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The state must restore the efficiency and legality of the GMP confirmation procedure in Ukraine, – EBA

31/ 08/ 2020
  According to the member companies of the EBA Health Care Committee, the State Service of Ukraine on Medicines and Drug Control has started to involve state-owned enterprises on a paid basis to examine the documents submitted to obtain GMP certificates or conclusions. It should be noted that previously such a procedure was carried out by the State Medical Service independently and free of charge, under the current legislation of Ukraine. Thus, the pharmaceutical business is confused about changes in the established practice which also leads to unexpected complications. Currently, the SE Ukrainian Pharmaceutical Quality Institute and the SE Central Laboratory for Quality Analysis of Medicines and Medical Products are additionally involved in the examination. The State Medical Service argues this decision, referring to the problem of limited resources for conducting work activities during the quarantine and the underfunding problems which entail a staff shortage. Understanding the situation in which the State Medical Service operates, the EBA experts still consider such a decision unfounded for the pharmaceutical market. Suddenly changing rules without making appropriate amendments to the regulatory framework is an unpredictable and non-transparent approach to interaction with market participants. Besides, the pharmaceutical business has no guarantee that such changes will have a positive impact or prevent delays in the GMP procedure. The EBA experts emphasize that today any paid services to confirm the conformity of drug production with the GMP are not explicitly provided by law. Accordingly, without amending the current legislation of Ukraine, the procedure should fully function on a gratuitous basis - as it was until recently. The position of the EBA HCC Committee remains the same: any changes must be predictable and transparent for the business. It is especially relevant to the pharmaceutical market, where the daily sustainability of drug manufacturers has a direct impact on the medicine supply available to the population. The experts of the EBA HCC Committee are ready to take part in joint work with the State Medical Service on the legislative settlement of this situation. However, we would like to emphasize that it is necessary to restore the transparent and gratuitous GMP procedure until there is a full and quality regulation developed, and the pharmaceutical business is properly informed of the changes.   For the reference:  On August 10, 2020, representatives of the EBA Health Care Committee met with the management of the State Medical Service to discuss the latest regulatory changes in the certification of the medicine production to the requirements of good manufacturing practice (GMP). Participants discussed several issues related to the functioning of the State Medical Service, including the quarantine restrictions caused by the COVID-19 pandemic, the introduction of remote assessment, as well as some significant delays in the procedures of the State Medical Service.   Be the first to learn about the latest EBA news with our Telegram-channel – EBAUkraine.

According to the member companies of the EBA Health Care Committee, the State Service of Ukraine on Medicines and Drug Control has started to involve state-owned enterprises on a paid basis to examine the documents submitted to obtain GMP certificates or conclusions. It should be noted that previously such a procedure was carried out by the State Medical Service independently and free of charge, under the current legislation of Ukraine. Thus, the pharmaceutical business is confused about changes in the established practice which also leads to unexpected complications.

Currently, the SE “Ukrainian Pharmaceutical Quality Institute” and the SE “Central Laboratory for Quality Analysis of Medicines and Medical Products” are additionally involved in the examination. The State Medical Service argues this decision, referring to the problem of limited resources for conducting work activities during the quarantine and the underfunding problems which entail a staff shortage.

Understanding the situation in which the State Medical Service operates, the EBA experts still consider such a decision unfounded for the pharmaceutical market. Suddenly changing rules without making appropriate amendments to the regulatory framework is an unpredictable and non-transparent approach to interaction with market participants. Besides, the pharmaceutical business has no guarantee that such changes will have a positive impact or prevent delays in the GMP procedure.

The EBA experts emphasize that today any paid services to confirm the conformity of drug production with the GMP are not explicitly provided by law. Accordingly, without amending the current legislation of Ukraine, the procedure should fully function on a gratuitous basis – as it was until recently. The position of the EBA HCC Committee remains the same: any changes must be predictable and transparent for the business. It is especially relevant to the pharmaceutical market, where the daily sustainability of drug manufacturers has a direct impact on the medicine supply available to the population.

The experts of the EBA HCC Committee are ready to take part in joint work with the State Medical Service on the legislative settlement of this situation. However, we would like to emphasize that it is necessary to restore the transparent and gratuitous GMP procedure until there is a full and quality regulation developed, and the pharmaceutical business is properly informed of the changes.

 

For the reference: 

On August 10, 2020, representatives of the EBA Health Care Committee met with the management of the State Medical Service to discuss the latest regulatory changes in the certification of the medicine production to the requirements of good manufacturing practice (GMP).

Participants discussed several issues related to the functioning of the State Medical Service, including the quarantine restrictions caused by the COVID-19 pandemic, the introduction of remote assessment, as well as some significant delays in the procedures of the State Medical Service.

 

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

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