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: 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

5. 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.

6. 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

7. 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

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 = 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, Arabie saoudite, 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 provide 10 primary packaging 10 cases 10 labels 10 records