Tariff Information
Tariff
Measures
| # | Name | Type | Agency | Description | Law | Procedure | Valid To | Apply To |
|---|---|---|---|---|---|---|---|---|
| 1 | 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 |
| 2 | 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 |
| 3 | 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 |
| 4 | 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 | |
| 5 | 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 |
| 6 | 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 | |
| 7 | Restriction of exports and imports on coca leaves, indian hemp and raw opium | Licensing Requirement | Ministry of Health | No person is allowed to import into or export from Malawi, Coca leaves, Indian Hemp and Raw Opium or plants from which such drugs are derived, without a licence. | Dangerous Drugs Act (35:02) | Application for a licence to import and export coca leaves, indian hemp and raw opium. | 9999-12-31 | ALL |
| 8 | Permission to export dangerous drugs to another country | Permit Requirement | Ministry of Health | If coca leaves, indian hemp, raw opium, prepared opium, medicinal opium, cocaine, morphine and any other similar drugs' preparation permitted under the law of any country outside Malawi to be exported from there to any destination outside Malawi is brought into Malawi, no person must cause or procure such drugs preparation to be diverted to any other destination unless he has been issued with a permit. | Dangerous Drugs Act (35:02) | 9999-12-31 | ALL | |
| 9 | Import restrictions on dangerous drugs | Registration Requirement | Ministry of Health | A person must not import or export any drug by ordinary or registered letter post. | Dangerous Drugs Act (35:02) | 9999-12-31 | ALL | |
| 10 | Export restrictions on dangerous drugs | Licensing Requirement | Ministry of Health | Any person exporting a drug which is to be exported in one package must place the duplicate licence to export that drug inside the outer wrapper of that package; And where the drugs are to be exported in more than one package, the exporter must place the duplicate licence to export that drug inside the outer wrapper of one package, consecutively number on the outer wrapper all the packages in which the drug is contained, and indicate on each package the number of the package in which the duplicate licence is to be found. | Dangerous Drugs Act (35:02) | 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 a licence to import and export coca leaves, indian hemp and raw opium. | Restriction of Exports and Imports on Coca Leaves, Indian Hemp and Raw Opium under Dangerous Drugs Act, 1956. Section 4,44 | Procedure | Ministry of Trade and Industry | Restriction of exports and imports on coca leaves, indian hemp and raw opium |
Legal Documents
| # | Title | Type | Issuing Agency | Responsible Agency | Issue Date |
|---|---|---|---|---|---|
| 1 | Dangerous Drugs Act (35:02) | Law | Ministry of Health | Directorate of Clinical Services | 1995-11-15 |
| 2 | Pharmacy, Medicines and Poisons Act (35:01) | Law | Ministry of Health | Poisons Board of Malawi | 1991-01-15 |
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 | Product License Application | Product License Application | Poisons Board of Malawi |
| 5 | Pharmaceutical Manufacturing Facility Application | Pharmaceutical Manufacturing Facility Application | Poisons Board of Malawi |