THE GLOBAL GUIDE
TO COMPASSIONATE
USE PROGRAMS

Given the conflict in Ukraine, we are making available the requirements for the Ukrainian Ministry of Health for distributing medicines to Ukraine.  Using this document, any manufacturer or sponsor can distribute medication to those in need.  Note that all medical and pharmacy services and institutions are operating under Ukrainian Martial Law.  The pharmacies that are currently operational are accessible using this link: Працюючі (в період воєнного стану) аптеки України – Google My Maps

Compassionate Use Programs in Ukraine

Regulatory Mechanism Available?

Yes

Type of Mechanism Available

Named Patient

Regulatory Agency

Ministry of Health Ukraine is the central executive body of the healthcare system

The State Service of Ukraine on Medicines and Drugs Control

Guidance Document

State Registration of Medicines and Active Pharmaceutical Ingredients

Program Description

Import of non-registered medicines and standards

The procedure for importation of non-registered medicinal products is approved by the Order of the Ministry of Health of Ukraine No. 237 dated April 26, 2011, “On Approval of the Procedure for Importation of Non-Registered Medicinal Products, Reference Materials, Reagents into the Territory of Ukraine” and describes the importation procedure:

• samples of substances (including samples in the form of pellets, premix, granules, etc.) for chemical, physical, biological, microbiological, pharmacological, toxicological and other scientific research, as well as stability studies, development and approbation of analytical methods for nonclinical studies of their specific activity and safety
• medicinal products, reference products, placebo samples (comparator drugs) for clinical studies and scientific researches• samples of medicinal products in dosage forms for state registration
• finished medicinal products for demonstrations in exhibitions, conferences without the rights for sale• finished medicinal products for medical supplies (without the rights for sale) units of the armed forces of other states that are allowed to enter the territory of Ukraine in accordance with the law
• finished medicinal products for individual use by citizens
• in the event of natural disaster, catastrophe, epidemic disease, etc.
• importation into the territory of Ukraine of reference standards of medicinal products and/or impurity-substances, biological reference products (reference substances), reference spectra and reagents for conducting laboratory research of the quality of medicinal products
• for medical supplies (medicinal use) to military personnel and enlisted and commanding personnel who perform tasks during the counter-terrorism operations, states of emergency situation or special periods
• non-registered medicinal products for the treatment of rare (orphan) diseases developed exclusively for the treatment of rare (orphan) diseases and approved for the use in the territories of the USA or the EU Member States

Previously Authorized CUP

Grillon C, Krishtel PR, Mellouk O, et al. Treatment advocate tactics to expand access to antiviral therapy for HIV and viral hepatitis C in low-to high-income settings: making sure no one is left behind. J Int AIDS Soc. 2018;21 Suppl 2:e25060.

Chargeable Component?

Charging for the medicine under named patient is possible.

Labeling Requirements for Named Patient

As the regulatory agency does not specify labeling requirements, a bona fide commercial pack is usually acceptable, i.e., US commercial pack or EU commercial pack; however, if a commercial pack is not available, the supplier of the drug can use a ‘white box label’ with the following label attributes in English language:

• name of medicinal product
• name of active substance
• strength
• pack size
• directions for use or “Take as directed by physician” statement
• batch identification and expiry date in month/year format (MM/YYYY)
• storage instructions (i.e., store between 15 – 25C, store in an upright position)
• “Keep out of sight and reach of children” statement
• special instructions or warnings where applicable• for patient _______________ (leave sufficient space for patient name, ID or number)
• sponsor name, address, country, (telephone number is optional)
• manufacturer name, address, country (note: listing manufacturer is optional)