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Ukraine may be left without medicines, CPPs and veterinary drugs in 2021 due to inconsistency of legislation

29/ 09/ 2020
  From January 1, 2021, a mandatory condition for the designation of SI units on products during its production and circulation will come into force.  However, the introduction of this system should be gradual for some sectors of the economy, namely plant protection products, veterinary drugs, medicines, etc., as making changes to the labeling of such products is strictly regulated by the state. For example, the process of making changes to the label for plant protection products takes up to 6 months in practice. Given the seasonality of the agrochemical business, it can lead to an actual loss of the market. After all, companies will have absolutely no time to rearrange the processes - there are only three months left. Viktor Pogorilyi. Senior Manager, Agrochemical Direction. The inconsistency appears in the legislation after the enactment of Order №914 of the Ministry for Development of Economy, Trade and Agriculture. Thus, according to the Order №490 of the Ministry of Environment of 2006, the units of measurement must be indicated on the label exclusively in Ukrainian, while the Order of the Ministry for Development of Economy, Trade and Agriculture requires duplication in the Latin alphabet. Accordingly, a business cannot fulfill both requirements at the same time. Moreover, even if we try to comply with the requirements of the Mineconomy, as of today, the State Register of Pesticides and Agrochemicals contains more than 3,000 items. The resources of the newly created Ministry of Environment are significantly limited. If every agrochemical market participant simultaneously applies to it for amendments to the label as it is required now, the process of state registration of CCPs and fertilizers will be blocked for the next 6-12 months. Such inconsistency in the work of government agencies may cause a shortage of products from January 1, 2021, - said Viktor Pogorilyi, Senior Manager of EBA Agrochemical Direction. There is a particular concern regarding the disruptions in the supply of medicines to Ukraine due to a number of inconsistencies and the unclear regulation in the application of the requirements on the medicine labeling set forth in the Order №914 of the Mineconomy. Besides, the need to amend the text on the packaging of medicines, the Order of the Mineconomy also establishes the term introduction into circulation, which cannot be interpreted in the context of the regulation of medicines. The respective legislation does not contain such a term; therefore, it is not applicable for use in this area. By this term, the Ministry for Development of Economy, Trade and Agriculture implies the whole process of import and customs clearance of products. It should be noted that such procedures cannot be done in such a short time. This, together with a long process of re-registration of labeling for technical changes not caused by patient needs, may lead to the fact that from January 1, 2021 Ukrainians may be left without drugs, which is extremely critical given the global pandemic. Therefore, the European Business Association appeals to the Prime Minister of Ukraine to intervene in resolving this situation so that innovative CPPs, veterinary drugs, and medicines do not disappear from the Ukrainian market. In this context, it is necessary to regulate the definition, such as introduction into circulation and allow the abovementioned categories of businesses to submit new labels in a planned manner (not limited to January 1, 2021). In this way, the risk of disruptions in supply and circulation will be minimized, and most importantly it will prevent patients from stopping treatment. We hope the voice of business will be heard!   Be the first to learn about the latest EBA news with our Telegram-channel – EBAUkraine.  

From January 1, 2021, a mandatory condition for the designation of SI units on products during its production and circulation will come into force.

 However, the introduction of this system should be gradual for some sectors of the economy, namely plant protection products, veterinary drugs, medicines, etc., as making changes to the labeling of such products is strictly regulated by the state. For example, the process of making changes to the label for plant protection products takes up to 6 months in practice. Given the seasonality of the agrochemical business, it can lead to an actual loss of the market. After all, companies will have absolutely no time to rearrange the processes – there are only three months left.

Viktor Pogorilyi Senior Manager, Agrochemical Direction
The inconsistency appears in the legislation after the enactment of Order №914 of the Ministry for Development of Economy, Trade and Agriculture. Thus, according to the Order №490 of the Ministry of Environment of 2006, the units of measurement must be indicated on the label exclusively in Ukrainian, while the Order of the Ministry for Development of Economy, Trade and Agriculture requires duplication in the Latin alphabet. Accordingly, a business cannot fulfill both requirements at the same time.

“Moreover, even if we try to comply with the requirements of the Mineconomy, as of today, the State Register of Pesticides and Agrochemicals contains more than 3,000 items. The resources of the newly created Ministry of Environment are significantly limited. If every agrochemical market participant simultaneously applies to it for amendments to the label as it is required now, the process of state registration of CCPs and fertilizers will be blocked for the next 6-12 months. Such inconsistency in the work of government agencies may cause a shortage of products from January 1, 2021, “- said Viktor Pogorilyi, Senior Manager of EBA Agrochemical Direction.

There is a particular concern regarding the disruptions in the supply of medicines to Ukraine due to a number of inconsistencies and the unclear regulation in the application of the requirements on the medicine labeling set forth in the Order №914 of the Mineconomy. Besides, the need to amend the text on the packaging of medicines, the Order of the Mineconomy also establishes the term “introduction into circulation”, which cannot be interpreted in the context of the regulation of medicines. The respective legislation does not contain such a term; therefore, it is not applicable for use in this area. By this term, the Ministry for Development of Economy, Trade and Agriculture implies the whole process of import and customs clearance of products. It should be noted that such procedures cannot be done in such a short time. This, together with a long process of re-registration of labeling for technical changes not caused by patient needs, may lead to the fact that from January 1, 2021 Ukrainians may be left without drugs, which is extremely critical given the global pandemic.

Therefore, the European Business Association appeals to the Prime Minister of Ukraine to intervene in resolving this situation so that innovative CPPs, veterinary drugs, and medicines do not disappear from the Ukrainian market. In this context, it is necessary to regulate the definition, such as “introduction into circulation” and allow the abovementioned categories of businesses to submit new labels in a planned manner (not limited to January 1, 2021). In this way, the risk of disruptions in supply and circulation will be minimized, and most importantly it will prevent patients from stopping treatment. 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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