Index

 

A | C | D | E | F | G | H | I | L | M | N | P | Q | R | S | T | V | W

A

assigned parts

ATC classifications

attribute extension

authorities, see regulatory authorities

C

calendar templates, see regulatory calendar templates

calendars, see regulatory calendars

Centralized Procedure

channel UI home page

checklists

creating

classification lifecycle

classifications

about

ATC

listing

path

variation submissions

clock start

clock stop

CMS

Co-Rapporteur

commitment submission

creating

companies, adding to request queues

company calendar

Concerned Member States

connection milestones

contact lifecycle

contacts

creating

properties

correspondence

editing

lifecycle

properties

sources

countries

adding to request queues

categories

following

leading

listing

products list

related items

country

lifecycle

CP

D

dashboard

milestones

defect

categories

derived from, submission types

dictionary

MedDRA

document

view

documents

checking in

checking out

checkingin

checkingout

downloading

locking

subscribing to

subscribing to

updating

dossier

about

for submission

publishing

volumes

E

eCopy

publish without PDF

publishing

European Union

F

folders

following country

follows leading country

G

global calendars

grouping submission projects

H

home page

channels

I

impact questionnaire

creating from template

lifecycle

templates

impact questionnaire template

questions

reference documents

revision

impact questionnaire template lifecycle

indication

MedDRA

indications

editing properties

lifecycle

listing

interactive review phase

creating

defining

process

review questions

review questions, defining

timeline page

L

language

lifecycle

languages

lead submission project

leader folders

leading country

lifecycle

lifecycles

local calendars

local folders

M

market authorizations

products list

market authorization

adding plants

market authorization changes

about

approving

categories

editing properties

lifecycle

obsolete

plants

properties

market authorizations

about

adding products

approval

categories

closing

editing properties

lifecycle

listing

plants

properties

related

rules for closing

master folders

MedDRA

installing

MedDRA, impact analysis

MedDRA,indication

MedDRA,indication coding

MedDRA,upgrading

milestone purposes

milestones

checklists

for submission schedule

model version

lifecycle

MRP

Mutual Recognition Procedure

N

notifications

regulatory milestones

P

package

pivot milestones

plants

adding to market authorization

policies

classification

contact

correspondence

country

impact questionnaire

impact questionnaire template

indication

language

market authorization

market authorization change

model version

project space

project template

question

region

regulatory authority

regulatory category

regulatory guideline

regulatory request

regulatory request action item

regulatory request queue

regulatory request type

regulatory submission type

storage condition

preferences

regulatory milestone notifications

products

adding to market authorization

adding to a submission

adding to regulatory request

categories

for a regulatory request

list for market authorization

listing for a submission

regulatory properties

related items

project spacelifecycle

project template lifecycle

publishing file format

Q

question

categories

question lifecycle

questionnaire

creating

listing

questions

editing in a questionnaire

interactive review phase

properties

R

Rapporteur

Reference Member State

region

lifecycle

regulatory authorities

editing

regulatory activity categories

market authorization changes

regulatory activity categories

submission master record

Regulatory Administrators

process

regulatory authorities

categories

creating

in regulatory context

lifecycle

listing

properties

regulatory calendar templates

about

categories

copying

creating

editing

import file format

importing

listing

properties

schedule

regulatory calendars

about

categories

global

interactive review phase

local

timeline

regulatory categories

categories

editing

in regulatory context

lifecycle

listing

properties

related regulatory authorities

regulatory category activities

for submissions

regulatory contexts

about

creation

listing

process

regulatory authorities

regulatory categories

submission types

regulatory dossier

regulatory guidelines

categories

creating

lifecycle

listing

regulatory information

editing

for a submission

products

regulatory milestones

checklists

descriptions

regulatory request action item

lifecycle

Regulatory Request Administrator

process

regulatory request queues

adding members

categories

configuration

configuring

creating

editing

lifecycle

listing

members

properties

rules

regulatory request types

adding to request queues

categories

creating

deleting

editing

lifecycle

listing

properties

questionnaire

regulatory requests

adding products

assigning

canceling

categories

creating

editing properties

lifecycle

listing

products

properties

reassigning

rejecting

regulatory submission types, see submission types

related items

repeal

request queues, see regulatory request queues

request types, see regulatory request types

review questions

listing

reviewer questionnaire

reviewers

creating

deleting

RMS

rules, request queues

S

schedules

about

clock start

clock stop

milestones

milestones automatically created

regulatory calendar template

tasks

snapshots

creating

deleting

storage condition

lifecycle

storage conditions

submission

eCopy

package

package without PDF

publish

publish without PDF

structure

submission projects

cancelling

submission templates

configuring

submission dossier

structure

submission projects

publishing

submission dossier

submission master records

categories

editing properties

folders

listing

products list

properties

submission projects

about

adding reviewers

adding market authorizations

adding related submissions

cancelling

categories

commitment

configuring

copying

creating

dashboard

derived

dossier

editing properties

grouped

justifying changes

lead

listing

market authorization

packaging

products list

properties

putting on hold

regulatory calendars

regulatory information, editing

removing market authorizations

repeal

restricted authorization

resuming

schedule

snapshots

submission master record

sunset clause exemption

tasks

using template

variations

work breakdown structure

submission templates

categories

creating

editing

listing

process

properties

tasks

submission types

categories

derived from

in regulatory context

lifecycle

listing

properties

submissionprojects

products list

submissions

adding products

submissiontypes

deleting

sunset clause exemption

T

tasks

creating

creating for submission schedule

deliverables

timeline

V

variation submission

classifications

volumes

W

work breakdown structure

work requests