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LIBERIA MEDICINE AND HEALTH PRODUCTS REGULATORY AUTHORITY (LMHRA) 2nd and 3rd Floor, Clay Building Sekou Toure Avenue, Mamba Point Monrovia, Montserrado County Republic of Liberia GUIDELINES FOR EXEMPTION OF FEES PAYMENT TO THE AUTHORITY FOR CERTAIN PRODUCTS AND SERVICES Version No. 001 LMHRA P.O BOX 1994 Cell: +231-777140555/888140555 Email: info@lmhra.gov.lr Website: www.lmhra.gov.lr Document Code: DOC-GDL-017 Date of Issue: April 13, 2026 Version: 01 Date of Implementation: April 16, 2026 i | Page GUIDELINES FOR EXEMPTION OF FEES PAYMENT TO THE AUTHORITY FOR CERTAIN PRODUCTS AND SERVICES

Table of Contents DECLARATION … 3 CHAPTER I: PRELIMINARY … 4 Section 1. Title … 4 Section 2: Application and Scope … 4 Section 3: Purpose … 4 Section 4. Definitions … 4 CHAPTER II: LABELING OF MEDICINES AND HEALTH PRODUCTS … 8 Section 1. Labeling Information … 8 Section 2: Name and Address of Manufacturer … 9 Section 3. Display of Generic and/or Brand Name … 10 Section 4. Package Inserts … 10 Section 5. Labeling of Parenteral and Suspension Preparations … 11 Section 6 Control of the conformity of the labelling of medicines and health Products Section 7 Declaration of Non-Nutritive sweeteners … 12 Section 8. Warning for Children … 12 Section 9. Manufacture and Expiry Dates … 12 Section 10. Batch/Lot number … 12 Section 11. Score line Information /Requirement for Scored Tablets … 12 CHAPTER III OFFENSES AND PENALTIES … 13 GUIDELINES FOR EXEMPTION OF FEES PAYMENT TO THE AUTHORITY FOR CERTAIN PRODUCTS AND SERVICES Page ii of 12

DECLARATION This Guideline is made in fulfilment of PART V, section 7 of the Liberia Medicines and Health Products Regulatory Authority Act of 2010, which confers upon the Authority the responsibility of regulating medicines and health products within the Republic of Liberia. The Management, with approval of the Board of Directors hereby promulgate this guideline designed for the “Exemption of Fees Payment” to the Authority for certain products or services this 13th day of April, 2026. GUIDELINES FOR EXEMPTION OF FEES PAYMENT TO THE AUTHORITY FOR CERTAIN PRODUCTS AND SERVICES Page iii of 12

CHAPTER I: PRELIMINARY Section 1. Title This Guideline shall be cited as the “Exemption of Fees Payment to the Authority for Certain Products or Services” Section 2: Application and Scope These guidelines apply to all individuals, organizations, and entities seeking exemption from LMHRA fee payments for specific products or services. They encompass regulatory activities such as registration, inspection, licensing, and other services LMHRA provides. The exemptions ensure that vital health products and services are not hindered by financial barriers, particularly in urgent or high-impact scenarios and covers a medicinal product designated as an orphan medicinal product if its sponsor can establish: (a) that it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10 thousand persons in the community when the application is made, or that it is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the community and that without incentives it is unlikely that the marketing of the medicinal product in the community would generate sufficient return to justify the necessary investment; and (b) that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorized in the community or, if such method exists, that the medicinal product will be of significant benefit to those affected by that condition. 4 | Page GUIDELINES FOR EXEMPTION OF FEES PAYMENT TO THE AUTHORITY FOR CERTAIN PRODUCTS AND SERVICES

Section 3: Purpose This guideline outlines the conditions, procedures, and categories of products or services that qualify for exemption from fee payments to the LMHRA. The objective is to promote public health, support humanitarian initiatives, and encourage accessibility to essential medicines and health products. Specifically, they aim to: • Facilitate access to critical health products during emergencies. • Support organizations involved in humanitarian and public health programs. • Encourage research and innovation in addressing public health challenges. Section 4. Definitions In this Guideline, unless the context otherwise requires, the following words and phrases shall have the meanings as ascribed to them in this section. “Act” means the Liberia Medicines and Health Products Regulatory Authority Act; "Adulteration” means the causing or doing any act that affects the purity, potency, strength or content of a product, so that it is not of good quality, safe and effective, or not what it purports to be. “Authority” means the Liberia Medicines and Health Products Regulatory Authority; “Medicinal Product” means a medicinal product for human use. “Orphan Medicinal Product” means a medicinal product designated as such under the terms and conditions of this Guideline “Sponsor” means any legal or natural person, established in the Community, seeking to obtain or having obtained the designation of a medicinal product as an orphan medicinal product packaging. “Drug” means any substance or preparation used or intended to be used for GUIDELINES FOR EXEMPTION OF FEES PAYMENT TO THE AUTHORITY FOR CERTAIN PRODUCTS AND SERVICES Page 5 of 12

internal or external application to the human or animal body either in the treatment or prevention of disease or for improving physiological functions, or for agricultural or industrial purposes. Essential Medicine List (EML) means a list of selected medications based on disease prevalence and public health relevance that are considered to be most effective, safe, cost effective and approved by the Ministry of Health of the Republic of Liberia. "Health Product" includes: a. "Medical Device," which means any instrument that is not a medicine, as defined herein, that is intended for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical or mental state, or symptoms thereof, in human or animal, or restoring, correcting, or beneficial modification of organic or mental functions in human or animal; and b. "Medical Supply," which means any article that is intended for diagnosis, treatment, mitigation or prevention of a disease disorder, abnormal, physical or mental state, or symptoms thereof in human or animal, or restoring, correcting, or beneficial modification of organic or mental functions in human or animal. This includes suturing materials, syringes, needles, bandages, gauze, cotton, artificial teeth, chemicals, and X-Ray film and other similar articles. "Medicine" means any substance or mixture of substances intended for use in: a. the diagnosis, treatment, mitigation, or prevention of a disease, disorder, abnormal physical or mental state, or symptoms thereof in man or animal; or b. restoring, correcting, or beneficial modification of organic or mental functions in human or animal; GUIDELINES FOR EXEMPTION OF FEES PAYMENT TO THE AUTHORITY FOR CERTAIN PRODUCTS AND SERVICES Page 6 of 12

c. Medicine shall include traditional medicines, narcotic drugs, psychotropic substances, blood and blood products, vaccines, sera, and radiopharmaceuticals, but not health products as defined herein. CHAPTER II: Procedure for designation as orphan medicinal product In order to obtain the designation of a medicinal product as an orphan medicinal product, the entities and organizations shall submit an application for review to the authority at any stage for a title in this guideline. Section 1. Procedure to be followed for exemption of fees: The application shall be accompanied by the following particulars and documents a) name or corporate name and permanent address of the entities or organization; (b) active ingredients of the medicinal product; (c) proposed therapeutic indication; (d) justification that the scope laid down in this Guideline as title are met and a description of the medicinal products including the indications expected are clearly stated. e) if it is established that the orphan products or services are for marketing and requesting market authorization, the LMHRA shall determine, in accordance with existing procedures, whether or not to grant an exception based on the prevailing circumstances Section 2: The term and conditions for exemption: • The medicine concerned is of significant importance to patient treatment • The Medicinal products should certified the condition as title in this guideline • the medicine cannot be replaced by another product marketed in Liberia • The marketing of the medicine is of no significant commercial interest to the marketing authorization holder • For veterinary medicines, the product must generally be intended for production animals. GUIDELINES FOR EXEMPTION OF FEES PAYMENT TO THE AUTHORITY FOR CERTAIN PRODUCTS AND SERVICES Page 7 of 12

Section 3: Eligibility Criteria 1. Humanitarian Donations: a) Medicines and health products donated for emergency relief, disaster response, or humanitarian aid by recognized international organizations, NGOs, or government agencies. b) Evidence of donation, such as a certificate or official communication from the donor, must be provided. 2. Public Health Programs: a) Products procured or distributed under national or international public health initiatives, such as vaccines, antiretrovirals, tuberculosis treatments, and malaria medications. b) Documentation demonstrating alignment with recognized public health goals is required 3. Research and Development (R&D): a) Clinical trial materials or investigational products used in approved research projects aimed at addressing critical public health issues. b) Proof of ethical approval and regulatory clearance for the research must be submitted. 4. Non-Profit Entities: a) Products imported or distributed by non-profit organizations for free public distribution. b) The organization must provide proof of non-profit status and details of the distribution plan. 5. National Emergency or Epidemic: GUIDELINES FOR EXEMPTION OF FEES PAYMENT TO THE AUTHORITY FOR CERTAIN PRODUCTS AND SERVICES Page 8 of 12

a) Products or services required during a declared national emergency or epidemic, as determined by the Ministry of Health or other authorized government bodies. b) Official declaration of the emergency and justification for the exemption must be presented CHAPTER III: Application Process/ procedure Section 1 : 1. Submission of Application: a) Applicants must submit a formal request to the LMHRA, including a completed Fee Exemption Application Form. b) The application must detail the product or service, the reason for the exemption, and supporting documents (e.g., donation certificates, and project details). 2. Review and Assessment: a) The LMHRA shall review the application within ten (10) business days. b) Additional documentation or clarification may be requested if necessary. 3. Decision and Notification: a) The LMHRA shall issue a written decision approving or rejecting the exemption request. b) Approved applicants will receive an official exemption certificate, valid for a specified period or project duration. Section 2: 1. Compliance with Regulations: a) Exempted products must comply with LMHRA’s quality, safety, and efficacy standards. 2. Non-Transferability: GUIDELINES FOR EXEMPTION OF FEES PAYMENT TO THE AUTHORITY FOR CERTAIN PRODUCTS AND SERVICES Page 9 of 12

a) Fee exemptions are non-transferable and apply only to the approved product or service. 3. Periodic Review: a) Exemptions may be subject to periodic review to ensure continued compliance with the exemption criteria. Section 3: Monitoring and Reporting 1. Accountability: a) Beneficiaries of fee exemptions must submit regular reports on the distribution and use of exempted products, as required by LMHRA. 2. Audit and Inspection: a) LMHRA reserves the right to audit exempted products and services to prevent abuse of the exemption privilege. Section 4: Appeals Process Applicants whose requests are denied may appeal the decision in writing within five (5) business days. Appeals will be reviewed by a designated LMHRA appeals committee, which will provide a final decision within ten (10) business days of receiving the appeal. Section 5: Enforcement and Penalties 1. Revocation of Exemption: a) Any misuse or violation of the exemption guidelines will result in revocation of the exemption and potential legal action. GUIDELINES FOR EXEMPTION OF FEES PAYMENT TO THE AUTHORITY FOR CERTAIN PRODUCTS AND SERVICES Page 10 of 12

2. Penalties for Misuse: a) Entities that have abused the exemption privilege may be subject to penalties, including fines or disqualification from future exemptions. This Guideline shall take effect immediately upon the approval of the Managing Director GUIDELINES FOR EXEMPTION OF FEES PAYMENT TO THE AUTHORITY FOR CERTAIN PRODUCTS AND SERVICES Page 11 of 12

The guideline for exemption of fees payment to the Authority for certain products and services is Hereby Promulgated and Approved by the managing director on this 13th Day of April, A. D. 2026. Hon. Luke Bawo Managing Director / LMHRA GUIDELINES FOR EXEMPTION OF FEES PAYMENT TO THE AUTHORITY FOR CERTAIN PRODUCTS AND SERVICES Page 12 of 12