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EU pharma law package puts pharmacy compounding in focus
Original: Pharmacy compounding under the EU pharma law package – What marketing authorisation holders and innovators need to know
The EU's pharmaceutical legislation package raises questions about pharmacy compounding, the practice of preparing medicines individually for patients, and how it interacts with marketing authorisations. Legal analysts highlight that marketing authorisation holders and innovator companies need to understand when compounded preparations may compete with or exempt themselves from authorised products under the proposed rules.
Why now: The EU pharmaceutical reform package is under debate, and industry stakeholders are assessing its impact on compounding rules.
European Unionmarketing authorisation holders
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Evidence
- Pharmacy compounding under the EU pharma law package – What marketing authorisation holders and innovators need to know · www.hlc.com
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