Data protection

Published 01.06.2015     Modified 01.06.2015

The rules for data protection under Regulation (EC) 1107/2009 are set out under Article 59-62, and further guidance is provided in the guidance document on data protection and the guidance document on preparing lists of tests and study reports. Concerning data protection, Norway has no specific national requirements. The following data sheets are to be used for data submitted to support authorisations in Norway:

Data protection allows for a period of exclusivity of interest for data owners who have invested in the generation of data to support authorisations. Where appropriate, data submitted in support of an application and used to make a regulatory decision will be protected in line with the provisions of the legislation under which the application was evaluated. The protection periods vary depending on the type of authorisation issued.

During the course of the protection period, a third party cannot use protected data in support of an application for authorisation of their product, without the permission of the data owner (via a letter of access). When the data protection period has expired, we can use the data on behalf of a third party, without gaining permission to do so from the data owner.

The Regulation lays down rules for data protection for both active substance and product data, for the avoidance of duplicate testing, and for sharing of tests and studies involving vertebrate animals. The protection periods applied to data submitted and used to support authorisations under Regulation (EC) 1107/2009 are summarised in the table below:

Data protection periods under Regulation (EC) 1107/2009:

Type of dataPeriod of protection
 Active substance and product data necessary for authorisation or amendment of an authorisation.

Ten years from the date of the authorisation in each Member State, therefore different periods of protection will apply in each Member State.

 

This will be extended to 13 years for products covered by Article 47 (low risk plant protection products).

 

The above periods shall be extended by 3 months for each minor use as defined in Article 51(1). The minor use application must be made by the product authorisation holder and the minor use must be supported by data and not based on extrapolation. The application must be made within 5 years of the first product authorisation in the UK and the total data protection period for the product may not exceed 13 years which is extended to 15 years for products covered by Article 47.

Active substance and product data for renewal or review of an authorisation.30 months from the date of the first authorisation in each Member State. This only applies to tests or studies necessary to support the continued/varied approval. 
Data submitted in support of minor uses. Ten years from the date of the first product authorisation in each Member State, therefore different periods of protection will apply in each Member States.This will be extended to 13 years for products covered by Article 47 (low risk plant protection products).
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