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central procedur

centralized procedure [ENGLISH]

The European Union-wide procedure for the authorisation of medicines, where there is a single application, a single evaluation and a single authorisation throughout the European Union. Only certain medicines, for example Advanced Therapy Medicinal Products, 'ATMP', are eligible for the centralised procedure.

central procedur [SWEDISH]

Europeiska läkemedelsmyndigheten ansvarar för centrala ansökningar om godkännande för försäljning. När godkännandet har beviljats av Europeiska kommissionen är det giltigt i alla EU:s medlemsländer samt Island, Liechtenstein och Norge.


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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