Principles and Practice of Pharmaceutical Medicine

during 1997. In this procedure, the initial or refer-
ence member state that granted marketing approval
forwards the necessary documents for registration
to the other member states where the manufacturer
wishes to market his prod uct, and a copy is also
sent to the EMEA/CPMP. If one or more member
states raise objections, the applicant had the right,
until 31 December 1997, to withdraw his request
for a MA in that member state. Thereby, the appli-

cant avoided the application being forwarded to the

CPMP for arbitration (Table 33.10).

Application for marketing approval

Application for marketing approval, using either

the centralized or decentralized procedure, has to

be accompanied by three expert reports, which

Application to first

Member State

First authorisation

(210 days from the application)

Update and issue of Assessment

Report within 90 days

Objections to be raised by

Day 50 of the procedure

Mutual recognition procedure starts

after validation (Day 0)

After dialogue and

Breakout Session on

Day 75:

Issue resolved

by Day 89

Final national decisions by

Day 90 of procedure

National

authorisations

Commission decision No EU

authorisations

Examination by CG ±

Artical 29 Referral to CHMP

After dialogue and

Breakout Session on

Day 75:

IssuesNOT resolved

by Day 89

Request for mutual recognition by applicant

Applicant responds within 10 days

Applicant may withdraw

Figure 33.2 Mutual recognition procedure for all products except those of biotechnology.Source: Griffin and O’Grady
(2006)

33.4 THE EUROPEAN CONTROLS OF MEDICINAL PRODUCTS 435