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Health Care

15/ 01/ 2013
  The Resolution of the Cabinet of Ministers of Ukraine No 1205 dated 26 December 2012 postponed the date of obligatory submission of UA GMP certificate Conclusion from 1 January 2013 to 15 February 2013. Background: According to the Resolution of the Cabinet of Ministers of Ukraine No 793 dated 8 August 2012 “On Amending the Order of State Quality Control of Medical Drugs Imported to Ukraine” (hereinafter – the CMU Resolution) starting from 1 January 2013 the importer had to obligatory submit a copy of the document issued by the State Service for Medical Drugs (hereinafter – the State Service)to confirm that medical drugs meet GMP requirements (hereinafter – UA GMP certificate Conclusion)  in order to obtain a quality conclusion necessary for medical drugs’ sale. As far back as summer 2012, during the CMU Draft Resolution elaboration, the European Business Association (hereinafter – the EBA) stressed that the implementation of this requirement within the mentioned period was unrealistic in view of the State Service’s resources to timely complete the GMP conformity procedure for all submitted applications; nor it was possible due to the procedure imperfection which brings many difficulties to the international medical drug manufacturers, for it does not provide objective conditions to fulfill the procedure requirements in terms of time constraints. However, despite the majority vote of the Ministry of Health of Ukraine’s (hereinafter – MOH of Ukraine), Working Group members ,including the EBA representatives for the date 1 July 2013 to be fixed in CMU Resolution, the date 1 January 2013 was officially adopted. The EBA sent out a number of appeals regarding the necessity to postpone the date 1 January 2013 to the following state authorities: Raisa Bohatyryova, the Vice Prime Minister of Ukraine/Minister of Health and Oleksiy Solovyov, the Head of the State Service for Medical Drugs. Also, the EBA stressed the importance of this issue during the working meetings with the abovementioned officials and with Mykhailo Brodskiy, the Head of the State Committee of Ukraine for Regulatory Policy and Entrepreneurship, Roman Bogachev, the Deputy Minister of Health of Ukraine and Taras Lyaskovskiy, Head of the Medical Drugs’ State Registration and Quality Control Department of MOH of Ukraine. On 26 November 2012 the CMU Draft Resolution “On Amending Article 2 of the CMU Resolution No 793 dated 8 August 2012” (hereinafter – the Draft) was published on the MOH web-site. According to this document, the submission of the UA GMP Certificate Conclusion would be mandatory to get the quality conclusion for the medical drugs since 1 July 2013. The EBA expressed its definite support of this Draft again. It was also supported by the State Committee of Ukraine for Regulatory Policy and Entrepreneurship. Nevertheless, the mentioned amendments were not adopted as of the end of December 2012. Given the lack of time until 1 January 2013 which could appear critical for both leading international manufacturers due to the absence of possibility to sell their medical drugs in Ukraine and the patients to access these medicines, the EBA made efforts to draw attention of not only the state authorities but also of the mass media and the public to this particular issue. EBA representatives participated in the press-conference “Problem of January the 1st: Would It Be Possible to Deliver Imported Medicines and Medical Devices of High Quality to Ukrainian Patients?”, held on 25 December 2012 which was devoted mostly to the issue of blocking a part of medicine produced by international manufacturers operating under GMP conditions. Also, on 27 December 2012 the EBA took part in the meeting with Kostyantyn Gryshchenko, the Vice Prime Minister of Ukraine, to emphasize once again the realistic nature of this problem, its reasons and extremely negative impact to appear. Now we would like to inform that on 3 January 2013 the Cabinet of Ministers of Ukraine Resolution No 1205 to postpone the requirement of obligatory submission the UA GMP Certificate Conclusion till 15 February 2013 came into effect. The postponement of this date shall remove the threat of limiting patients’ access to essential medicines at this stage. The EBA is also looking forward to the adoption of amendments to the GMP confirmation procedure at the soonest, which shall simplify operation of companies and take away the market tension.

The Resolution of the Cabinet of Ministers of Ukraine No 1205 dated 26 December 2012 postponed the date of obligatory submission of UA GMP certificate Conclusion from 1 January 2013 to 15 February 2013.

Background: According to the Resolution of the Cabinet of Ministers of Ukraine No 793 dated 8 August 2012 “On Amending the Order of State Quality Control of Medical Drugs Imported to Ukraine” (hereinafter – the CMU Resolution) starting from 1 January 2013 the importer had to obligatory submit a copy of the document issued by the State Service for Medical Drugs (hereinafter – the State Service)to confirm that medical drugs meet GMP requirements (hereinafter – UA GMP certificate Conclusion)  in order to obtain a quality conclusion necessary for medical drugs’ sale.

As far back as summer 2012, during the CMU Draft Resolution elaboration, the European Business Association (hereinafter – the EBA) stressed that the implementation of this requirement within the mentioned period was unrealistic in view of the State Service’s resources to timely complete the GMP conformity procedure for all submitted applications; nor it was possible due to the procedure imperfection which brings many difficulties to the international medical drug manufacturers, for it does not provide objective conditions to fulfill the procedure requirements in terms of time constraints.

However, despite the majority vote of the Ministry of Health of Ukraine’s (hereinafter – MOH of Ukraine), Working Group members ,including the EBA representatives for the date 1 July 2013 to be fixed in CMU Resolution, the date 1 January 2013 was officially adopted.

The EBA sent out a number of appeals regarding the necessity to postpone the date 1 January 2013 to the following state authorities: Raisa Bohatyryova, the Vice Prime Minister of Ukraine/Minister of Health and Oleksiy Solovyov, the Head of the State Service for Medical Drugs. Also, the EBA stressed the importance of this issue during the working meetings with the abovementioned officials and with Mykhailo Brodskiy, the Head of the State Committee of Ukraine for Regulatory Policy and Entrepreneurship, Roman Bogachev, the Deputy Minister of Health of Ukraine and Taras Lyaskovskiy, Head of the Medical Drugs’ State Registration and Quality Control Department of MOH of Ukraine.

On 26 November 2012 the CMU Draft Resolution “On Amending Article 2 of the CMU Resolution No 793 dated 8 August 2012” (hereinafter – the Draft) was published on the MOH web-site. According to this document, the submission of the UA GMP Certificate Conclusion would be mandatory to get the quality conclusion for the medical drugs since 1 July 2013. The EBA expressed its definite support of this Draft again. It was also supported by the State Committee of Ukraine for Regulatory Policy and Entrepreneurship. Nevertheless, the mentioned amendments were not adopted as of the end of December 2012.

Given the lack of time until 1 January 2013 which could appear critical for both leading international manufacturers due to the absence of possibility to sell their medical drugs in Ukraine and the patients to access these medicines, the EBA made efforts to draw attention of not only the state authorities but also of the mass media and the public to this particular issue.

EBA representatives participated in the press-conference “Problem of January the 1st: Would It Be Possible to Deliver Imported Medicines and Medical Devices of High Quality to Ukrainian Patients?”, held on 25 December 2012 which was devoted mostly to the issue of blocking a part of medicine produced by international manufacturers operating under GMP conditions.

Also, on 27 December 2012 the EBA took part in the meeting with Kostyantyn Gryshchenko, the Vice Prime Minister of Ukraine, to emphasize once again the realistic nature of this problem, its reasons and extremely negative impact to appear.

Now we would like to inform that on 3 January 2013 the Cabinet of Ministers of Ukraine Resolution No 1205 to postpone the requirement of obligatory submission the UA GMP Certificate Conclusion till 15 February 2013 came into effect.

The postponement of this date shall remove the threat of limiting patients’ access to essential medicines at this stage.

The EBA is also looking forward to the adoption of amendments to the GMP confirmation procedure at the soonest, which shall simplify operation of companies and take away the market tension.

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