Pharmacy, Medicines and Poisons Act
- Assented to on 18 May 1988
- Commenced on 15 January 1991
- [This is the version of this document at 31 December 2014.]
- [Note: This version of the Act was revised and consolidated in the Fifth Revised Edition of the Laws of Malawi (L.R.O. 1/2018), by the Solicitor General and Secretary for Justice under the authority of the Revision of the Laws Act.]
1. Short titleThis Act may be cited as the Pharmacy, Medicines and Poisons Act.
Part I – Preliminary
Part II – Administration
3. Establishment of a Pharmacy, Medicines and Poisons BoardThere is hereby established a board to be known as the Pharmacy, Medicines and Poisons Board (in this Act referred to as the “Board”) which shall be a body corporate having perpetual succession and a common seal and shall under that name, be capable of suing and being sued and of purchasing or otherwise acquiring, holding and alienating moveable or immoveable property and, subject to the provisions of this Act, of doing or performing all such acts and things as bodies corporate may by law perform.[30 of 1991]
4. Composition of the Board
5. Vacation, etc., of members from office
6. Filling of vacancies on the Board
7. Co-opted personsThe Board may in its discretion at any time and for any length of period invite any person, and the Minister may in like manner nominate any officer in the public service, to attend any meeting of the Board and take part in the deliberations of the Board, but such person or officer shall not be entitled to vote at that meeting.
8. Chairman and Vice-Chairman
9. Meetings of the Board
10. Functions of the BoardThe Board shall be the sole registering authority of all persons required to be registered under this Act and shall have the following further functions—
11. Powers of the BoardFor the better performance of its functions, the Board shall, subject to this Act, have power—
12. Committees of the Board
13. Appointment of the Registrar and other staff
14. Funds, accounts and audit
15. LevyThe Minister may from time to time, by order published in the Gazette, impose a levy on gross or net income accruing to any person or class of persons registered under this Act and such levy shall be appropriated for the general operations of the Board or for such operations of the Board as the Minister may specify in the order.
16. Remuneration and expenses of members of the BoardMembers of the Board shall be paid from the funds of the Board such allowances as the Minister may determine and in determining the allowance the Minister may make provision for the reimbursement of any reasonable expenses incurred by a member of the Board or of a committee in connexion with the business of the Board or the committee.
Part III – Pharmacy
17. No person to carry on pharmacy business unless registered
18. Persons registered under the repealed Act
19. Residence of registered persons
20. Persons eligible to be registered as pharmacists, pharmacy technologists or pharmacy assistants
21. Procedure for registration
22. Certificate of registrationUpon registration by the Board of the applicant in—
23. Application for retention of name on register
24. Removal of name of registered pharmacist, etc., from the register
25. Notification of registration and of removal from registerThe Board shall, from time to time and not less frequently than once every year, cause to be published in the Gazette a notification of all registrations effected under this Act and of all removals from any register.
26. Appeals against refusal to register or against removal from register
27. Display of certificate of registration on premises where pharmacy business is carried onNo person shall carry on a retail pharmacy business unless the name and certificate of registration of the person having control of the premises in which such business is carried on are conspicuously exhibited therein.
28. Registration of premises where pharmacy business is to be carried on
29. Company may carry on a retail pharmacy business upon certain conditions
30. Representatives of deceased or insolvent pharmacistsNotwithstanding anything contained in the foregoing provisions of this Part—
31. Exemptions from this Part
32. Pharmacy Committee
33. Pharmacy Committee to be the disciplinary committee of the Board
Part IV – Medicinal products
34. Licensing authorityThe Board shall be the licensing authority responsible for the granting, renewal, variation, suspension and revocation of licences and certificates under this Part.[19 of 1995]
35. Classes of licences
36. ExemptionsThe provisions of section 35 shall not apply to—
37. Application for licences
38. Matters to be considered before issuing a licenceWhere an application is made for a licence under this Part, the licensing authority shall, before issuing the licence to which the application relates, consider the following—
39. Issue of licences
40. Suspension and revocation of a licence
41. Variation of a licenceSubject to section 37, the licensing authority may, on the application of the holder of a licence under this Part, vary the provisions of the licence in accordance with any proposals contained in the application, if the licensing authority is satisfied that the variation will not adversely affect the safety, quality or efficacy of medicinal products.
42. Clinical trial
43. Animal test
44. Clinical trial and animal test certificates
Part V – Provisions relating to dealings in medicinal products
45. Restrictions on sale of medicinal products
46. Circumstances in which restrictions on sale of medicinal product may not apply
47. Sale and administration of medicinal product to be subject to prescription by appropriate practitioner
48. Restrictions on wholesale dealingsThe Minister may by Order published in the Gazette provide for restrictions on the sale or supply of medicinal products by way of wholesale dealing.
49. Prohibition of adding to or abstraction of any substance from medicinal products
Part VI – Containers, package, and identification of medicinal products
50. Medicinal product to be in labelled containers or packages
Part VII – Promotion of sales of medicinal products
52. Regulations for advertising of medicinal productsThe Minister may make regulations which may prohibit any issue of advertisements—
53. Meaning of advertisement
54. Medicines Committee
Part VIII – Poisons
55. Preparation of poisons list
56. Prohibition of, and conditions with respect to, sale of poisons
57. Poisons Committee
Part IX – Provisions for non-medicinal products
58. Provisions relating to substances which are not medicinal products
Part X – Inspection
60. Entry into premises
61. Mode of inspection
61A. Closure of premises and seizure of equipment, etc.
62. Non-disclosure of information
63. Inspectors not to be personally liable for acts done by them under the ActAn inspector shall not be personally liable in respect of any act done by him in the course of his employment and in the execution or purported execution of any duty under this Act.
64. Offences by a corporate bodyWhere under this Act, an offence committed by a body corporate is proved to have been committed with the consent and connivance of, or to be attributable to any neglect on the part of, any director, manager, secretary or other similar officer of the body corporate or any person who was supposed to act in any capacity, such officer and the body corporate shall severally and jointly be guilty of an offence.
Part XI – Regulations and savings
66. RegulationsThe Minister may, with the advice of the Board, make regulations for carrying out or giving effect to the provisions of this Act and, without prejudice to the generality of the foregoing, such regulations may—
67. Repeal and savings
History of this document
31 December 2014 this version
15 January 1991
18 May 1988