Authorisation procedure for plant protection products Description of the procedure for applications for zonal authorisations in Germany
Contact address: Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Dienststelle Braunschweig Messeweg 11/12 38104 Braunschweig Telephone: +49 531 299-3401 Email: 200@bvl.bund.de www.bvl.bund.de November 2012
Index Page 1. Legal basis... 4 2. Types of applications and procedures... 4 3. Procedures for evaluating and authorising plant protection products... 4 3.1. Application type ZV1: Zonal authorisation procedure; Germany is the Rapporteur Member State (ZRMS) - initial authorisation... 4 3.2. Application type ZV2: Zonal authorisation procedure; Germany is the Rapporteur Member State (ZRMS) - renewal of authorisation... 8 3.3. Application type ZV3: Zonal authorisation procedure; Germany is the concerned Member State (cms) - initial authorisation... 12 3.4. Application type ZV4: Zonal authorisation procedure; Germany is the concerned Member State (cms) - renewal of authorisation... 15 3.5. Application type ZV5: Zonal authorisation procedure; Germany is not concerned.. 18 3.6. Application type ZVU: Mutual recognition... 19 4. List of abbreviations and glossary... 20 5. References... 21 Page 3 of 21
1. Legal basis Based on Regulation (EC) No 1107/2009, applications for the authorisation of plant protection products in Germany have been processed since 14 June 2012 according to zonal procedures. In addition to this Regulation there are guidelines on zonal authorisations and mutual recognition, and also for renewing, withdrawing or amending authorisations: "Guidance document on zonal evaluation and mutual recognition under Regulation 1107/2009" SANCO/13169/2010 rev.5 of 11 March 2011 and Guidance document on renewal, withdrawal and amendment of authorization under Regulation (EC) No 1107/2009 SANCO/ 2010/13170 rev.7 of 11 March 2011. These were taken into consideration for developing procedures. Moreover, the legal provisions contained in the Plant Protection Act of 6 February 2012 were taken into consideration for describing the procedures. 2. Types of applications and procedures The following types of applications and procedures exist in Germany: ZV1 ZV2 ZV3 ZV4 ZV5 ZVU Zonal authorisation procedure, DE is ZRMS; initial application Zonal authorisation procedure, DE is ZRMS; renewal Zonal authorisation procedure, DE is cms; initial application Zonal authorisation procedure, DE is cms; renewal Zonal authorisation procedure, DE is neither ZRMS nor cms Mutual recognition ZRMS: Zonal Rapporteur Member State cms: concerned Member State 3. Procedures for evaluating and authorising plant protection products 3.1. Application type ZV1: Zonal authorisation procedure; Germany is the Rapporteur Member State (ZRMS) - initial authorisation This procedure applies to applications for zonal authorisations according to Article 33 to 39, for applications for extensions of use according to Article 45 and for applications for provisional authorisations according to Article 30 of Regulation (EC) No 1107/2009. In principal Page 4 of 21
the procedure takes 12 months from the receipt of an application to the issuing of a certificate. The procedure can be longer if, for example, the processing of an application is stopped (for a maximum of 6 months) because additional documentation is requested or due to waiting periods for applications with active substances which have not yet been approved. 3.1.1. Pre-meetings with the applicant As intended in Regulation (EC) No 1107/2009, optional pre-meetings with the applicant take place at the latest 6 months before submitting an application. At this point the applicant shall give an undertaking that he will submit his application in Germany. The aim of the meetings is to clarify as reliably as possible the documentation which has to be submitted. This includes questions to do with protected data. In particular the issue of access to a complete active substance dossier is clarified. Furthermore, it is important to clarify whether an assessment of equivalence is necessary. The way in which applications or uses are formulated is determined. If the applicant does not believe a pre-meeting is necessary, the BVL (Federal Office of Consumer Protection and Food Safety) recommends consultation on the planned GAP list and how uses are formulated in the application form. 3.1.2. Initial examination After the application has been received and, if applicable, the data have been transferred (application data and CADDY) to the BVL databases, a confirmation of receipt is sent. Starting from receipt of the application, one week is planned for the initial examination. An administrative reconciliation follows with regard to the facts stated by Regulation (EC) No 1107/2009. There is a check to see whether studies, or information are physically available. If the application is not believed to be eligible for evaluation because documentation is missing, the applicant can submit further documentation within 6 months. The time required for this will be deducted if the processing of the application is interrupted at a later date following assessment phase I (cf. 3.1.4). 3.1.3. Initial evaluation For the initial evaluation, the metadata for the and studies are inputted at the BVL, the uses are examined by experts and are entered into the fact database at the BVL (INFOZUPF). Paper applications or paper are scanned at the BVL before being sent to the assessment authorities and are provided with metadata. If the uses are applied for as determined in the pre-meeting the data can be transferred directly from the application form. The assessment authorities are commissioned with the task of evaluation. After 6 weeks, the evaluation including the studies and their metadata are handed to the assessment authorities. The information on the specification of the active substance or the report by the BVL on the equivalence assessment, the composition of the plant protection product and how to formulate the uses are submitted at the latest 8 weeks after the start of the initial evaluation during the assessment phase (see 3.1.4) to the Page 5 of 21
JKI (Federal Research Centre for Cultivated Plants), the BfR (Federal Institute for Risk Assessment) and UBA (Federal Environment Agency). Up to this point, the applicant receives one first interim reply with possible information on deficiencies regarding the application and regarding the way the uses are formulated. At this point processing of the application is not stopped or interrupted. Feedback on the way the uses are formulated is taken into consideration up to 2 weeks after the interim reply for the assessment has been sent. At this point other additional information should not be submitted; it should be saved and handed in when additional documentation is submitted after the processing of an application is stopped, following assessment phase I, should this be the case. For applications for the initial authorisation of plant protection products which contain active substances which have not yet been approved and for which the plant protection product and its intended uses do not comply with those of the Draft Assessment Report (DAR) of the EU evaluation programme for active substances, the DAR is awaited before the assessment phase begins. In the case of renewing authorisation for plant protection products containing active substances which have not yet been approved, the assessment phase does not begin until consolidated EU endpoints have been presented. Charging the advance payment and checking receipt of the advance payment do not depend on the progress of the procedure. The equivalence assessment for the active substance and the procedure for setting maximum residues (MRL procedure), if appropriate, also run parallel. 3.1.4. Assessment phase I A first assessment phase of 15 weeks follows at the BVL, BfR, JKI and UBA after which additional information which has been requested in order that the procedure may continue must be submitted to the BVL. This is because the applicant must be informed of any additional information he is required to submit for the procedure to be able to continue at the latest 6 months after he has submitted his application. 3.1.5. Processing of the application is subjected to 'stop the clock' The BVL calculates 2 weeks' time for writing and sending the applicant a notification to the effect that the application has been subjected to 'stop the clock'. Processing of the application can be interrupted for a maximum duration of 6 months. If the applicant has to submit additional documentation in the course of the initial examination, the time required for this is deducted from the 6 months. 3.1.6. Assessment phase II The documentation received on the grounds of the notification that information is missing is recorded at the BVL within one week, completed by adding metadata and passed on to the assessment authorities. The latter submit their decision on consent and their assessments (contributions to the draft Registration Report (drr)) at the latest after 6 further weeks. Page 6 of 21
3.1.7. Management The BVL compiles the draft Registration Report (drr) within 2 weeks using the contributions from the assessment authorities and the BVL including the proposals for risk management. The drr is put into the EU database by the BVL and made available to the applicant who is informed by a second interim reply. 3.1.8. Commenting The applicant and all Member States in the involved zone(s) receive a 6-week commenting deadline. During commenting, the applicant can also state any trade and business secrets which should be blackened out. 3.1.9. Decision The comments received from the Member States and the applicant are put together within 2 weeks by the BVL in special commenting tables and sent to the JKI, UBA and BfR for consideration for the final assessment. Using this, the BVL compiles the end version of the RR within 3 weeks. If deviations are found in relation to the 2nd interim reply, a 3 rd interim reply is sent to the applicant. If a refusal seems likely, the applicant is allowed a hearing with this additional interim reply. 3.1.10. The certificate is issued The procedure is completed within 2 weeks after the certificate is issued. 3.1.11. The RR is published The end version of the RR (including the certificate) is added to the EU database and published on the BVL's website. 3.1.12. Fees charged The fees are charged after the certificate has been issued and not within the deadline of one year. Page 7 of 21
3.1.13. Time schedule for the ZV1 procedure: Zonal authorisation procedure; Germany is the Rapporteur Member State (ZRMS) - initial authorisation Incoming Application Additional information submitted Comments from other MS, applicants Activity Preliminary meeting Receipt of application Initial examination Outgoing Confirmation of receipt Deadline > 26 w 1 w Initial evaluation 1 st interim reply 6 w Assessment phase I BfR, BVL, JKI, UBA 'Stop the clock' Additional information is forwarded Assessment phase II BfR, BVL, JKI, UBA Management BVL drr commenting Summary of comments BVL Assessment and compilation RR BfR, BVL, JKI, UBA Management BVL 'Stop the clock' notification 2. 2 nd interim reply, drr 15 w 2 w max. 26 w 1 w 6 w 2 w 6 w 2 w 5 w 3 w Certificate is issued Certificate 2 w RR is published RR - Fees Advice of costs - 3.2. Application type ZV2: Zonal authorisation procedure; Germany is the Rapporteur Member State (ZRMS) - renewal of authorisation This procedure applies to the renewal of authorisations according to Article 43 of Regulation (EC) No 1107/2009. The procedure takes 9 months. Three months less time are available for Page 8 of 21
this procedure than for initial authorisation because the one-year deadline begins with the renewal of the approval of an active substance, safener or synergist; the applicant is granted 3 months' time to submit his application. 3.2.1. Pre-meetings with the applicant Optional preliminary meetings with the applicant are also intended when renewing authorisations; they take place at least 6 months before the application is submitted. The aim of the meetings is to clarify as reliably as possible the documentation which has to be submitted. If possible, the previous authorisation is merged with possible previous extensions of authorisations and/or additional approvals. It is important to clarify whether an assessment of equivalence is necessary. The way in which uses are formulated is determined. 3.2.2. Initial examination After the application has been received and, if applicable, the data have been transferred (application data and CADDY) to the WfMS (workflow management system), a confirmation of receipt is sent. Starting from receipt of the application, one week is planned for the initial examination. An administrative reconciliation follows with regard to the facts stated by the Regulation. There is a check to see whether studies, or information are physically available. For applications for renewals of authorisation, only a reduced data set is expected. Only new documentation should be submitted. Reference does not need to be made to documentation which has already been submitted. 3.2.3. Initial evaluation For the initial evaluation, the metadata for the new and studies are inputted at the BVL, the uses are examined by experts and are entered into the fact database at the BVL (INFOZUPF) and the assessment authorities' evaluation task is worded. Paper applications or paper are scanned at the BVL before being sent to the assessment authorities and are provided with metadata. After 5 weeks at the latest, the evaluation including the studies and their metadata are handed to the assessment authorities. The information on the specification of the active substance or the report by the BVL on the equivalence assessment, the composition of the plant protection product and how to formulate the uses are also submitted at the latest 5 weeks after the start of the initial evaluation when the assessment phase begins to the JKI, BfR and UBA, if no assessment of equivalence is necessary. If an assessment of equivalence is necessary, the information on the specification of the active substance or the report by the BVL on the assessment of equivalence and the composition of the plant protection product is submitted at the latest 8 weeks later. After 5 weeks, the applicant receives one first interim reply with possible information on deficiencies regarding the application and regarding the way the uses are formulated. At this point, processing of the application is not subjected to 'stop the clock' nor is it interrupted. Page 9 of 21
Charging the advance payment and checking receipt of the advance payment do not depend on the progress of the procedure. 3.2.4. Assessment Only new documentation is to be assessed. A review of the old data set is not intended as far as current scientific knowledge allows. BVL, JKI, UBA and BfR carry out their assessment within 16 weeks. The consulting authority and the authority of consent issue negative decisions in the case of data gaps. The contributions to the drr are sent with the decisions from the consulting authority and the authority of consent. 3.2.5. 'Stop the clock' notification For the renewal procedure for authorisations, no interruption of processing is intended. The application has to be refused if the assessment authorities have issued negative declarations or the BVL has issued a negative assessment. 3.2.6. Management The BVL compiles the drr within 2 weeks using the contributions from the assessment authorities and the BVL including the proposals for risk management. The drr is added to the EU database. A 2nd interim reply is written for the applicant and made available to him together with the drr. 3.2.7. Commenting The applicant and all Member States in the involved zone(s) receive a 6-week commenting deadline. 3.2.8. Decision The comments received are put together within one week by the BVL in special commenting tables and sent to the assessment authorities for consideration for the final assessment. Where necessary, the latter adapt their decisions and contributions for the Registration Report (RR) within 4 weeks. Using this, the BVL compiles the end version of the RR within a further week. If deviations are found in relation to the 2nd interim reply, a 3 rd interim reply is sent to the applicant. If a refusal seems likely, the applicant is allowed a hearing. 3.2.9. The certificate is issued The procedure is completed within 2 weeks after the certificate is issued. Page 10 of 21
3.2.10. The RR is published The end version of the RR (including the certificate) is added to the EU database and published on the BVL's website. 3.2.11. Fees charged The fees are charged after the certificate has been issued and not within the deadline of one year. 3.2.12. Time schedule for the ZV2 procedure: Zonal authorisation procedure; Germany is the Rapporteur Member State (ZRMS) - renewal of authorisation Incoming Application Comments from other MS, applicants Activity Preliminary meeting Receipt of application Initial examination Outgoing Confirmation of receipt Deadline > 26 w 1 w Initial evaluation 1. 1 st interim reply 5 w Assessment BfR, BVL, JKI, UBA Management BVL drr commenting Summary of comments BVL Assessment and compilation RR BfR, BVL, JKI, UBA Management BVL 2. 2 nd interim reply, drr 16 w 2 w 6 w 1 w 4 w 2 w Certificate is issued Certificate 2 w RR is published RR - Fees Advice of costs - Page 11 of 21
3.3. Application type ZV3: Zonal authorisation procedure; Germany is the concerned Member State (cms) - initial authorisation This procedure applies to applications for zonal authorisations according to Article 33 to 39, for applications for extensions of use according to Article 45 and for applications for provisional authorisations according to Article 30 of Regulation (EC) No 1107/2009. The ZRMS carries out the assessment. DE contributes by commenting the drr. The procedure must be completed within 120 days after receipt of the RR and the certificate of authorisation from the ZRMS. The assessment authorities are involved in the procedure. 3.3.1. Pre-meetings with the applicant The applicant is also offered pre-meetings in this procedure so that questions on the way the uses are formulated and on the national addendum can be clarified beforehand if necessary. 3.3.2. Receipt of application Receipt of the application is expected at the same time as it is submitted to the ZRMS. 3.3.3. Initial examination After the application has been received and, if applicable, the data have been transferred (application data and CADDY) to the BVL databases, a confirmation of receipt is sent. Starting from receipt of the application, two weeks are planned for the initial examination. 3.3.4. Initial evaluation For the initial evaluation, the metadata for the and studies are inputted at the BVL, the uses are examined by experts and are entered into the fact database at the BVL (INFOZUPF). If the uses have been determined in a pre-meeting, the data can be transferred directly from the application form. The metadata for the documentation submitted are inputted within 8 weeks. Paper applications or paper are scanned at the BVL before being sent to the assessment authorities and are provided with metadata. After the initial evaluation is completed, the evaluation including the studies and their metadata are handed to the assessment authorities. The information on the specification of the active substance and the composition of the plant protection product according to the data supplied by the applicant and also on the way the uses are formulated is passed on to the assessment authorities. DE is involved as a co- Rapporteur in the procedure, the ZRMS is consulted in this period. Page 12 of 21
3.3.5. Waiting for drr A waiting period follows until the drr is submitted by the ZRMS. 3.3.6. Commenting the drr The submitted drr is distributed within a week within the BVL and to the assessment authorities. Before it is distributed the intended uses in DE are compared with the uses described in the drr. The German comments are entered into the special commenting tables by the assessment authorities and made available within 4 weeks. The BVL compiles the entire opinion in a further week and sends it to the ZRMS. Following the commenting the applicant receives a first interim reply. 3.3.7. Waiting for the RR and the certificate of authorisation A waiting period follows until the RR is submitted by the ZRMS and the certificate of authorisation (in the German or English language) is submitted by the applicant. The 120-day deadline begins when the RR and certificate of authorisation are available. In his own interest, the applicant should apply for the continuation of the procedure (there is no specific form). 3.3.8. Distribution and assessment The received must be recorded and distributed within 20 days (RR and certificate of authorisation) to the assessment authorities so that they can assess these in 60 days for applicability to German conditions. As a result, the BVL receives decisions from the consulting authorities and the authority of consent, and also contributions for the final national addendum on the RR. 3.3.9. Final management The BVL implements the risk management proposals for issuing the certificate within 30 days. 3.3.10. The certificate is issued The procedure is completed within 10 days after the certificate is issued. 3.3.11. The RR is published The end version of the RR (national addendum including the certificate) is added to the EU database and published on the BVL's website. Page 13 of 21
3.3.12. Fees charged The fees are charged after the certificate has been issued and not within the deadline of one year. 3.3.13. Time schedule for the ZV3 procedure: Zonal authorisation procedure; Germany is the concerned Member State (cms); initial authorisation Incoming Application drr RR and certificate of ZRMS Activity Receipt of application Initial examination Initial evaluation Waiting for drr Receipt drr Processing, distribution BVL drr commenting BfR, BVL, JKI, UBA Management drr commenting BVL Outgoing Confirmation of receipt Deadline 2 w 8 w 1 w 4 w 1 w Compiling 1 st interim reply 1. Interim reply 1 w Waiting for RR and certificate of ZRMS Receipt RR and certificate of authorisation Beginning assessment BVL Assessment is completed BfR, BVL, JKI, UBA Management BVL is completed 20 d 60 d 30 d Certificate is issued Certificate 10 d RR is published RR, national addendum Fees Advice of costs - - Page 14 of 21
3.4. Application type ZV4: Zonal authorisation procedure; Germany is the concerned Member State (cms) - renewal of authorisation This procedure applies to the renewal of authorisations according to Article 43 of Regulation (EC) No 1107/2009. The basis corresponds largely with that of the procedure for application type ZV3. It is assumed that the scope of the submitted and the amount of work involved for renewals of authorisation is considerably less than for first-time authorisations. The MS therefore only have 9 instead of 12 months to process these applications. In Article 43 (2), the coordination of renewals of authorisation is allocated to the ZRMS in the respective zone. This leads to the problem that the ZRMS either has only 5 months to reach his decision on authorisation (12 months minus 3 months for the applicant and minus 120 days for the examination in the other MS) or that the concerned MS do not wait for the certificate to be issued by the ZRMS. A final decision on the procedure is dependant on clarification between the concerned Member States. This description of the procedure presumes that the decision in DE is taken at the same time as the decision in the ZRMS and on the basis of the drr without the RR and the certificate of authorisation having been submitted by the ZRMS. 3.4.1. Pre-meetings with the applicant The applicant is also offered pre-meetings in this procedure so that questions on the way the uses are formulated and on the national addendum can be clarified beforehand if necessary. 3.4.2. Receipt of application Receipt of the application is expected at the same time as it is submitted to the ZRMS. 3.4.3. Initial examination After the application has been received and, if applicable, the data have been transferred (application data and CADDY) to the BVL databases, a confirmation of receipt is sent. Starting from receipt of the application, two weeks are planned for the initial examination. 3.4.4. Initial evaluation For the initial evaluation, the metadata for the and studies are inputted at the BVL, the uses are examined by experts and are entered into the fact database at the BVL (INFOZUPF). If the uses have been determined in a pre-meeting, the data can be transferred directly from the application form. The metadata for the documentation submitted are inputted within 8 weeks. Paper applications or paper are scanned at the BVL before being sent to the assessment authorities and are provided with metadata. After the initial evaluation is completed, the evaluation including the studies and their metadata are handed to the assessment authorities. The information on the specifica- Page 15 of 21
tion of the active substance and the composition of the plant protection product according to the data supplied by the applicant and also on the way the uses are formulated is passed on to the assessment authorities. If DE is involved as a co- Rapporteur in the procedure, the ZRMS is consulted during this period. 3.4.5. Waiting for drr A waiting period follows until the drr is submitted by the ZRMS. 3.4.6. Commenting the drr The submitted drr is distributed within a week within the BVL and to the assessment authorities. Before it is distributed the intended uses in the DE are compared with the uses described in the drr. The German comments are entered into the special commenting tables by the assessment authorities and made available within 4 weeks. The BVL compiles the entire opinion in a further week and sends it to the ZRMS. Following the commenting the applicant receives a first interim reply. 3.4.7. Waiting for the RR and the certificate of authorisation The Registration Report and the certificate of authorisation from the ZRMS are not awaited. 3.4.8. Assessment is completed The assessment authorities complete their contributions to the national addendum within 3 weeks and send their decision on consent. 3.4.9. Final management The BVL implements the risk management proposals for issuing the certificate within 2 weeks. 3.4.10. The certificate is issued The procedure is completed within 10 days after the certificate is issued. Page 16 of 21
3.4.11. The RR is published The end version of the RR (national addendum including the certificate) is added to the EU database and published on the BVL's website. 3.4.12. Fees charged The fees are charged after the certificate has been issued and not within the deadline of one year. 3.4.13. Time schedule for the ZV4 procedure: Zonal authorisation procedure; Germany is the concerned Member State (cms) - renewal of authorisation. Incoming Application drr Activity Receipt of application Initial examination Initial evaluation Waiting for drr Receipt drr Processing, distribution BVL drr commenting BfR, BVL, JKI, UBA Management drr commenting BVL Assessment is completed BfR, BVL, JKI, UBA Management BVL is completed Outgoing Confirmation of receipt Deadline 2 w 8 w 1 w 4 w 1 w 3 w 2 w Certificate is issued Certificate 1 w RR is published RR, national addendum Fees Advice of costs - - Page 17 of 21
3.5. Application type ZV5: Zonal authorisation procedure; Germany is not concerned This procedure applies to applications for zonal authorisations according to Article 33 to 39, for applications for extensions of use according to Article 45 and for applications for provisional authorisations according to Article 30 of Regulation (EC) No 1107/2009. If the applicant does not submit an application in DE, it is still possible to comment once the ZRMS has submitted the drr. Neither a German addendum nor an authorisation certificate has to be issued in this case. If original studies are submitted in DE, no metadata are put together for these. The studies are forwarded as they are submitted by the applicant. 3.5.1. Submitting applications and documentation The applications are not submitted in DE. Information on submitted applications can be found via the EU database, which still has to be compiled, the zonal steering group or the applicant. Commenting only happens in individual cases according to criteria which the authorities still have to agree on. 3.5.2. Waiting for drr After the request for comments and the submission of the drr by the ZRMS, the BVL decides on involvement in commenting. 3.5.3. Commenting on the drr The submitted drr is distributed within a week within the BVL and to the assessment authorities. The German comments are entered into the special commenting tables by the assessment authorities and made available within 4 weeks. The BVL compiles the entire opinion in a further week and sends it to the ZRMS. By having commented on the drr, involvement in this procedure is finalised. 3.5.4. Time schedule for the ZV5 procedure: Zonal authorisation procedure; Germany is not concerned Incoming Activity Outgoing Deadline drr by ZRMS Processing, distribution BVL 1 w drr commenting BfR, BVL, JKI, UBA Management drr commenting BVL 4 w 1 w Page 18 of 21
3.6. Application type ZVU: Mutual recognition This procedure applies to applications for zonal authorisations for mutual recognition according to Article 40 to 42 of Regulation (EC) No 1107/2009. Mutual recognition is compulsory. Exceptions are defined in Article 41. The procedure applies only to products which have run through the zonal authorisation. 120 days after the application has been received, the procedure must be completed with the certificate. 3.6.1. Receipt of application The deadline of 120 days begins with the receipt of the application. 3.6.2. Receipt of application and initial evaluation After the application has been received and, if applicable, the data have been transferred (application data and CADDY) to the WfMS (workflow management system), a confirmation of receipt is sent. The metadata are inputted for the submitted documentation according to Article 42. The BVL adapts the way the uses are formulated to the German conditions as far this is possible and submits the documentation at the latest 20 days after the application has been submitted to the assessment authorities. Metadata are not inputted for original studies. 3.6.3. Assessment Within 60 days the applicability of the RR to German conditions is examined by the authorities involved. At the BVL the composition of the plant protection product and the identity of the active substance are recorded. Decisions on consent and assessment reports are compiled which describe the implementation of zonal authorisation. A national addendum is not compiled for the RR. 3.6.4. Management/Decision The BVL implements the risk management proposals for issuing the certificate within 30 days. 3.6.5. The certificate is issued The procedure is completed at the latest 120 days after the application is submitted with the issuing of a certificate. Page 19 of 21
3.6.6. Time schedule for the ZVU procedure: Procedure C: Mutual recognition Incoming Application Activity Receipt of application Initial examination Initial evaluation Assessment BfR, BVL, JKI, UBA Management BVL is completed Outgoing Confirmation of receipt Deadline 6 d 14 d 60 d 30 d Certificate is issued Certificate 10 d Fees Advice of costs - 4. List of abbreviations and glossary Addendum additional national assessment for the Core Assessment of the drr / RR BVL BfR CADDY CIRCA cms co-assessor Core Assessment DAR DE drr EU Bundesamt für Verbraucherschutz und Lebensmittelsicherheit = Federal Office of Consumer Protection and Food Safety Bundesinstitut für Risikobewertung = Federal Institute for Risk Assessment Computer Aided Dossier and Data Supply, electronic format for the exchange, archiving and assessment of complex dossiers developed by ECPA in cooperation with European authorisation authorities. (http://caddy.ecpa.be) software developed by the EU Commission (Communication and Information Resource Centre Administrator) concerned Member State MS involved in the assessment in consultation with the ZRMS main part of the drr and RR Draft Assessment Report (draft of assessment report with proposal for decision regarding the evaluation of active substances) Deutschland = Germany draft Registration Report European Union Page 20 of 21
INFOZUPF JKI MS PflSchG PSM RR MRL Safener Synergist UBA WfMS ZRMS information system concerning the authorisation of plant protection products database application for the professional processing of applications for authorisation in the area of plant protection Julius Kühn-Institute Member State German Plant Protection Act plant protection product Registration Report maximum residue level substance which is added to a plant protection product to suppress or reduce the phytotoxic effect of the plant protection product on certain plants substance which has no impact or only a weak on but which fortifies the impact of the active substance contained in a plant protection product Umweltbundesamt = Federal Environmental Agency workflow management system Zonal Rapporteur Member State 5. References German Plant Protection Act in the version of the notification of 14 May 1998 (BGBl. I p. 971, 1527, 3512), last amended by Article 4 of the Act of 2 November 2011 (BGBl. I p. 2162) in conjunction with 74(3) p. 1 of the Act Concerning the Protection of Crop Plants (Plant Protection Act - PflSchG) of 6 February 2012 (BGBl. 1 p. 148, 1281). Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009, Official Journal of the European Union L 309/1-50. Guidance document on zonal evaluation and mutual recognition under Regulation 1107/2009, SANCO/13169/2010 rev.5 of 11 March 2011 Guidance document on renewal, withdrawal and amendment of authorization under Regulation (EC) No 1107/2009, SANCO/2010/13170 rev.7 of 11 March 2011 Page 21 of 21