Market Products Under Your Brand Name
You can now quickly put a new, fully branded, registered and approved product on the shelf. We do the work, you get the credit. Aurena is more than a contract manufacturing organization. We offer a range of aerosol products that are registered and approved (CE-marked).
Your brand can work with Aurena
Your brand can work with Aurena as an Original Equipment Manufacturer (OEM) to market a product under your brand name.
There are two options available to make this successful:
Private Brand Label
Aurena will be both legal manufacturer and the OEM. A new label, including the customer brand name, will be designed specifically for your brand.
Aurena will add this artwork to the existing product list and technical file for the already CE-marked product. Aurena will take full responsibility as a manufacturer and stated as the manufacturer on the product.
The client will source the product from Aurena under a distribution agreement.
Key considerations include:
- Verify that the product conforms to your brand’s claims.
- Development of new artwork, and if needed, language translation.
- The distribution agreement between Aurena and distributor, including commercial conditions, as well as: traceability vigilance, product changes, and post-market surveillance.
- Products are “generic” versions on registered products and provided to distributors on a non-exclusive basis.
- Once we finalize the design of the new label with the new brand name, Aurena will add the latest version of the product list of the original products.
- Aurena will be responsible for making sure the product complies with all requirements.
- We include the new brand version of the product in the ongoing regulatory work with Notified Bodies and Competent Authorities.
Own Brand Label (OBL)
With this option, the OBL-company will place the product on the market under its name and will thereby become the manufacturer. You will obtain a CE-mark based on an OEM registration.
The Own Brand Label company will not design, manufacture, package and label the product; however, the regulatory falls on the OBL.
As the OEM, Aurena will hold the original registration files for the product.
Key Considerations Include:
- Following the appropriate conformity assessment procedure.
- If appropriate, an application is filed by the OBL to a Notified Body. The Notified Body must review the contract between the “Own Brander” and Aurena, and the documents confirming existing Notified Body approval. The extent of the review will vary.
- Any Notified Body, which may be involved and the Competent Authority, has access to the appropriate documentation.
- Procedures are in place to prepare and review the EC declaration of conformities.
- Post-market obligations such as post-market surveillance and vigilance are satisfied.
