Regulation 1107/2009 introduces new rules from 14 June 2011

Data protection and data sharing

Regulation (EC) No 1107/2009 applies from 14 June 2011 and puts in place new data protection rules for both active substance and product data and for the first time includes data protection for extensions to authorisations for minor uses. In addition rules for the avoidance of duplicate testing and sharing of tests and studies involving vertebrate data have been included. The purpose of this Regulatory Update is to outline the new data protection and data sharing procedures which will apply from 14 June 2011.

The rules for data protection under Regulation (EC) 1107/2009 are set out under Article 59. In order to be eligible for data protection the tests and study reports must be certified as compliant with the principles of good laboratory practice (GLP) or good experimental practice (GEP) and you must claim data protection for the tests and studies at the time of application.

The protection periods applied to data submitted and used to support authorisations (including extensions for minor uses as defined in Article 51(1)) under Regulation (EC) 1107/2009 are summarised below:

• Active substance and product data necessary for authorisation or amendment of an authorisation: Ten years from the date of the first product authorisation in each Member State, therefore different periods of protection will apply in each Member State.
• Low risk plant protection products: 13 years

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 low risk product.

• 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 in respect to tests or studies necessary to support the continued/varied approval.
• Data submitted in support of minor uses as defined in Article 51(1)): Ten years from the date of the first authorisation in each Member State, therefore different periods of protection will apply in each Member State.

Avoidance of duplicate testing

Regulation (EC) 1107/2009, Article 61, introduces general rules on the avoidance of duplicative testing which allows prospective applicants to request from Member States a list of test and study reports (prepared in accordance with Article 60) for a product which they have identified in accordance with Article 57 to have the same active substance(s). Such requests must be accompanied by all data regarding the identity and impurities of the active substance(s) and evidence that an application is intended. Once we are satisfied that the prospective applicant intends to apply for authorisation, or the renewal or review thereof, the name and address of the authorisation holder(s) shall be provided and at the same time the authorisation holder(s) shall be informed of the name and address of the prospective applicant. The prospective applicant and authorisation holder(s) should take all reasonable steps to reach an agreement on the sharing of any tests and study reports protected under Article 59.

Vertebrate data sharing

Regulation (EC) 1107/2009, Article 62, introduces new vertebrate data sharing provisions which allows Member States to use vertebrate studies on behalf of prospective applicants if an agreement with the holder(s) of the authorisation cannot be reached. Article (Article 62(3) states that the prospective applicant and authorisation holder(s) must make ‘every effort’ to ensure that they share vertebrate tests and studies and the costs must be determined in a ‘fair, transparent and non-discriminatory way’.

What constitutes ‘every effort’ has been discussed between Member States and the European Commission. It has been agreed that the prospective applicant should submit an official letter to the Member State demonstrating that they have made an attempt to gain access and have allowed sufficient time for the authorisation holder(s) to respond. It was also agreed to be good administrative practice that Member States contact the original notifier to confirm contact has been made. If no agreement has been reached then Member States may use the studies.

For further advice on the new requirements introduced by Regulation (EC) 1107/2009 please contact JSC: +44(0)1423 520245, enquiries@jsci.co.uk