When importing medicines in foreign packaging that were manufactured for the markets of other countries, the distribution of these imported medicines is carried out in accordance with general rules.
As the Ukrainian Agency for Medicines notes, the possibility of importing medicines in foreign packaging is permitted for the entire duration of martial law and for 6 months following its termination. This provision is intended to ensure the supply of medicines to all healthcare facilities, including hospitals and pharmacies.
“The law does not require any additional notifications or special confirmations that a batch is being imported for a specific healthcare facility; the distribution of such medicines is carried out in accordance with general regulations,” the Ukrainian State Agency for Medicines clarifies.
At the same time, the agency notes that a drug in foreign packaging must be completely identical to the one registered in Ukraine—that is, it must match 100% in terms of the qualitative and quantitative composition of active and excipients, packaging, and must have the same approved manufacturing sites, specifications, quality control methods, and expiration dates, among other things.
However, differences in the labeling and design of the packaging itself are permitted.
Each package must be accompanied by a package insert approved in Ukraine.
“The responsibility to provide this accompanying documentation rests with the importer,” emphasizes the Ukrainian Agency for Medicines.
IMPORT, MARTIAL LAW, MEDICINES, PHARMACEUTICALS, Ukrainian Agency for Medicines
