🗓️ On June 15, 2025, the law came into force allowing generic manufacturers to register medicines before the original drug’s patent expires.

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🔍 What is the “Bolar Rule”?
It is an international provision that:
✅ allows conducting research,
✅ submitting registration applications,
✅ obtaining sales permits
for generic drugs before the original drug’s patent expires.

❗️ However, selling, advertising, or placing the drug on the market is only allowed after the patent expires.

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⚖️ Why does Ukraine need this?
To:
– avoid delays in generic drugs entering the market,
– ensure patients have access to cheaper medicines,
– prevent artificial monopolies after patent expiration.

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📜 Summary of the law:
✅ registration of generics is allowed during the patent period,
✅ submitting applications, undergoing examinations, etc. is not considered a violation,
✅ the manufacturer must notify the patent holder 80 days before registering a generic.

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🔗 Details:
– Law: zakon.rada.gov.ua (https://zakon.rada.gov.ua/laws/show/4454-20#Text)
– Explanation: Yurydychna Hazeta (https://yur-gazeta.com/dumka-eksperta/pravilo-bolar-v-ukrayini-chi-vipravdala-nadiyi-reforma-patentnogo-zakonodavstva-2020-roku.html)

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💊 Now in Ukraine — like in the EU, Canada, and the USA:
access to medicines is faster, cheaper, and transparent.