Data protection for test and study reports
Data protection can apply to test and study reports. This means that the reports cannot be used for the benefit of another applicant of a product authorisation for a plant protection product.
Claim for data protection
If you want to prevent that your test and study reports are used for the benefit of other applicants you must claim data protection in connection with your application for product authorisation. This is done by submitting a list specifying each test and study report for which you claim data protection. Along with the claim, you must state the reasons why the studies are necessary for the authorisation and certify that the test and study reports are compliant with the principles of good laboratory practise (GLP) or good experimental practise (GEP). For each test and study report, you must also confirm that a period of data protection has never been granted before.
You can use the template for the reference list when preparing your claim for data protection. In the template, you list all test and study reports that your application for authorisation is based on and indicate each study for which you claim data protection. To enable an evaluation of your claim for data protection, you must list each test and study report included in the biological assessment dossier (BAD) separately.
In connection with your application for authorisation, you must justify the steps taken to avoid animal testing and duplication of test and study reports on vertebrate animals. This applies to all test and study reports concerning vertebrates.
Requirement for data protection
Data protection shall apply to test and study reports if they have been necessary for a product authorisation or an amendment of a product authorisation in order to allow the use on another crop. Test and study reports, which have been necessary for a renewal or review of an authorisation, or for an extension of an authorisation for minor use, can also benefit from data protection.
Additional requirements for data protection are that all test and study reports shall be certified as compliant with the principles of good laboratory practise (GLP) or good experimental practise (GEP), and that a period of data protection has never been granted before.
The period of data protection
The period of data protection is usually 10 years starting at the date when a product authorisation starts to apply in a Member State. For low-risk plant protection products, the period is 13 years. For a renewal or review of a product authorisation, the period of data protection is 30 months.
The data protection is only valid in the member state where it has been granted.
Test and study reports that benefit from a valid period of data protection, or has benefited from a period that has expired, cannot be granted another period of data protection. This also applies to data protection granted in accordance with previous legislation. Data protection in accordance with the previous legislation of EU directive 91/414/EEC apply throughout the EU. This means that data protection can apply for a test or study report in Sweden even though it has never been used to support a product authorisation here.