Draft Agenda PA&MRFG OPEN Meeting Sept 2012

PA&MRFG-July13-Doc.2_BEcomments_Draftminutes

DRAFT Minutes

25thmeeting of representatives of Members States Competent Authorities for the implementation of Directive 98/8/EC concerning the placing of biocidal products on the market

Product Authorisation and Mutual Recognition Facilitation Group – Open Session

14May 2013 (Centre A. Borschette)

Starting at 11:30– Ending at 17:00 on 14th May

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1. Adoption of the agenda

The agenda document PA&MRFG-May13-Doc.1.rev3was adopted without further additions.

The chairman also welcomed and introduced colleagues from ECHA, Stephen Hollins and Diana Antal, as they will be dealing with the Secretariat tasks of the Coordination Group.

1. Adoptionof the draft minutes of the last meeting held on 26-27 February 2013

The minutes PA&MRFG-May13-Doc.2.rev2_with_SE&Cefic_commentswere adopted.

AISE asked to track the discussions on two documents: food and feed derogation and multi-PT.

COM informed that the food&feed derogation document was endorsed at last PA&MRFG meeting and is tabled at CA meeting for final adoption. The multi-PT document is subject to consultation with the legal services of the COM, and will be tabled again at this meeting as soon as the feedback is received.

1. Reports

Due to time constraints, COM invited the meeting to take note the documentsPA&MRFG-May13-Doc.3.1 and 3.2, which were tabled for information.

1. Guidance documents

COM briefly introduced the updated version of the document (PA&MRFG-May13-Doc.4.1), which is tabled for endorsement by the PA&MRFG.

DEsupports the document but would like to include 2 more guidance documents in footnote 4: TNO (1999) and SCCS (2010). DEalso suggested removing the footnote 8 as with the new examples it became a bit unclear. SE agreed with the footnote deletion.

NL would like to add a sentence in paragraph 17 regarding new data to be generated before a risk mitigation is prescribed and will send the comment in writing to COM.

CONCLUSION: the document was endorsed with the changessuggested at the meeting by DE and NL. The document will be tabled for endorsement at the July CA meeting.

COMthanked MSs and IND for sending written comments. COM also informed the meeting that the latest comments submitted by FI have been also uploaded on CIRCABC (PA&MRFG-May13-Doc.4.2.a).

COM introduced the latest version of the paper (PA&MRFG-May13-Doc.4.2.rev1), which also takes into account some of the FI comments. The main differences in relation to the previous version of the document (visible in track-changes) were commented.

AISE welcomed the updated version and thanked COM for taking on board some of their suggestions. Additional comments will follow in writing, also to the FI paper.

NLwelcomed the paper in terms of harmonised guidance but mentioned that expert judgement also raises problems of common interpretation. NL also asked whether the document will onlyaffect decisions to be made for future authorisations or also the existing products on the market.

DEsuggested replacing the term "non-professional population"by"non-professional users". DE also asked for clarification in paragraph (16) (a) first dash,on whether the wording refers to the substance or the product. Written comments will be sent after the meeting.

ATmentioned in the context of the discussion that for the simplified procedure, Art. 25(e) clearly mentions that products are not eligible if PPE is required. Art. 28 also mention that active substances wit skin sensitizer properties give rise to concern and cannot be included in Annex I to BPR. In connection with paragraph 17, a harmonised model for the risk assessment of skin sensitisers should be developed to avoid further disagreements being referred to the Coordination Group.

FIbriefly introduced its paper, highlighting that BPR aims to achieve a high level of protection and taking into account that skin sensitisation is a severe effect, the precautionary principle should be applied.

COMprovided some feedback on the questions raised by MSs. On the question by DE on paragraph (16) (a) first dash, COM mentioned that this criterion is proposed to take into account the hazard properties of the active any substance included in the biocidal product’, which then can have an impact if a potential failure in the wearing of the PPEoccurs when using the biocidal product. The term "non-professional population"can be replaced.

On the point made by NL on the potential applicability of this guidance to existing products, COM mentioned that as a basic principle new guidance should not be applied retrospectively unless there is an evident serious risk to the human health. Therefore this document should be used in accordance with the Note for Guidance on the Relevance of new guidance becoming available during the process of authorisation and mutual recognition of authorisations of biocidal products(CA-July12-Doc.6.2d - Final).

Regarding the paper from FI,COM has taken on board some elements but others cannot, as it proposes a very conservative approach. In accordance with Art. 19(4) of BPR, it was not the intention of the co-legislator to forbid the authorisation for the general public of biocidal products classified as skin sensitisers.

COM will further reflect on the point made by ATand asked for the comments being sent in writing after the meeting.

CONCLUSION: Written comments to be sent by June15th. The updated version will be tabled for endorsement at next meeting in July.

1. BPR implementation

COMbriefly introduced the paperPA&MRFG-May13-Doc.5.1. The updated version includes now the legal reference to Regulation 354/2013on changes. In accordance with the final version of that Regulation, the obligation to amend the authorisation within 60 days from the notification has been delete. No comments were received from MSs after the last meeting and IND supports the paper, so the document was proposed for endorsement at this meeting.

DE asked the meeting to postpone the endorsement of this paper until the point raised to the CA meeting on the applicability of the new procedures on old applications for product authorisation (Art. 91 of BPR) has been discussed and is subject to a common understanding. DE briefly reported on the above mentioned e-mail sent to the CA meeting, where DE is proposing that existing product applications (e.g.submitted before 1stSeptember 2013) will be processed according to the BPD procedures. Only products with active substances that meet the exclusion criteria or the criteria for comparative assessment will be authorised according to Article 19 or 23 of BPR, respectively.

COM mentioned that this point is to be discussed in connection with CA agenda item 3.0. The preliminary views of the COM on this subject are that after September 1stthe BPR procedures apply, and that the decisions have to be based on BPR. It would be complicated to operate two different, parallel decision making and conflict resolution procedures, one under BPD and one under BPR, and there is no obvious interest in doing that. Most products, however, will only have to comply with the criteria of BPD to be authorised. Article 91 only talks about the "evaluation" of the dossier submitted by the applicant, not about the decision making. The derogations in the second subparagraph refer to Articles 19 and 23, which concern only the conditions for authorisation, not the procedure.

On the paper under discussionDE also raised the issue of fees, which could create problems for the transfer from the FF to a BP family. COM considers that the fee issue is to be dealt with at national level and that a case by case approach could be necessary.

CONCLUSION: the endorsement of the document is postponed until the July meeting to be in line with the discussion on the transitional measures for product authorisation.Subject to that discussion, it will be also tabled for endorsement at the July CA meeting.

COM introduced the paper PA&MRFG-May13-Doc.5.2.The proposal addresses the renewal of national authorisations subject to mutual recognition (MR)in accordance with BPD or BPR, both in the RMS and in the CMSs granting authorisations through MR of the first authorisations.It also aims to adapt the rules on the renewal of purely national authorisations (according to Art. 31 of the BPR) to the specific characteristics of the MR.

COM highlighted the key elements of the proposal, which aims to facilitate the smooth running of the renewal procedures and the work of the MSs involved in the renewal of theseauthorisations:

-Procedural approach as in the MR in parallel, where the RMS, on the basis of the information submitted by the applicant, drafts an assessment report and makes a proposal for an SPC to which CMSs have to agree on.

-Following the principles established by the changes Regulation, the applicant is allowed to choose the RMS from one of the MSs in which the authorisation is granted.

-Art. 6 sets provisions for disagreements to be referred to the Coordination group and also for derogations from mutual recognition in accordance to Art. 37 of the BPR.

-The content of the application for renewal is further specified to meet the specific characteristics of the MR procedures (list of MSs, RMS, etc.). It also refers to the changes Regulation, as changes agreed by the CAs can also be used to better describe the relevant data that the applicant has generated since the initial authorisation.

Data and documents referred to in Art. 2already submitted to the CA and available through the IT tolls (UCLID/R4BP) should not be re-submitted to avoid unnecessary administrative burden.

-The RMS to decide on whether a full evaluation of the application is necessary, taking over the same deadlines as in Art. 31. Where appropriate, the AR of the RMS should take into account the conclusions of a comparative assessment.

-ECHA is empowered to draw up guidelines on the details related to the handling of renewals of authorisations covered by this Regulation.

FRwelcomed the proposal and asked about the possibility of applying for MR in a new CMS in the context of the renewal procedure. Another point was how to mutually recognise the renewal; due to the possibility of applyingfor a change just in one or few MSs, after 10 years the product could be different in each MS.

NL supported FR that products can change within the 10-year period. NL also mentioned that the evaluation process should allow an early involvement of the CMSs, with some kind of evaluation in parallel. NL supported the principle that the applicant is responsible for the completeness of the dossier and should always send in all the required information. NL also supported that for discussions between MSs, it will be essential to have a SPC in English.

SEhad the same question as FR and NL, and asked if the authorisation holder has to apply for changes in the CMSs to update the existing SPC. SE also asked how to deal with the procedural aspects when the authorisation holder is not anymorethe same in the RMS and CMSs.In Art. 2 (content of application) the wording "shall contain" could be inconsistent with the non-mandatory submission of certain data or documents already available through the IT tools. Comments in writing will follow after the meeting.

ATalso addressed the issue of applications for changes, and pointed out that changes would have been made before the entry into force of the changes Regulation. AT also highlighted the unaffordable workload for the RMS if it has to check the changes made in the other MSs.

UK welcomed that the original RMS does not need to be the RMS at the renewal, and mentioned that it is up to the applicant's responsibility to choose the RMS in which the majority of changes were submitted and agreed. Then this RMS makes its assessment which is subject to MR as in normal MR procedures for product authorisation. It will help in terms of resource savings and market harmonisation through MSs. IE agreed with this view too.

UK also mentioned that the situation reflected in Art. 5(4) is likely to happen, so a change in the timelines could be also considered to avoid additional workload for MSs.

ELconsiders that the RMS should be the same as in the authorisation MR procedure. Art. 5(1) refers to Art. 5(2) but should refer to 4(2).

DEwill send written comments, but pointed out the issue of the availability of data and documents through UCLID/R4BP, which could still be limited.

COM thanked MSs for the contributions to the discussion and briefly answered to some of them. In response to FR, applying for a new CMS during the renewal is not possible (a MR in sequence should be used). With regard to the points made by SE, the procedural aspectsin relation to different holders will be considered. It is not the COM intention that applicants will have to apply for any change after the renewal.

On the workload for the RMSs from AT and the general approach to products that might have become different over time, the UK intervention clarified this. The chosen RMS will assess all the relevant information and then, in line with the MR spirit and trust on that assessment, CMS should mutually recognise the renewal. COM considers this approach to be consistent with the principle of harmonising these products in the different MSs.

On the submission of documents already available to CA through the IT tolls pointed out by NL and DE, COM follows the principle of reducing administrative burden for companies, which is of particular interest for SMEs.

CONCLUSION: comments to be sent by June 15th. The proposal will come back to the July meeting.

COM presented the documentPA&MRFG-May13-Doc.5.3. The submission of the very first proposal of the SPC in all the official languages of the MSs addressed by the applicant in the MR procedure has been identified as an unnecessary burden, as this version of the SPC will be subject to further modifications in the context of the RMS's assessment and the subsequent agreement on it with the CMSs. Therefore, this paper suggests that SPC is submitted and discussed in EN, and once the SPC in English is agreed (by day 90 of the MR phase), the applicant has to provide in a few days a good translation of the SPC to CAs before granting the national authorisation in 30 days.

NLstrongly supported the paper and asked for an alternative wording at paragraph 10, to make clear that the 30-day period for the CA to grant the national authorisation only starts when the applicant's translation of the SPC has been considered as acceptable.

SeveralMSs (FR, PT, DE) raised the issue of the 7 days to provide the translation, and whether this time would reduce the 30-day period for the CMSs to grant the national authorisation in accordance with Art. 34(5) of BPR.

FR suggested that this paper could be also used for the Regulation on changes.

PTraised the issue of what would be considered an acceptable translation, and whether MSs could ask for an official translation. COM responded that BPR does not provide a legal basis to ask for official translation, and that it is not the common practice in other pieces of legislation (e.g. medicines).

CEFIC welcomed the paper and the SPC in English for the MR in parallel, but 7 days might be too short to providegood quality national translations.

COMcould expect that 7 days would be a bit controversial deadline, being considered as too short for IND but long for MSs, as according to Art. 34(5) the national authorisation has to be granted within the 30 days following day 90 of the MR phase. COM also referred to the veterinary medicines legislation, whereonly 5 days are given to the applicant.

In response to IND, COM mentioned that the applicant should be able to start the translations in the MR stage (RMS's proposal for a SPC is known by the applicant), and once the SPC has been agreed by day 90,just to make the final corrections and not all the work. This would mean an effort at that stage, but will certainly balance the administrative burden avoided at the time of the submission of the application.

CONCLUSION: Comments to be sent by June 15th.

1. For information

COM invited MSs to update the list PA&MRFG-May13-Doc.6.1 as necessary.

COM/JRC informed the meeting that UK is preparing the workshop based on the outcome of the e-mail discussion in the SoC WG and will chair the workshop. The workshop will be organised on June 12thfrom 9:00 until 17:30.

The purpose of the workshop is to discuss the issues that were not solved during TMIV 2012, included in the checklist document prepared by SE and the outstanding issues from the compiled document prepared by the UK. The aim of the workshop is to reach a consensus on the above mentioned issues and facilitate further development of the guidance document on the SoC. The workshop is mostly dedicated to the relevant TM experts, the members of the SoC WG, the industry representatives as well as the experts designated by the industry associations. A more detailed agenda, meeting documents and other information related to the workshop will be distributed separately to the participants.