REGISTR

ATIO

N IN

LEBANON

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 - EUROPEStandard 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 – EUROPECOMPOSITION OF AMM (MARKET AUTHORIZATION)

Part I: Part IA:Administrative documents– packaging – samplesPart IBRCP – instruction– casePart ICExpert reports

Part II: Chemical , pharmaceutical and biological data :Composition - Formulation - manufacturing processes - analytical tests - bioavailability - bioequivalence.

ENREGISTREMENT – EUROPECOMPOSITION 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 - EUROPEFiling of the registration

dossier

Start of procedure

J1

Evaluation by (co-)

reportersJ70

Comment CHMPJ115

Sending a list of

questions to the firm

J120 *

Submission of responses

by the company

J121

Joint report of the co-reporters

J150

Comment CHMPJ170

CHMP request oral

explanations to the firmJ180 *

Oral explanation

from the company

J181Final draft of the SPC, the record

and the case submitted by the firm to the EMA

J185

CHMP decision

J210

*Arrêt de la montre en attendant la réponse du déposant du dossierSPC = 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 provide10 primary packaging10 cases10 labels10 records