Data protection for test and study reports

Content:

Data protection can apply to test and study reports. It is a temporary right of the owner of the report. Data protected 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 a test and study report is used for the benefit of other applicants, you must claim data protection in connection with your application. You indicate whether you are claiming data protection for a study by answering “Y” (yes) in column “Data protection claimed – Y/N” for the respective study in the reference list of your submitted registration report part A. Along with the claim, you must state whether the test and study reports are compliant with the principles of good laboratory practise (GLP) or good experimental practise (GEP) and confirm that a period of data protection has never been granted before.

Test and study reports included in the biological assessment dossier (BAD) need to be listed separately, to allow an evaluation of your data protection claim for those studies.

If your application does not contain a part A or if an older version of part A is used please provide a reference list that is in the current format of the reference list in Part A, Appendix 4 (Format of a draft Registration Report version 2016).

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 (13 years for low-risk plant protection products) starting at the date when a product authorisation starts to apply in a Member State. For a renewal or review of a product authorisation, the period of data protection is 30 months. The period of data protection for studies submitted within a minor use application is in line with the product data protection expiry in each Member State.

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.

The notable exception to this rule is that data protection periods can be extended by three months for every minor use extension added by the authorisation holder (when submitted within 5 years of product authorisation and not based on extrapolation).

Guidance document

EU Commission Technical Guidelines on Data Protection (2019/C 229/01)external link

Guidance document on preparing lists of test and study reports (external linkSANCO/12580/2012– rev. 4 22 March 2019external link)external link



Last published 11 December 2020