Registration 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 - Europe Standard procedure: National 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 Start of procedure J1 Evaluation by (co-) reporters J70 Comment CHMP J115 Sending a list of questions to the firm J120 * Submission of responses by the company J121 Joint report of the co-reporters J150 Comment CHMP J170 CHMP request oral explanations to the firm J180 * Oral explanation from the company J181 Final 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 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