IN EXERCISE of the powers conferred on the Minister of Health by sections 6(h), 26(1)(d), 26(1)(f) and 123 of the Medicines and Related Substances Act, 2025, after consultation with the Botswana Medicines Regulatory Authority, the following Regulations are hereby made— Botswana Medicines Regulatory Authority | Page 2 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026
PART I — PRELIMINARY
Regulation 1 · Citation and commencement
(1) These Regulations may be cited as the Medicines and Related Substances (Fees, Levies and Penalties) Regulations, 2026. (2) These Regulations shall come into operation on such date as the Minister may, by notice published in the Gazette, appoint. (3) Different dates may be appointed for different provisions or Schedules.
Regulation 2 · Interpretation
In these Regulations, unless the context otherwise requires— "Act" means the Medicines and Related Substances Act, 2025; "abridged pathway" means a regulatory pathway for products approved by recognised regulatory authorities with reduced evaluation requirements; "administrative penalty" means a penalty imposed by the Authority without court proceedings for specified violations under section 119(i) of the Act; "annual retention fee" means the fee payable annually to maintain a valid registration or licence; "Authority" means the Botswana Medicines Regulatory Authority continued under section 5 of the Act; "combined facility" means premises licensed for two or more regulatory activities under a single licence; "compound penalty" means a penalty accepted by a person in lieu of prosecution for an offence under section 121 of the Act; "expedited service" means priority processing of applications within reduced timelines for an additional fee; "Fees Regulations" means these Regulations; "full evaluation pathway" means a regulatory pathway requiring complete assessment of quality, safety and efficacy data; "General Regulations" means the Medicines and Related Substances (General) Regulations, 2026; "grouped application" means a single application covering multiple related products or variants; "international applicant" means an applicant whose principal place of business is outside Botswana; "levy" means a mandatory charge imposed to fund specific regulatory activities; "line extension" means a variation to an existing product that requires a separate marketing authorisation; "local applicant" means an applicant whose principal place of business is in Botswana, including companies incorporated in Botswana; "local manufacturer" means an entity manufacturing regulated products wholly or partly within Botswana; "notification pathway" means a simplified regulatory pathway for low-risk products; Botswana Medicines Regulatory Authority | Page 3 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026 "orphan medical product" means a medical product for rare diseases as defined in section 44 of the Act; "recognised regulatory authority" means a regulatory authority recognised by the Authority for purposes of abridged or verification pathways; "risk category" means the classification of a product or activity based on potential risk to public health; "small-scale applicant" means a micro, small or medium enterprise as classified under relevant Botswana legislation; and, until such classification is prescribed, means an enterprise with an annual turnover not exceeding the threshold specified by the Authority by notice on its website "stringent regulatory authority" means a regulatory authority that is a member, observer or associate of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use "working day" means any day other than a Saturday, Sunday or public holiday in Botswana.
Regulation 3 · Application
(1) These Regulations apply to all fees, levies and penalties payable in connection with— (a) registration of regulated products; (b) licensing of operators; (c) permits for import, transit, export and other activities; (d) inspection services; (e) laboratory services; (f) other regulatory services; and (g) penalties for violations. (2) Product-specific regulations may prescribe additional fees not covered by these Regulations. (3) Where there is conflict between these Regulations and product-specific fee provisions, these Regulations shall prevail unless the product-specific regulations expressly provide otherwise. (4) In relation to cosmetic products, only the fees expressly designated for cosmetics in these Regulations and the Schedules shall apply, and Part VIII (Levies), regulation 27 (clinical trial authorisation fees) and regulation 34 (clinical trial site inspection fees) shall not apply to cosmetic products.
PART II — GENERAL PROVISIONS ON FEES
Regulation 4 · Fees payable
(1) The fees set out in Schedules 1 to 15 are payable for the applications, services, licences, permits, certificates and other matters specified therein. (2) Fees may be charged based on— (a) whether the applicant is a local or international applicant; (b) the regulatory pathway applicable; (c) the risk classification of the product, establishment or regulated or activity; (d) whether the product is locally manufactured; Botswana Medicines Regulatory Authority | Page 4 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026 (e) whether expedited service is requested; and (f). such other factors as may be prescribed by the Authority and published in the applicable fee schedule (3) No application shall be processed until the prescribed fee has been paid in full, unless a fee waiver or deferment has been granted under regulation 7. (4) The Authority shall publish a consolidated fee schedule on its website and update it whenever fees are amended. (5) The Authority may apply grouped-application and bulk-submission discounts, as set out in the Schedules, where multiple related applications or notifications are submitted by the same applicant within a period specified in guidelines.
Regulation 5 · Payment methods
(1) Fees, levies, administrative penalties and compound penalties shall be paid by— (a) electronic funds transfer to the Authority’s designated bank account (b) credit or debit card through the Authority’s payment portal; (c) mobile money platforms approved by the Authority; or (d) any other method approved by the Authority and published on its website. (2) Proof of payment shall— (a) accompany every application; (b) include the applicant’s name and application reference number; (c) be verifiable by the Authority; and (d) be retained by the applicant for a period of not less than five years. (3) Where payment is made from outside Botswana— (a) all bank charges shall be borne by the applicant; (b) the full fee must be received by the Authority; and (c) payment shall be made in the currency specified or its equivalent.
Regulation 6 · Currency provisions
(1) Fees for international applicants are expressed in United States Dollars in the Schedules. (2) Fees for local applicants are expressed in Botswana Pula in the Schedules. (3) Where payment is made in a currency other than that specified— (a) the exchange rate shall be the Bank of Botswana rate on the date of payment; (b) the applicant shall ensure the full equivalent amount is received by the Authority; and (c) any shortfall must be paid before processing commences. (4) All fees are exclusive of— (a) Value Added Tax, where applicable; (b) bank charges; and (c) any other applicable statutory levies.
Regulation 7 · Fee waiver and reductions
Botswana Medicines Regulatory Authority | Page 5 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026 (1) The Authority may at its discretion grant a full or partial fee waiver from, or reduction of, any fee payable under these Regulations where— (a) the product is intended for a Government health programme or public health emergency response; (b) the product is a donation authorised under the General Regulations and intended for humanitarian purposes; (c) the product is an orphan medical product within the meaning of section 44 of the Act; (d) the applicant is a small-scale applicant, in respect of the fee categories specified in the Schedules; (e) the applicant is a local manufacturer qualifying for an incentive under regulation 19 or regulation 31; or (f) the Authority determines, on written application and for reasons recorded, that payment of the full fee would be contrary to the public interest or would unduly restrict access to essential medical products. (2) An application for an exemption, reduction, waiver or deferment shall be made in writing to the Chief Executive Officer, stating the grounds relied upon and accompanied by supporting information. (3) The Authority shall determine an application under subregulation (2) within thirty working days and shall communicate the decision, with reasons, to the applicant. (4) The Authority shall maintain and publish criteria for waivers and reductions in guidelines, and shall report annually on exemptions granted. (5) An exemption or reduction granted under this regulation may be withdrawn where it was obtained on false or misleading information, and the full fee shall thereupon become payable.
Regulation 8 · Refund policy
(1) Fees paid are generally non-refundable. (2) A refund may be granted where— (a) the Authority is unable to provide the service applied for; or(b) a fee has been paid in error or in excess; or (c) the application is withdrawn in writing before evaluation or inspection has commenced. (3) Where a refund is approved as per 2(c) above— Botswana Medicines Regulatory Authority | Page 6 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026 (a) an administrative charge of ten per cent shall be retained for applications withdrawn ; (4) A refund request shall be made in writing within thirty days of the event giving rise to the request.
Regulation 9 · Annual review mechanism
(1) The Authority shall review all fees annually, considering— (a) changes in the Consumer Price Index; (b) the actual cost of providing regulatory services; (c) regional and international fee benchmarks; (d) stakeholder capacity to pay; (e) public health objectives; (f) the need to encourage local manufacturing; and (g) sustainability of the Authority’s operations. (2) Proposed fee adjustments exceeding ten per cent shall be subject to stakeholder consultation for not less than thirty days. (3) Fee adjustments shall— (a) be published in the Gazette; (b) be posted on the Authority’s website at least sixty days before taking effect; (c) take effect from 1st April each year, or such other date as may be determined; and (d) not apply to applications submitted before the effective date. (4) The Minister may, by statutory instrument, amend the Schedules to these Regulations. (5) The Authority shall publish on its website the methodology, cost analysis and benchmarking outcomes underpinning each annual fee review, before any fee adjustment takes effect.
PART III — PRODUCT REGISTRATION FEES
Regulation 10 · Human medicines registration fees
(1) Fees for registration of human medicines are set out in Schedules 4 and 5. (2.) Reduced fees apply for products manufactured locally and orphan medical products, 11. Veterinary medicines registration fees (1) Fees for registration of veterinary medicines are set out in Schedules 4 and 9. (2) The fee structure makes provision for vaccines and biologicals, antimicrobials subject to stewardship programmes, products for food-producing animals requiring residue data, and medicated feed premixes.
Regulation 12 · Medical devices registration fees
(1) Fees for registration of medical devices, including in-vitro diagnostics, are set out in Schedule 4. (2) Fees are differentiated by risk classification: Class A (low risk) notification pathway fees; Class B (low-moderate risk) standard evaluation fees; Class C (moderate-high risk) enhanced evaluation fees; and Class D (high risk) full evaluation fees. Botswana Medicines Regulatory Authority | Page 7 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026 (3) Grouped application discounts apply where multiple variants of the same device family are submitted at the same manufacturing site with the same intended use and risk classification.
Regulation 13 · In-vitro diagnostics registration fees
(1) Fees for registration of in-vitro diagnostic medical devices are set out in Schedules 6 and 7 and are differentiated by risk classification in the same manner as medical devices.
Regulation 14 · Blood and blood products fees
(1) Fees for blood and blood products are as prescribed by the applicable regulations. Reduced fees apply for public sector blood establishments.
Regulation 15 · Complementary medicines registration fees
(1) Fees for complementary medicines are set out in Schedules.
Regulation 16 · Cosmetics notification and registration fees
(1) Fees for cosmetics are set out in Schedules. Fee levels differentiate between notification for general-use cosmetics and registration for special-use cosmetics.
Regulation 17 · Traditional medicines registration fees
(1) Fees for traditional medicines are as prescribed by the applicable product regulations. Simplified registration pathways and reduced fees support indigenous knowledge holders and traditional health practitioners.
Regulation 18 · Orphan medical products fee provisions
(1) Reduced fees, as set out in the respective Schedules, apply to the registration, variation, renewal and retention of orphan medical products designated under section 44 of the Act. (2) The Authority may waive the registration fee entirely where the orphan medical product addresses a condition for which no registered alternative exists in Botswana. (3) An applicant seeking orphan fee treatment shall provide evidence of orphan designation or of eligibility for such designation with the application.
PART IV — LICENSING FEES
Regulation 19 · Manufacturing facility licensing fees
The fees payable in respect of the licensing, renewal, and variation of domestic manufacturing facilities shall be as set out in Schedule 2, differentiated according to the type of products manufactured, the scale of operations, and whether manufacturing involves sterile or non-sterile processes, provided that— • (a) the fees prescribed in Schedule 2 shall apply only to local manufacturers; and • (b) a full fee waiver shall apply to local manufacturing facilities establishing operations in Botswana for the first time, in support of citizen economic Botswana Medicines Regulatory Authority | Page 8 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026 empowerment and the development of domestic pharmaceutical production capacity
Regulation 20 · Import and export licensing fees
(1) The fees payable in respect of the grant, renewal and variation of import and export licences are set out in Schedule 2. Fees for consignment-specific import, export and transit permits are set out in Schedule 3 and are dealt with under Part V.
Regulation 21 · Wholesale and distribution licensing fees
(1) The fees payable in respect of the licensing, renewal, and variation of wholesale, distribution, storage, and other supply chain operations relating to regulated products shall be as set out in Schedule 2..
Regulation 22 · Retail and dispensing licensing fees
(1) Retail and dispensing licensing fees are set out in Schedule 2. Categories include community pharmacies, hospital pharmacies, veterinary pharmacies, dispensaries, authorised health facility dispensaries, and group practice pharmacies.
Regulation 23 · Blood establishment licensing fees
(1) Blood establishment licensing fees are as prescribed by the applicable regulations.
Regulation 24 · Special purpose licensing fees
(1) Special purpose licensing fees, including for authorised premises and cosmetics operations, are set out in Schedule 2.
PART V — PERMIT AND SERVICE FEES
Regulation 25 · Import and export permit fees
(1) Import and export permit fees as well as importation invoice fee for all registered or listed products and unregistered products are set out in Schedule 3. The letter of authorisation fee is as set out in Schedule 3. (2) The Authority may issue an annual or consolidated import permit covering multiple consignments of routinely imported registered products, on payment of the consolidated permit fee set out in Schedule 3, subject to conditions specified in guidelines.
Regulation 26 · Transit permit fees
(1) Transit permit fees are set out in Schedule 3.
Regulation 27 · Clinical trial authorisation fees
(1) Clinical trial authorisation fees are set out in Schedule 5. Reduced fees apply for locally-sponsored trials, trials addressing local health priorities, academic and investigator-initiated trials, and trials in collaboration with Government. Amendment fees are lower than initial application fees.
Regulation 28 · Advertising approval fees
Botswana Medicines Regulatory Authority | Page 9 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026 (1) Advertising approval fees are set out in Schedule 6. Fees are differentiated by media type and whether the applicant is an international or local applicant.
Regulation 29 · Laboratory services fees
(1) Laboratory testing fees shall be as determined and published by the Authority from time to time.
Regulation 30 · Certificate and document fees
(1) Certificate and document fees are set out in Schedules. Categories include Certificate of Pharmaceutical Product, Free Sale Certificate, Good Manufacturing Practice Certificate, and other letters of authorisation or confirmation.
PART VI — INSPECTION FEES
Regulation 31 · Good manufacturing practice inspection fees
The fees payable in respect of good manufacturing practice inspections shall be as set out in Schedule 1, provided that— • (a) fees for inspection of foreign manufacturing sites shall be differentiated by geographic location as prescribed in Schedule 1; • (b) fees for inspection of local manufacturing sites shall be as prescribed in Schedule 1, differentiated by the type of products manufactured and whether manufacturing involves sterile or non-sterile processes; • (c) additional fees shall apply in respect of— o (i) additional manufacturing blocks or production lines at the same site; o (ii) re-inspection necessitated by significant non-compliance findings; and o (iii) expedited inspection scheduling at the request of the applicant; • (d) where an on-site inspection is not required, desk review fees as prescribed in Schedule 1 shall apply in lieu of inspection fees; and • (e) reduced fees shall apply where— o (i) the site holds a current good manufacturing practice certification issued by a recognised and listed regulatory authority; o (ii) the inspection is conducted jointly with another regulatory authority; o (iii) the application is processed through a reliance pathway recognised by the Authority; or o (iv) the site is a local manufacturing facility undergoing its first good manufacturing practice inspection, in support of citizen economic empowerment and the development of domestic pharmaceutical production capacity.
Regulation 32 · Good distribution practice inspection fees
(1) The fees payable in respect of good distribution practice inspections of wholesale, distribution, storage and transportation operations shall be as set out in Schedule 1, differentiated by the scale and risk classification of the operation. Botswana Medicines Regulatory Authority | Page 10 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026 (2) Reduced fees shall apply where the operation holds a current good distribution practice certification issued by a recognised regulatory authority, or where the inspection is conducted through a reliance pathway recognised by the Authority. (3) Re-inspection fees shall apply where a further inspection is necessitated by significant non-compliance findings.
Regulation 33 · Blood establishment inspection fees
(1) Blood establishment inspection fees reflect the complexity and scope of the establishment’s operations. Public sector facilities receive reduced inspection fees.
Regulation 34 · Clinical trial site inspection fees
(1) The fees payable in respect of the inspection of clinical trial sites, including good clinical practice inspections of investigator sites, sponsor facilities and contract research organisations, shall be as set out by the authority.. (2) Reduced fees shall apply for locally-sponsored trials, academic and investigator- initiated trials, and trials conducted in collaboration with Government. (3) This regulation does not apply to voluntary studies conducted in respect of cosmetic products.
Regulation 35 · Special inspection fees
(1) The fees payable in respect of special inspections shall be as set out in Schedule 1, and shall apply to— (a) for-cause inspections triggered by complaints, adverse events, or suspected non- compliance, provided that where significant non-compliance is confirmed, the cost of the inspection shall be recoverable from the person inspected; (b) follow-up and verification inspections; (c) pre-approval inspections requested by an applicant; and (d) joint inspections with other regulatory authorities, in respect of which the Authority may apportion fees. (2) No fee shall be payable by the person inspected in respect of a routine risk-based surveillance inspection initiated by the Authority, or a for-cause inspection in which no significant non-compliance is found.
PART VII — POST APPROVAL FEES
Botswana Medicines Regulatory Authority | Page 11 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026
Regulation 36 · Annual retention fees
(1) Annual retention fees to maintain valid registrations are set out in the respective Schedules. (2) Retention fees are due on the anniversary of the date of initial registration. (3) A grace period of thirty days shall apply before late payment penalties accrue. (4) Failure to pay retention fees for ninety days shall result in suspension of registration.
Regulation 37 · Variation fees
(1) Variation fees are set out in the respective Schedules. Fees are differentiated by variation type: major variations attract the highest fees for changes with potential significant impact on quality, safety or efficacy; minor variations attract moderate fees for changes with limited impact; and notifications attract the lowest fees.
Regulation 38 · Renewal fees
(1) Renewal fees for registrations and licences are set out in the respective Schedules. Expedited renewal fees apply where late submission necessitates priority processing. (2) Failure to pay renewal fees ninety days after expiry of marketing authorization shall result in suspension of registration.
PART VIII — LEVIES
Regulation 39 · Regulatory levy
(1) A regulatory levy of 0.5 per cent of the cost, insurance and freight value of imported regulated products shall be payable to support the regulatory operations of the Authority. (2) The levy shall be— (a) collected at the point of import; (b) remitted to the Authority on a monthly basis; and (c) reported by importers in monthly returns. (3) Exemptions from the regulatory levy apply to products imported for Government programmes, humanitarian donations, and products imported for re-export. (4) The levy rate may be reviewed annually by the Minister. (5) The regulatory levy is distinct from, and in addition to, the consignment-specific permit fees set out by the authority , and the Authority shall publish annually a consolidated statement of the effective aggregate charge on imported regulated products, including all applicable fees and levies.
Regulation 40 · Pharmacovigilance levy
(1) Marketing authorisation holders shall pay an annual pharmacovigilance levy to support the national vigilance programme established under section 71 of the Act. Botswana Medicines Regulatory Authority | Page 12 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026 (2) The pharmacovigilance levy shall be calculated at the rate, and payable at the times, set out in Schedule 15, and shall be applied exclusively to the funding of the national vigilance programme. (3) The Authority shall account separately for levy income and shall report annually on its application. (4) This regulation does not apply to cosmetic products.
PART IX — PENALTIES AND SANCTIONS
Regulation 42 · Late payment penalties
(1) Late payment penalties apply to overdue fees to late payments of regulatory fees as follows— | Days Overdue | | | Penalty | -30 days | | | Warning | | 31–60 days | | | 10% of outstanding amount | | 61–90 days | | | 20% of outstanding amount | | Over 90 days | | | Suspension of registration or licence, plus 30% penalty | | (2) Late penalties are in addition to, and not in substitution for, any other sanction under the Act.
Regulation 43 · Administrative penalties
(1) The following administrative penalties may, together with other regulatory sanctions,be imposed by the Authority for the specified violations— Violation | | Maximum Penalty | | | (BWP) | Operating without a valid license | 500,000 | | Supplying unregistered and/or unauthorized products | 1,000,000 | | Exports, imports, distributions manufactures, advertises, promoting, dispensing or stores or sale of substandard or falsified products | 1,000,000 | | Sale of or in possession for purposes of sale of expired medicines | 5,000,000 | | Tampering with products under quarantine | | 5,000,000 | Botswana Medicines Regulatory Authority | Page 13 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026 Failure to meet consignment verification requirements at ports of entry e.g., PSI requirements | 5,000,000 Violation of licensing requirements | 1,000,000 Violation of conditions of an import/export/transit permit | 5,000,000 Disposal of expired, unregistered and/or unauthorized products | Cost incurred for disposal Imports or exports a prohibited regulated product | 5,000,000 Failure to meet packaging and labelling requirements | 1,000,000 Failure to maintain adequate records | 250,000 Obstruction of an inspector | 300,000 Failure to report adverse events | 200,000 Failure to submit required reports | 150,000 Advertising without approval | 1,000,000 Breach of data protection obligations | 200,000 Falsifying of documentation representing The Authority | 5,000,000 Impersonating an employee of The Authority or any other person delegated duties of The Authority | 5,000,000 (2) Repeat violations may attract a prescribed fine as outlined in the relevant guideline. (3) Administrative penalties may be appealed to the Board within thirty days of imposition. (4) Imposing an administrative penalty does not preclude criminal prosecution for the same conduct.
Regulation 44 · Compound penalties
(1) In accordance with section 121 of the Act, the following offences may be compounded— Offence | | Maximum Compound | | | Amount (BWP) | Advertising without approval | 500,000 | | Minor labelling violations | 250,000 | | Failure to notify the Authority on Cosmetics products placed in the supply chain | 250 000 | | Minor record-keeping violations | 100,000 | | Manufacturing, selling, supply, export, import, distribute, dispensing, storage of regulated products without Authorisation | 500,000 | | Failure to submit required reports | 75,000 | | Late renewal applications | 50,000 | | Botswana Medicines Regulatory Authority | Page 14 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026 First-time import documentation violations 250,000 Minor premises compliance issues 150,000 Failure to submit required reports 100,000 (2) Compound amounts shall not exceed fifty per cent of the maximum fine for the relevant offence under the Act. (3) Serious offences involving falsified products, controlled substances, or deliberate deception are not compoundable. (4) The procedure for compounding requires the person to admit the offence in writing, the compound offer to be made before the commencement of court proceedings, payment to be made within thirty days of the offer, and failure to pay within the specified period shall result in prosecution.
Regulation 45 · Risk-based penalty framework
(1) The Authority shall determine administrative penalties using a risk- based approach that considers the following factors— • (a) the potential for harm to patients; • (b) the size of the population exposed to the violation; • (c) whether the violation was intentional or negligent; • (d) the duration of the violation; and • (e) the ease or difficulty of detecting the violation. (2) For the purposes of subregulation (1), the Authority shall apply penalty levels as follows— • (a) where the risk assessment yields a high risk score, the maximum prescribed penalty range shall apply; • (b) where the risk assessment yields a medium risk score, the mid- range prescribed penalty shall apply; and • (c) where the risk assessment yields a low risk score, the minimum prescribed penalty range shall apply. (3) The Authority shall take into account the following mitigating factors when determining the appropriate penalty— • (a) voluntary disclosure of the violation by the regulated entity; • (b) prompt corrective action taken upon discovery of the violation; Botswana Medicines Regulatory Authority | Page 15 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026 • (c) cooperation with the Authority's investigation; • (d) absence of prior violations; • (e) demonstrated good faith efforts to comply with applicable requirements; and • (f) documented financial hardship of the regulated entity. (4) The Authority shall take into account the following aggravating factors when determining the appropriate penalty— • (a) repeated violations of the same or similar nature; (b) vulnerability of the population affected by the violation. (5) The Authority shall issue Guidelines prescribing the risk scoring methodology, score ranges, corresponding penalty bands, and procedures for applying mitigating and aggravating factors under this regulation and may review and amend such Guidelines as circumstances require. (6) In the case of a first-time administrative contravention that is minor, unintentional and promptly remediated, the Authority shall, before imposing a financial penalty, consider issuing a written warning or compliance notice requiring corrective action within a specified period.
PART X — TRANSITIONAL AND FINAL PROVISIONS
Regulation 46 · Transitional provisions
(1) Fees paid under the repealed regulations before the commencement of these Regulations shall remain valid for the period for which they were paid. (2) Applications submitted before commencement shall be processed under the fee structure in force at the date of submission. (3) Where new fees represent an increase of more than fifty per cent over previous fees— (a) the increase shall be phased over two years; (b) in year one, the fee payable shall be the previous fee plus fifty per cent of the increase; and (c) in year two, the full new fee shall apply. (4) Registrations and licences valid at the date of commencement shall continue with existing fee obligations until renewal.
Regulation 47 · Repeal
The fees and penalties provisions in the Medicines and Related Substances Regulations, 2019, are hereby repealed. Botswana Medicines Regulatory Authority | Page 16 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026 Made this _______ day of _________________, 2026 _________________________ Minister of Health Botswana Medicines Regulatory Authority | Page 17 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026
SCHEDULE 1
GMP COMPLIANCE FEES 1.1. Application for cGMP (Medicines) Inspection GMP Inspection | Fee (USD) SADC | 3 500 REST OF AFRICA | 5 000 ASIA | 6 500 REST OF THE WORLD | 7 000 Desk review | 3 500 Additional - Onsite Inspection, Extra manufacturing block (each) | 1 000 Additional - Desk review, Extra manufacturing line (each) | 1 000 Expedited | SADC | 7 000 REST OF AFRICA | 10 000 ASIA | 13 000 REST OF THE WORLD | 14 000 1.2. Application for Quality Audit (Medical Devices) Quality Audit | Fee (USD) SADC | 3 500 REST OF AFRICA | 5 000 ASIA | 6 500 REST OF THE WORLD | 7 000 Desk review | 3 500 Additional - Onsite Inspection, Extra manufacturing block (each) | 1 000 Additional - Desk review, Extra manufacturing line (each) | 1 000 Expedited | SADC | 7 000 Botswana Medicines Regulatory Authority | Page 18 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026 REST OF AFRICA 10 000 ASIA 13 000 REST OF THE WORLD 14 000 Botswana Medicines Regulatory Authority | Page 19 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026
SCHEDULE 2
LICENSING FEES 2.1. Local Manufacturer Licensing — New Premises and Renewals Licensing fees – Non-Sterile | Fee (BWP) cGMP - Full Manufacturing | Fee Waived cGMP - Part Manufacturing | 10 000 Re-inspection | 5 000 Annual Manufacturing License | 500 Licence variation | 250 Expedited | cGMP - Full Manufacturing | 5 000 cGMP - Part Manufacturing | 20 000 Licensing fees – Sterile | cGMP - Full Manufacturing | Fee Waived cGMP - Part Manufacturing | 10 000 Re-inspection | 7 500 Annual Manufacturing License | 500 Licence variation | 250 Expedited | cGMP - Full Manufacturing | 5 000 cGMP - Part Manufacturing | 20 000 Licensing Fees – Medical Devices | cGMP - Full manufacturing | Fee Waived cGMP - Part manufacturing | 10 000 Re-inspection | 5 000 Annual manufacturing License | 500 Licence variation | 250 Expedited | cGMP - Full manufacturing | 5 000 cGMP - Part manufacturing | 20 000 2.2. Other Pharmaceutical Operations — New Premises Activity | Fee (BWP) Distributor / Wholesaler - Medicines and Medical Devices | 5 500 Retailer (Pharmacy dispensary, agriculture shops, Vet Clinics) | 4 500 Pharmacy - Within Group Practice | 4 500 Institutional Dispensary - Medicines and Medical Devices | 2 500 Botswana Medicines Regulatory Authority | Page 20 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026 Expedited | Distributor / Wholesaler - Medicines and Medical Devices | 11 000 Retailer (Pharmacy dispensary, Agric Shops, Vet Clinic) | 9 000 Pharmacy - Within Group Practice | 9 000 Institutional Dispensary - Medicines and Devices | 5 000 Authorised Premises | - Medium to Large Scale | 500 2.3. Licensing Renewal Activity | Fee (BWP) Distributor/Wholesaler - Medicines and Medical Devices | 5 500 Retailer - pharmacy dispensary, agricultural shops, vet clinics | 4 500 Pharmacy - Within Group Practice | 4 500 Institutional Pharmacy - Medicines and Medical Devices | 4 800 Authorised Premises | - Medium to Large Scale | 500 - Small scale | 250 Re-inspection | 2 750 Licence variation | 500 Voluntary consignment verification/inspection fee | 1 500 Cosmetics - importer/distributor | 5 000 Cosmetics - importer/retailer | 2 500 Cosmetics - Cosmetics trader | 500 Expedited | Distributor / Wholesaler - Medicines and Medical Devices | 11 000 Retailer - Pharmacy dispensary, agriculture shops, veterinary clinic | 9 000 Pharmacy - within group practice | 9 000 Institutional Pharmacy - Medicines and Devices | 9 600 Botswana Medicines Regulatory Authority | Page 21 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026
SCHEDULE 3
PERMIT FEES Activity | Fee (BWP) Application to import / export for all regulated products excluding Narcotics psychotropics & precursor chemicals | 250 Application to import/export Narcotics psychotropics & precursor chemicals | 500 Application to vary the import or export permit of Narcotics psychotropics & precursor chemicals | 100 Importation fee for wholesale exempted products | 1.25% of consignment value Import Invoice fee for repeat wholesale exempted products without parallel dossier submission | 1.5% of consignment value Importation Invoice fee for all other products | 0.8% of consignment value Application for Transit Permit | 250 Permit Variation for all (medicines and devices) except HFDs | 100 Expedited | Application to import / export for all regulated products excluding Narcotics psychotropics & precursor chemicals | 500 Application to import/export Narcotics psychotropics & precursor chemicals | 1 000 Application to vary the import or export permit of Narcotics psychotropics & precursor chemicals | 200 Botswana Medicines Regulatory Authority | Page 22 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026
SCHEDULE 4
REGISTRATION FEES 4.1. HUMAN MEDICINES (INTERNATIONAL APPLICANTS) (New Chemical Entity) | Fee (USD) Biologic & biosimilar | 1 800 Small Molecules, including B-listed products | 1 800 Vaccine | 1 800 Expedited | Biologic & biosimilar | 3 600 Small Molecules, including B-listed products | 3 600 Vaccine | 3 600 (Generic) | Small Molecules | 1 260 Evaluation of additional submitted clinical data (pre-registration) | 1 260 Line extension (New Chemical Entity and Generic) | 1 260 Registration of an orphan medicine | 1 260 Expedited | Small Molecules | 2 520 Evaluation of additional submitted clinical data (pre-registration) | 2 520 Line extension (New Chemical Entity and Generic) | 2 520 Registration of an orphan medicine | 2 520 Renewals | (New Chemical Entity) | Biologic & biosimilar | 900 Small Molecules, including B-listed products | 900 Vaccine | 900 (Generic) | Small Molecules | 630 Orphan medicine | 630 Retentions | Annual Retention Fee for All Products | 150 Variations (NCE & Generic) | - major | 415 - minor | 275 - notification | 195 4.2. APPLICATION FOR REGISTRATION OF HUMAN MEDICINES – LOCAL APPLICANTS Locally Manufactured Products | Fee (BWP) Medicine partly manufactured in Botswana | 12 000 Botswana Medicines Regulatory Authority | Page 23 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026 Medicine fully manufactured in Botswana | 10 000 Line extension (New Chemical Entity) | 6 000 Line extension (Generics) | 6 000 Expedited | Medicine partly manufactured in Botswana | 24 000 Medicine fully manufactured in Botswana | 20 000 Renewals | Medicine partly manufactured in Botswana | 6 000 Medicine fully manufactured in Botswana | 5 000 Retentions | Annual Retention Fee for All Products | 1 500 Application for Variation (NCE & Generic) | - major | 6 000 - minor | 3 000 - notification | 2 000 Exemptions | Exemptions (Wholesale) | 1.25 of consignment value or 8 500 whichever is greater Repeat Wholesale exemption without proof of Application for registration | 1.5% of consignment value + 10 000 whichever is greater Exemptions (group hospital import) | 350 Exemptions (prescription/patient-based) | Fee waived 4.3. APPLICATION FOR REGISTRATION OF MEDICAL DEVICES (MD) INCLUDING IN-VITRO DIAGNOSTICS (IVDs) - INTERNATIONAL APPLICANTS New Applications (MD including IVDs) | Fee (USD) Class A & notifiable | 185 Class B | 1 110 Class C&D | 1 555 Expedited | Class A & notifiable | 370 Class B | 2 220 Class C&D | 3 110 Renewal | Class A & notifiable | 93 Class B | 556 Class C&D | 778 Retentions | Annual retention fee for all products | 1500 Variations | Botswana Medicines Regulatory Authority | Page 24 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026 - Major 225 - Minor 150 - Notification / notified variations 75 4.4. APPLICATION FOR REGISTRATION OF MEDICAL DEVICES (MD) INCLUDING IN-VITRO DIAGNOSTICS (IVDs) - LOCAL APPLICANTS New Applications (MD including IVDs) | Fee (BWP) Class A & notifiable fully manufactured in Botswana | 1 500 Class A & notifiable partly manufactured in Botswana | 1 875 Class B fully manufactured in Botswana | 8 600 Class B partly manufactured in Botswana | 12 800 Classes C&D fully manufactured in Botswana | 10 300 Classes C&D partly manufactured in Botswana | 15 400 Expedited | Class A & notifiable fully manufactured in Botswana | 3 000 Class A & notifiable partly manufactured in Botswana | 3 750 Class B fully manufactured in Botswana | 17 200 Class B partly manufactured in Botswana | 25 600 Classes C&D fully manufactured in Botswana | 20 600 Classes C&D partly manufactured in Botswana | 30 800 Renewal | Class A & notifiable fully manufactured in Botswana | 750 Class A & notifiable partly manufactured in Botswana | 938 Class B fully manufactured in Botswana | 4 300 Class B partly manufactured in Botswana | 6 400 Classes C&D fully manufactured in Botswana | 5 150 Classes C&D partly manufactured in Botswana | 7 700 Retentions | Annual retention fee for all products | 1 500 Variations | - Major | 3 000 - Minor | 2 000 - Notification / notified variations | 1 000 Exemptions | MD including IVDs exemptions | 500 Exemptions (prescription/patient-based) (Classes A & B) | Fee waived Botswana Medicines Regulatory Authority | Page 25 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026 4.5. APPLICATION FOR REGISTRATION OF VETERINARY MEDICINES (VMPs) - INTERNATIONAL APPLICANTS Imported Fully Finished VMPs | Fee (USD) Small-molecule medicines | 1 125 Line extension | 560 Vaccine/Biologicals | 1 125 Complementary VMPs incl. premixes | 560 Additional submitted data (pre-reg) | 560 Orphan medicines | 280 Expedited | Small-molecule medicines | 2 250 Line extension | 1120 Vaccine/Biologicals | 2 250 Complementary VMPs incl. remixes | 1 120 Additional submitted data (pre-reg) | 1 120 Orphan medicines | 560 Renewals | Small-molecule medicines | 563 Line Extension | 280 Vaccines/Biologicals | 563 Complementary VMP including premixes | 280 Additional submitted data (pre-reg) | 280 Orphan medicines | 140 Retentions | Annual Retention Fee for all VMPs, excluding orphan medicines | 150 Variation | - major | 370 - minor | 280 - notification | 190 4.6. APPLICATION FOR REGISTRATION OF VETERINARY MEDICINES (VMPs) - LOCAL APPLICANTS Registration for imported fully finished VMPs | Fee (BWP) Small-molecule medicines | 15 200 Line extension | 7 600 Vaccine/Biologicals | 15 200 Complementary VMPs incl. premixes | 7 600 Additional submitted data (pre-reg) | 7 600 Orphan medicines | 3 800 Expedited | Small-molecule medicines | 30 400 Botswana Medicines Regulatory Authority | Page 26 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026 Line extension | 15 200 Vaccine/Biologicals | 30 400 Complementary VMPs incl. premixes | 15 200 Additional submitted data (pre-reg) | 15 200 Orphan medicines | 7 600 Registration of partially Locally manufactured VMPs | Small-molecule medicines | 11 400 Line Extension | 5 700 Vaccines/Biologicals | 11 000 Complementary VMP incl premixes | 5 700 Additional submitted data (pre-reg) | 5 700 Orphan medicines | 2 800 Expedited | Small-molecule medicines | 22 800 Line Extension | 11 400 Vaccines/Biologicals | 22 000 Complementary VMP incl premixes | 11 400 Additional submitted data (pre-reg) | 11 400 Orphan medicines | 5 600 Registration of fully locally manufactured VMPs | Small-molecule medicines | 7 600 Line Extension | 3 800 Vaccines/Biologicals | 7 600 Complementary VMP incl Premixes | 3 800 Additional submitted data (pre-reg) | 3 800 Orphan medicines | 1 900 Expedited | Small-molecule medicines | 15 200 Line Extension | 7 600 Vaccines/Biologicals | 15 200 Complementary VMP incl premixes | 7 600 Additional submitted data (pre-reg) | 7 600 Orphan medicines | 3 800 Retention | Annual Retention Fee for all VMPs excl orphan medicines | 1 500 Annual Retention of orphan medicines | Fee waived Renewal | Renewal for Imported Fully Finished VMPs | Small-molecule medicines | 7 600 Line extension | 3 800 Vaccine/Biologicals | 7 600 Complementary VMPs incl. premixes | 3 800 Additional submitted data (pre-reg) | 3 800 Orphan medicines | 1 900 Renewal of partially Locally manufactured VMPs | Small molecule medicines | 5 700 Line Extension | 2 850 Vaccines/Biologicals | 5 500 Botswana Medicines Regulatory Authority | Page 27 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026 Complementary VMP incl premixes | 2 850 Additional submitted data (pre-reg) | 2 850 Orphan medicines | 1 400 Renewal of fully locally manufactured VMPs | Small-molecule medicines | 3 800 Line Extension | 1 900 Vaccines/Biologicals | 3 800 Complementary VMP incl premixes | 1 900 Additional submitted data (pre-reg) | 1 900 Orphan medicines | 950 Exemption from registration of VMPs | Prescription/patients based | Nil Hospital/Vet clinics | 50 Research | 150 Wholesale | 3000 Application for Variation of all VMPs | - Major | 3 700 - Minor | 2 800 - Notification | 1 900 4.7. APPLICATION FOR REGISTRATION OF COMPLEMENTARY MEDICINES-INTERNATIONAL APPLICANT Imported Fully Finished Complementary Medicine | Fee (USD) Complementary medicines registration | 585 A line extension of Complementary medicine | 370 Expedited | Complementary medicines registration | 1170 Renewal | Renewal of registration | 293 Retention | Annual fee/ retention fee | 150 Variation | Variation | 185 Registrability | Determination of Product Registrability | 80 4,8. APPLICATION FOR REGISTRATION OF COMPLEMENTARY MEDICINES - LOCAL APPLICANT Registration of Partially Locally Manufactured Complementary Medicine | Fee (BWP) Complementary medicine partially manufactured in Botswana | 6 000 Registration of Fully Locally Manufactured | Full manufacturing of complementary medicines | 4 000 Botswana Medicines Regulatory Authority | Page 28 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026 Expedited | Registration of partially manufactured complementary medicine in Botswana | 12 000 Complementary medicine fully manufactured in Botswana | 8 000 Retentions | Annual fee/ retention fee | 1 500 Renewal | Registration of partially locally manufactured complementary medicine | 3 000 Registration of fully locally manufactured | 2 000 Variations | Variations | 2 500 Registrability | Determination of Product Registrability | 400 4.9. APPLICATION FOR REGISTRATION OF COSMETICS - INTERNATIONAL APPLICANTS Notification/listing of Imported cosmetics | Fee (USD) Cosmetics partially manufactured in Botswana | 90 Registration of imported cosmetics | Imported Cosmetics registration | 300 A line extension of Cosmetics | 225 Renewal of Registration | Renewal of imported cosmetics registration | 150 Retention | Retention of imported cosmetics | 22 Variations | Variations | 40 Exemption | Exemption from registration | 225 4.10. APPLICATION FOR REGISTRATION OF COSMETICS - LOCAL APPLICANTS Notification/listing of Partially Locally Manufactured | Fee (BWP) Cosmetics partially manufactured in Botswana | 1200 Notification/listing of Fully Locally Manufactured | Full manufacturing of cosmetics | 600 Registration or Partially Locally Manufactured | Registration of partially locally manufactured complementary medicine | 4 000 Registration of fully locally manufactured | 2 000 Renewal of Registration | Renewal of partially locally manufactured cosmetics | 2 000 Renewal of fully locally manufactured cosmetics | 1 000 Retention | Retention of partially locally manufactured cosmetics | 300 Retention of fully locally manufactured cosmetics | 200 Botswana Medicines Regulatory Authority | Page 29 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026 Variation Variation 500 Exemption Exemption from registration 400 4.8. Botswana Medicines Regulatory Authority | Page 30 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026
SCHEDULE 5
APPLICATION TO CONDUCT CLINICAL TRIALS Foreign Sponsor | Fee (USD) Phase 1 study | 3 700 Phase 2 study | 3 000 Phase 3/4 study | 2 500 Sub-study | 1 000 Bioequivalence/Bioavailability | 1 000 Amendment Application | Amendment | 200 By Local Sponsor | Fee (BWP) Clinical trial | 22 500 Sub-study | 11 250 Bioequivalence/Bioavailability study | 7 500 Amendment Application | Local sponsor | 1 000
SCHEDULE 6
APPLICATION FOR APPROVAL OF ADVERTISEMENT/PROMOTIONAL MATERIAL Botswana Medicines Regulatory Authority | Page 31 of 32 MEDICINES AND RELATED SUBSTANCES (FEES, LEVIES AND PENALTIES) REGULATIONS, 2026 International Applicant Fee (USD) Print/ electronic media 125 Local Applicant Fee (BWP) Print/ electronic media 1 250
SCHEDULE 7
OTHER REGULATORY FEES Re-issue of certificates | 100 Certificate (all products) | 300 Variations (penalty fee) | 5 000 Late submission of applications, including renewals retentions (penalty fee) | 20% of the applicable process fee Botswana Medicines Regulatory Authority | Page 32 of 32