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LEGAL ALLIANCE, founded in 1995, is today one of the leading Ukrainian law firms specializing in legal support to pharmaceutical companies doing business in Ukraine and CIS countries.

OUR CLIENTS represent the following industries: pharmaceuticals, medical devices, consumer goods, medicine, cosmetics, para-pharmaceuticals, chemistry, biotechnology, agriculture and food products.

LEADING ASSOCIATIONS — AIPM Ukraine, APRaD as well as the EBA Healthcare Committee have chosen Legal Alliance as their legal advisor.

Recent legislative changes seek to strengthen physician prescribing practices

SAFE, AFFORDABLE, AND EFFECTIVE MEDICINES FOR UKRAINIANS (SAFEMed) ACTIVITY

MONTHLY NEWS DIGEST NOVEMBER 2023


On October 17, the MOH approved legislation, drafted with support from SAFEMed partner Legal Alliance, requiring the international non-proprietary name (INN) of medicines to be indicated on paper and electronic prescriptions along with the mandatory indication of the form and dosage.This change is designed to expand use of generic medicines that are of equal quality but lower cost, thus increasing access and affordability of medicines for the Ukrainian population. Order No. 1806 amends the Rules for Prescribing Medicinal Products and Medical Devices, which has been in place since 2005, and states that, at the start of the new year, both paper and ePrescriptions will be issued under the trade name of the medicinal product only in the following cases:

  • The medicinal product does not have an INN and contains more than four active substances.
  • The medicinal product belongs to medicinal products of biological origin or similar biological products (biosimilars).

These changes come after the Antimonopoly Committee of Ukraine recommended strengthening the requirements regarding the possibility for health care professionals to indicate the trade names of medicinal products in prescriptions, taking into account international experience. Also, according to the amendments, ePrescriptions for products providing reimbursed palliative care are issued by family doctors for all patients, except those with mental and behavioral disorders. For individuals with mental and behavioral disorders, ePrescriptions for these specified products are exclusively issued by doctors specializing in psychiatry, child psychiatry, and narcology.


MONTHLY NEWS DIGEST - NOVEMBER 2023

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