Become a partner

särskilda skyldigheter

specific obligations [ENGLISH]

Requirements imposed on holders of conditional marketing authorisations or marketing authorisations granted under exceptional circumstances.

särskilda skyldigheter [SWEDISH]

Krav som ställs på innehavare av villkorade försäljningstillstånd eller försäljningstillstånd som beviljats ​​under exceptionella omständigheter.


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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