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Minor Errors in Braille Printing Will Not Affect the Sale of Medicines

02/ 09/ 2024
  The Healthcare Committee of the European Business Association held a meeting with Roman Isaienko, Head of the State Service of Ukraine on Medicines and Drugs Control. The discussion focused on the regulation of Braille printing on the secondary packaging of medicinal products. Currently, Ukraine lacks regulatory documents that address this issue, making it difficult for both businesses and the regulator to operate within a unified legal framework. This complicates the interaction between companies and the State Service on this matter. During the meeting, it was concluded that minor errors in Braille printing that do not affect the quality or safety of the medicinal product, are not related to the drugs name or dosage, and do not distort the perception of the medication for visually impaired individuals should not be grounds for blocking the medicinal product. Such blocking would limit patient access to these medicines. It was also agreed that developing a document to regulate this issue is urgently needed. The Association has already reached out to the Ministry of Health and plans to contact the Ministry of Education to request the development of such an act. The Associations Committee sincerely thanks Mr. Roman for his attention to business concerns and for engaging in constructive dialogue to resolve these issues.

The Healthcare Committee of the European Business Association held a meeting with Roman Isaienko, Head of the State Service of Ukraine on Medicines and Drugs Control. The discussion focused on the regulation of Braille printing on the secondary packaging of medicinal products.

Currently, Ukraine lacks regulatory documents that address this issue, making it difficult for both businesses and the regulator to operate within a unified legal framework. This complicates the interaction between companies and the State Service on this matter.

During the meeting, it was concluded that minor errors in Braille printing that do not affect the quality or safety of the medicinal product, are not related to the drug’s name or dosage, and do not distort the perception of the medication for visually impaired individuals should not be grounds for blocking the medicinal product. Such blocking would limit patient access to these medicines.

It was also agreed that developing a document to regulate this issue is urgently needed. The Association has already reached out to the Ministry of Health and plans to contact the Ministry of Education to request the development of such an act.

The Association’s Committee sincerely thanks Mr. Roman for his attention to business concerns and for engaging in constructive dialogue to resolve these issues.

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