jump to navigation
jump to content
Search in Articles and Documents
generate
PDF
-Version of this page
1:
H
ome
(ALT-H)
2:
H
M
A Joint
(ALT-M)
3:
H
u
man Medicines
(ALT-U)
4:
V
eterinary Medicines
(ALT-V)
Sitemap
Home
HMA
Joint
Heads of Agencies
About
HMA
HMA
-Management Group / Permanent Secretariat
Transparency
Working Groups
HMA
WG of Communication Professionals
Mutual Recognition Co-ordination Group
The Approval system
HMA
Topics
HMA
Working Group on Product Testing
HMA
Strategy Paper
Joint
HMA
/EMA Office of Training Steering Group
Benchmarking of European Medicines Agencies
Availability of Medicines
Telematics
eCTD Implementation Survey Report
Stakeholder Information
HMA
Calendar
FAQ
Contact form
Contact Points
Human Medicines
Heads of Agencies
About
HMA
HMA
-Management Group / Permanent Secretariat
Working Groups
Clinical Trials Facilitation Group
Homeopathic Medicinal Products Working Group (
HMPWG
)
Working Group on
PSUR
synchronisation
HMA
Topics
Risk Management
Medicines for children
Stakeholder Information
HMA
Calendar
FAQ
PSUR
synchronisation
Contact form
Contact points
CMDh
About CMDh
CMDh Composition
CMDh Activities
CMDh Workplan
CMDh Reports
Contacts with Representative Organisations
Transparency Measures
Calendar for CMDh meetings
MRFG
(1995-2005)
Statistics
Press Releases
2012
2011
2010
2009
2008
2007
2006
2005
2004
2003
2002
2001
2000
Procedural Guidance
General Info
Application for
MA
DCP
MRP
eSubmissions
Generics
Applicant´s Responses
Renewal
Variation
Art 5 recommendations
USR
Art 61.3 Procedure
Consultation with target patient groups
Post Referral Phase
Pandemic Plan
CMDh-Referrals
Product Information
PhVWP
Recommendations
CMDh Recommendations
Harmonisation of SmPCs - Article 30 Referrals
Core SmPC/PL
Advice from CMDh
Templates
QRD
AR
DCP
(AR/Comments)
MRP
Renewals
Variations
Art 61.3 Procedure
Public AR
Paediatric Data
Applications for
MA
Art.29 Referrals
Variations
CMD subgroups / working groups
Working Group on Active Substance Master File Procedures
Working Party on Future of the CMDh
Subgroup on Paediatric Regulation
Subgroup on Variation Regulation
Subgroup on Harmonisation of SmPCs
Joint CMDh/
PhVWP
WG
CTS Working Group
Joint CMDh/GCP Inspectors Subgroup
Paediatric Regulation
Guidance Documents
Article 45 and previous Worksharing
Assessment Reports
Article 45 work-sharing
Article 46 work-sharing
Previous worksharing project
Questions & Answers
Applications for
MA
CMDh Referrals
Variations
Post referral phase
PSURs & Renewals
PSURs
Renewals
Product Information / Information on medicinal products
Generics & Usage Patents
Generics
Usage Patents
Biologicals
Homeopathics
Advice from CMDh
EU
-Enlargement
Contact Form
Contact Points
What's new history
MRI
Product Index
Directory
Veterinary Medicines
Heads of Agencies
About
HMA
HMA
-Management Group / Permanent Secretariat
Working Groups
TIGes-vet Telematics Implemetation Group electronic submission veterinary
PSUR
synchronisation and work-sharing
HMA
Task Force
Veterinary Legislation
Availability of Veterinary Medicines
The Approval system
HMA
Topics
HMA
Strategic Plan on Antimicrobial Issues
Stakeholder Information
ETPGAH-European Technology Platform
HMA
Calendar (
HMA
meetings)
FAQ
Contact Form
Contact points
CMD(v)
About
CMD(v)
, Activities
Role of
CMD(v)
CMD(v)
Composition
General documents
CMD(v)
guidance
General Info on Licensing System
Applications
Marketing Authorisation procedures
Variations
Renewals
Referrals
SPC
, Labelling and Package leaflet
Miscellaneous
Definition of
Pharmacovigiliance
Reports for Release
Statistics
Annual Reports
IFAH
Europe -
CMD(v)
Survey
Calendar
Meeting dates
Clock start dates
Frequently asked questions
Questions from industry and answers
Specific issues
Contact Form
Contact Points
What's new Archive (6 months)
VMRI
Product Index
Directory
Search
Credits & Disclaimer
Sitemap
Related Links
Newsletter
