LIFE CYCLE OF A DRUG
DOSSIER D’ENREGISTREMENT D’UN
MÉDICAMENT
Standard procedure:
 Centralized procedure
 Marketing authorization (MA) is granted by the European Commission after
consulting the Commission for authorization to the European market
(European Medicines Agency or EMA).
Mutual recognition procedure (MRP)
Granting a marketing authorization in some States selected by the applicant
after the initial granting of a marketing authorization in the Member States
REGISTRATION - EUROPE
Standard procedure:
Decentralized procedure
 none of the selected states has issued an initial marketing authorization
 evaluation is immediately shared between states
.
National procedure
 marketing authorization is granted by the Drug Agency of a State, and is
valid only within that State.
 In France: ANSM
REGISTRATION – EUROPE
COMPOSITION OF AMM (MARKET AUTHORIZATION)
Part I:
Part IA:
Administrative documents– packaging – samples
Part IB
RCP – instruction– case
Part IC
Expert reports
Part II:
Chemical , pharmaceutical and biological data :
Composition - Formulation - manufacturing processes - analytical tests - bioavailability bioequivalence.
ENREGISTREMENT – EUROPE
COMPOSITION DU DOSSIER D’AMM
Part III:
Toxicity data: Toxicity (single and repeated administration) - reproductive toxicity
- fetal toxicity - genotoxicity - carcinogénotoxicité - pharmacodynamics pharmacokinetics - local tolerance
Part IV :
Clinical documentation :
Pharmacodynamics - pharmacokinetics, all clinical studies (with individual patient
data) - postmarketing experience
REGISTRATION - EUROPE
Filing of the
registration
dossier
Comment
CHMP
J170
CHMP request
oral explanations
to the firm
J180 *
Start of
procedure
J1
Joint report of
the coreporters
J150
Oral
explanation
from the
company
J181
Evaluation by
(co-) reporters
J70
Submission of
responses by
the company
J121
Final draft of the
SPC, the record and
the case submitted
by the firm to the
EMA
J185
Comment
CHMP
J115
Sending a list
of questions
to the firm
J120 *
CHMP
decision
J210
*Arrêt de la montre en attendant la réponse du déposant du dossier
SPC = RCP
REGISTRATION IN LEBANON
•
Source regulations
•
•
Registration Order No. 571 issued on 30/10/2008.
Implementation of Articles 3 and 5 of Law No. 530 of
16/07/2003 and Articles 52 to 54 and 60 of the pharmacy
law from 1994
Order No. Price 306/1 published on 09/06/2005 and
amended by Decree No. 51/1 published on 02/02/2006
•
ENREGISTREMENT - LIBAN
• Registration
•
•
•
•
•
Registration dossier in French or English
Prior laboratory registration is obligatory
Manufacturing site registration is obligatory
Cost 1400$
Unlimited validity (unlimited authorization)
• Average time to obtain a certificate of
registration = 18 - 24 months
Must import the product within 2 years after the certificate of registration
ENREGISTREMENT - LIBAN
• Renewal
•
•
No renewal is required
Re-pricing every 5 years
• Variation
•
No cost for changes (new indications,
pharmaceutical)
Mandatory local representative
Local manufacturing not obligatory
No obligation of a local registration holder
ENREGISTREMENT - LIBAN
• Adminstrative documents :
• Content License Verification (CLV) or WHO
certificate legalized by the Embassy of Lebanon
• Certificate of Good Manufacturing Practice:
 The manufacturing site shall be recognized by
a number of countries: U.S., Canada, Europe
(France, UK, Germany, Spain, Italy),
Switzerland, Japan, Australia.
• List of registration countries
• 2 countries other than country of origin
 Questionnaire on the manufacturing site
authenticated by the Embassy
 Questionnaire on laboratory legalized by
the Embassy
ENREGISTREMENT - LIBAN
 Price certification
 One for Lebanon
 One for a middle east or gulf country (Jordanie,
Arabie saoudite, Koweit, Oman, EAU, Bahrein,
Qatar)
 Two European countries (France, UK, Belgique,
Suisse, Italie, Espagne, Portugal)
•
Summary of product characteristics
ENREGISTREMENT - LIBAN
Samples:
10 samples of the finished
product to provide
10 primary packaging
10 cases
10 labels
10 records