(Follow-up of the discussion at the 66th CA meeting) Derogation from MR (Follow-up of the discussion at the 66th CA meeting) Discussion points: Article 37 vs. Article 35/36 procedures Link between subparagraphs 1 and 2 of Article 37(1)

Derogation from MR Article 37 vs. Article 35/36 procedures Article 35 of the BPR clearly specifies the elements to be discussed in the CG, which are “other than matters referred to in Article 37” Therefore, it is not expected that the same matter can be addressed both by Articles 35 and 37. However the same product ca be subject to both procedures (e.g. for an anticoagulant rodenticide): Art. 37 to not authorise the general public as a user Art. 35 for any discrepancy on whether the conditions in Article 19 are met for intended uses by professional users

Derogation from MR Article 37 vs. Article 35/36 procedures Where a MS wants to derogate in accordance with Article 37(1), especially where it is proposed to refuse the whole authorisation, that MS should: not check the PAR for the purpose of the SPC agreement or launch an Article 35 procedure, but propose to the applicant the Article 37 derogation soon in the MR phase

Derogation from MR Article 37 vs. Article 35/36 procedures The purpose of an Article 37 procedure is "to refuse to grant the authorisation or to adjust the terms and conditions of the authorisation to be granted" (i.e. before the product authorisation is granted). Article 37 may be applied to still on-going MR- procedures and no longer once the NA has been granted in accordance with an Article 36(4) COM decision (i.e. when the MR procedure is closed)

There is a similar provision for UA (see Art. 44.5) Derogation from MR Link between subparagraphs 1 and 2 of Article 37(1) "Any of the Member States concerned may, in particular, propose in accordance with the first subparagraph to refuse to grant an authorisation or to adjust the terms and conditions of the authorisation to be granted for a biocidal product containing an active substance to which Article 5(2) or Article 10(1) applies". "In particular"  "incentive" to substitution in the context of MR (even before the MR application is processed by the cMS or a comparative assessment is done!!) There is a similar provision for UA (see Art. 44.5)

Incentive to substitution in UA (see Art. 44.5) Derogation from MR Link between subparagraphs 1 and 2 of Article 37(1) Incentive to substitution in UA (see Art. 44.5) "The Commission shall, at the request of a Member State, decide to adjust certain conditions of a Union authorisation specifically for the territory of that Member State or decide that a Union authorisation shall not apply in the territory of that Member State, provided that such a request can be justified on one or more of the grounds referred to in Article 37(1)".

Derogation from MR Link between subparagraphs 1 and 2 of Article 37(1) "Any of the Member States concerned may, in particular, propose in accordance with the first subparagraph to refuse to grant an authorisation or to adjust the terms and conditions of the authorisation to be granted for a biocidal product containing an active substance to which Article 5(2) or Article 10(1) applies". "In accordance with the first subparagraph"  both subparagraphs would need to be fulfilled for candidates for substitution

P/B/T active substances: 37(1)(a) the protection of the environment Derogation from MR Link between subparagraphs 1 and 2 of Article 37(1) "In accordance with the first subparagraph"  both subparagraphs would need to be fulfilled No problem at all: P/B/T active substances: 37(1)(a) the protection of the environment C/M/R active substances: 37(1)(c) the protection of health and life of humans, particularly of vulnerable groups, or of animals or plants

Does the CA meeting agree with the proposed views? Derogation from MR (Follow-up of the discussion at the 66th CA meeting) Discussion points: Article 37 vs. Article 35/36 procedures Link between subparagraphs 1 and 2 of Article 37(1) Does the CA meeting agree with the proposed views?