Why Healthcare Product Graphics can’t disregard Regulatory Requirements
In the world of health and wellness, a graphic error is not only an aesthetic issue: it’s a legal and business risk. Whether it is an OTC, a food supplement or a face cream, the packaging and information material must pass the scrutiny of the competent authorities (such as AIFA, Ministry of Health, or Notified Bodies).
Entrusting an agency that integrates the work of the graphics department with that of the regulatory affairs means to eliminate any risk of sanctions or delays in the launch on the market. Let’s see how Di Renzo Regulatory Affairs can support companies in the various sectors.
Pharmaceutical Packaging: Precision and Artwork Management
In the pharmaceutical packaging sector, the margin of error is zero. The preparation of pharmaceutical artworks requires a deep knowledge of the readability guidelines (font size, line-spacing) and of the management of sensible data, such as the MA code and the stickers released by the Italian State Printer. Our service ensures that stickers, leaflets and cartons are ready for marketing, in compliance with GMP standards and the serialisation requirements, thus avoiding any costs for manufacturing scraps due to non compliant materials.
Food supplements: Management of Claims and Nutraceutics
The success of a food supplement packaging is in the balance between market appeal and regulatory accuracy. Here the challenge is the management of the health claims: our graphics team works in strict cooperation with regulatory experts to ensure that each “promise” stated on the product is formulated according to Regulation (EC) 1924/2006. Not only do we create a captivating design, but we also check that the nutrition facts table and any warning are correctly positioned in order to pass the official controls.
Medical Devices: CE marking and Instructions for Use
For medical devices, graphics should transmit safety and immediacy. We take care of the design of labels and information materials, including all harmonised symbols required and a correct display of the CE marking. We all know how critical it is for IFUs to be clear and in compliance with the new MDR/IVDR regulations: we transform technical difficulties into readable layouts, ensuring that the UDI identification is always managed with the utmost technical precision.
Cosmetics: Aesthetics, INCI and Health Advertising
In the cosmetic packaging design, the image of the brand is essential, but it must coexist with specific obligations such as the INCI list, the P.A.O. (Period After Opening) and the batch traceability. Along with the packaging, we also take care of the graphics for the product advertising, ensuring that every brochure or social campaign meets the norms on health advertising. This integrated approach allows cosmetic companies to show up in the market with elegance, with no fear that promotional materials are challenged for lack of the expected requirements or for misleading promises.
With us your next project is safe
Matching creativity and compliance is our mission. If are looking for a partner that is capable to turn regulations into a competitive advantage for your brand, we are ready to help.
Do you wish to have your current packaging revised or do you need to develop a new line of products? Contact us for technical advice.
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