Product registration
I Product registration (application)
Objective: Placing the product on the EU market for the first time.
For whom: for producers (OEM, OBL), authorized representatives.
Range of services:
- class verification of the product
- checking and completion of required documents
- codification (coded catalog GMDN)
- filling in an application
- submitting an application in the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
Benefits: Risk reduction related to the non-compliance of product with EU requirements.
II Product registration (notification)
Objective: Placing the product with the CE marking on the Polish market.
For whom: for importers and distributors.
Range of services:
- checking and completion of required documents
- filling in an application
- submitting the application at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
Benefits: Convenience and safety resulting from the preparation and submission of an application in the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
Duration of service 7-14 days from delivering documents by the client.