RSS
Sitemap
Contact
About
HMA
Human Medicines
Veterinary Medicines
You are here:
Home
>
Human Medicines
>
CMDh
>
Procedural Guidance
>
Generics
CMDh
About CMDh
Statistics
Agendas and Minutes
Press Releases
BREXIT
Procedural Guidance
General Info
Application for
MA
eSubmissions
Generics
Applicant´s Responses
Renewal
Consultation with target patient groups
Variation
USR
Art 61.3 Procedure
Post Referral Phase
CMDh-Referrals
Product Information
Advice from CMDh
Templates
CMD Working Parties / Working Groups
Paediatric Regulation
Pharmacovigilance
Falsified Medicines
IGDRP
Questions & Answers
Contact Points
What's new history
MRI
Product Index
Pharmacovigilance
Publications and reports
National Contacts
Generics in
MRP
and
DCP
List of
MRP
/
DCP
finalised in 2006-2010 with new active substances
(November 2011)
CMDh Position paper on processing of generic applications when the generic has more indications or fewer indications than the reference product in the
CMS
(July 2014)
[
Track version
]
Information to be submitted by the Member State of the European Reference Medicinal Product
(October 2016)
[
Track version
]
Annex II: Standard form to be sent by the
RMS
to the MS of the ERP
(December 2015)
CMDh Recommendations for Applications submitted according to Article 10 when the strength and/or pharmaceutical form of the reference medicinal product differs between
RMS
/
CMS
(s)
(May 2009) [
Track version
]
CMDh Recommendations on implementation of Article 30 Decisions cf. Directive 2001/83/
EC
, as amended for Generic/Hybrid/Biosimilar Medicinal Products approved through
MRP
/
DCP
(July 2013) [
Track version
]
