lebanon Life cycle of a drug Dossier denregistrement dun 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 ID: 547575
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Slide1
Registration in lebanonSlide2
Life cycle of a drugSlide3
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 StatesSlide4
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: ANSMSlide5
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.Slide6
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
experienceSlide7
REGISTRATION
- Europe
*Arrêt de la montre en attendant la réponse du déposant du dossier
SPC = RCPSlide8
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 02/02/2006Slide9
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 registrationSlide10
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 holderSlide11
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
.Slide12
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 EmbassySlide13
Enregistrement - Liban
Price certification
One for Lebanon
One for a middle east or gulf country (
Jordanie
,
Arabie
saoudite
,
Koweit
, Oman, EAU,
Bahrein
, Qatar)
Two
E
uropean countries (France, UK,
Belgique
, Suisse,
Italie
,
Espagne
, Portugal)
Summary of product characteristicsSlide14
Enregistrement
-
Liban
Samples:
10 samples of the finished product to provide
10 primary packaging
10 cases
10 labels
10 records