dataskydd | ATMP Sweden

dataskydd

market protection (i EU: Regulatory data protection) [ENGLISH]

The protection of an approved medicine against competition from generic medicines that extends beyond the protection conferred by data exclusivity. During this period, applications for generics can be accepted and authorised, but the generic medicines cannot be placed on the market.

dataskydd [SWEDISH]

Skydd för ett godkänt läkemedel mot konkurrens av generiska läkemedel som sträcker sig utöver det skydd som ges av dataexklusivitet. Under denna period kan ansökningar om generika accepteras och godkännas, men de generiska läkemedlen kan inte släppas ut på marknaden.

2024-01-29

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Resources and references

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

1. American Society of Gene and Cell Therapy Glossary https://www.asgct.org/education/more-resources/glossary
2. Clinical Trials Information System https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/clinical-trials-human-medicines/clinical-trials-information-system
3. EMA Glossary of Regulatory Terms https://www.ema.europa.eu/en/about-us/glossaries/glossary-regulatory-terms
4. EMA Medical Terms simplifier https://www.ema.europa.eu/en/documents/other/ema-medical-terms-simplifier_en.pdf
5. Glossary of Terms used in EU Clinical Trials Register https://www.clinicaltrialsregister.eu/doc/EU_Clinical_Trials_Register_Glossary.pdf
6. Glossary of Terms U.S Food and Drug Administration https://www.fda.gov/patients/clinical-trials-what-patients-need-know/glossary-terms
7. National Human Genome Research Institute “Talking Glossary of Genomic and Genetic Terms” https://www.genome.gov/genetics-glossary/m#glossary
8. The Glossary for Advanced Therapies Regen. Med. Dec 2020 Vol. 15 No. 12 Suppl. 1
9. Toolkit For Patient Focused Therapy Development Glossary https://toolkit.ncats.nih.gov/glossary-2/

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