EXPORTER/ IMPORTER LICENSE BY REGULATING COMMISSION OF PHARMACEUTICAL ACTIVITIES

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. Business Registration Certificate

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

3. Proof of contractual relationship with a duly qualified technical manager

4. Localisation map, map, and descriptive memory of the facilities for storing and commercializing medicines

5. Indication of the means for transporting the medicines (If Applicable)

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 submit additional information if required

Step 5:  If the application is approved a Importer/Exporter License will be issued to the trader

The decision to grant a license shall take place within a maximum period of 90 days counting from the date of submission of the application duly completed, and the license shall be valid for three years

Step 6: Trader collects the Importer/Exporter License

NOTE

1. The technical manager shall be either a pharmacist, a pharmacy technician, or a pharmacy assistant who shall be responsible for complying with the technical norms relating to medicines as contained in the law and in the regulations issued by the Ministry of Health but whose permanent presence in the pharmacy shall not be required.

2. Licenses shall be renewable for equal periods whenever the initial conditions are maintained, and the requests for renewals shall be submitted within a minimum period of 30 days before their expiration dates.

3. Licenses shall be personal and non-transferable, and any act of alienation, trespass, or cessation of activities of the companies or commercial establishments covered by the present statute shall be communicated in advance to the Regulating Commission of Pharmaceutical Activities to enable it verify and ensure that the new entity holds a license for the respective activity

PROCESS MAP

 

Forms
# Title Description Issued By File
Measures
# Name Description Measure Type Agency Comments Legal Document Validity To Measure Class
1 Exporter/ Importer License by Regulating Commission of Pharmaceutical Activities Decree-Law No. 12/2004 on Pharmaceutical Activities set down the requirements for licensing the import of and export of medicines for human use. To import or export medicines the business is required to be registered as a licensed business (Licensing of Commercial Activities 24/2011) and licensed by the Regulating Commission of Pharmaceutical Activities. The detailed information required by the Regulating Commission is listed under Article 3. A technical manager must be designated as the responsible person for complying with all the technical norms, and must be a pharmacist, pharmacy technician or pharmacy assistant. The Ministry of Health is required to verify through inspection the technical adequacy of the premises and the means of transport for importing or exporting the pharmaceuticals. Licensing Requirement Ministry of Health Decree-Law No. 12/2004 on Pharmaceutical Activities set down the requirements for licensing the import of and export of medicines for human use. To import or export medicines the business is required to be registered as a licensed business (Licensing of Commercial Activities 24/2011) and licensed by the Regulating Commission of Pharmaceutical Activities. The detailed information required by the Regulating Commission is listed under Article 3. A technical manager must be designated as the responsible person for complying with all the technical norms, and must be a pharmacist, pharmacy technician or pharmacy assistant. The Ministry of Health is required to verify through inspection the technical adequacy of the premises and the means of transport for importing or exporting the pharmaceuticals. Pharmaceutical Activities 9999-09-09 Good
Step-by-Step Guide
# Process name Process short name Activity
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