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EAS · EAS Complete Dossier (CADDY) Additional Summary Dossier (word processing format) Complete Dossier Additional Summary Dossier Complete Dossier (paper)

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Page 1: EAS · EAS Complete Dossier (CADDY) Additional Summary Dossier (word processing format) Complete Dossier Additional Summary Dossier Complete Dossier (paper)

EASComplete Dossier

(CADDY)

Additional Summary

Dossier (word processing

format)

Complete Dossier

Additional Summary Dossier

Complete Dossier (paper)

Additional Summary Dossier (paper)

Additional Summary Dossier (word

processing format)

acting as RMS 1 1 1 1 1 - -not RMS 1 1 - - 1 - -

acting as RMS 2 2

1 full version

+1 complete toxicology

dossier (IIA 5 and IIIA

7)

1

1 full version

+1 complete toxicology

dossier (IIA 5 and IIIA

7)

1 2

not RMS 2 - - - - 1 1

acting as RMS 3 3 1 3 1 3 3not RMS 3 3 - 1 - 1 3

acting as RMS 1 1 - 1not RMS 1 1 - 1

acting as RMS 2 2

1full version + 1 toxicology dossier (IIA 5

+ IIIA 7) + 1 residues dossier (IIA 6

+ IIIA 8)

2

1full version + 1 toxicology dossier (IIA 5

+ IIIA 7) + 1 residues dossier (IIA 6

+ IIIA 8)

2 2

not RMS 2 2 - -

1full version + 1 toxicology dossier (IIA 5

+ IIIA 7) + 1 residues dossier (IIA 6

+ IIIA 8)

2 2

not RMS + EAS is not on the market

2 - - - - - 2

acting as RMS 3 5 1 - 1 1 5not RMS 3 1 - - - 1 1

Electronic submission

Czech Republic

Cyprus

Bulgaria

Denmark

Paper submission

Additional paper copies Submission on paper and/or electronic summary dossier

Austria

Belgium

Electronic submission

EAS

Page 2: EAS · EAS Complete Dossier (CADDY) Additional Summary Dossier (word processing format) Complete Dossier Additional Summary Dossier Complete Dossier (paper)

EASComplete Dossier

(CADDY)

Additional Summary

Dossier (word processing

format)

Complete Dossier

Additional Summary Dossier

Complete Dossier (paper)

Additional Summary Dossier (paper)

Additional Summary Dossier (word

processing format)

Electronic submission

Paper submission

Additional paper copies Submission on paper and/or electronic summary dossier

Electronic submission

acting as RMS 2 2

1full version + 1 toxicology dossier (IIA 5

+ IIIA 7) + 1 residues dossier (IIA 6

+ IIIA 8)

1

1full version + 1 toxicology dossier (IIA 5

+ IIIA 7) + 1 residues dossier (IIA 6

+ IIIA 8)

1 2

not RMS 2 2 - -

1full version + 1 toxicology dossier (IIA 5

+ IIIA 7) + 1 residues dossier (IIA 6

+ IIIA 8)

1 2

acting as RMS 3 3 3 - 3 - 3not RMS 1 1 - - - - 1

acting as RMSor co-RMS 2 (AFSSA) 2 (AFSSA) 2 (AFSSA)

not RMS 1 (AFSSA) 1 (AFSSA)

acting as RMS 4 - 2 - 4 2 4 *not RMS 4 - - - 1 2 4 *

* reference list also required in electronic format according to DOK interface

acting as RMS 6 2 2 - 2 1 2not RMS 6 - - - - - 2

acting as RMS 1 1 1 - 2 - 1not RMS 1 1 - 1 1 1 1

acting as RMS 4 1 1 4 1 4 1not RMS 1 1 1 - 1 - 1

acting as RMS 1 1 1 1 1 - -not RMS 1 - - - - 1 1

acting as RMS 1* 1 - - - - -not RMS 1 1 - - - - -

* Plus a copy in EUCLID

format

acting as RMS 1 1 1 1 1 - 1not RMS 1 1 - 1 1 - 1MS is not RMS and has no application for provisional authorization

- - - - - - -

acting as RMSnot RMS 1 1 1 1

Finland

Estonia

AFSSA DiVE -UGAMM

10 rue Pierre Curie94704 Maison-Alfort cedex.

France

Ireland

Greece

where electronic submission in CADDY format is not achievable, this electronic submission must be replaced in all cases using pdf processing format, content of each report have to be easily identifiable

Germany

Lithuania

Luxemburg

Hungary

Italy

Latvia

France

EAS

Page 3: EAS · EAS Complete Dossier (CADDY) Additional Summary Dossier (word processing format) Complete Dossier Additional Summary Dossier Complete Dossier (paper)

EASComplete Dossier

(CADDY)

Additional Summary

Dossier (word processing

format)

Complete Dossier

Additional Summary Dossier

Complete Dossier (paper)

Additional Summary Dossier (paper)

Additional Summary Dossier (word

processing format)

Electronic submission

Paper submission

Additional paper copies Submission on paper and/or electronic summary dossier

Electronic submission

acting as RMS 1 1 1 1 1 1 1not RMS 1 1 - 1 - - -

acting as RMS 5 1 1 1not RMS 1 5 - 1 1 5 5

Maltacontact Ministry for practical detailscontact Ministry for practical details

contact Ministry for practical detailsPoland

EAS

Page 4: EAS · EAS Complete Dossier (CADDY) Additional Summary Dossier (word processing format) Complete Dossier Additional Summary Dossier Complete Dossier (paper)

EASComplete Dossier

(CADDY)

Additional Summary

Dossier (word processing

format)

Complete Dossier

Additional Summary Dossier

Complete Dossier (paper)

Additional Summary Dossier (paper)

Additional Summary Dossier (word

processing format)

Electronic submission

Paper submission

Additional paper copies Submission on paper and/or electronic summary dossier

Electronic submission

acting as RMS

2 2 1 - 1

4*(only needed if

word processing

format is not available

2

not RMS

1 - - - -

1*(only needed if

word processing

format is not available

1

acting as RMS 6 6 1 1 1 1 2not RMS 3 3 - 1 - 1 1

acting as RMS 2 2 1 2 2 2 2

not RMS 2 2

MII and MIII summaries +

Doc J confidential

information + KII and KIII

(identitiy + fyz-chem.

properties + analytical methods) - 1 - 1

acting as RMS 2 1 - 1 - -not RMS 2 - - - - -

Acting as RMS/CoRMS

1(MAPA) 1(INIA)*

1(MAPA) 1(INIA) 1(INIA)

not RMS 1(MAPA) 1(INIA)*

1(MAPA) 1(INIA)

acting as RMS 2 2 - - - - 2not RMS 2 2 - - - - 2

acting as RMS 3 1 2 1 2 1 1not RMS 2 1 - 1 - 1 1

acting as RMS 1 1 - - - - -not RMS 1 1 - - - - -

- 1 - - - - 1

1 1 - - 1 - 1

(only if summary

dossier is not contained on CADDY set)

C/Alfonso XII, 62ES - 28071 Madrid

Paper submission only necessary if

Whereas one dossier shall be sent to the published contact point in DG Health and Consumer

Ctra de La Coruña Km 7ES - 28040 Madrid

Grupo Fitosanitario (EDIFICIO EL CUBO)José Mª García Baudín/José Luis Alonso Prados

Departamento de Protección Vegetal

Romania

Portugal

INIA

*pdf format is desirable instead of CADDYMinisterio de Agricultura Pesca y Alimentación (MAPA)Subdirección General de Medios de Producción AgrícolasConcha Pastor

EFSA

Slovenia

Spain

Slovakia

Sweden

The Netherlands

United Kingdom

COM

EAS

Page 5: EAS · EAS Complete Dossier (CADDY) Additional Summary Dossier (word processing format) Complete Dossier Additional Summary Dossier Complete Dossier (paper)

EASComplete Dossier

(CADDY)

Additional Summary

Dossier (word processing

format)

Complete Dossier

Additional Summary Dossier

Complete Dossier (paper)

Additional Summary Dossier (paper)

Additional Summary Dossier (word

processing format)

Electronic submission

Paper submission

Additional paper copies Submission on paper and/or electronic summary dossier

Electronic submission

explanation:

this colums relates to

the number of full

dossiers in electronic

format

this column relates to

the number of summary dossiers in electronic

format, which are required

additionally to the

number of full dossiers

In addition to the

electronic submission

some Member

States would like to recieve paper

copies. Please fill in the numer of

additional paper copies

of the full dossier.

this column relates to

the number of additional

summary dossiers on paper to the

whole request

regarding the

electronic submission

this column relates to

the number of full

dosiiers on paper

this column relates to

the number of additional

summary dossiers on

paper

this column

relates to the

number of additional summary dossiers

in electronic

format, which are required on to of

the paper submissio

n

EAS