The pharmaceutical industry plays a critical role in Tanzania's economic development, public health, industrialization, and investment growth. As the demand for medicines, medical supplies, and healthcare products continues to increase, many investors and entrepreneurs are seeking opportunities to establish pharmaceutical manufacturing plants, processing facilities, storage centers, and related projects throughout the country.
However, before commencing any pharmaceutical project, developers must understand that environmental compliance is not merely an administrative requirement but a legal obligation imposed by Tanzanian law.
The law undersection 81(1),81(2) AND 81(3) of the Environmental Management Act, Cap R.E. 2023.provides that developer of a project specified under the Third Schedule must undertake an Environmental Impact Assessment (EIA) at his own cost. Furthermore, the law requires that the Environmental Impact Assessment be conducted before the commencement or financing of the project. Most importantly, the law makes it clear that the possession of a permit, license, registration certificate, or any other authorization under another law does not exempt a developer from obtaining an Environmental Impact Assessment Certificate issued under the Environmental Management Act.
The purpose of these legal requirements is to ensure that pharmaceutical projects are designed, constructed, and operated in a manner that protects public health and the environment. Through the Environmental Impact Assessment process, potential environmental risks such as chemical pollution, hazardous waste generation, wastewater discharge, air emissions, and occupational health concerns can be identified and managed before project implementation.
This article examines the legal requirements governing Environmental Impact Assessments for pharmaceutical projects in Tanzania, the procedures for obtaining an Environmental Impact Assessment Certificate, the responsibilities of project developers, and the legal consequences of non-compliance under the Environmental Management Act and its Regulations.
Any person who intends to obtain an Environmental Impact Assessment (EIA) Certificate for Type A, B1, or B2 projects is required to submit an application for the purpose of application and issuance of an Environmental Impact Assessment Certificate, all projects are classified into four categories as provided by The Environmental Management (Environmental Impact Assessment and Audit) (Amendment) Regulations, 2018.
The projects in consideration of magnitude of impacts on the environment for the purpose of application and issuance of Environmental Impact Assessment Certificate, is classified into 4 cocategories as follows
The law under Regulation 3 of The Environmental Management (Environmental Impact Assessment and Audit) (Amendment) Regulations, 2018 provides that,
The developer or proponent shall submit to the Council the following for the application for a certificate of environmental assessment.
During this process, the Council reviews the Environmental Management Plan (EMP) to assess whether it properly identifies potential environmental impacts, proposes appropriate mitigation measures, and provides clear implementation and monitoring mechanisms.
Based on this evaluation, the Council decides whether the EMP meets the required standards for approval or whether additional information or revision is necessary before an (EIA) Certificate can be recommended or issued.
Where the Council determines that the Environmental Management Plan does not disclose sufficient mitigation measures shall, within seven days, require the developer or proponent to resubmit the Plan.
The law under regulation 4, 5,6 and7 of The Environmental Management (Environmental Impact Assessment and Audit) (Amendment) Regulations, 2018 provides that,
Where the Council is satisfied that the project shall not have significant negative impact on the environment and the project brief discloses sufficient mitigation measures, the Council may recommend to the Minister to approve the project.
The Minister shall, within fourteen days, approve or disapprove the project and issue a certificate or otherwise communicate his decision.
Upon approval of the project, the Minister shall issue an Environmental Impact Assessment Certificate in the form set out in the Third Schedule to these Regulations.
For purposes of inspection or verification of the project, the Council may visit project site at the proponent’s or developer’s cost.
Type B1 Projects are projects with medium to high potential environmental impacts. These projects are not automatically subjected to a full Environmental Impact Assessment (EIA). Instead, they undergo a screening process to determine whether they should be classified as Type A Projects, which require a mandatory EIA, or Type B2 Projects, which are subject to a less extensive assessment process. The purpose of screening is to evaluate the nature, scale, location, and potential environmental risks of the proposed project before the appropriate level of environmental assessment is determined.
Type B1 Projects generally include medium- to large-scale activities in sectors such as agriculture, livestock, fisheries, forestry, tourism, energy, petroleum, transport and infrastructure, manufacturing, construction, mining, waste management, and water supply. Examples include medium-scale farming and irrigation schemes, fish processing facilities, forest plantations, tourism developments, power generation and distribution projects, fuel storage facilities, major urban developments, industrial processing plants, small-scale mining operations, wastewater treatment facilities, and water treatment plants.
Because these projects may have significant environmental and social impacts depending on their size, location, and operational characteristics, they are subjected to screening before a final environmental assessment requirement is determined.
The application of this category, shall be made by submitting to the Council a Scoping Report as set out in the Third Schedule of the Regulations. The report shall state the nature of the project, provide proof of land ownership including the location of the project and the physical area that may be affected by the project's activities, and describe the activities to be undertaken during the construction, operation, and decommissioning phases.
It shall include the project design, a site layout plan, details of the materials to be used and their sources, products and by-products, types and sources of waste to be generated by the project and their management, as well as the potential environmental impacts of the project and the mitigation measures to be taken during and after implementation.
The report shall further contain an action plan to ensure the health and safety of workers and neighboring communities throughout the project life cycle, a declaration that the proposed project is not located within or near a sensitive ecosystem, an Environmental and Social Management Plan (ESMP) and Monitoring Plan, and an assessment of the economic and socio-cultural impacts on the local community and the nation at large.
In addition, it shall provide the project budget, explain how the scoping was undertaken, identify issues and problems, present a synthesis of the scoping results including details of potential positive and negative impacts, identify stakeholder groups and explain how they were involved in the scoping process, define the spatial, temporal, and institutional boundaries of the project, describe project alternatives, and include any other relevant information that the Council may require.
A proponent or developer shall submit copies of the Scoping Report to the relevant authorities and provide evidence of such service to the Council. Three copies of the Scoping Report, Terms of Reference, and evidence of service, together with the prescribed fee, shall be submitted to the Council for project registration and approval of the Terms of Reference.
A proponent or developer may use applicable electronic media to submit the Scoping Report to the relevant authority and the Council. Relevant authorities shall, within seven days from the date of receipt of the Scoping Report, submit their comments to the Council.
Type A Projects are projects that are likely to have significant environmental impacts and therefore require a mandatory Environmental Impact Assessment (EIA) to determine the nature, scale, extent, and significance of such impacts and to identify appropriate mitigation measures.
These projects generally include large-scale activities in sectors such as agriculture, livestock, forestry, fisheries, wildlife management, tourism, energy, petroleum, transport and infrastructure, manufacturing industries, chemical production, mining and extractive activities, waste treatment and disposal, water supply, and land development. They also include projects involving environmentally sensitive areas, major resource use, large scale industrial operations, resettlement of communities, and developments that have the potential to cause substantial environmental and social impacts.
An application for a Category A Projects Certificate shall be made in the prescribed form and a Project Scoping Report set out in the Third Schedule of the Regulations, stating the following the nature of the project, the proof of land ownership, including location of the project and the physical area that may be affected by the project's activities, the activities that shall be undertaken during the project construction, operation and decommissioning phases, the design of the project, a site layout plan, the materials to be used and source, products and byproducts, including waste to be generated by the project and the methods of their management, the potential environmental impacts of the project and the mitigation measures to be taken during and after implementation of the project, an action plan to ensure the health and safety of the workers and neighboring communities during the project, a declaration that the proposed project is not within or near sensitive ecosystem, Environmental and Social Management Plan (ESMP) and Monitoring Plan,
The economic and sociocultural impacts to the local community and the nation in general, the project budget how the scoping exercise was undertaken, identification of issues and problem, synthesis of results of the scoping exercise including details of potential negative and positive impacts, stakeholder groups identified and how they were involved in the scoping exercise.
spatial, temporal and institutional boundaries of the project, project alternatives; and any other relevant information which the Council may require.
A proponent or developer shall submit copies of the Scoping Report to the relevant authorities and evidence of service to the Council.
Three copies of Scoping Report, Terms of Reference, and evidence of service together with the prescribed fee shall be submitted to the Council for registration of the Project and approval of Terms of Reference.
A proponent or developer may use applicable electronic media to submit Scoping Report to the relevant authority and the Council or an agent of the Council. Relevant authorities shall, within seven days from the date of receipt of Scoping Report, submit their comments to the Council.
The Council shall, within fourteen days of receipt of Scoping Report, whether comments have been received or not, scrutinize the Scoping Report and Terms of Reference and may approve or disapprove the Terms of Reference and communicate its decision to the proponent or developer.
Where the Scoping Report has been disapproved, the Council shall give reasons for disapproval and the proponent may be required to resubmit the Report.
Point to Note: Validity of Documents During the Pending EIA Process Pending the issuance of EIA Certificate, the validity of any document submitted to the Council shall be two years and after expiration of the time, the Council may deregister the application.
Type B2 Projects are small-scale activities and enterprises that are required only to be registered with the Council and do not require a full Environmental Impact Assessment (EIA). These projects also do not go through screening or scoping. Instead, a Project Brief is submitted and reviewed, after which an Environmental Impact Assessment Certificate may be issued if the requirements are satisfied.
These projects generally include small-scale activities with limited environmental impacts across sectors such as agriculture, livestock, forestry, fisheries, tourism, industry, construction, education, health services, communications, and waste management.
Examples include small-scale farming and irrigation activities, livestock rearing, selective removal of tree species, small fish processing, camping activities, small slaughterhouses, tobacco processing, simple textile and weaving units, garages, schools and health centers of limited capacity, communication towers, and basic waste management activities such as composting and sewage handling.
In general, Type B2 Projects are considered to have low environmental risk, and therefore they are managed through simplified procedures focused mainly on registration and review of the Project Brief rather than full environmental assessment processes.
The Regulations classify certain projects as Special Category Projects where potential environmental risks are uncertain and require detailed specialized studies before an Environmental Impact Assessment (EIA) is conducted. Such projects are treated as Type A Projects, for which EIA is mandatory.
In the forestry sector, the introduction of alien tree species and the development of forest plantations fall under this category, while selective removal of single tree species may also require special consideration. The law under the Second Schedule establishes screening criteria for determining whether a project is likely to have significant environmental impacts.
A project may be considered suitable where its impacts are minor, well understood, easily mitigated, and where reliable measures exist to manage environmental effects. The project should not substantially pre empty the use of natural resources, displace significant populations, or require further developments that may create substantial environmental impacts.
The Regulations further require that projects should not be located in or adversely affect environmentally sensitive areas, including national parks, wetlands, protected areas, productive agricultural land, areas containing rare or endangered species, culturally significant sites, major water resources, and other ecologically important locations.
Additionally, projects should not cause significant environmental degradation, pollution, adverse socio-economic effects, or public concern arising from their environmental consequences.
The developer submits a registration form and Project Brief or Scoping Report to the Council. The Council then screens the proposed project and determines the applicable EIA requirements in accordance with the Regulations.
The developer and environmental experts identify key stakeholders, major concerns, project alternatives, likely impacts, data requirements, and project boundaries. A Scoping Report and Terms of Reference are then prepared and submitted to the Council for approval.
Environmental experts conduct detailed studies of the existing environmental, social, economic, cultural, and institutional conditions within the project area while ensuring stakeholder participation.
Potential environmental and social impacts are identified, predicted, and evaluated. Stakeholder concerns are considered, and project alternatives are assessed to determine the most suitable option.
Measures are developed to avoid, reduce, or remedy significant negative impacts and enhance positive impacts. A Mitigation and Enhancement Plan, Monitoring Plan, and Environmental and Social Management Plan (ESMP) are also prepared.
Environmental experts prepare the Environmental Impact Statement, including a non-technical summary in both Kiswahili and English, together with all supporting technical information and appendices.
The Council reviews the EIS, may conduct public hearings where necessary, and submits its recommendations and review report to the Minister for approval or disapproval.
The Council and the developer monitor project implementation to ensure compliance with approved mitigation measures, environmental standards, and EIA certificate conditions. Environmental audits are conducted to assess compliance, effectiveness of mitigation measures, and accuracy of impact predictions.
At the end of the project life, the developer implements the decommissioning plan and prepares a decommissioning report. The Council continues monitoring rehabilitation activities to ensure environmental restoration and protection of affected workers and communities.
Dar State Attorneys Firm provides professional legal support to investors, developers, and institutions in ensuring full compliance with Tanzania’s Environmental Management Act and EIA Regulations.
The firm assists clients in project classification, preparation and review of Environmental Impact Assessment documents, submission of applications, and liaison with regulatory authorities such as the National Environment Management Council.
It also ensures that all procedural and substantive legal requirements are properly met to avoid delays, rejection, or penalties.
In addition, the firm offers legal advisory services throughout the entire project lifecycle, including risk assessment, environmental compliance, contract review, and representation in regulatory engagements.
By working with Dar State Attorneys Firm, developers of pharmaceutical and other industrial projects can ensure that their investments are legally protected, environmentally compliant, and aligned with national development and sustainability goals.
In Tanzania, all investment projects must comply with Environmental Impact Assessment (EIA) laws before they begin. These laws ensure that projects are properly reviewed and classified to determine their potential impact on the environment and public health.
Investors are required to follow the approved procedures, including submitting the necessary project documents and obtaining an EIA Certificate where applicable.
Compliance with EIA requirements is not optional, it is a legal obligation for all developers. Abide to these procedures helps protect the environment, avoids legal penalties, and ensures that investment projects are approved and implemented smoothly in Tanzania.
Antonia J. Ndutu is a junior associate currently training at Darstate Attorneys. She is passionate about learning and professional growth, with a strong interest in law in general. Antonia is dedicated to building her skills and gaining practical experience across different areas of legal practice. She aspires to develop into a versatile and competent lawyer in the future.
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