registration certificate of medicine which status is confirmed by the national operator of state member from which territory the marked medicines are exported. State members determine (in need of) other participants of turnover who performed marking of medicines which means of identification are recognized in the territory of these state members according to the procedure, established by this Decision;

availability of data on the marked medicines in the national register of state member on which territory such medicines, or about their registration in the Unified register of the registered medicines of the Eurasian Economic Union taking into account recognition of the registration certificate of such medicine in state members on which territory these medicines are imported are imported;

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