Général
|
| Pays |
Zimbabwe |
| Région géographique: |
Southern Africa |
| Le niveau de revenu (Banque mondiale ): |
Low income |
| Population (women 15-49 years) in millions, 2015: |
3,9 |
| Are condoms (male/female) regulated in the country? |
yes |
| If yes, describe the applicable regulation or directive: |
Medicines & Allied Substances (condoms) Control Regulations 2005 |
| Condom classification (medical device, medicines, others): |
Medical device (allied substances) |
| National competent (regulatory) authority: |
Medicines Control Authority, Zimbabwe |
Essential Medicines List
|
Registration Requirements
|
| Administrative documents: |
"Completed application form with: details of applicant including name, address & location; details of manufacturer; details of importer and distributor if applicable; trademark name of the condom; packaging details;" |
| Technical documents: |
"Completed application form with: details of applicant including name, address & location; details of manufacturer; details of importer and distributor if applicable; trademark name of the condom; packaging details;" |
| Sample: |
Samples to be submitted for QC testing |
| Process: |
Application to be submitted to Director General, Medicines Control Authority |
