Data protection
The GB Biocidal Products Regulation (GB BPR) specifies protection periods for data submitted for the first time in support of active substance approvals and biocidal product authorisations. This is intended to protect the interests of companies that have submitted proprietary information. It also allows them to recover some of the cost of generating data from other companies who wish to use the data in support of their own applications.
Under these protections, the data may only be used by HSE for the benefit of another applicant if one of the following conditions is met:
- that applicant provides a letter of access from the original data submitter
- the data protection has expired
The data protection periods begin when the data are submitted for the first time and vary in length depending on the circumstances of the data submission.
Once the data protection has expired, HSE may grant permission for subsequent applicants to refer to the data. However, data which are no longer protected are still the property of the original data owner and HSE will not give copies of such data to other applicants.
Data protection cannot be granted for:
- data that are published / available in the public domain
- data that have already been submitted in support of an active substance approval or product authorisation
- data that were already protected following an approval or authorisation decision before the end of the Transition Period which followed the UK leaving the EU – the existing protection periods remain valid and extensions to the existing expiry dates or new data protection periods will not be granted
Active substances
| If the data are submitted for … | …and the active substance is… | …the data protection will end… |
|---|---|---|
| active substance approval | new | 15 years from the first day of the month following the date of approval or inclusion onto the GB Simplified Active Substance List |
| existing | 10 years from the first day of the month following the date of approval or inclusion onto the GB Simplified Active Substance List | |
| renewal of an active substance approval | new or existing | 5 years from the first day of the month following the date of renewal |
Biocidal products
| If the data are submitted for … | …and the active substance is… | …the data protection will end… |
|---|---|---|
| product authorisation | new | 15 years from the first day of the month following the date of authorisation |
| existing | 10 years from the first day of the month following the date of authorisation | |
| renewal of a product authorisation | new or existing | 5 years from the first day of the month following the date of renewal |
| change of a product authorisation | new or existing | 5 years from the first day of the month following the date of authorisation of the change |