Category: Subsidiary Legislation

EXPORT PROCESSING ZONES: SUBSIDIARY LEGISLATION EXPORT PROCESSING ZONES REGULATIONS ARRANGEMENT OF REGULATION REGULATION PART IPRELIMINARY 1. Citation 2. The Export Processing Zones Appraisal Committee 3. Application for Export Processing Zones Certificate 4. Issue of the Proessing Zone Certificate 5. Calculation of time PART IIEXPORT PROCESSING ZONES ACTIVITIES 6. Failure to commence 7. Monitoring of export enterprises 8. Local sales by an export enterprise 9. Accounting records PART IIIRENEWAL, AMENDMENT, SUSPENSION AND REVOCATION OF EXPORT PROCESSING ZONES CERTIFICATES 10. Renewal and amendment 11. Refusal to renew, amend suspend or revoke certificate PART IVMISCELLANEOUS 12. Notice of hearing 13. Power to order particulars 14. Admission to a hearing 15. Appearance at hearing 16. Procedure at hearing 17. Imposition of a penalty 18. Offences and penalties 19. Fees FIRST SCHEDULE SECOND SCHEDULE G.N. 82/2020 EXPORT PROCESSING ZONES REGULATIONS under s. 21 PART IPRELIMINARY 1. Citation These Regulations may be cited as the Export Processing Zones Regulations. 2. The Export Processing Zones Appraisal Committee (1) Where under the Act or these Regulations a decision of the Committee is required, six members shall form a quorum for any purpose. (2) Any communication from the Committee shall be under the hand of the Chairperson of the Export Processing Zones Committee, hereinafter referred to as the “Chairperson”. 3. Application for Export Processing Zones Certificate (1) A company duly registered under the laws of Malawi may, on payment of the prescribed fee, apply for an Export Processing Zone Certificate using Form EPZ 1 in the First Schedule hereto. (2) An application under subregulation (1) shall be accompanied by— (a) evidence of the payment of the prescribed application fee; (b) a Certificate of Incorporation or Registration; (c) a business plan; (d) proof of title to the land on which the export enterprise shall carry out the business such as a deed, lease or such other document; (e) five year financial and production projections; and (f) an Environmental Impact Assessment report, where applicable. 4. Issue of the Proessing Zone Certificate (1) The Minister shall, on the recommendation of the Committee, accept or reject an application for an Export Processing Zone Certificate. (2) The Committee in making any recommendation to the Minister shall give priority to promoting the export of non-traditional value added products in compliance with the National Export Strategy and consistent with the Act. (3) Where the Minister approves the application of an export enterprise, he shall issue an Export Processing Zone Certificate to the enterprise in the format contained in Form EPZ 2 in the First Schedule. (4) Where the Committee recommends to the Minister to reject an application, the Committee shall furnish the Minister with reasons for the recommendation of the rejection in writing. (5) An export enterprise that contravenes any condition stipulated in its certificate commits an offence and shall be liable to pay a penalty of five per cent of the annual turnover: Provided that the penalty shall not exceed K20,000,000. 5. Calculation of time For the purposes of calculating the time within which anything needs to be done under the Act by the Minister, such time shall start running from the date of receipt by the Chairperson of the relevant application. PART IIEXPORT PROCESSING ZONES ACTIVITIES 6. Failure to commence (1) The Minister shall revoke a certificate of an export enterprise, where the export enterprise fails to commence its operations within twelve months or during such an extension as the Minister, on the recommendation of the Committee, may grant. (2) The Minister, before revoking a certificate of an enterprise under subregulation (1) shall give the enterprise an opportunity to be heard in accordance with regulations 11 to 15. 7. Monitoring of export enterprises (1) An export enterprise shall prepare and submit a report to the Committee, on a quarterly basis, within thirty days after the end of each quarter, specifying— (a) total production and turnover; (b) total exports, including evidence thereof such as any CD 1 Form under the Customs and Excise Act; (c) evidence of exports proceeds certified by an authorized dealer bank under the Exchange Control Act; (d) evidence of any sales made locally not exceeding twenty per cent of total production; and (e) evidence of any taxes payable on equivalent goods produced for local sale. (2) Where the export enterprise fails to submit any information in compliance with subregulation (1), the export enterprise shall submit an explanation to the Committee giving reasons for the failure. (3) An export enterprise which fails to comply with subregulations (1) and (2) commits an offence and shall be liable to a penalty of three per cent of its annual turnover: Provided that the penalty shall not exceed K20,000,000. 8. Local sales by an export enterprise (1) An export enterprise may sale any part of its production within Malawi if the sales shall not, in aggregate,…

PUBLIC FINANCE MANAGEMENT: SUBSIDIARY LEGISLATION PUBLIC FINANCE MANAGEMENT (DEBT AND AID MANAGEMENT) REGULATIONS ARRANGEMENT OF REGULATIONS REGULATION 1. Citation 2. Preparation of the debt management strategy 3. Preparation of the annual borrowing plan 4. Subsidiary loans 5. Duty to account for subsidiary loans 6. Repayment of subsidiary loans 7. Issuance of guarantee 8. Submission of reports 9. Treatment of accounts payable 10. Accounting for foreign gains and losses 11. Donations and grants G.N. 55/2023 PUBLIC FINANCE MANAGEMENT (DEBT AND AID MANAGEMENT) REGULATIONS under s. 115 1. Citation These Regulations may be cited as the Public Finance Management (Debt and Aid Management) Regulations. 2. Preparation of the debt management strategy (1) The Secretary to the Treasury shall, in consultation with relevant stakeholders, facilitate all activities for the preparation of the debt management strategy. (2) The Secretary to the Treasury may— (a) organize key stakeholder consultations to inform the debt management strategy; (b) carry out detailed public debt analysis and identify critical success factors and challenges; (c) assess past public debt performance and identify key strategies for sustainable public debt management; and (d) assess and identify priority areas which may justify debt financing. (3) The Secretary to the Treasury shall, at the beginning of every financial year, include the activities provided for in subregulation (2) in the annual work plan. 3. Preparation of the annual borrowing plan (1) The Secretary to the Treasury shall— (a) analyze the annual revenue and expenditure projections to identify funding gaps; (b) identify the most cost-effective and efficient external resources to bridge the funding gap; and (c) prepare and submit the annual borrowing plan to the Minister, by end February, in each financial year. (2) The Secretary to the Treasury shall, at the beginning of every’ financial year, include the activities in subregulation (1) in the annual work plan. 4. Subsidiary loans Where the Minister decides to on-lend, the Secretary to the Treasury shall— (a) carry out a due diligence of the intended recipient of the subsidiary loan by— (i) assessing the feasibility, viability and public interest of the proposed project for which the subsidiary loan is required; (ii) assessing the capacity of the recipient to properly apply the funds, account for them and repay the loan to the Government; (iii) assessing the terms of the principal loan and synchronizing the subsidiary loan accordingly; and (iv) identifying and proposing critical strategies to be implemented to ensure that risks and challenges associated with both the principal and subsidiary loans are mitigated; (b) negotiate the terms and conditions of the subsidiary loan agreements; and (c) prepare a term sheet setting out the on-lending details which shall, together with the signed subsidiary loan agreement, be recorded in the debt recording and management system. 5. Duty to account for subsidiary loans (1) The Secretary to the Treasury shall account for amounts which are on-lent under a subsidiary loan agreement. (2) A recipient of a subsidiary loan shall— (a) keep records of all receipts and payments under a subsidiary loan agreement; and (b) submit to the Accountant General reports on all receipts and payments under the subsidiary loan. 6. Repayment of subsidiary loans (1) The Secretary to the Treasury shall, when a payment under a subsidiary loan is due, prepare a payment notice and serve it on a recipient of a subsidiary loan. (2) A copy of the notice of repayment under subregulation (1) shall be submitted to the Accountant General for record purposes. (3) A payment made by a recipient of a subsidiary loan shall be recorded in the debt recording and management system. (4) The Secretary to the Treasury shall, as soon as reasonably possible, notify the Accountant General of receipt of any payment from a recipient of a subsidiary loan. 7. Issuance of guarantee (1) Where a person, body corporate, organization or statutory body seeks to obtain a loan guaranteed by Government, the person, body corporate, organization or statutory body shall apply for a loan guarantee. (2) The application under subregulation (1) shall be accompanied by— (a) a board resolution approving the intention to seek a loan guaranteed by Government; (b) a detailed project proposal replete with its objectives and justification for the involvement of the Government; (c) term sheet setting out the terms and conditions of the loan, including the proposed repayment schedule and liquidation model; (d) audited financial statements for the immediate past five financial years; and (e) letters from at least two immediate previous creditors of the applicant stating the performance of the applicant from the date of borrowing to the debt of full repayment. (3) The Secretary to the Treasury shall, upon receipt of an application for a loan guarantee, assess— (a) if the proposed project, or activity, for which the money is being borrowed is consistent with the principles of prudent fiscal management and…

PUBLIC PROCUREMENT AND DISPOSAL OF PUBLIC ASSETS: SUBSIDIARY LEGISLATION PUBLIC PROCUREMENT AND DISPOSAL OF ASSETS (REGISTRATION FEES FOR SUPPLIERS) ORDER under s. 54 G.N. 71/2019 1. Citation This Order may be cited as the Public Procurement and Disposal of Public Assets (Registration Fees for Suppliers) Order. 2. Registration of suppliers A supplier shall apply for registration with the Director General at any time. 3. Registration fees The registration fees described in the Schedule shall be payable by a supplier at the time of registration. SCHEDULE reg. 3 REGISTRATION FEES FOR SUPPLIERS Category (Goods and Services)Value of Procurement ContractFees K t 1.Up to K10 million10,000 00 2.Above K10 million – K30 million 20,000 00 3.Above K30 million – K80 million 30,000 00 4.Above K80 million – K100 million60,000 00 5.Above K100 million – K500 million100,000 00 6.Above K500 million – K1 billion 200,000 00 7.Above K1 billion 500,000 00 PUBLIC PROCUREMENT REGULATIONS ARRANGEMENT OF REGULATIONS REGULATION PART IPRELIMINARY 1. Citation 2. Interpretation 3. Scope of procurement regulations 4. Accessibility of legal texts governing public procurement PART IIINSTITUTIONAL AND ORGANIZATIONAL ARRANGEMENTS FOR PROCUREMENT Division IPublic Procurement and Disposal of Public Assets Authority 5. Functions of the Authority 6. Membership of the Authority 7. Funds of the Authority 8. Quorum requirements 9. Functions of the Director General Division IIInternal Procurement and Disposal Committee 10. Composition of Internal Procurement and Disposal Committee Division IIIAd hoc Evaluation Team 11. Ad hoc evaluation team Division IVProcurement and Disposal Units 12. Procurement and disposal units 13. Functions of a procurement disposal unit PART IIIPRINCIPLES OF PUBLIC PROCUREMENT Division ITransparency 14. Record keeping 15. Disclosure 16. Availability of record for oversight 17. Annual register 18. Contents of a procurement file 19. Notice of procurement contract 20. Publication of award notice 21. Publication of contract award 22. Information disclosure 23. Project identification 24. Project preparation 25. Project procurement 26. Project implementation 27. Project completion Division IIAccountability 28. Declaration and disclosure requirements 29. Conflict of interest 30. Post-employment restrictions on procurement professionals 31. Contingent fee arrangements 32. Conspicuous notice of prohibitions 33. Prohibition of solicitation of improper inducement 34. Prohibition of contract award to a bidder affiliated with a consultant 35. Confidentiality of procurement information 36. Dissemination of applicable conflict of interest and conduct rules to public employees 37. Remedies against breach of conduct standards by public officials 38. Reporting of violations by procuring and disposing entities Division IIIFairness, Economy and Efficiency 39. Principles of non-discrimination 40. Uniformity of bidding documents 41. Economy and efficiency PART IVPROCUREMENT METHODS Division IGeneral Provision 42. Notice of procurement method to be used 43. Clarification and notice of procurement method 44. Bid security 45. Extension of deadline for submission of bid documents 46. Receipt and security of bids 47. Rejection of late bids 48. Bid validity period 49. Evaluation of bids in different currency 50. Prompt payment discount units 51. Unrealistically low bids 52. Rejection of bids 53. Notice required for rejection of all bids 54. Return of samples Division IIProcedures for Procurement Consultants’ Services 55. Preparation of shortlist 56. Issuance of request for proposals 57. Contents of request for proposals for services 58. Avoidance of conflict of interest 59. Choice of selection procedures 60. Submission of proposals 61. Evaluation and selection 62. Evaluation of proposals in quality and cost-based selection procedure 63. Criteria for evaluation of quality of a proposal 64. Relative weighting of criteria 65. Subcriteria for evaluation of key personnel 66. Quality rating of proposals 67. Rejection of unresponsive proposals 68. Notification of results of technical evaluation 69. Technical evaluation report 70. Opening of financial proposals 71. Evaluation of financial proposal 72. Selection of successful proposal 73. Combined technical and financial evaluation 74. Negotiations and award of contract 75. Failure to reach agreement with successful bidder 76. Rejection of all proposals 77. Selection based on quality 78. Selection based on least cost 79. Design contents Division IIIRequest for Quotations Procedures 80. Conditions for use of request for quotations procedure 81. Quotations acceptance procedure Division IVSingle-Source Procurement 82. Requirements for due diligence 83. Monetary threshold for low value single-source 84. Procurement of functionally equivalent goods 85. Single-source procurement on the grounds of emergency 86. Documentation of single-source procurement 87. Publication of prior notice Division VProcedure for Community Participation Method 88. Procurement by means of community participation Division VIProcedure for Restricted Tendering A—Restricted Tendering 89. Procedures for restricting tendering 90. Two-stage tendering B—Open Tendering 91. Open tendering for defense related materials 92. Publication of invitation notice 93. Contents of an invitation notice 94. Preparation of bidding documents/contents of bidding documents PART VPROCUREMENT PLANNING Division IPreparation Steps for Initiating Procurement Proceedings 95. Annual planning for budget preparation purposes 96. Apportioning of procurement 97. Planning for individual procurement proceedings 98. Initiation of procurement proceedings 99. Valuation of procurement 100. Requisitioning for procurement 101. General principles…

NURSES AND MIDWIVES: SUBSIDIARY LEGISLATION NURSES AND MIDWIVES (FEES) REGULATIONS ARRANGEMENT OF REGULATION REGULATION 1. Citation 2. Fees 3. Failure to renew registration 4. Renewal of registration after being barred from practice 5. Revocation of Regulations SCHEDULE G.N. 70/201928/2024 NURSES AND MIDWIVES (FEES) REGULATIONS under s. 85 1. Citation These Regulations may be cited as the Nurses and Midwives (Fees) Regulations. 2. Fees The fees set out in the Schedule hereto shall be payable in respect of the matters to which they relate. 3. Failure to renew registration Any registered person who does not renew the membership with the Council by the prescribed date shall not be allowed to practice anywhere in Malawi and the Council shall remove his name from the register. 4. Renewal of registration after being barred from practice Where a person who has been barred from practice wishes to be restored in the Register and renew membership, the person shall pay in addition to the penalty, the prescribed registration fees as prescribed in the Schedule for each period not. 5. Revocation of Cap. 36:02 sub. leg. p. 41 The Nurses and Midwives (Fees) Regulations are hereby revoked. G.N. 28/2024 reg. 2 SCHEDULE ItemMatterFees K t 1.Index fees for— (a)a Malawian student25,000 00 (b)a non-Malawian student US$ 200 00 2.Initial application fee for training institution 1,000,000 00 3.Assessment of training institution/programme for accreditation— (a)institution/degree programme1,125,000 00 (b)institution/diploma programme750,000 00 (c)institution/certificate programme750,000 00 (d)accreditation certificate250,000 00 (e)annual subscription per programme300,000 00 4.Verification fees for— (a)a Malawian national from outside to work in Malawi with a licence150,000 00 (b)a Malawian national from outside to work in Malawi without a licence125,000 00 (c)registration for a non-Malawian national to work in MalawiUS$ 450 00 (d)registration for a non-Malawian national on voluntary work for a minimum period of six months in Malawi US$ 400 00 (e)temporary registration for a non-Malawian national on voluntary work for a period of less than six months in MalawiUS$ 450 00 5.Verification and validation fees for Malawian Nurses and Midwives intending to practice outside Malawi for— (a)work300,000 00 (b)voluntary work100,000 00 6.Verification fees for a Malawian student for— (a)studies outside Malawi100,000 00 (b)studies within Malawi50,000 00 7.Registration fees for private health facilities providing nursing and/or midwifery services— (a)inspection for nurse/midwife led clinic, agency150,000 00 (b)initial licence for nurse/midwife led clinic, agency200,000 00 (c)annual renewal of a licence for nurse/midwife led clinic, agency 75,000 00 (d)inspection for nurse/midwife led hospital200,000 00 (e)initial licence for nurse/midwife led hospital 200,000 00 (f)annual renewal of a licence for nurse/midwife led hospital150,000 00 (g)inspection for a clinic providing nursing and midwifery services 150,000 00 (h)initial licence for a clinic providing nursing and midwifery services 150,000 00 (i)annual renewal of a licence for a clinic providing nursing and midwifery services75,000 00 (j)inspection for a hospital providing nursing and midwifery services-tertiary 500,000 00 (k)initial licence for a hospital providing nursing and midwifery services-tertiary500,000 00 (l)annual renewal of a licence for a hospital providing nursing and midwifery services tertiary450,000 00 (m)inspection for a hospital providing nursing and midwifery services-secondary300,000 00 (n)initial licence for a hospital providing nursing and midwifery services-secondary300,000 00 (o)annual renewal of a licence for a hospital providing nursing and midwifery services-secondary250 000 00 (p)inspection for a school or trailing institution clinic providing nursing and midwifery services150,000 00 (q)initial licence for a school or training institution clinic providing nursing and midwifery services 150,000 00 (r)annual renewal of a for a school or training institution clinic providing nursing and midwifery services 150,000 00 (s)inspection for a company or organizational clinic providing nursing and midwifery services250,000 00 (t)initial licence for a company or organizational clinic providing nursing and midwifery services250,000 00 (u)annual renewal of a licence for a company or organizational clinic providing nursing and midwifery services 200,000 00 8.Annual licence fees for public and faith based health institution providing nursing and midwifery services— (a)OPD/Dispensary clinic75,000 00 (b)Health Centres100,000 00 (c)Secondary health facilities (CHAM hospitals/community hospitals, district hospitals)150,000 00 (d)Tertiary health facilities 300,000 00 9.Fees for Nurses and Midwives annual licence renewal— (a)Community Midwife Assistant10,000 00 (b)Nurses Midwife Technicians (NMT)18,750 00 (c)University Diplomats (RN) 18,750 00 (d)Bachelors Degree (RN) 28,750 00 (e)Master’s Degree37,500 00 (f)Doctorate Degree (PhD)56,250 00 10.Professional examination fee per paper31,250 00 11.Replacement fees for— (a)notification of results slip5,000 00 (b)index certificate6,500 00 (c)registration certificate25,000 00 (d)receipt5,000 00 12.Fees for curriculum review6,000,000 00 NURSES AND MIDWIVES (SCOPE OF NURSING PRACTICE) REGULATIONS under s. 85 G.N. 12/2002 1. Citation These Regulations may be cited as Nurses and Midwives (Scope of Nursing Practice) Regulations. 2. Interpretation In these Regulations, unless the context otherwise require— “assessment” means collection of data about a person relating to the person’s status; “decision-making” means a deliberative cognitive process consisting of sequential steps that can be analyzed, refined and integrated to yield greater precision and accuracy in solving problems and initiating…

DANGEROUS DRUGS: SUBSIDIARY LEGISLATION DANGEROUS DRUGS REGULATIONS ARRANGEMENT OF REGULATIONS PRELIMINARY REGULATION 1. Citation 2. Interpretation PART IPART I DRUGS 3. Occupier and owner 4. Restrictions on unauthorized or unlicensed persons 5. Restrictions on authorized or licensed persons 6. Cultivation 7. Clearing of land 8. Persons permitted to acquire, possess, and supply Part I drugs 9. Records PART IIPART III DRUGS 10. Manufacture only by authorized persons 11. Conditions of manufacture 12. Supply by unauthorized person 13. Supply and administration 14. Possession 15. Conditions on authorized possession 16. Treatment 17. Persons authorized to administer treatment 18. Authority of authorized seller 19. Midwife’s use of drugs 20. Use of drugs by an aircraft operator 21. Licensing by the Minister 22. Form of prescription 23. Preconditions to supplying Part III drug or preparation 24. Procurement by an authorized or licensed person 25. Report of necessity of prescribing a Part III drug 26. Addiction 27. Marking of package or bottle 28. Register of quantity dispersed 29. Diacetylmorphine PART IIIPARTIALLY CONTROLLED DRUGS 30. Possession and manufacture 31. Restrictions 32. Marking and quantity 33. Register of quantity and purchase 34. Exceptions PART IVGENERAL 35. Possession 36. Interpretation 37. Revocation 38. Withdrawal of authority 39. Delivery to an agent of the recipient 40. Export from another country 41. Exemption 42. Method of keeping a register 43. Preservation of records 44. Form of application for a licence or permit 45. Import and export restrictions 46. Consignment of drugs 47. Cessation of practice Schedules G.N. 59/1956(F227/1956(F)321/1959(F)138/1961(F250/1963(F)224/1963 DANGEROUS DRUGS REGULATIONS under s. 2 (1) PRELIMINARY 1. Citation These regulations may be cited as the Dangerous Drugs Regulations. 2. Interpretation (1) In these Regulations, unless inconsistent with the context— “authorized person” means a person authorized or treated as authorized in terms of regulation 8, 16 (1), 17, 18, 19, 20 or 39 (2), as the context in each case requires, to supply, administer, distribute, procure, advertise for sale, acquire, possess, carry on any process in the manufacture of or manufacture any drug by virtue of being a person or a member of a class of persons specified in that section, and “authorized” shall be construed accordingly; “authorized seller of poisons” means any person authorized to sell poisons in terms of any pharmacy or poisons law; “dangerous drugs register” means the register required to be kept in terms of regulation 9,28 or 33; “dental surgeon” means a person (registered or exempted from registration as a dental surgeon or dentist under the Medical Practitioners and Dentists Registration Act; “drug” means any Part I drug, any Part III drug, any any Part III preparation or any partially controlled drug; “licensed person” means a person authorized to supply, distribute, procure, advertise for sale, acquire, possess or, as the case may be, carry on any process in the manufacture of or manufacture any drug or cultivate any plant from which a drug is derived by virtue of the terms and conditions of a licence issued to him for that purpose, and “licence” and “licensed” shall be construed accordingly; “medical practitioner” means a person registered or exempted from registration as a medical practitioner under the Medical Practitioners and Dentists Registration Act; “midwife” means a fully trained practising midwife who is in possession of a valid midwife’s supply order; “midwife’s supply order” means an order in the form prescribed in the First Schedule for the supply of tincture of opium and any preparation containing pethidine; “Part I drug” means any drug to which Part I of the Act applies, other than an extract or tincture of Indian hemp; “Part III drug” means any drug to which Part III of the Act applies which is not— (a) a partially controlled drug; or (b) a Part III preparation; “Part III preparation” means a preparation containing such proportion of any drug to which Part III of the Act applies, other than a partially controlled drug, as is sufficient to make the preparation a drug to which Part III of the Act applies, but does not include— (a) any preparation with respect to which the Minister has, in terms of section 10 (4) of the Act, declared that Part III of the Act shall not or shall cease to apply; or (b) any preparation specified in the Second Schedule; “partially controlled drug” means any drug or product to which the Minister has, in terms of section 10 (3) or, as the case may be, section 14 of the Act, applied Part III of the Act with the modification that the said drug or product shall not be treated as a drug to which Part III of the Act applies for the purposes of Part II of these Regulations; “pharmacist” means a pharmacist or chemist and druggist registered or exempted from registration in terms of the Pharmacy and Poisons Act; “prescription” means…

PESTICIDES: SUBSIDIARY LEGISLATION PESTICIDES (CESS) ORDER under s. 13 G.N. 40/2020 1. Citation This Order may be cited as the Pesticides (Cess) Order. 2. Pesticides cess (1) The Board shall impose a levy to be known as “pesticides cess” on all importation into, or manufacturing in, Malawi of a pesticide. (2) The pesticides cess referred to under subparagraph (1) shall be levied at the rate of— (a) for imported pesticides, 0.05 per cent of landed costs; and (b) for pesticides manufactured in Malawi, 0.05 per cent of production costs of the pesticide. (3) All the monies due and payable in respect of the pesticides cess levied under this paragraph shall be payable to the Board, at the time of applying for a permit to manufacture a pesticide or import a pesticide. PESTICIDES REGULATIONS ARRANGEMENT OF REGULATIONS REGULATION PART IPRELIMINARY 1. Citation 2. Interpretation PART IIREGISTRATION OF PESTICIDES 3. Application for registration 4. Processing of application 5. Registration of a pesticide 6. Invalid application 7. Form of certificate of registration 8. Simplified assessment 9. Application for permit to import pesticides 10. Form of permit PART IIIPRESENTATION OF PESTICIDES 11. Packaging 12. Labelling 13. Information to be contained on a label 14. Label to bear a colour band 15. Hazard statement on labels 16. Terms not to be printed on label 17. Household pesticides 18. Residues and time 19. Advertising 20. Hazard statement on advertisements 21. Puffery or misleading advertisement PART IVMANUFACTURING, IMPORTATION, EXPORTATION, TRANSPORTATION, SALE, STORAGE, APPLICATION AND PACKAGING OF PESTICIDES 22. Application for a licence to manufacture or a permit to export or transport pesticides 23. Application for a commercial pesticide applicator’s licence 24. Application for a sale or storage licence 25. Additional authorization to sale licence, etc. 26. Form of sale or storage licence 27. Persons to whom licence may be issued 28. Display of licence, etc. PART VCONTROL OF STOCKPILING, POLLUTION AND SMUGGLING OF PESTICIDES 29. Temporary ban 30. Smuggling prevention 31. Extension of shelf life 32. Declaration of stockpiling 33. Declaration of contamination 34. Pesticides register PART VIMISCELLANEOUS 35. General penalty 36. Fees 37. Administrative fines 38. Revocation FIRST SCHEDULE SECOND SCHEDULE THIRD SCHEDULE FOURTH SCHEDULE FIFTH SCHEDULE SIXTH SCHEDULE SEVENTH SCHEDULE EIGHTH SCHEDULE G.N. 11/2023 PESTICIDES REGULATIONS under s. 53 PART IPRELIMINARY 1. Citation These Regulations may be cited as the Pesticides Regulations. 2. Interpretation In these Regulations, unless the context otherwise requires— “biopesticide” means a substance derived from nature, such as microbial or biochemical which include botanicals (plant extracts) and semiochemicals, that may be formulated and applied in a manner similar to a conventional chemical pesticide and that is used for pest control; “botanical pesticide” means a botanical substance that consists of one or more components found in plants and obtained by subjecting plants or parts of plants of the same species to a process such as pressing, milling, crushing, distillation or extraction and the process may include further concentration, purification or blending, provided that the chemical nature of the components is not intentionally modified or altered by chemical or microbial processes; “consignment” means a pesticide lot as per import permit; “country of origin” means a country where the pesticide was manufactured or formulated; “microbial pesticide” means a microorganism, including a protozoan, fungus, bacterium, virus, or other microscopic self-replicating biotic entity and any associated metabolites, to which the effects of pest control are attributed; “obsolete pesticides” means stocked pesticides that can no longer be used for their original purpose or any other purpose and therefore require disposal; “permit” means a permit issued in accordance with section 20 of the Act, authorizing the importation, exportation and transportation of a pesticide; “pesticide waste” means pesticides, empty pesticide containers and materials contaminated with pesticides that are no longer wanted or needed; “sales licence” means a licence issued in accordance with the provisions of section 25 of the Act; “smuggling” means bringing pesticides whether registered or unregistered into Malawi, with the intention to deprive the Government of Malawi of any revenue or to defeat any of the provisions of the Act, these Regulations or any other written law; “stockpiling” means inessential gradual accumulation of obsolete pesticides or used pesticide containers or materials contaminated with pesticides; “storage licence” means a licence issued in accordance with the provisions of section 25 of the Act; and “transportation” includes conveying, ferrying, moving, relocating, shifting and shipping of pesticides. PART IIREGISTRAITON OF PESTICIDES 3. Application for registration (1) An application for registration or re-registration of a pesticide in accordance with Part IV of the Act shall be in the form set out in Form I in the First Schedule. (2) Every application for registration shall be accompanied by— (a) a commercial sample of the pesticide, unless this requirement is waived by the Board, with sufficient reasons in writing; (b) an analytical standard of the…

MEDICAL PRACTITIONERS AND DENTISTS: SUBSIDIARY LEGISLATION MEDICAL PRACTITIONERS AND DENTISTS (PRIVATE PRACTICE) REGULATIONS ARRANGEMENT OF REGULATIONS REGULATION PART IPRELIMINARY 1. Citation 2. Interpretation PART IIELIGIBILITY FOR A PRIVATE PRACTICE LICENCE 3. Eligibility for a private practice licence under Part IX of the Act 3A. Specialists engaging in general practice 4. Practitioners in public service eligible for a private practice licence 5. Absence from active clinical practice PART IIIPRIVATE PRACTICE LICENCE 6. Application for issue or renewal of licence 7. Form, validity and renewal of licence 8. Licence fees 9. Replacement of licence 10. Number of clinics 11. Types of clinics 12. Assistants PART IVLOCUM PRACTICE 13. Locums PART VX-RAY FACILITIES AND CLINICAL LABORATORIES 14. X-ray facilities 15. Clinical laboratories 16. Use of X-ray facilities and clinical laboratories for referred cases 17. Unlawful use of X-ray facilities or clinical laboratories PART VIGENERAL 18. The Council to approve premises 19. Conditions of licence 19A. Council to inspect and register health facilities 20. Notification of diseases, etc., and monthly returns 21. Restriction on practice outside field of specialization 22. Personal conduct 23. Manner of indicating name, etc., of the licencee 24. Change of premises and other particulars relating to a licence 25. Cancellation of licence 26. Penalty PART VIITRANSITIONAL PROVISIONS 27. Transitional provisions SCHEDULES G.N. 127/198884/198919/1991120/199340/199427/199730/200435/20048/200548/200710/20091/20167/2023 MEDICAL PRACTITIONERS AND DENTISTS (PRIVATE PRACTICE) REGULATIONS under s. 69 PART IPRELIMINARY 1. Citation These Regulations may be cited as the Medical Practitioners and Dentists (Private Practice) Regulations. 2. Interpretation In these Regulations, unless the context otherwise requires— “approved institution” means an institution specified in the First Schedule; G.N. 10/2009 “institutional facility” means a clinic or dispensary operated by a company or other organization solely for providing services to its employees and any dependants living with the employees; “locum” means a medical practitioner or dentist substituting or providing service for another medical practitioner or dentist in the absence of that other; Third Schedule G.N. 84/1989 “notifiable disease” means a disease specified in the Third Schedule; Sixth Schedule “private practice” means the giving of medical, surgical or dental advice or treatment by a medical practitioner or a dentist for a fee, but does not include such activity if undertaken by a medical practitioner or dentist as part of his duties as an employee at an institution specified in the Sixth Schedule. PART IIELIGIBILITY FOR A PRIVATE PRACTICE LICENCE G.N. 40/1994 3. Eligibility for a private practice licence under Part IX of the Act (1) Subject to subregulation (2), no person shall be issued with a licence authorizing him to engage in private practice on his own behalf as a private practitioner or to be employed, either whole time or part-time, as a private practitioner unless he has served as a medical practitioner or dentist in an approved institution for a continuous period of not less than two years. (2) Where the Council is satisfied that an applicant for a private practice licence has, from his practice undertaken wholly in another country or partly in Malawi and partly in another country, obtained sufficient experience appropriate to the conditions in Malawi in relation to the kind of private practice in which he intends to engage, the Council may, notwithstanding that the applicant has not served the minimum period specified under subregulation (1), issue to him a private practice licence subject to such conditions as the Council may impose; and the Council may require such conditions to be fulfilled either prior or subsequent to the grant of the licence. G.N. 48/2007 3A. Specialists engaging in general practice All specialists who want to engage in general practice work except for specialists in paediatrics, surgery, medicine and obstetrics and gynaecology shall be required to undergo an orientation for a minimum period of six (6) months at a hospital approved by the Council before being allowed to practice as such. Sixth Schedule G.N. 84/1989 4. Practitioners in public service eligible for a practice licence Save as otherwise provided in the contract of employment in the case of a contract or an expatriate officer, a medical practitioner or dentist employed in the public service or other organization owning or operating an establishment specified in the Sixth Schedule shall be eligible for a private practice licence under these Regulations if he satisfies the other requirements of these Regulations, but a licence issued to him shall be subject to such arrangements as may be approved by the Minister (in the case of those in the public service) or by or on behalf of the organization (in the case of those in such other organization) with regard to— (a) the time when such medical practitioner or dentist may or may not engage in private practice; (b) the use, by such medical practitioner or dentist for the purposes of his private practice, of any premises, equipment and facilities within,…

PHARMACY AND MEDICINES REGULATORY AUTHORITY: SUBSIDIARY LEGISLATION PHARMACY AND MEDICINES REGULATORY AUTHORITY (FEES AND FORMS) REGULATIONS under s. 129 G.N. 9/2022 1. Citation These Regulations may be cited as the Pharmacy and Medicines Regulatory Authority (Fees and Forms) Regulations. 2. Fees The Authority shall charge the fees specified in the First Schedule, in respect of the matters correspondingly specified herein. 3. Surcharge (1) The Authority shall charge a surcharge to any person who fails to pay retention fees as specified in the First Schedule. (2) A person who fails to pay retention fees— (a) within three months of the commencement of the Authority’s financial year, shall pay a surcharge of fifty per cent of the retention fees payable; and (b) after three months of the commencement of the Authority’s financial year, shall pay a surcharge of one hundred per cent of the retention fees payable. 4. Forms The forms set out in the Second Schedule shall be used for the purposes of the Act. FIRST SCHEDULE reg. 2 PRESCRIBED FEES MatterFeesK t 1. Registration fees for pharmacy personnel: on application for registration including issuance of a certificate— (a) pharmacist— (i) Malawian pharmacist, including internship50,000 00 (ii) non-Malawian pharmacist including vettingUS$1,000 00 (iii) Malawian pharmacist re-examination fees, per subject25,000 00 (iv) non-Malawian pharmacist re-examination fees, per subjectUS$215 00 (v) non-Malawian volunteer pharmacistUS$250 00 (b) pharmacy technologist— (i) Malawian technologist 30,000 00 (ii) non-Malawian technologist, including vetting US$700 00 (iii) Malawian technologist re-examination fees, per subject 10,000 00 (iv) non-Malawian technologist re-examination fees, per subject US$175 00 (c) pharmacy assistant— (i) Malawian pharmacy assistant20,000 00 (ii) non-Malawian pharmacy assistant, including vetting US$400 00 (iii) Malawian pharmacy assistant re-examination fees, per subject8,000 00 (iv) non-Malawian pharmacy assistant re-examination fees, per subject US$100 00 (d) medical representative— (i) Malawian medical representative150,000 00 (ii) non-Malawian medical representative US$700 00 2. Retention fees for pharmacy personnel— (a) pharmacist— (i) Malawian pharmacist 30,000 00 (ii) non-Malawian pharmacist US$550 00 (iii) non-Malawian volunteer pharmacistUS$250 00 (b) pharmacy technologist— (i) Malawian technologist 20,000 00 (ii) non-Malawian technologist US$300 00 (c) pharmacy assistant— (i) Malawian pharmacy assistant15,000 00 (ii) non-Malawian pharmacy assistantUS$300 00 (d) medical representatives— (i) Malawian medical representative75,000 00 (ii) non-Malawian medical representativeUS$300 00 3. Licencing of premises— (a) manufacturing licence— (i) inspection and processing for oral dosage forms (solids and liquids) 1,500,000 00 (ii) inspection and processing for external preparations 1,300,000 00 (iii) inspection and processing for sterile preparations 1,700,000 00 (iv) inspection and processing for primary and secondary packaging 1,000,000 00 (v) reinspection of premises, if previously failed*cost of travel (b) wholesale pharmacy licence— (i) inspection and processing 760,000 00 (ii) reinspection fees of premises, if previously failed *cost of travel (c) retail pharmacy licence— (i) inspection and processing 385,000 00 (ii) reinspection fees of premises, if previously failed *cost of travel (d) medicine store licence or veterinary shop licence— (i) inspection and processing200,000 00 (ii) reinspection fees of premises if previously failed *cost of travel (e) dispensing licence— (i) inspection and processing of licence for a facility with an admission service335,000 00 (ii) inspection and processing of licence for a facility without an admission service200,000 00 (iii) reinspection fees of premises, if previously failed *cost of travel (f) medical device: wholesale, retail and cosmetic shop— (i) inspection and processing710,000 00 (ii) reinspection fees of premises, if previously failed *cost of travel *Cost of travel shall be determined by agreement between the Authority and the applicant. 4. Retention fees for premises— (a) manufacturing licence— (i) premises with oral dosage forms (solids and liquids) 350,000 00 (ii) premises with external preparations 260,000 00 (iii) premises with sterile preparations400,000 00 (iv) primary packaging only 200,000 00 (v) secondary packaging only 120,000 00 (b) wholesale pharmacy licence— (i) retention fees320,000 00 (ii) inspection and relocation processing 520,000 00 (c) retail pharmacy licence— (i) retention fees 160,000 00 (ii) inspection and relocation processing235,000 00 (d) medicine store and veterinary shop licence— (i) retention fees60,000 00 (ii) inspection and relocation processing160,000 00 (e) medical device: wholesale, retail and cosmetic shop— (i) retention fees320,000 00 (ii) inspection and relocation processing 560,000 00 (f) dispensing licence— (i) retention for a facility with an admission service 160,000 00 (ii) inspection and relocation processing235,000 00 (iii) retention for a facility without and admission service 55,000 00 (iv) inspection and relocation processing155,000 00 5. Registration of medicinal products— (a) human, veterinary and herbal medicinal products— (i) human or veterinary product manufactured in Malawi300,000 00 (ii) human or veterinary product manufactured in Malawi (expedited processing of application)600,000 00 (iii) human or veterinary product manufactured outside MalawiUS$1500 00 (iv) human or veterinary product manufactured outside Malawi (expedited processing of application)US$3000 00 (v) herbal product manufactured in Malawi80,000 00 (vi) herbal product manufactured outside MalawiUS$1,100 00 (vii) human or veterinary product packed in Malawi but manufactured outside MalawiUS$450 00…

PUBLIC HEALTH: SUBSIDIARY LEGISLATION APPLICATION OF ACT NOTICES under s. 2 G.N. 144/1948230/1949127/1950211/1950178/1952268/197088/1971 It has been directed that the provisions of the Act specified in the first column of the Schedule hereto shall apply in whole or in part to Malawi as specified in the second column of the said Schedule— SCHEDULE Provisions of the ActMalawi, or part thereof The whole, except section 120Those areas which are within a radius of two miles from the Monkey Bay Hotel, in the Mangochi District PART IThe whole of Malawi PART IIThe whole of Malawi PART IIIThe whole of Malawi PART IVThe whole of Malawi PART VThe whole of Malawi PART VIThe whole of Malawi PART VIIThe whole of Malawi PART VIIIThe whole of Malawi PART IX— Sections 59–61 inclusive; 62 subsections (1)–(4) inclusive, (9), (10), (13), (15), (17), (19), and (23); 63–70 inclusive; and 72–77 inclusiveThe whole of Malawi Section 62 subsections (5)–(8) inclusive, (11), (12), (14), (16), (18), (20), (21), and (22); and 71All Municipalities, Townships and the settled areas of Chinteche, Mzimba, Nkhotakota, Kasungu, Ncheu, Chiradzulu, Mulanje, Luchenza, Chikwawa PART X— Sections 79–94 inclusive Those areas which are within a radius of four miles from the District Commissioner’s office at Zomba in the Zomba District The settled areas of the Thyolo District PART XI— Sections 96–100 inclusive and 102 PART XV— Sections 120, 121, 124 and 125 PART X— Sections 78 and 95The whole of Malawi Those areas which are within a radius of one mile from the Cape Maclear Hotel in the Mangochi District PART XI— Sections 96–100 inclusive and 102 Section 101The whole of Malawi PART XIIThe whole of Malawi PART XIIIThe whole of Malawi PART XIVThe whole of Malawi PART XV—Sections 122,123 and 126The whole of Malawi PART XVIThe whole of Malawi PUBLIC HEALTH (INFECTED AREAS) (HUMAN TRYPANOSOMIASIS) RULES under s. 31 G.N. 196/1952197/1954(F)224/1963 1. Citation These Rules may be cited as the Public Health (Infected Areas) (Human Trypanosomiasis) Rules. 2. Interpretation In these Rules, the expression “infected area” means any part of Malawi which has been declared by the Minister to be an infected area by reason of the disease of human trypanosomiasis under section 31 of the Act. 3. Powers of officials The Secretary for Health, a medical officer, and any person authorized in writing by the Secretary for Health or a medical officer, may— (a) require any person residing in an infected area who is suffering or suspected to be suffering from human trypanosomiasis to submit to medical examination; (b) require any person who enters or leaves an infected area to submit to medical examination; (c) cause any person found to be suffering from human trypanosomiasis or who has been in contact with any person suffering from human trypanosomiasis to be removed to a hospital or to any other place designated by the Secretary for Health for the reception of such persons; (d) require any person found to be suffering from human trypanosomiasis to undergo medical treatment for that disease for such period of time and at such place as a medical officer may direct; (e) provide any medical aids which may be required for the treatment of persons suffering from human trypanosomiasis, including the provision of emergency hospitals, camps and stations; (f) require all persons resident in an infected area or in any part thereof to attend at such place as may be specified by the Secretary for Health for registration; (g) require the owner of any vehicle normally kept in an infected area to register such vehicle at such place and in such manner as may be specified by the Secretary for Health; (h) restrict the movement of vehicles or animals within an infected area; (i) specify the areas in which wood may not be cut in an infected area; (j) prohibit or control the entry of persons into an infected area who are not normally resident therein; (k) prohibit or control any hunting within an infected area; (l) require vehicles and persons to stop at any place indicated for the purpose and to submit to disinsectization to prevent the spread of tsetse flies. 4. Entrance into places within infected area The Secretary for Health, a medical officer and any person authorized in writing by the Secretary for Health or a medical officer, may at all times enter into any building or place within an infected area for any purpose connected with the performance of any power conferred by rule 3. 5. Offences Any person who— (a) obstructs the Secretary for Health, a medical officer, or a person duly authorized by the Secretary for Health or a medical officer under these Rules, in the exercise of any power conferred by these Rules; or (b) fails, neglects or refuses to comply with any requirement made under these Rules; or (c) does any act…

MENTAL TREATMENT: SUBSIDIARY LEGISLATION (Subsidiary legislation made under the Asylums Ordinance, 1928(18 of 1928) and still in force by virtue of section 68 of the Mental Treatment Act is omitted as it is shortly to be replaced) MENTAL TREATMENT (PRESCRIBED FORMS) RULES under s. 67 G.N. 61/1949224/1963 1. Citation These Rules may be cited as the Mental Treatment (Prescribed Forms) Rules. 2. Forms The Forms to be used for the purposes of the Act shall be the Forms prescribed in the Schedule hereto. r. 2 SCHEDULE FORM No. 1 THE MENTAL TREATMENT ACT (CAP. 34:02) APPLICATION FOR RECEPTION ORDER (under section 11 of the Act) In the ……………………………………… Subordinate Court of ………………………… The petition of ……………………………………. of ………………………………………….. 1. I hereby make application for the reception into a Mental Hospital of …………………………………………………………………. of …………………………….. as a person of unsound mind. 2. I am over 21 years of age and I have personally seen the said ………………………………………… ………………………………… within fourteen days immediately prior to the date hereof. 3. (a) I am the husband/wife of the said ………………………………………………………………….. or (b) I am related to the said ………………………………………….. in the following manner ……………………………………………. and the said …………………………………………………………………. is unmarried or the husband/wife of the said ………………………………….. is absent, incapacitated, has neglected, is unwilling to present a petition or (c) I am not related to the said ……………………………………….. I am connected with the said ……………………………………………. in the following manner: The reasons why this petition is not presented by a relative of the said ……………………………. are as follows— ……………………………………………………………………………………………… 4. I submit herewith a medical certificate signed by ………………………………………….. who is/is not a relative, partner, or assistant of the said ……………………….. or of the petitioner. The said …………………………….. is related to ……………………………… the said …………………… ………………………………… or to the petitioner in the following manner: 5. No previous application has been presented in any Court for a judicial inquiry into the mental capacity of the said …………………………………………………. or A previous application was presented on the ………………….. day of ……………………. 19 ….. in the …………………………………………. Court …………………………………….. for a judicial inquiry into the mental capacity of the said …………………………………………….. A certified copy of the order made thereon is attached hereto. The Petitioner therefore prays that the Court will be pleased to make a reception order as prayed. I certify that the above statements are true. Dated ………………………………………………… Signature …………………………………… Petitioner STATEMENT OF PARTICULARS (If any of the particulars in this statement are not known, the fact to be so stated.) The following is a statement of particulars relating to the said person: Name of patient at length………………………………………………………………………………………… Sex and age………………………………………………………………………………………………………… Married, single or widowed ……………………………………………………………………………………… Occupation …………………………………………………………………………………………………………. Tribe and religious belief, as far as known …………………………………………………………………… Residence ………………………………………………………………………………………………………….. Names of relatives ………………………………………………………………………………………………… When first showed signs of unsoundness of mind………………………………………………………….. Age (if known) on first attack ……………………………………………………………………………………. Whether previously under care and treatment ……………………………………………………………….. Supposed cause ……………………………………………………………………………………………………. Whether the patient is subject to epilepsy ……………………………………………………………………. Whether suicidal ……………………………………………………………………………………………………. Whether he is known to be suffering from phthisis or any form of tubercular disease…………………. ………………………………………………………. Whether dangerous to others, and in what way …………………………………………………………….. Whether he is capable of looking after himself ……………………………………………………………… With whom he has been living ………………………………………………………………………………….. Whether the patient is addicted to the use of any drug or intoxicant …………………………………… Whether any near relative (stating the relationship) has been afflicted with insanity …………………. ………………………………………………………….. I certify that the above statements are true. Date ……………………………………………………………………………………………. Signature of person making the Statement FORM No. 2 THE MENTAL TREATMENT ACT (Cap. 34:02) MEDICAL CERTIFICATE (under section 22 of the Act) In the matter of …………………………… In the District of ………………………….. I, …………………………………. do hereby certify as follows— 1. On the ………………… day of ………………19 …, at ……………………………….. in the District of ……………………… I personally examined the said ……………………………….. and I am of opinion that the said ……………………………. is of unsound mind and a proper person to be taken charge of and detained under care. 2. I formed this conclusion on the following grounds— (a) Facts indicating insanity observed by myself:— (Here state observations) (b) Other facts, if any, indicating insanity communicated to me by others. (Here state information and from whom)— Here state whether the person giving the certificate is a registered or a licensed medical practitioner. Signed ……………………………….. Qualifications …………………………….. FORM No. 3 THE MENTAL TREATMENT ACT (Cap. 34:02) RECEPTION ORDER (under section 16 of the Act) In the ……………………………………. Subordinate Court of …………………………….. Whereas …………………………………………………………………………………. has been brought before this Court (on the petition of …………………………………………………….. ) under section ………………………………….. of this Act. And whereas ……………………………………………………………………. *State whether a registered or a licensed medical practitioner. has examined the said ………………………………………………………………. and furnished me with a certificate as to mental state. Now I, ………………………………………………………………………………………. Magistrate of the ………………………………………………………………………………………. Class Subordinate Court at ………………………………………………………………………………… having considered the…