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årlig utvärdering

annual re-assessment [ENGLISH]

An annual review of the benefits and risks of a medicine that has been authorised under exceptional circumstances. As part of the process, the specific obligations imposed on the marketing-authorisation holder are also reviewed.

årlig utvärdering [SWEDISH]

En årlig översyn av fördelarna och riskerna med ett läkemedel som har godkänts under exceptionella omständigheter. Som en del av processen ses också de specifika skyldigheter som åläggs innehavaren av godkännandet för försäljning över.


Resources and references

Definitions have been translated into the Swedish language from the following sources:

  1. 1. American Society of Gene and Cell Therapy Glossary
  2. 2. Clinical Trials Information System
  3. 3. EMA Glossary of Regulatory Terms
  4. 4. EMA Medical Terms simplifier
  5. 5. Glossary of Terms used in EU Clinical Trials Register
  6. 6. Glossary of Terms U.S Food and Drug Administration
  7. 7. National Human Genome Research Institute “Talking Glossary of Genomic and Genetic Terms”
  8. 8. The Glossary for Advanced Therapies Regen. Med. Dec 2020 Vol. 15 No. 12 Suppl. 1
  9. 9. Toolkit For Patient Focused Therapy Development Glossary

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