How is Product Dossier defined in a legal contract?
- Product Dossier means the assortment of various documents and data. These include regulatory data related to the research, development, safety, and effectiveness of the particular product. Seen in 2 SEC filings
- Product Dossier means the specific set of customer product documents relating to specific products. Seen in 1 SEC Filing
- Product Dossier means the package of technical and clinical information about a product. This information is crucial or useful to obtain and preserve regulatory approval for the product. This also includes, but not limited to, the package insert, data supporting registered indications, bioequivalent data, clinical data, pharmaco-toxicologic data, analytical methods, stability, and pharmaceutical data about the product. Seen in 1 SEC Filing
Note: pulled this data out of the SEC EDGAR Database of 500,000 records from the past 22 years of filings. We regularly update this page as new filings and definitions come in.
yourself to verify these results. We are always keen to point people to source documents.
Which definition should you use?
🤔 has combined and improved the above descriptions to create market-standard 'Genie definitions' below, with guidance on which documents and which industry to use for each.
Genie Definition 1
Product Dossier means the collection of critical documents and data about a product.
Relevant Contract Types
Relevant Circumstances
- Merge or acquisition scenarios where product information requires consolidation.
- Outsourcing product manufacturing or development.
- Licensing out intellectual property.
Relevant Sectors
Genie Definition 2
Product Dossier means the data relevant to gain and keep regulatory approval for a product.
Relevant Contract Types
Relevant Circumstances
- New product development requiring regulatory approval.
- Product exports to other countries.
- Intellectual property licensing involving regulated products.
Relevant Sectors
Are you creating, reviewing or negotiating a document?
🚀 Try It can suggest a definition just for your specific needs (Simply , then ask it to draft a definition suitable for your document, that's it!)
Product Dossier means the collection of critical documents and data about a product
.png)
