The Product Information File (PIF) is the basis for all regulatory work and needs continuous updating. We will jointly create a fully compliant PIF and have clear instructions and checklists for your R&D, manufacturing, QC and procurement departments to ensure that all required data, documents and test reports are timely and correctly included in the PIF.
Presuming that all required PIF information will be available, TRC can support you with the following comprehensive services:
· Compiling and managing the PIF
· Advice on product testing
· Performing the food safety assessment
· Assessment of regulatory compliance per EU member state· Delivery of the Food Safety & Compliance Report (FSCR)
· Support the implementation of the appropriate risk management measures
· Review of the labels & claims
· Notification in individual EU member states*
· Support in case of local competent authority inspections
In countries such as Germany, France, Belgium, Ireland and Spain we can notify the products for you. Some EU member states do not have a notification requirement such as the UK, the Netherlands and Austria. In these countries food supplements can be marketed as soon as the product PIFs are completed and products are approved as fully compliant and safe by TRC. In other EU member states TRC will need to make use of partners in our network, 3rd parties or your local representatives to notify products. This is the case when notifications are only possible in a local language that we are unfamiliar with, and in some cases because notification can only be submitted by local legal entities.