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Registration in lebanon

Registration in lebanon. Life cycle of a drug. Dossier d’enregistrement d’un médicament. Standard procedure: Centralized procedure

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Registration in lebanon

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  1. Registration in lebanon

  2. Life cycle of a drug

  3. 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

  4. 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

  5. REGISTRATION – EuropeComposition 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.

  6. 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

  7. REGISTRATION - Europe *Arrêt de la montre en attendant la réponse du déposant du dossier SPC = RCP

  8. 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

  9. 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

  10. 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

  11. 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.

  12. 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

  13. Enregistrement - Liban • Price certification • One for Lebanon • One for a middle east or gulf country (Jordanie, Arabiesaoudite, Koweit, Oman, EAU, Bahrein, Qatar) • Two European countries (France, UK, Belgique, Suisse, Italie, Espagne, Portugal) • Summary of product characteristics

  14. Enregistrement - Liban • Samples:10 samples of the finished product to provide10 primary packaging10 cases10 labels10 records

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