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produkt-specifikt undantag

product-specific waiver [ENGLISH]

An exemption from the obligation to acquire data, through a paediatric investigation plan, in some or all subsets of the paediatric population for a given condition, route of administration and pharmaceutical form of a specified medicine. Product-specific waivers are adopted by the Paediatric Committee (PDCO).

produkt-specifikt undantag [SWEDISH]

Ett beslut av myndigheten om undantag för produkten.


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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