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Eswatini Drug Product Registration

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Eswatini Drug Product Registration

Eswatini Ministry of Health Guidelines on Import Procedures for Medicines

MoH

Eswatini Ministry of Health

Link for Regulatory Authority

https://www.gov.sz/index.php/about-us-sp-866448837

Local Authorised

Yes

License Validity

6 Months 

Legal Considerations

Authorized Transactions

All transactions related to importing medicinal products should be conducted either through the Ministry of Health or through independent authorized pharmaceutical importers authorized by the Ministry of Health.

Authorized Medicinal Products

Unless otherwise specified, only authorized medicinal products are permitted to be imported or exported into or out of the country.

Designated Ports of Entry

  • The importation of medicinal product consignments should go through designated ports of entry and be cleared by customs in consultation with the Ministry of Health.
  • Medicines and their documentation should not be manipulated while in transit to the country in bonded warehouses. 

Application for Import/Export Permit 

An application for an import or export permit must be submitted by an authorized importer to the Ministry of Health using a prescribed form. 

Validity of Permits

The period of validity for import and export permits will be determined by the Ministry of Health, with a maximum validity period not exceeding six (6) months.

Importer Registration

  • An applicant for an import permit must be registered with the Ministry of Health as an importer of medicines.
  • The authority to import medicines will be determined by the Ministry of Health, and it is subject to renewal upon expiry.

Restrictions on Postal Import/Export

Importation or exportation of medicines shall not be done through postal services.

Exemptions from Requirements of a Pharmaceutical Import/Export Authorization Certificate 

  1. Importation of Medicines for Personal Use: Importation of medicines for personal use or for family members is limited to a 90-day supply, requiring prior approval from the Ministry after this period.

Documentation 

  1.   Full particulars of the authorized importer.
  2.  Full particulars of the manufacturer of the products to be imported.
  3.  Full description of the products using generic and trade names.
  4.  Quantities of the products to be imported.
  5.  Product Registration Certificates for all medicines issued by relevant authorities in the country of origin.
  6.  Batch Analysis Certificates of the products intended for import.

Customs Documentation

  1.   Authorization Certificate from the Ministry of Health confirming the importer’s authorization and the medicine’s approval.
  2.  Relevant invoices and bill of lading.
  3.  Classification of the medicine into prescribed or non-prescribed.
  4. b) Importation and Exportation of Controlled Substances:

Similar requirements as for medicines apply to controlled substances, complying with relevant legislation and international conventions.

Documentation

Presentation of a certified copy of the import permit issued by the Ministry of Health and other relevant documentation from the exporting country.

Export Permit 

Furnishing the Ministry of Health with the original copy of the export permit from the exporting country.

Additional Import Permit

  • Required for psychotropic substances in Schedules I, II, III, and IV of the 1971 Convention and narcotic medicines in Schedules I and II of the 1961 Single Convention on Narcotic Drugs.
  • Issued to authorized importers with valid pharmaceutical import authorization and appropriate premises.

Additional Import Permit Details

  1. Number and date of the permit.
  2. Name and address of the importer.
  • Name of controlled substance(s)
  1. Strength and dosage form.
  2. Quantity to be imported.
  3. Name and address of the exporter.
  • Route of entry.
  • Ministry of Health’s name, date stamp, and signature.

Application for Permit

Application for a permit to import controlled substances is made to the Ministry of Health in the prescribed form.

Criteria for Issue of Authorization to Import

The criteria for issuing a pharmaceutical import permit include

  1. Suitable premises, facilities, and equipment for proper pharmaceutical warehousing/storage.
  2. Qualified pharmaceutical personnel overseeing quality assurance.
  3. Adequate arrangements, programs, and systems for procurement, storage, documentation, stock surveillance, and distribution.

Application for Issue of an Import Permit

An application for the issue of an import permit must adhere to the following guidelines:

The application should be submitted on the prescribed form

For each medicine intended for import, the application should include the following information:

  1.  Generic Name or International Non-proprietary Name (INN): – Clearly specify the generic name or INN of the medicine.
  2. Trade Name or Proprietary Name (if any): – Indicate the trade name or proprietary name if applicable.
  • Strength and Dosage Form: – Provide information on the strength and dosage form of the medicine.
  1. Name and Strength of the Active Pharmaceutical Ingredient (API): – Clearly state the name and strength of the active pharmaceutical ingredient.
  2. Total Quantity to be Imported: – Specify the total quantity of the medicine intended for import.
  3. Name and Address of the Supplier/Importer: – Provide details of the entity responsible for supplying or importing the medicine.
  • Name and Address of the Manufacturer: – Include the name and address of the manufacturer of the medicine.
  • Country of Origin: – Clearly state the country of origin of the medicine.
  1. Route of Entry: – Indicate the designated route through which the importation will occur.
  2. Expected Date of Arrival: – Provide an anticipated date of arrival for the imported medicines.
  3. For controlled substances, a separate import permit will be applicable as prescribed by the Ministry of Health and in compliance with relevant treaty obligations.
  4. The application for controlled substances should be accompanied by copies of proforma invoices.

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