Principles and Practice of Pharmaceutical Medicine

applicant to submit an identical dossier for a new
application, before any marketing authorization
has been granted, in selected MS, asking the
RMS to prepare a draft assessment report, a draft
SmPC, label and package leaflet and forward
them to the CMS and applicant within 120 days
after receipt of a valid application. Thereafter,
the procedure will not be different from the MRP
and should be completed within 90 days, totaling
the 210 days as foreseen for all national applica-
tions.

The MRP can be used for both full-length and

abridged applications. Variations to an authoriza-

tion obtained through the MRP or the decentralized

procedure follow the same regulatory pathway.

The MRP cannot be used for products that have

received a negative opinion or have been with-

drawn from the CP (see below), except by submit-

ting a completely new dossier.

Figure 34.3 provides a flowchart and timelines

for the MRP (see also Vol. 2A of theNotice to

applicants: Proceduresfor Marketing Authorisation

Apply to first MS Parallel MS applications

(may suspend when first

authorizationobtained)

First authorization

210 days

Applicant requests

mutual recognition

of this Reference MS.

Issue of assessment

report

90 days

MUTUAL RECOGNITION PROCEDURE BEGINS

Objections (if any)

from CMS

55 days

NO

Clarification, dialogue

and applicant’s oral/

written submissions

Unresolved serious

MUTUAL objections?

RECOGNITION

NO

30 days

FINAL NATIONAL

DECISIONS

YES

Arbitration

CHMP decision

Draft opinion

EU Commissiondecision Final opinion

* If

favorable

*

*

*

* *

Figure 34.3 Mutual recognition procedure (MRP): member state (MS), concerned member states (CMS)

458 CH34 MEDICINES REGULATION IN THE EUROPEAN UNION