BPR Letter of Access

What is a BPR Letter of Access, and how do you issue one?

A BPR Letter of Access is a formal authorisation from a data owner (or an Article 95-listed supplier) that lets another company cite specific studies, or a complete active-substance or product dossier, for example, under Regulation (EU) No 528/2012. It is submitted to the evaluating authority and/or ECHA. It does not transfer ownership of the data.

When you need one

You need an LoA when you do not own the data required for: inclusion on the Article 95 list; biocidal product authorisation that relies on someone else's active-substance data; a Same Biocidal Product application; in some cases, support for a technical-equivalence assessment.

Articles 61 to 63 BPR require the parties to make every effort to agree data sharing on fair, transparent and non-discriminatory terms. The LoA is the instrument that implements citation rights after that agreement (or alongside a data-sharing / compensation contract).

What a compliant LoA must make clear

ECHA guidance on data sharing and Letters of Access expects at least: name and contact details of the grantor and the beneficiary; the active substance or biocidal product; the date the access takes effect; the scope: complete dossier or a listed set of studies; any territorial or time limits; confirmation that the grantor has the right to grant access.

A Word file can contain those fields and still be hard to prove later: version confusion, unsigned copies, and no shared record both parties can check.

How AlexSignum issues this LoA

AlexSignum's live EU template is a BPR Active Substance Letter of Access, written to that ECHA guidance. A product / product-family LoA is also live. The case is pre-filled for the dossier. Review is optional (none, internal, ARL, or both). Each party is invited by email to sign. After signature the record cannot be altered; both sides keep the same copy; anyone can check it has not been tampered with.

Related live templates: Data Sharing Agreement (short or long), NDA, Data Owner Declaration.

Back to What is AlexSignum: https://www.allianceregulatory.com/what-is-alexsignum

Open workspace: https://alexsignum.com/

Third-party signing layer: https://boldsign.com/customer-stories/lucile-brunin/

Contact: contact@allianceregulatory.com