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User guide
KӔLTIA Plant Protection Consortium (KPPC) IT System
KÆLTIA Compliance Services, S.L., ES B-74306788, Avenida de la Argentina, 132, 33213, Gijón, España, Tel.: +34 984 39 1044 /1280, Fax: +34 985 30 82 28
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KÆLTIA Compliance Services, S.L., ES B-74306788, Avenida de la Argentina, 132, 33213, Gijón,
España, Tel.: +34 984 39 1044 /1280, Fax: +34 985 30 82 28
User guide
KÆLTIA Plant Protection Consortium (KPPC) IT System
Publ. date: April 2017
Language: EN
If you have questions or comments in relation to this document please send them (quote the
reference and issue date) at [email protected]
KÆLTIA Compliance Services S.L.
Mailing and Visiting address: Avenida Argentina 132, 33213-Gijón, Spain
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KÆLTIA Compliance Services, S.L., ES B-74306788, Avenida de la Argentina, 132, 33213,
Gijón, España, Tel.: +34 984 39 1044 /1280, Fax: +34 985 30 82 28
Version Changes Date
Version 1.0 First version April 2017
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KÆLTIA Compliance Services, S.L., ES B-74306788, Avenida de la Argentina, 132, 33213,
Gijón, España, Tel.: +34 984 39 1044 /1280, Fax: +34 985 30 82 28
Table of Contents
1 INTRODUCTION ................................................................................................... 5
2 WHAT IS KPPC? ................................................................................................... 6
2.1 KPPC potential registrant interface ................................................................. 6
2.2 What is a consortium in the context of the BPR? ............................................ 7
2.3 KPPC user registration ................................................................................... 7
2.4 KPPC homepage ............................................................................................ 9
2.5 Insert your applications ................................................................................... 9
2.6 Manage your applications ............................................................................. 11
3 MONITORING THE PROCESS ........................................................................... 11
Table of Figures
Figure 1: KPPC Accounts login page ............................................................................ 7
Figure 2: KPPC Registration Form ................................................................................ 8
Figure 3: KPPC homepage ........................................................................................... 9
Figure 4: Insert your applications ................................................................................ 10
Figure 5: Manage your applications ............................................................................ 11
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KÆLTIA Compliance Services, S.L., ES B-74306788, Avenida de la Argentina, 132, 33213,
Gijón, España, Tel.: +34 984 39 1044 /1280, Fax: +34 985 30 82 28
1 INTRODUCTION
For the purposes of the EU registration of Plant Protection Products under the
Regulation 1107/2009 and in order to facilitate manufacturers, formulators and
distributors to work together and to cooperate in the preparation of dossiers for
authorisation, KÆLTIA have developed an IT System (KÆLTIA Plant Protection
Consortium, KPPC) for cooperation where the parties can express their interest to
achieve an understanding to support jointly their products by establishing a voluntary
agreement.
The use of this IT System is free of charge.
KÆLTIA will be in charge of the formation of each potential “Registration Group” and
will communicate the parties interested for cooperation that a potential “Registration
Group” has been formed. This service is subject to an initial fee that will be deducted
from the final cost of the EU registration dossier/s that will be managed by KÆLTIA.
This process is structured in 5 phases as follows:
Phase 1: User Registration on the IT System, where a Service Provider/Non-
disclosure Agreement will be signed before entering any product/s data into the
system and where each user will be assigned with a confidential user name and
password.
Phase 2: Creating the list of products of interest to each user. In this phase,
each user must provide the relevant information for each plant protection
product.
Phase 3: "Registration Group" Formation. Once a "Registration Group" is
formed, KÆLTIA will inform all group members. If members agree to cooperate
together, a voluntary agreement between the parties will be signed.
Phase 4: Registration Strategy Design. KÆLTIA will design the EU registration
strategy based on the information provided by each member of the
"Registration Group" about their products and will discuss the strategy with the
Group.
Phase 5: Preparation, submission and follow-up of European registration
dossier/s. Once the registration strategy is agreed within the "Registration
Group", KÆLTIA will prepare the European registration dossier/s for their
submission to the relevant Member States of the EU.
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KÆLTIA Compliance Services, S.L., ES B-74306788, Avenida de la Argentina, 132, 33213,
Gijón, España, Tel.: +34 984 39 1044 /1280, Fax: +34 985 30 82 28
Please be aware that all the information provided in this IT System will be managed by
KÆLTIA and treated as strictly confidential. In addition, a Service Provider/Non-
Disclosure Agreement will be established between each participant and KÆLTIA,
before sharing any product information. Please be also aware that the members of
each “Registration Group” will not be publicly available in this IT System as it is
considered confidential.
2 WHAT IS KPPC?
KPPC (KÆLTIA Plant Protection Consortium) is an IT System established and
maintained by KÆLTIA Compliance Services S.L. (hereinafter referred as KÆLTIA)
with the aim to provide support to potential co-registrants of similar plant protection
products to cooperate in the preparation, submission and follow-up their registration
dossiers under the Regulation 1107/2009.
KPPC IT System consists of two independent interfaces, one dedicated to the users
(potential co-registrants) and one to KÆLTIA.
2.1 KPPC users interface
The KPPC user (potential registrant) interface is dedicated to all companies interested
in working together and in cooperating in order to achieve a common purpose under
the Regulation 1107/2009, e.g. the preparation of a dossier for product authorisation at
EU-wide or EU Member State level, allowing for the notification of their plant protection
products and exchange of information with potential co-registrants of similar products.
Through this interface, users can login to KPPC System and notify those products, for
which they are interested in cooperating with other companies, see their applications
and update them at any time.
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KÆLTIA Compliance Services, S.L., ES B-74306788, Avenida de la Argentina, 132, 33213,
Gijón, España, Tel.: +34 984 39 1044 /1280, Fax: +34 985 30 82 28
2.2 What is a consortium in the context of the Regulation
1107/2009?
The word “consortium” is not defined under the Regulation 1107/2009 but the forming
of consortia could constitute a useful tool that could offer possible benefits in the
context of product authorisation applications under the Regulation 1107/2009. It is not
obligatory to call the group of companies a consortium. Different names can be used to
refer to the joint cooperation of two or more companies including “cooperation
agreement”, “task force” or “registration group” as they all share the same meaning: a
group of companies that has decided to work together in order to achieve a common
goal under the Regulation 1107/2009.
In principle, a consortium is not a legal entity. It is simply a grouping of companies
connected to each other by the common purpose as established in general by a written
agreement or contract between them.
2.3 KPPC user registration
The account management in the KPPC System allows you to create and update a user
account and to reset a user password. All users who wish to access KPPC System
must first log in to KPPC Accounts (Figure 1).
Figure 1: KPPC Accounts login page
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KÆLTIA Compliance Services, S.L., ES B-74306788, Avenida de la Argentina, 132, 33213,
Gijón, España, Tel.: +34 984 39 1044 /1280, Fax: +34 985 30 82 28
If you are not yet a user, the creation of a KPPC account will require you ‘Create my
account” (see Figure 2) by entering your user details (name, company, business
activity, position in the company, phone and e-mail address). As soon as the
registration form is completed and sent, users will receive an e-mail from the KPPC
System with a password. The username is the e-mail address entered in the
registration form.
In the case that you forgot your password, you must enter the e-mail address, select
the box “Forgot my password” and by clicking “Enter”, you will receive immediately a
new password in your email address.
Figure 2: KPPC Registration Form
All personal data collected by KÆLTIA Compliance Services, S.L. are subject to all the
guarantees of Confidentiality and Security. Therefore, before getting the login details,
the user must review and accept the privacy policy related to the personal data
protection as well as review and accept the Service Provider/Non-Disclosure
Agreement. In addition, a copy of the signed Non-Disclosure Agreement must be
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KÆLTIA Compliance Services, S.L., ES B-74306788, Avenida de la Argentina, 132, 33213,
Gijón, España, Tel.: +34 984 39 1044 /1280, Fax: +34 985 30 82 28
submitted to [email protected] before providing any data on your products
in the IT System.
Once you have successfully created your KPPC account, you will then be able to log in
with your user credentials from the KPPC landing page (pppconsortium.kaeltia.com).
2.4 KPPC homepage
Once you have logged into KPPC System, the homepage is displayed as shown in
Figure 3. The logged in ‘User ID’ (contact person and company) are displayed in the
top left corner. There is a toolbar available that contains four tabs. Each tab allows you
to perform certain actions (logout, insert new applications or register a new user) or
view information related to KÆLTIA (home).
Figure 3: KPPC homepage
2.5 Insert your applications
Clicking on the ‘INSERT YOUR APPLICATION’ tab below the “User ID” information
launches the application ‘wizard’ (Figure 4) which assists you to fill in and submit an
application.
Application requirements and instructions are given below:
- Application date: you must select the date of each application from the calendar.
- Formulation type: you must select the correct formulation type from the available list.
- Intended User/s: you must select the correct user/s from the list (professional and/or
non-professional user)
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KÆLTIA Compliance Services, S.L., ES B-74306788, Avenida de la Argentina, 132, 33213,
Gijón, España, Tel.: +34 984 39 1044 /1280, Fax: +34 985 30 82 28
- Active substance/s present in the formulation and its content: by clicking + you must
add an active substance. You need to introduce the chemical name of the Plant
Protection active substance as listed in the EU:
http://ec.europa.eu/food/plant/pesticides/eu-pesticides-
database/public/?event=activesubstance.selection&language=EN. More than one
active substance can be selected. In addition, you must enter the content (% w/w) of
each active substance/s present in the formulation.
- Plant Protection Product Use/s: by clicking + you can select the plant protection
product type/s from the list. More than one product type can be selected.
- EU countries: by clicking + you can select all those countries where this product is
being marketed and/or is intended to be marketed. In addition, you must also indicate if
you are not willing to cooperate with companies that are interested in the same product
in the same market area by clicking the corresponding box.
Figure 4: Insert your applications
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KÆLTIA Compliance Services, S.L., ES B-74306788, Avenida de la Argentina, 132, 33213,
Gijón, España, Tel.: +34 984 39 1044 /1280, Fax: +34 985 30 82 28
The user must review the information entered for each product application before
accepting the notification as this will avoid further modifications. Nevertheless, if the
user realized that any information is incorrect, they could update the application at any
time.
2.6 Manage your applications
Once you have entered your applications, you can check the list that is displayed in the
applications “wizard” (see Figure 5). From this “wizard”, the user can insert new
applications and amend the previous applications. If you need to delete an application,
please contact us in [email protected], so you can proceed.
Figure 5: Manage your applications
3 MONITORING THE PROCESS
Once a potential “Registration Group” of cooperation is formed, KÆLTIA will
communicate each member of the group the list of potential co-registrants that are
willing to cooperate to support similar products at the EU level. No information about
the products included in each "Registration Group" will be provided at this phase. At
this time, an initial fee for the "Registration Group" formation will be paid to KÆLTIA by
each member of the potential "Registration Group". This initial cost will be deducted
from the final cost of the EU registration dossiers that will be managed by KÆLTIA in
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KÆLTIA Compliance Services, S.L., ES B-74306788, Avenida de la Argentina, 132, 33213,
Gijón, España, Tel.: +34 984 39 1044 /1280, Fax: +34 985 30 82 28
the case the members of the group decide to continue with the joint registration
process. On the contrary, if any member decides not to continue with the process, the
initial fee will not be refunded to this member as it corresponds to the coordination work
performed by KÆLTIA up to this date.