Registration in - PowerPoint Presentation

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