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The implementation of the 2D coding system for medicines has been resumed

17/ 08/ 2020
  At the beginning of August, a Working Group on the implementation of the special 2D coding system for the labeling of drug packaging was established on the basis of the Ministry of Health. The group included the EBA Health Care Committee members, representatives of various areas of the pharmaceutical market, and public authorities. Business welcomes the establishment of the Working Group and the step towards the development of regulations for the implementation of the 2D coding system as the tool to combat counterfeit medicines. The European Business Association emphasizes that the Working Group should primarily focus its activities on developing such a mechanism for the 2D coding system implementation that is fully compliant with the effective mechanism in the EU. Thus, it is necessary to consider all relevant directives and regulations, including the rules on the content and structure of the code, the establishment of an independent organization that will be a code database holder, the procedure for interaction between the organization and the state control authorities, etc. Besides, the Working Group concluded that it is necessary to develop a number of regulations that clarify the lists of prescription and over-the-counter medicines for which the use of 2D-coding will be mandatory, as well as determine a sufficient transition period. Thus, the EU needed more than 3 years for such a transition. The business also emphasizes the need to harmonize Ukrainian legislation with EU regulations, which, in turn, ensure the establishment of an individual coding system that can be integrated into the EU system without any regulatory or technical changes. Thus, the two systems will be identical to each other. This integration will make it easier for both national manufacturers-exporters and importers of medicines to restructure their relevant internal systems. So, businesses will spend significantly less money on technical work that originated from the imperfect legislation. As previously reported by the Association, due to the lack of harmonization of Ukrainian legislation with EU regulations, inadequate technical facilities and unrealistic deadlines, the international drug manufacturers could not participate in the Pilot Project on 2D coding of medicines (CMU Resolution №653 of July 24, 2019 ), which was launched last year. Therefore, the European Business Association is ready to cooperate and provide quality proposals so that the 2D-coding system is eventually regulated, and pharmaceutical market participants can start its implementation in Ukraine.  Also, the business draws attention to the need for cooperation between the Working Group and the Ministry of Health of Ukraine with EU regulators in this area, such as the European Medicines Verification Organization and national drug verification organizations to create a truly European coding system. We hope the voice of business will be heard.     Be the first to learn about the latest EBA news with our Telegram-channel – EBAUkraine.  

At the beginning of August, a Working Group on the implementation of the special 2D coding system for the labeling of drug packaging was established on the basis of the Ministry of Health. The group included the EBA Health Care Committee members, representatives of various areas of the pharmaceutical market, and public authorities.

Business welcomes the establishment of the Working Group and the step towards the development of regulations for the implementation of the 2D coding system as the tool to combat counterfeit medicines.

The European Business Association emphasizes that the Working Group should primarily focus its activities on developing such a mechanism for the 2D coding system implementation that is fully compliant with the effective mechanism in the EU. Thus, it is necessary to consider all relevant directives and regulations, including the rules on the content and structure of the code, the establishment of an independent organization that will be a code database holder, the procedure for interaction between the organization and the state control authorities, etc.

Besides, the Working Group concluded that it is necessary to develop a number of regulations that clarify the lists of prescription and over-the-counter medicines for which the use of 2D-coding will be mandatory, as well as determine a sufficient transition period. Thus, the EU needed more than 3 years for such a transition.

The business also emphasizes the need to harmonize Ukrainian legislation with EU regulations, which, in turn, ensure the establishment of an individual coding system that can be integrated into the EU system without any regulatory or technical changes. Thus, the two systems will be identical to each other. This integration will make it easier for both national manufacturers-exporters and importers of medicines to restructure their relevant internal systems. So, businesses will spend significantly less money on technical work that originated from the imperfect legislation.

As previously reported by the Association, due to the lack of harmonization of Ukrainian legislation with EU regulations, inadequate technical facilities and unrealistic deadlines, the international drug manufacturers could not participate in the Pilot Project on 2D coding of medicines (CMU Resolution №653 of July 24, 2019 ), which was launched last year.

Therefore, the European Business Association is ready to cooperate and provide quality proposals so that the 2D-coding system is eventually regulated, and pharmaceutical market participants can start its implementation in Ukraine. 

Also, the business draws attention to the need for cooperation between the Working Group and the Ministry of Health of Ukraine with EU regulators in this area, such as the European Medicines Verification Organization and national drug verification organizations to create a truly European coding system. We hope the voice of business will be heard.

 

 

Be the first to learn about the latest EBA news with our Telegram-channel EBAUkraine.

 

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