Requirements For Importers

1.1 Requirements for Importers

• All pharmaceutical products to be imported must be in the essential list drug approved by the Ministry of Health Development (MoHD).
• All importation of pharmaceutical products must be done by importers who poses valid licenses from the Ministry of Health and/ Ministry of Trade Development (MoTD).
• All importers must import pharmaceuticals through the authorized Point of Entry (PoE).
• No entity shall import pharmaceutical products of no less than a shelf life of 12 months upon entry.

1.2 Procedure for Importation of Pharmaceutical Products

• Authorized importer intending to import pharmaceuticals shall apply to SQCC department of Quality Assurance and Inspection, filling in application form (market authorization form ‘Annex A’).
• The application form shall be accompanied by the following document
  i. Importing authority/individual should pose valid license from Ministry of Health.
  ii. Market authorization form
  iii. Packing list
  iv. Certificate of origin
  v. Certificate of analysis
  
  NB: All applications shall be submitted one day before the arrival of the consignment to avoid delays in the issuance of importing permits.

1.3 Processing of Application

• Upon receiving the application as specified above, SQCC will scrutinize to verify whether the requirements have been fulfilled.
• If the application meets the prescribed requirements, SQCC will issue an import permit (Annex B).
• An application will be rejected if it does not meet any of the importation requirements.
• All applications will be processed within two (2) working days, with exception of special requests, which may take a longer period.

1.4 Special Importation Requirement

• The same application requirements and procedures as prescribed under sections 1.3 and 1.4 respectively shall apply.