+255742850702 Get Counsel →
Legal Resources

Guidelines & regulations.

Guidelines, regulations and guidance notes issued by regulators and authorities.

Tanzania Medicines and Medical Devices Authority (TMDA) Medicines, medical devices and diagnostics 52 documents
01 BLOOD REGULATION - SWAHILI VERSION 2026 Regulations · 2026 · PDF 718 KB
02 DAWA ZISIZOPEWA KIPAUMBELE ORPHAN DRUG REGULATION - DEC 2025 Regulations · 2025 · PDF 279 KB
03 KANUNI MATANGAZO DAWA BINADAMU NA MIFUGO SWAHILI VERSION - DEC 2025 Regulations · 2025 · PDF 471 KB
04 SCHEDULING OF MEDICINES REGULATION - DEC 2025 - ENGLISH VERSION Regulations · 2025 · PDF 677 KB
05 SCHEDULING OF MEDICINES REGULATION - SWAHILI VERSION DEC 2025 Regulations · 2025 · PDF 643 KB
06 The Guidelines on Regulatory Reliance for Marketing Authorisation of Human Medicinal Products July, 2025 Guideline · 2025 · PDF 1 MB
07 TMDA Guidelines for Good Manufacturing Practices inspection- 3rd Edn July 2025 Guideline · 2025 · PDF 372 KB
08 GUIDANCE ON INHALATION AND NASAL MEDICINES May 2024 Guidance · 2024 · PDF 794 KB
09 GUIDELINES FOR EMERGENCY USE AUTHORIZATION OF MEDICINAL PRODUCTS, April 2023 Guideline · 2023 · PDF 1.3 MB
10 Good Manufacturing Practices Guidelines for Veterinary Medicinal Products manufacturing facilities Guideline · 2022 · PDF 1.2 MB
11 GUIDELINES FOR EMERGENCY USE AUTHORIZATION OF MEDICINAL PRODUCTS, September 2022 Guideline · 2022 · PDF 804 KB
12 Guidelines on Submission of Documentation for Renewal of Marketing Authorization of Human and Veterinary Medicinal Products, January 2021 Guideline · 2021 · PDF 908 KB
13 TMDA Fees and charges Regulations 2021 Regulations · 2021 · PDF 576 KB
14 Appointment of Inspectors and Analysts, order 2020 Order · 2020 · PDF 988 KB
15 CLINICAL TRIAL GUIDELINES - 2020 Guideline · 2020 · PDF 2.4 MB
16 COMPENDIUM GUIDELINES FOR MARKETING AUTHORIZATION OF MEDICINAL PRODUCTS JULY 2020 Guideline · 2020 · PDF 3 MB
17 Guidelines for Recall, Handling and Disposal of Unfit Medicinal Products, Third Edition (October 2020) Guideline · 2020 · PDF 745 KB
18 GUIDELINES ON SUBMISSION OF DOCUMENTATION FOR MARKETING AUTHORIZATION OF HERBAL MEDICINAL PRODUCTS JULY 2020 Guideline · 2020 · PDF 927 KB
19 Guidelines on Submission of Documentation for Registration of Immunological Veterinary Products March, 2020 Guideline · 2020 · PDF 1.2 MB
20 The Tanzania Medicines and Medical Devices (Appointment of Inspectors) Order, 2020 (GN 1009) Order · 2020 · PDF 1.8 MB
← Prev 1 / 3 Next →