Noteagreed by Member States' Competent Authorities for Biocidal Products
This document is drafted in the interest of consistency of the implementation of Regulation (EU) No 528/2012 and with the aim of finding an agreement between Member States' Competent Authorities for biocidal products on a harmonised approach. Please note, however, it does not represent the official position of the Commission and that Member States are not legally obliged to follow the approach set out in this document, since only the Court of Justice of the European Union can give authoritative interpretations on the contents of Union law.
Subject:Handling the "stop of the clock" during the assessment of applications for product authorisation[1]
1.- Background and purpose of the document
(1)At the 66th CA meeting, a number of actions were agreed in order to mitigate delays in product authorisations. In that context,the role of the evaluating body[2]was identified as a key factor in the whole authorisation process, not onlyfrom the perspective of handling any technical issues arising from the assessment of the applications but alsoconcerning the impact that the delays originated by the evaluating body might have in other MSs.
(2)As a follow-up of the above-mentioned actions, the Commission, with the support of ECHA, is monitoring the delays linked to the phase of evaluation by the evaluating body and has also requested feedback from MSs on the identified late procedures. From this feedback, it follows that the evaluation phase is in some cases consuming the whole three-year period referred to in Article 89(3) of the BPR due to, among others, the following reasons:
(a)The initial quality of the dossier,
(b)The need to require additional information to the applicant in order to carry out the assessment,
(c)Delayed submissionof the required information by applicants,
(d)The time needed by the evaluating body to assess the submitted information,
(e)In some cases, the above-mentioned "process" is repeated several times.
(3)Against this background, it is considered that, as most of the applications for product authorisation are submitted at the same time (i.e. by the date of approval of the relevant AS/PT combination), having a more harmonised approach regarding the practical implementation of the so-called "stop of the clock" provisions would be beneficial in order to:
(a)Identify any technical or regulatory issues arising from the assessment of the applications by different evaluating bodies at the same time and at an earlier stage, so that they can still be discussed in the relevant EU fora to find a solution within the legal deadlines,
(b)Make the product authorisation process more efficient and allow all MSs to deliver the product authorisations within the three-year period referred to in Article 89(3) of the BPR.
(4)Therefore, this note aims at agreeing a harmonised way forward for the implementation of the "stop of the clock" provision during the assessment of applications for product authorisation.
2.- Relevant provisions in the BPRand agreedway forward
(5)One of the main objectives of the BPR is to ensure a high level of protection of both human and animal health and the environment. In order to reach this objective, among the conditions for granting a product authorisation, Article 19(3) mentions that "A biocidal product shall only be authorised for uses for which relevant information has been submitted in accordance with Article 20". Article 20 specifies the data that the applicant shall submitwithin the application.
(6)Following the validation of that application, which shall not include an assessment of the quality or the adequacy of the data or justifications submitted[3], the evaluation of the application is a critical step in order to confirm that the conditions in Article 19 of the BPR are met.
(7)It has to be noted though that Articles 30(1), 34(4) and 44(1) of the BPR establish the legal deadline (365 days) for the evaluating body to conclude the evaluation of an application. Observing these deadlines ensures the proper functioning of the system of product authorisation, responds to the legitimate expectations of applicants and facilitates the access to the market of safe and efficacious biocidal products.
(8)In accordance with Articles 30(2) and 44(2) of the BPR, where the evaluating body considers that additional information is necessary to carry out the evaluation, it shall ask the applicant to submit such information within a specified time limit, during which the 365-day period is suspended.
(9)Regarding the amount or the relevance of the additional information that would be needed to carry out the evaluation, paragraph 19 of Annex VI to the BPR clearly points out that the evaluating body shall request the minimum additional information necessary to complete the assessment. In other words, this provision should not be used to build up a good quality dossier during the evaluation phase.
(10)Concerning the length of suspension of the evaluation, Articles 30(2) and 44(2) of the BPR, while providing for some flexibility in case of well justified situations, establishes that the interruption shall normally not exceed 180 days. This is in a way consistent with the intrinsic nature of the provision, which could be seen asa derogation to the general principle according to which the dossier has to be complete and of adequate quality at its submission. As such, exceptions to a basic principle would have to be implementedin a restrictive manner.
(11)Therefore, when setting the suspension period, the evaluating body should carefully consider:
(a)The time needed by the applicant to provide the required additional information, as well the time needed for its evaluation,
(b)That the authorisation process still allows compatibility with the 3-year deadline laid down in Article 89(3) of the BPR for the authorisation of existing products according to the BPR rules; in other words, it should be ensured that sufficient time is left for the mutual recognition (MR) phase or the peer reviewby the BPC in the procedure for Union authorisation.
(12)When the applicant fails to submit the requested information within the given deadline and depending on whether the required information affects all the intended uses in the application or just some of them, the evaluating body will have to decide whether:
(a)To reject the whole application when no intended use can be assessedand inform the applicant accordingly, or
(b)To resume and continue with the assessment of the intended uses for which sufficient information is available in order to conclude whether the product authorisation can be granted.
(13)In case of applications for authorisation of products subject to the provisions in Article 89(3) of the BPR, the periods of grace referred to in Article 89(4) shall applywhere the whole the application is rejected or the authorisation is granted for a reduced number of the intended uses.
3.- Practical implementation
(14)When setting the suspension period, the evaluating body will haveto consider the time needed by the applicant to provide the required additional information. It should also carefully consider the time needed for its evaluation, which shall not go beyond what is left from the whole 365-day period provided for in Article 30 of the BPR.
(15)The evaluating body should respect a180-day suspension period as much as possible, in order to avoid any impact on the compliance with the legal deadline in Article 89(3) of the BPR. In other words, suspension periods above 180 days should be properly justified and remain exceptional (rather than the rule).
(16)In all cases (i.e. including those for which the suspension period is longer than 180 days), the evaluating body shall make sure that the PAR and the draft SPC is always delivered not later than 1 year before the 3-year deadline set in Article 89(3) of the BPR.
(17)Therefore, the evaluating body will have a 2-year period for the tasks to be carried out with an application before the submission of the PAR:
(a)Acceptance and validation of the application;
(b)Initial assessment (before the suspension period);
(c)Requirement(s) to the applicant for additional data (the whole suspension period should normally not exceed 180 days);
(d)Assessment of the additional information (after the suspension period);
(e)Comparative assessment (where relevant);
(f)Preparation of the PAR, draft SPC, one-month consultation with the applicant and consideration of his comments;
(g)Submission of the PAR and draft SPC to cMSs (in case of MR) or ECHA (in case of UA).
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[1]This paper does not address the simplified procedure for the authorisation of biocidal products meeting the conditions laid down in Article 25 of the BPR.
[2]The reference Member State (refMS) in case of mutual recognition (MR) procedures or the evaluating competent authority (eCA) in case of Union authorisation (UA) procedures.
[3]It has to be noted that significant delays in the validation phase will also have an impact on the compliance with the legal deadlines in Article 89(3) of the BPR.