Atinza offer full support for clients in term of drug label
When a DIN application is submitted, it must include a draft of the label (in either English or French)
Atinza will support clients to:
- Understand all the claims that TPD may (or may not) allow.
- Accurately include all of the legally required Risk Information (cautions, warnings, interactions, contraindications, or known adverse reactions / side effects.
- Correct units for ingredient (mg, mcg, IU, mL, mcg/mL)
- Determine marketing / advertising claims allowed or not.
- Information placement (front panel vs. any other panel)
- Minimum font sizes & contrast for the different sections of the label.
- Which headings and/or statements must also be bold.
- Proper format & location of expiry date & lot number
- Which terms or phrases must be bilingual (or optional), and either provide or source out certain translations.
- Once the DIN is approved, Atinza will work with client to adjust graphics / label contractor to ensure the artwork is fully compliant.
Overlook minimal details in the label can be serious for regulated products as drugs. This is due to label is not only the primary interface between the drug and consumers, but also acts as an important competitive feature for a product. A non-compliant label may trigger compliance and enforcement activities such as stop sales, recalls, and audits against the brand owner, and these actions can be detrimental for both importer and manufacturer.