Principles and Practice of Pharmaceutical Medicine

Coordination group

An informally instituted coordination group recently
replaced the formal Mutual Recognition Facilitation
Group (MRFG) that had been active since 1995. The
MRFG issued many guidances, SOPs, recommen-
dations and position papers to help initiation and
development of the MRP. The Coordination Group
is composed of one representative per MS and is
entitled to examine any question relating to MA of a
medicinal product in two or more MS.

Centralized procedure

TheCPprovidesforasingleapplicationtoresultina
single MA decision that applies to the whole EU.
The CP concerns itself purely with the scientific and
technical assessment of quality, safety and efficacy
of the product. Pricing, classification for supply and
marketing aspects (e.g. advertising) are left to the
individual MS after CP approval. Thus, starting
from an approved pan-European SmPC, for each
MS, MA holders may select from the approved
indications, pack sizes, PILs and so on that fit the
nationalhealthsystem.ThemainobjectiveoftheCP
is that of creating a harmonized European environ-
ment for innovative products, through a highly qua-
lified single assessment made on a single dossier,
resulting in the same recommendations for use of
the product throughout the EU, and thus ensuring
the same safeguard for all EU citizens.
The CP iscompulsoryfor products, which are
(Regulation 726/2004)

manufactured using recombinant DNA technol-
ogy;

synthesized through controlled expression of
genes coding for biologically active proteins in
prokaryotes and eukaryotes (including trans-
formed mammalian cells);

produced by hybridoma or other monoclonal
antibody biosynthesis;

veterinary products, intended primarily for use
as performance enhancers in order to promote

the growth of treated animals or to increase

yields from treated animals;

containing a new active substance(s) intended

for the treatment of

• AIDS


• Cancer


• Neurodegenerative disorder


• Diabetes


• Autoimmune diseases, other immune dysfu-
  nction and viral diseases (after 20 May 2008)

orphan medicinal products (see below).

Any medicinal product not included in the above

listmay, but is not obligated to, use the CP if

‘the medicinal product contains a new active

substance which, on the date of entry into force

of the regulation, was not authorized in the com-

munity’ or

‘the applicant shows that the medicinal product

constitutes a significant therapeutic, scientific or

technical innovation or that the granting of

authorization in accordance with this regulation

is in the interest of patients or animal health at

community level.’

Abridged applications are possible for new appli-

cations regarding products that have previously

been approved through the CP.

The CP is divided into the following phases:

1. Pre-submission


2. Submission and validation of the dossier


3. Scientific evaluation


4. Decision-making process


5. Post-authorization provisions

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