EXPORTER/ IMPORTER LICENSE BY REGULATING COMMISSION OF PHARMACEUTICAL ACTIVITIES |
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RESPONSIBLE AGENCY Ministry of Health Address: Palácio das Cinzas, Caicoli-Dili NM 87109, Timor Leste Telephone: 333 1206 Email: info@ms.gov.tl Website: https://www.ms.gov.tl/ REQUIRED DOCUMENTS |
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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 |
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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 |
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PROCESS MAP
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# | Title | Description | Issued By | File |
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# | Name | Description | Measure Type | Agency | Comments | Legal Document | Validity To | Measure Class |
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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 |
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