Tariff Information
Tariff
Measures
| # | Name | Type | Agency | Description | Law | Procedure | Valid To | Apply To |
|---|---|---|---|---|---|---|---|---|
| 1 | Supervision of importation or manufacture of vaccines, etc. | Labelling, Marking and Packaging | Ministry of Health | The Minister may provide for the inspection of vaccines, vaccine lymph, sera, and similar substances imported into in Malawi and may prohibit the importation of any substance which is considered to be unsafe or harmful. | Public Health Act (34:01) | 9999-12-31 | ALL | |
| 2 | Medicine import licences | Licensing Requirement | Poisons Board of Malawi | Any person importing any medicinal product must apply for a product licence. | Pharmacy, Medicines and Poisons Act (35:01) | Application for a medicine importation license. | 9999-12-31 | ALL |
| 3 | Medicine export licences | Licensing Requirement | Poisons Board of Malawi | Any person exporting any medicinal product into malawi must apply for a product licence. | Pharmacy, Medicines and Poisons Act (35:01) | Application for a medicine exportation license. | 9999-12-31 | ALL |
| 4 | Exemptions in medicine import licences | Licensing Requirement | Poisons Board of Malawi | The importation of a medicinal product by any person for administration to himself or to any persons who are members of his household, or the importation of a medicinal product where it is specially imported by or to the order of a medical practitioner or dentist for administration to his patient can be made without a licence provided that in either case the quantity imported is not too much. | Pharmacy, Medicines and Poisons Act (35:01) | Application for an exemption to medicine license. | 9999-12-31 | ALL |
| 5 | Containers, package, and identification of medicinal products | Labelling Requirement | Poisons Board of Malawi | All medicinal products for the purpose of selling or supplying must be in a container or package and properly labelled. | Pharmacy, Medicines and Poisons Act (35:01) | 9999-12-31 | ALL | |
| 6 | Application for registration and retention of registration of medicinal products | Registration Requirement | Poisons Board of Malawi | Every applicant must, without delay, inform the Board either before or after the registration of a medicinal product whether the medicinal product is to be imported as a finished product into Malawi, or re-labelled. or repackaged or dealt with in any other manner, in Malawi. | Pharmacy, Medicines and Poisons Act (35:01) | Application for registration of medicinal products. | 9999-12-31 | ALL |
| 7 | Importation of medicinal products with less than one-half of shelf-life | Prohibition | Poisons Board of Malawi | No person can, without the prior written approval of the Board, import into Malawi any medicinal product which has less than one-half of its shelf-life remaining upon arrival in Malawi. | Pharmacy, Medicines and Poisons Act (35:01) | 9999-12-31 | ALL | |
| 8 | GMO licence | Certification requirement | Ministry of Natural Resources | Any person wishing to engage in the genetic modification of organisms; the importation, development, production, testing, release, use and application of genetically modified organisms; and the use of gene therapy in animals, including human beings must have a licence. | Biosafety (60:03) | Application for GMO licence. | 1999-12-31 | ALL |
| 9 | Licence to import or export GMO products | Certification requirement | Ministry of Natural Resources | Any person intending to export or import genetically modified organisms or products; procure for supply or exportation of genetically modified organisms or products thereof; and procure the manufacture of genetically modified organisms or products for for export needs a licence. | Biosafety (60:03) | Application for a licence to export or import GMO products. | 9999-12-31 | ALL |
| 10 | GMO inspector duties | Import monitoring and surveillance | Ministry of Natural Resources | An inspector may require any person involved in the importation, use, and distribution of genetically modified organisms or products to produce any books or documents relating to the business which are in his possession or under his control. | Biosafety (60:03) | 9999-12-31 | ALL | |
| 11 | Licences for renewable energy technologies activities | Licensing Requirement | Malawi Energy Regulatory Authority | No person must import renewable energy technologies without a licence. | Energy Regulation Act(73:02) | Application for licences and permits to export and import GMO. | 9999-12-31 | ALL |
Standard
Procedures
| # | Name | Description | Category | Agency | Measure | Form |
|---|---|---|---|---|---|---|
| 1 | Application for a medicine importation license. | Application for a Medicine Importation License Under Pharmacy Medicines and Poisons Act. Section 35, 36, 37, 38, 38, 39,40,41,66. | Procedure | Ministry of Trade and Industry | Medicine import licences | |
| 2 | Application for a medicine exportation license. | Application for a Medicine Exportation License Under Pharmacy Medicines and Poisons Act. Section 35, 36, 37, 38, 38, 39,40,41,66. | Procedure | Ministry of Trade and Industry | Medicine export licences | |
| 3 | Application for an exemption to medicine license. | Application for an Exemption to Medicine License Under Pharmacy Medicines and Poisons Act. Section 36 (g). | Procedure | Ministry of Trade and Industry | Exemptions in medicine import licences | Product License Application |
| 4 | Application for registration of medicinal products. | Application for Registration of medicinal Products Under Pharmacy, Medicines and Poisons (Fees and Forms) Regulations. Rule 13(3) and (4). | Procedure | Ministry of Trade and Industry | Application for registration and retention of registration of medicinal products | |
| 5 | Application for licences and permits to export and import GMO. | GMO Licences and Permits under BIOSAFETY (MANAGEMENT OF GENETICALLY MODIFIED ORGANISMS) REGULATIONS. (No 13 of 2002) Rule 12(4). | Procedure | Ministry of Trade and Industry | Licences for renewable energy technologies activities | GMO License Application |
| 6 | Application for GMO licence. | GMO licence under BIOSAFETY ACT (No 13 of 2002) Section 17 | Procedure | Ministry of Trade and Industry | GMO licence | GMO License Application |
| 7 | Application for a licence to export or import GMO products. | GMO Product licence under BIOSAFETY ACT (No 13 of 2002) Section 19 and section 20 | Procedure | Ministry of Trade and Industry | Licence to import or export GMO products |
Legal Documents
| # | Title | Type | Issuing Agency | Responsible Agency | Issue Date |
|---|---|---|---|---|---|
| 1 | Public Health Act (34:01) | Law | Ministry of Health | Ministry of Health | 2012-02-16 |
| 2 | Pharmacy, Medicines and Poisons Act (35:01) | Law | Ministry of Health | Poisons Board of Malawi | 1991-01-15 |
| 3 | Energy Regulation Act(73:02) | Law | Ministry of Natural Resources | Malawi Energy Regulatory Authority | 2004-11-01 |
| 4 | Biosafety (60:03) | Law | Ministry of Natural Resources | Malawi Energy Regulatory Authority | 2007-08-20 |
Forms
| # | Title | Description | Issued By |
|---|---|---|---|
| 1 | Manufacturing Inspector Form No. 17 | Manufacturing Inspector Form No. 17 under Pharmacy, Medicines and Poisons Regulations | Cotton Council |
| 2 | Wholesale Inspection Report Form 18 | Wholesale inspection Report | Malawi Bureau of Standards |
| 3 | Form No. 9. Product Licence | Product Licence under under Pharmacy, Medicines and Poisons Act. | Poisons Board of Malawi |
| 4 | GMO License Application | Application for a GMO licence. | Ministry of Natural Resources |
| 5 | Product License Application | Product License Application | Poisons Board of Malawi |
| 6 | Pharmaceutical Manufacturing Facility Application | Pharmaceutical Manufacturing Facility Application | Poisons Board of Malawi |