Practical-17 Date.13/12/2023
Faculty of Pharmacy, Marwadi University
Aim : Comparison study of Marketing authorization procedure in EU.
Feature
Centralized
Procedure (CP)
Mutual
Recognition
Procedure (MRP)
Decentralized
Procedure
(DCP)
National
Procedure
Who can use
it?
Mandatory for
certain types of
products, optional
for others
Products already
authorized in at
least one EU
member state
Products not
yet authorized
in any EU
member state
-
Process
Single application
to EMA
Reference member
state (RMS)
assessment with
potential
objections from
other member
states (CMS)
Similar to
MRP, but for
products not
yet authorized
in any EU
member state
-
Timeline
270 days
(extendable)
210 days
(extendable)
210 days
(extendable)
-
Advantages
Harmonized
assessment, faster
access to market,
single MA for all
EU member states
Lower fees than
CP, faster than
DCP for certain
products
Lower fees
than CP and
MRP, can be
used for new
products
-
Disadvantages
Higher fees, less
flexibility for
national
considerations
Potential for delays
due to objections
from CMS,
separate national
MAs for each
participating
member state
Similar to
MRP, but for
new products
-
Format and
Language
eCTD Format and
English
national formats
and English and
national
formats and
National
formats and
