Authorization to Import Commercialize Medicines

RESPONSIBLE AGENCY

Ministry of Health 

Address: 

Palácio das Cinzas,  Caicoli-Dili

NM 87109, Timor Leste

Telephone: 333 1206

Email: info@ms.gov.tl
            support@ms.gov.tl

Website: https://www.ms.gov.tl/

REQUIRED DOCUMENTS

1. Number of the license of the activity

2. Civil as well as fiscal identification, including residence or head office address

3. Name of the medicine

4. Pharmaceutical form and composition in so far as active substances, excipients, dosage, presentation, and administration way are concerned

5. Therapeutic indication

6. Summary of the characteristics of the medicine

7. Project for labeling and informative leaflet in one of the official languages of Timor-Leste or, provisionally, in English or Indonesian

8. Sample of the medicine

9. Official document, accompanied by a translation into one of the official languages of Timor-Leste, certifying the existence of authorization to commercialize the medicine in the country of its production and in the country from where it is exported

PROCESS STEPS

Step 1: Prepare Applications along with all required documents.  

Step 2: Submit the application to Regulating Commission of Pharmaceutical Activities

Step 3: Regulating Commission of Pharmaceutical Activities reviews the application submitted

Step 4:  Trader submits samples of the medicine if required

Step 5:  If the application is approved an Authorisation to commercialise medicines will be issued to the trader

Requests for authorizations shall be the object of a decision within a maximum period of 30 days to be counted from the date of submission of the application and priority shall be given to applications relating to generic medicines.

PROCESS MAP

 
Forms
# Title Description Issued By File
Measures
# Name Description Measure Type Agency Comments Legal Document Validity To Measure Class
1 Authorization to Import Commercialize Medicines No medicine may be imported, stored, sold, or exported without prior authorization of commercialization granted by the Ministry of Health Permit Requirement Ministry of Health The Autonomous Service of Medicines and Health Equipment, a public company, shall be the sole public entity with the competence to apply for authorizations to commercialize and import medicines Pharmaceutical Activities 0002-12-08 Good
Super process
# Process name Process short name Activity
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