Marketing Authorization

Procedures in European Union

1. National Procedure (NP)

Marketing Authorization in specific EU member state.

Assessment time for NP is 210 days

Each EU member state has its own National Authorization procedure

2. Centralized Procedure (CP)

1ST day Start of procedure

80 days

Receipt of assessment Report from rapporteur & co-

rapporteur by CHMP & EMA
EMA sends it to applicant telling him its just for his

Rapporteur & co- rapporteur & CHMP members & EMA

100th day receive comments from other CHMP members
 Draft list of que is made by Rapporteur & co- rapporteur
including the comments from CHMP members & their
115th day discussion and send it to CHMP & EMA.

CHMP adopts & sends the list of que to applicant through

120th day
EMA

CLOCK STOPS

CLOCK SARTS

121th day Submission of response by applicant including revised SPC,

labelling & package leaflet in English

Joint Response assessment report is made by Rapporteur &

150th day
co-rapporteur which is send to EMA & CHMP members &
EMA will send it to applicant for information

Deadline for CHMP members to comment on this

170th day Assessment & sent it to Rapporteur & co- rapporteur, EMA
& other CHMP members.

Need for adoption of list of Outstanding issues and /or oral

180th day
explanation by applicant if required is decided by CHMP

Clock Stop continue

d

181th day CLOCK START by oral explanation of applicant.

 Final draft of SPC, LABELLING & PACKAGING LEAFLET is submitted by
applicant to rapporteur, co-rapporteur, EMA & other CHMP members
Till 210 day &
Adoption of CHMP opinion & CHMP assessment report & time table for
provision of product information translation

Applicant provides EMA with SPC, annex II, labelling &

215th day packaging leaflet & annex A in 20 languages
EMA circulates translations to all MS for review.

Applicant provides EMA with Final translations of SPC,

annex II, labelling & packaging leaflet & annex A in 20
232nd day
languages
(taking into account that comments were received from MS
by day 229)

EMA sends opinion & annexes in all EU languages to

By 237th day applicant commission & members of standing committee &
Norway & Iceland

Applicant provides EMA with one final full color “worst

By 246th day
case” mock up of outer & inner packaging for each
pharmaceutical form.
3. Decentralized Procedure (DP)

Applicant submits application to RMS & CMS

70 days RMS & CMS validates the application

RMS distributes the preliminary assessment report

to the CMS

30 days

RMS sends preliminary assessment report & all

comments of the CMS to the applicant

Clock stops, applicant responds, clock runs

14 days

RMS sends draft assessment report to the CMS &

applicant

90 days or less CMS approve the assessment report

Market Authorization in RMS & each of the CMS

4. Mutual Recognition

Applicant updates the dossier in the RMS

Application is submitted to RMS & CMS

RMS validates the

90 days
application

RMS forwards Assessment Report

to CMS

CMS validate the

90 days
application

CMS Approves Assessment

Report

Approval of MA