20.05.2009 was introduced an amendment to the law of Ukraine “On medicines” (№ 124/96ВР of 4.04.96) which orders to use Braille script on packages. Changes came into force until 01.01.10. In Ukraine live approximately 45 000 of semi-blind people and 10 000 – 20 000 from this number are totally blind.
It’s important to pay attention for this question: for example EU producers had approximately 7 years preparation for new law concerning the Braille script.
What does it mean for producers of drugs? All new registration and renewal procedures from 01.01.10 would include part respondent for Braille script. Producers must add Braille description on the packages. Also this amendment means purchasing special equipment for plotting and marking the packages. Ukraine goes in direction of EU standards. It’s important to pay attention for this question: for example EU producers had approximately 7 years preparation for new law concerning the Braille script.
What does it mean for producers of drugs? All new registration and renewal procedures from 01.01.10 would include part respondent for Braille script. Producers must add Braille description on the packages. Also this amendment means purchasing special equipment for plotting and marking the packages. Ukraine goes in direction of EU standards.
30 December 2009 Victor Korzh, the author of amendment, in his statement about bill #506 “About amendments and changes in article #12 of Law of Ukraine “On medicines””. He notes that transferring the date from 01.01.10 to 01.01.11 “would be reasonably for all producers to observe the law about Braille script in full measure”.
Today there are some questions about new law: for example is it worth of marking with Braille injection solutions? Blind patients are not able to make injection by themselves, so there is no need to mark injection solutions. What information would be on the packages: only name of drug and doze or additional information as formulation and brief instruction for use? Hopefully, we will get answers on these questions during 2010 year.
