Submission under the BPR Simplified Authorisation Procedure
Challenge
Our client manufactures a mold-prevention product. The product is being manufactured outside the EU but once imported into the EU the product would meet the definition of a biocidal product. The client needed to identify and meet their regulatory obligations in the EU.
Our Solution
Addressing our client’s challenge required a four-step solution:
Step 1: Information Gathering and Data Review
Yordas required information from the client to initiate this Project. This information included an SDS for the product, technical certificates related to its composition, information on how the product is used and its shelf-life as well as efficacy testing data to substantiate any claims. Once the initial information was gathered, our team reviewed the quality and completeness of the data received before initiating discussions with the evaluating Competent Authority (eCA).
Step 2: Meeting with the eCA
Yordas met with the eCA to discuss the applicability of the Simplified Authorisation Route and to confirm any specific information requests from the eCA based on the type of product to be authorised and the regulatory requirements.
Step 3: Testing
To support the application Yordas developed a testing strategy to address the data gaps and commissioned accelerated storage stability testing and additional efficacy testing on the product through Contract Research Organisations (CRO). Yordas were involved in the planning and monitoring of these studies.
Step 4: Dossier Preparation
Yordas prepared the Dossier for submission to the eCA. As part of the dossier preparation, the hazard profile of the biocidal product was assessed to establish any classification and labelling requirements, draft labels were generated and attached to the application and an EU compliant SDS was prepared. Once the draft dossier was completed, it underwent a period of internal review followed by review and sign-off by the client prior to submission. The dossier is currently under evaluation.
Benefits for the Client
Overall, Yordas Group’s solution has provided a method of efficiently submitting a biocidal product authorisation application via the Simplified Authorisation Procedure. Yordas assisted in the development of the required dataset including commissioning new studies as needed and preparing the regulatory submission documents. Yordas continues to support by communicating with the eCA as the product goes through evaluation.