[lg policy] Ukraine: American Chamber of Commerce asking president to amend language law on labeling of medicine and dosage information

[Harold Schiffman]

American Chamber of Commerce asking president to amend language law on
labeling of medicine and dosage information

12:38

An obligatory requirement to additionally label medicine and insert
dosage information in the regional language or languages of minority
groups is not in line with state policy in the healthcare sector,
according to the Ukrainian representative office of the American
Chamber of Commerce.

According to a letter of the Chamber to Ukrainian President Viktor
Yanukovych published on Monday, the necessity to amend the
registration documents could cause large extra expenses for producers
supplying a large number of medicines.

The experts said that the State Expert center of the Health Ministry
of Ukraine, which examines changes in the labeling of medicines and
prescribing information, will have to check the Ukrainian version of
the dosage information is identically presented in other language.
Taking into account the large number of medicines registered in the
country (over 13,000) this will result in large delays in the
amendment procedure.

The Chamber also said that large expenses of producers could be
included in the cost of medicine, which will lead to an increase in
their prices. Some foreign pharmaceutical companies could refuse to
suppply medicine to the Ukrainian market until changes to the
registration documents are made.

The Chamber also said that many medicines have a lot of dosage
information, and the necessity to present them in an additional
language will make it impossible to put them in a standard package.
The letter points that the change in the size of the package is a
problematic step for international producers, first, from the
technological point of view, as expenditure on the change of its form
could be unjustifiable compared to profits expected from the sale of
the medicine in Ukraine.

The Chamber addressed the head of state and asked him to amend the law
on principals of the state language policy, according to which goods
are labeled and dosage information is presented in the state language,
and the decision to duplicate it in regional languages and languages
of minority groups would be made by producers.

http://www.interfax.com.ua/eng/main/121765/

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