7.

It is critical that Member States consider carefully the context in which data have been submitted in order to correctly apply the periods of protection. Below is a summary of several different scenarios for data submission, and the data protection applied in each case: Active substance data – as defined in Annex II of Directive 91/414/EEC, Regulation (EU) No 544/2011 and Regulation (EU) No 283/2013 (4) Scenario – type of data submitted and necessary to support…. Period of protection Comment 8. Active substance data submitted for a new active substance initially included on Annex I of Dir. 91/414/EEC (NAS under Dir. 91/414/EEC) – see Art 80 (2) b. 10 years from date of first (inclusion in Annex I) approval of the active substance. Such active substance data protection expires at the same time in all Member States. 9. Active substance data submitted for an existing substance initially included on Annex I of Dir. 91/414/EEC (EAS under Dir. 91/414/EEC). See Art 80 (2) a. 5 years from date of first (inclusion in Annex I) approval of the active substance for the additional data necessary to support first inclusion in Annex I. Such active substance data protection expires at the same time in all Member States, for data which are essential for Annex I inclusion/approval and which were not used for national authorisation before submission of the dossier. If the tests and studies were used for national authorisations before submission of the active substance dossier, old national rules may apply. 10. Active substance confirmatory data submitted under Dir. 91/414/EEC for NAS or EAS (assessed post-approval). See Guidance document SANCO 5634/2009 (5). These data are not protected unless the approval Regulation is amended as a result of the evaluation of the confirmatory data (or critical end points change as a result). In that case data protection for confirmatory data will be protected +5 years from the original approval (not the amended approval). These data are generally not protected 11. Active substance data submitted for a NAS considered under Article 80 1 (a) – ‘pending’ NAS under Dir 91/414/EEC (PNAS) which are substances covered by Regulation (EU) No 188/2011). See Article 80(2) b. 10 years from date of approval of the active substance. Such active substance data protection expires at the same time in all Member States. 12. Active substance data submitted with an application considered under Article 80(1)(b), (c) and (d) – AIR1 actives and resubmissions (substances listed in Regulation (EC) No 737/2007, substances, covered by Regulation (EC) No 33/2008, and listed in Decisions 2008/934/EC and 2008/941/EC). See Article 80(2)(a) and (c). 5 years from date of (re)approval of the active substance. Data protection expires at the same time in all Member States. For re-submissions data protection applies to the whole dossier (including the ‘old’ data submitted for the first non-inclusion since they were necessary for approval). 13. Active substance data submitted with an application under Article 7 of the Regulation (NAS under Regulation) and with the application for authorisation of the corresponding product (Article 33 of the Regulation) 10 years from date of first authorisation of first product containing that active substance in each Member State where the data is necessary for the authorisation. Data protection may expire at different times in each Member State, depending on date of national authorisation. Studies necessary for the active substance approval are defined by the Rapporteur Member State (RMS) (Member States subsequently define the list of studies that are protected nationally). Note 1: same protection periods apply if active substance is identified as a Candidate for Substitution. Note 2: this also applies in case the first authorisation was granted in accordance with Article 30 (provisional authorisations) 14. Active substance data submitted with an application under Article 22 of the Regulation (low risk NAS) and with the application for authorisation of the corresponding product. 13 years from date of first authorisation of a low-risk product containing that low-risk active substance in each Member State. Data protection may expire at different times in each Member State, depending on date of national authorisation. Studies necessary for the active substance approval are defined by the RMS (Member States subsequently define the list of studies that are protected nationally). 15. New active substance data submitted and justified with an application under Article 15 of the Regulation (renewal) and with the application for renewal of authorisation (Article 43) of the corresponding product. Applies also to low risk active substances. 30 months from date of first renewal of authorisation of product containing that active substance in each Member State where the data is necessary for the renewal of authorisation Data protection may expire at different times in each Member State, depending on date of national authorisation, although renewal timescales are harmonised. Applies only to new data used to support the renewal of approval of the active substance, where the data concerned are also necessary to support the renewal of authorisation of a product containing it. Note same protection periods apply if active substance is identified as a Candidate for Substitution. 16. Active substance confirmatory information submitted for NAS or EAS (assessed post approval) for approvals issued under Reg. (EC) No 1107/2009. The situation arises when confirmatory information is submitted after the granting of an authorisation. In the case where the confirmatory information is necessary for the authorisation, confirmatory information will be protected in line with the main active substance data package for NAS i.e. for +10 years from the first authorisation), or for renewed active substances, 30 months from the date of amended authorisation or from the date of decision to maintain the authorisation in each Member State. Generally the submission of confirmatory information will not be necessary for the authorisation (Article 59(1) subparagraph 1 (a)). Where it is necessary, protection timelines as indicated will apply. 17. Active substance data submitted for an application for first authorisation of a new product, or for a new use for an already authorised product, that was not necessary for the renewal of approval of that active substance. 10 years from date of authorisation of the product applied for. When new active substance data is required for an amendment of a product authorisation, the protection period of that data is counted from the date of first authorisation of the product, not of the new use. 18. New active substance data submitted and justified with an application under Article 15 of the Regulation (renewal) and with the application for a New product authorisation (Article 33). 10 years from date of first authorisation of the NEW product containing that active substance in each Member State where the data is necessary for the authorisation of the NEW product and the authorisation is granted before an existing product authorisation is renewed under Art.43. If data protection is claimed for a renewal, as well as for a new product, the data is no longer protected after expiration of the shortest period. The data protection period is linked to the authorisation which comes first: — 10 years if the Art. 33 authorisation is granted before the Art. 43 — 30 months if Art. 43 renewal is granted before the Art. 33.

Product data – as defined in Annex III of Directive 91/414/EEC, Regulation (EU) No 545/2011 and Regulation (EU) No 284/2013 (6) Scenario – type of data submitted and necessary to support…. Period of protection Comment 19. Product data submitted with an application under Article 4 of Directive 91/414/EEC and pending on 14/6/2011 (new product submitted before 14/6/2011). For the active substance data provided to support that authorisation see points 8, 9 or 12. 10 years for product data from the date of the first authorisation in each Member State. Article 80(5)(a) of the Regulation applies. Data protection is triggered by the decision on a pending authorisation. Therefore once the decision to authorise a product is adopted, Regulation (EC) No 1107/2009 applies, in particular Article 59. 20. Product data submitted with an application under Article 33 of the Regulation (new product under Regulation). For the active substance data provided to support that authorisation see points 8, 9, 13, 16 or 18. 10 years from date of first authorisation of that product in each Member State. Data protection may expire at different times in each Member State, based on date of first authorisation in that Member State. It should be noted that for any application for product authorisation submitted after 14/6/2011, the Regulation applies, as provided in Article 80(5). 21. Product data submitted with an application under Article 40 of the Regulation (mutual recognition (MR)). For the active substance data provided to support that authorisation see points 8, 9, 13, 16 or 18. 10 years from date of first authorisation of that product in each Member State. Protection must be applied to data supporting MR authorisations, noting however that submission of dossier is required for MR only where requested by the Member State concerned. Even if data are not submitted, they are still effectively protected in the mutually recognising Member State. It is the responsibility of Member State to confirm that a period of protection has not been granted for the data or that any period granted has expired in their territory. They may use information submitted by applicants (see paragraph 31) 22. New product/use data submitted with an application for amendment (new crop) under Article 33 of the Regulation (new crop amendment). 10 years from date of first authorisation of that product in each Member State (not the date of authorisation of the new crop). Note Article 59 1 (a) refers specifically to amendment to allow the use on another crop. 23. New product/use data submitted with an application for amendment (new good agriculture practices (GAP) on existing crop) under Article 33 of the Regulation (new GAP existing crop amendment). No protection for ‘new GAP data’, but original dossier data protection remains unchanged. Note: Article 59 1 (a) refers only to amendment to allow the use on another crop. 24. New product/use data submitted with an application for new formulation of existing product under Article 33 of the Regulation (new formulation). 10 years from date of first authorisation of that product in each Member State (but only for data submitted to support the new formulation). This period is 13 years in case of low-risk products (see paragraph 25). A significant formulation change requiring the submission of data is effectively a new product submission. See the guidance document (7) SANCO 12638/2011 on significant and non-significant changes of the chemical composition of authorised plant protection products. 25. Product data submitted with an application under Article 47 of the Regulation (low risk products). For the active substance data provided to support that authorisation see point 14. 13 years from date of first authorisation of that product in each Member State. Data protection may expire at different times in each Member State. 26. Product data submitted with an application for renewal of authorisation under Article 43 of the Regulation – containing at least one active substance considered under AIR2 onwards. For the active substance data provided to support that authorisation see point 15. 30 months from date of first renewal of authorisation of that product in each Member State. Data protection may expire at different times in each Member State (although because of renewal timescales these dates should be similar). Applies only to new data necessary to support the re-authorisation of the product.

Minor use data as defined in Article 51(2)(d) Scenario – type of data submitted and necessary to support…. Period of protection Comment 27. Data submitted by authorisation holder to support minor use extension (under Article 51) – e.g. residues data. Protection in line with product data protection expiry in each Member State (not 10 years from date of authorisation of extension of use). Note active and product data protection granted in accordance with Article 59 is extended by three months for each minor use extension. Note active and product data protection granted under Article 80(2) is not extended. To extend ‘core protection’ for data protected under Article 59, minor use may not be based on extrapolation and the application must be submitted within 5 years of original product authorisation. Extension up to maximum of 13 years (15 years for low risk). 28. Data submitted by official or scientific bodies, professional agricultural organisations or professional users (not-authorisation holders) to support minor use extension (under Article 51) e.g. residues data. Protected in line with product data protection expiry in each Member State. Note the 10 year protection for the data supporting the original authorisation remains unchanged (no 3-month extension). No extension of ‘core protection’ if application submitted by someone other than authorisation holder. – even if data are generated by the authorisation holder