Dangerous Drugs (Production of Cannabis for Medicinal and Scientific Use) Regulations, 2018 (S.I. 62 of 2018)

Page 1 of 43 Statutory Instrument 62 of 2018. [CAP. 15:02 Dangerous Drugs (Production of Cannabis for Medicinal and Scientific Use) Regulations, 2018  ARRANGEMENT OF SECTIONS PART I PRELIMINARY Section 1. Title. 2. Interpretation. 3. Application. PART II LICENSING OF SITES AND PERSONS 4. Application for producers’ licence. 5. Authorised person in charge and responsible person in charge. 6. Issuance of licences. 7. Grounds for refusal. 8. Duration of licence. 9. Display of licences. 10. Production and return of licences. 11. Application for variation or amendment of licences. 12. Notice to Minister on change of personnel 13. Notice to Minister on various changes 14. Application for renewal of licence. 15. Statement by signatory of Notice. 16. Annual returns 17. Temporary suspension of licences. 18. Reinstatement of suspended licences. 19. Cancellation of licences following suspension. Page 2 of 43 20. Cancellation on other grounds. 21. Notice of cessation of activities. PART III SECURITY MEASURES PART A- PERIMETER OF SITE 22. Compliance with security measures. 23. Unauthorised access. 24. Visual monitoring of the perimeter of site. 25. Intrusion detection system of the perimeter of site. 26. Monitoring by personnel of the perimeter of site. PART B – AREAS WHERE CANNABIS IS HANDLED 27. Restricted access. 28. Physical barriers. 29. Visual monitoring. 30. Intrusion detection system. 31. Filtration of air. 32. Monitoring by personnel PART IV GENERAL CONDITIONS OF PRODUCTION 33. Good production practices 34. Cultivation of cannabis. 35. Soil and fertilisers. 36. Irrigation. 37. Pest control products 38. Harvesting. 39. Drying. 40. Microbial and chemical contaminants. Page 3 of 43 41. Disintegration of capsule. 42. Maximum yield quantity- cannabis oil. 43. Solvents. 44. Analytical testing. 45. Premises. 46. Equipment. 47. Sanitation programme. 48. Standard operating procedures. 49. Recall. 50. Recall reporting. 51. Quality assurance. 52. Sample of lot or batch. PART V PACKAGING, LABELLING AND SHIPPING 53. Packaging. 54. Accuracy of weight. 55. Accuracy of number of plants. 56. Product label for cannabis oil. 57. Product label for cannabis seeds. 58. Product label for cannabis plants. 59. Presentation of information on label. 60. Expiry date. 61. Reference to Act or Regulations. 62. Shipping. 63. Import and export. 64. Persons authorised to handle cannabis. Page 4 of 43 PART VI RECORD KEEPING 65. Record keeping by licensed producers. 66. Record keeping by authorised persons. 67. Manner of keeping records. 68. Preservation of records. 69. Cannabis inventory. 70. Returned substances. 71. Order for export. 72. Security inventory. 73. Dried cannabis equivalency factor. 74. Batch reconciliation. 75. Research and Development. 76. Destroyed cannabis. 77. Disposal of cannabis. 78. Adverse reactions. 79. Destruction of cannabis after the change in production area. 80. Advertisement of cannabis. PART VII GENERAL 81. Fees. 82. Penalties. 83. Appeals First Schedule: Fees Second Schedule: Forms IT is hereby notified that the Minister of Health and Child Care has, in terms of section 6 of the Dangerous Drugs Act [Chapter 15:02], made the following regulations— PART I Page 5 of 43 PRELIMINARY Title 1. These regulations may be cited as the Dangerous Drugs (Production of Cannabis for Medicinal and Scientific Use) Regulations, 2018. Interpretation 2. In these regulations — “appropriate fee” means the fee prescribed in the First Schedule; “cannabis” includes fresh or dried cannabis, cannabis oil, cannabis plants or cannabis seeds; “cannabis oil” means an oil, in liquid form at room temperature of 22 ± 2°C, that contains cannabis in its natural form; “cannabis plant” includes the whole or any portion, whether green or dry, of any plant of the genus cannabis also known as “Indian hemp”, bhang, camba, dagga, mbanje or intsangu, but excludes— (a) any fibre extracted from the plant for use as or in the manufacture of cordage, canvas or similar products; or (b) any seed which has been crushed, comminuted or otherwise processed in such a manner as to prevent germination; or (c) the fixed oil obtained from the seed; “cannabis resin” means the separated resin, whether crude or purified; “delta-9-tetrahydrocannabinol” means Δ9-tetrahydrocannabinol ((6aR, 10aR) 6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo [b,d] pyran-1-ol); “dried cannabis” means harvested cannabis that has been subjected to any drying process, but does not include seeds; “form” means the appropriate form set out in the Second Schedule; “fresh cannabis” means freshly harvested cannabis buds and leaves, but does not include plant material that can be used to propagate cannabis; “licensed producer” means the holder of a licence issued under Part II; “medical practitioner” means a person registered as such in terms of the Health Professions Act (Chapter 27: 19); “production” means cultivation, drying, extraction, packaging, labelling, storage, and processing of cannabis; “Secretary” means the Secretary responsible for health; Page 6 of 43 “site” means — (a) a building or a place in a building used by a licensed producer; or (b) an area occupied exclusively by buildings used by a licensed producer. Application 3. These regulations shall apply to the production of cannabis intended for medicinal or scientific purposes. PART II LICENSING OF SITES AND PERSONS Application for producer’s licence 4 (1) An application for the issue of a licence in terms of section 27 of the Act shall be made to the Minister, in duplicate and shall be accompanied by— (a) the appropriate fee; (b) three copies of a plan of the site proposed to be licensed which shall comply with the requirement specified in these Regulations; (c) in the case of an individual, proof of citizenship or proof of being ordinarily resident in Zimbabwe or proof of an exemption by the Minister; (d) in the case of a company, proof of citizenship or proof of being ordinarily resident in Zimbabwe of the majority of directors or proof of an exemption by the Minister and proof of incorporation in Zimbabwe of the company; and (e) a declaration, signed and dated by the proposed authorised person in charge, stating that the proposed authorised person in charge, the proposed responsible person in charge and, if applicable, the proposed alternate responsible person in charge are familiar with the provisions of the Act. (2) The application shall contain a detailed description of the method that the applicant proposes to use for keeping records, which shall permit— (a) compliance with the requirements of Part VI; (b) the Minister to audit the activities of the licensed producer with respect to cannabis; and (c) the reconciliation of orders for cannabis and shipments and inventories of cannabis. (3) The application shall also contain the following— (a) if applicable, the maximum quantity expressed as the net weight in grams of fresh cannabis, dried cannabis, cannabis oil to be produced by the applicant under the licence and the production period; dps://#ptII dps://#ptII dps://ZS@1503/#57.1 Page 7 of 43 (b) if applicable, the maximum quantity expressed as the net weight in 6grams of fresh cannabis, dried cannabis, cannabis oil and cannabis seeds to be sold or provided by the applicant under the licence and the period in which that quantity is to be sold or provided; and (c) if applicable, the maximum number of cannabis plants to be sold or provided by the applicant under the licence and the period in which that quantity is to be sold or provided. (4) An application made in terms of subsection (1) shall be accompanied by a security clearance referred to in the Third Schedule, for the following persons— (a) the authorised person in charge; (b) the responsible person in charge; (c) if applicable, the alternate responsible person in charge; (d) if a producer’s licence is applied for by an individual, that individual; and (e) if a producer’s licence is applied for by a company, each officer and director of the company. (5) In the case of an application for a licence to sell or provide fresh cannabis or cannabis oil under, the applicant shall provide the Minister, before commencing to sell or provide the substance, with the dried cannabis equivalency factor determined under section 73 and the method that they used to determine it. (6) If the applicant intends to possess, produce, sell, provide, ship, deliver, transport or destroy cannabis at more than one site, a separate application shall be submitted for each proposed site. (7) An application made in terms of subsection (1) shall— (a) be signed and dated by the proposed authorised person in charge; and (b) include a statement signed and dated by that person indicating that— (i) all of the information and documents submitted in support of the application are correct and complete to the best of their knowledge, and (ii) they have the authority to bind the applicant. Authorised person in charge and responsible person in charge 5. (1) A licensed producer shall designate — (a) one authorised person in charge to have overall responsibility for management of the activities conducted by the licensed producer under their licence at their site who may, if appropriate, be the licensed producer; and (b) one responsible person in charge to work at the licensed producer’s site and have responsibility for supervising the activities with respect to cannabis conducted by the licensed producer under their licence at that site and for ensuring that the activities comply with the Act and these regulations who may, if appropriate, be the authorised person in charge. Page 8 of 43 (2) A licensed producer may designate one or more alternate responsible persons in charge to work at the licensed producer’s site and have authority to replace the responsible person in charge when that person is absent. (3) The authorised person in charge, the responsible person in charge and, if applicable, the alternate responsible person in charge shall be familiar with the provisions of the Act and its regulations. Issuance of licence 6. Subject to section 7, the Minister shall, after examining the application under section 4 issue to the applicant a producer’s licence that indicates— (a) the licence number; (b) the name of the licence holder; (c) the list of authorised activities; (d) the address of the site and, if applicable, of each building within the site where the licensed producer may conduct the authorised activities; (e) in respect of each building, the authorised activities that may be conducted at that building and, in respect of each activity, the substances in respect of which the activity may be conducted; (f) the security level, determined in accordance with the security requirements, of each location within the site where cannabis is stored; (g) the effective date of the licence; (h) the expiry date of the licence,; (i) Any conditions that the licence holder shall meet in order to— (i) comply with any international obligations and any other obligations that may be imposed by the Minister from time to time; (ii) provide the security level referred to in paragraph (f); (iii) put in place the security measures referred to in Part III; or (iv) reduce any potential public health, safety or security risk, including the risk of cannabis being diverted to an illicit market or use. Grounds for refusal 7. The Minister shall refuse to issue, renew or amend a producer’s licence in the following circumstances— (a) the applicant is not eligible under section 4; (b) the requirements of section 11 have not been met; (c) an inspector, who has requested an inspection, has not been given the opportunity by the applicant to conduct an inspection; Page 9 of 43 (d) the Minister has reasonable grounds to believe that false or misleading information was submitted in, or false or falsified documents were submitted with, the application; (e) information received from a peace officer, a competent authority or the United Nations raises reasonable grounds to believe that the applicant has been involved in the diversion of a controlled substance or precursor to an illicit market or use; (f) the applicant does not have in place the security measures set out in the Part III in respect of an activity for which the licence is sought; (g) the applicant is in contravention of or has contravened in the past 10 years— (i) a provision of the Act or these regulations, or (ii) a term or condition of another licence or a permit issued to it under any other Act. (h) the issuance, renewal or amendment of the licence is likely to create a risk to public health, safety or security, including the risk of cannabis being diverted to an illicit market or use; (i) any of the following persons does not hold a security clearance— (i) the authorised person in charge; (ii) the responsible person in charge; (iii) if applicable, the alternate responsible person in charge; (iv) if the applicant is an individual, that individual; and (v) if the applicant is a company, any of its officers or directors; (j) the proposed method of record keeping does not meet the requirements of section 65; or (k) if applicable, the information required under section 16 has not been provided or is insufficient to process the application. Duration of licence 8. A producer’s licence issued by the Minister in terms of section 6 shall be valid for a period of five years and may be renewed thereafter before its expiry. Display of licence 9. (1) Subject to subsection (2), a holder of a producer’s licence shall ensure that his or her licence is conspicuously displayed at all times on the licensed site to which they relate. (2) Subsection (1) shall not apply in respect of any period during which the licence is necessarily removed from the licensed site concerned for the purposes of doing anything in terms of the Act or for any other lawful purpose the proof whereof, in any proceedings against any person for contravention of subsection (1), shall lie upon that person. Production and return of licence dps://#13.2 dps://#13.1 dps://#13.1 Page 10 of 43 10. (1) Whenever the Minister— (a) cancels any licence; or (b) varies or amends the conditions of any licence; or (c) imposes new conditions on the renewal of any licence the Minister shall request the holder of the licence to produce such licence within such period as he or she may specify and the holder thereof shall produce such licence within the specified period. (2) Any person who fails to comply with a request in terms of subsection (1) shall be guilty of an offence and liable to a fine not exceeding level six or to imprisonment for a period not exceeding one year or to both such fine and such imprisonment. (3) Whenever the Minister varies, amends or imposes any new conditions on any licence, the Minister shall return such licence duly endorsed to the holder thereof. Application for variation or amendment of a licence 11 (1) A licensed producer proposing to amend the content of his or her licence shall provide the Minister with the following documents— (a) an application in writing describing the proposed amendment, as well as any information or documents mentioned in section 4 that are relevant to the proposed amendment; (b) if applicable, a declaration signed and dated by the authorised person in charge stating that the notices to local authorities have been provided and specifying the names, titles and addresses of the senior officials to whom they were addressed and the dates on which they were provided, together with a copy of each notice; and (c) a copy of the original licence. (2) The application shall— (a) be signed and dated by the authorised person in charge; and (b) include a statement signed and dated by that person indicating that all of the information and documents submitted in support of the application are correct and complete to the best of his or her knowledge. (3) Subject to section 7, the Minister shall, after examining the information and documents required under this section and, if applicable, section 16, amend the licence accordingly and may add any conditions that the licence holder shall meet in order to— (a) comply with any international obligations; (b) provide the security level referred to in section 6(f) or the new level applicable as a result of the amendment of the licence; (c) put in place the security measures referred to in Part III; or (d) reduce any potential public health, safety or security risk, including the risk of cannabis being diverted to an illicit market or use. dps://#14.1 Page 11 of 43 Notice to Minister on change of personnel 12. (1) A licensed producer shall— (a) apply for and obtain the Minister’s approval before making a change involving the replacement or the addition of— (i) the authorised person in charge; (ii) the responsible person in charge and, if applicable, the alternate responsible person in charge; (iii) if applicable, an officer or director referred to in section 4(2)(d) or (iv) an individual authorised to place an order for cannabis on behalf of the licensed producer; (b) except in the case referred to in subsection (3), notify the Minister, not later than five days after the event, when a person referred to in section 5 ceases to carry out their duties; and (c) notify the Minister, not later than five days after the event, when a person referred to in section 4(1)(d) ceases to be an officer or director. (2) The licensed producer shall, with the application for approval referred to in subsection (1) (a), provide the Minister with the following information and documents with respect to the new person— (a) in the case of the replacement of the senior person in charge or the responsible person in charge or the replacement or addition of an alternate responsible person in charge— (i) the information stated in Form DDPC1 and Form DDPC2, and (ii) the declaration specified in section 4 (1)(e); (b) in the case of the replacement or addition of an officer or director, the information specified in Form DDPC1 concerning that person. (3) A licensed producer shall notify the Minister not later than the next business day if the responsible person in charge ceases to carry out their duties and there is no person designated as an alternate responsible person in charge. Notice to Minister on various changes 13. A licensed producer shall, within five days after the change, notify the Minister of any change to— (a) the method used for keeping records; (b) the telephone number, mobile number and, if applicable, the email address ; (c) their site; and Page 12 of 43 (d) if applicable, each building within the site where the activities are conducted under the licence; or (e) the security of their site, other than a change that affects the security level of any location within the site where cannabis, other than cannabis plants, is stored. Application for renewal of licence 14. (1) An application for the renewal of a producer’s licence shall be made by a licensed producer and lodged with the Minister before the expiry of such licence and shall be accompanied by the following— (a) the appropriate fee; and (b) a copy of the original licence; and (c) a declaration signed and dated by the authorised person in charge stating that as of the date of the application— (i) to the best of that person’s knowledge the information shown on the producer’s licence as specified in section 6 (a) to (i) is correct and complete, and if applicable, the requirements of sections 12 and 13 have been met. (2) Subject to section 7, the Minister shall, after examining the information and documents required under subsection (1) and, if applicable, section 16, issue a renewed licence that contains the information set out in section 6 (a) to (j) (3) If a licensed producer submits an application in terms of section 11 or 12 together with an application in terms of subsection (1), the Minister may process them together. (4) Where an application for the renewal of a licence has been lodged with the Minister, the validity of the licence shall, where the applicant has not been given notice of the renewal or refusal of the application by the date of expiry of such licence, continue after the date of expiry until the decision of the Minister on the application is notified to the applicant by the Minister. Statement by signatory of notice 15. An application or notification made under section 12 or 13, respectively, shall – (a) be signed and dated by the authorised person in charge; and (b) include a statement signed and dated by that person indicating that— (i) all information and, if applicable, documents submitted in support of the application or notification are correct and complete to the best of their knowledge, and (ii) they have the authority to bind the licensed producer. Annual returns Page 13 of 43 16. (1) Every licensed producer shall submit to the Minister, at every anniversary of the licence and upon payment of annual return fees specified in the First Schedule, records of all transactions which are required to be kept in terms of this Act. (2) The Minister may prescribe the manner in which records may be submitted to him or her. (3) Every licensed producer who fails to submit to the Minister the records by the period specified in subsection (1) shall be liable to the daily penalty of US$ 500 which shall stop to accrue after a period of one month. (4) The Minister may suspend the licence of a producer who has failed to submit the records within the one month referred to in subsection (3): Provided that— (i) before suspending the licence, the Minister shall invite the producer to make representations; (ii) the suspension of the licence shall not prevent the Minister from instituting a claim for the recovery of outstanding daily penalties which may have accrued in terms of subsection (3). (5) Upon considering the evidence which he or she may have received, the Minister may proceed to act in terms of section 18 or section 19. (6) The Minister may require information from the licensed producer at any time and whereupon such producer shall, within seven days or any shorter or longer period as the Minister may fix, submit such information. Temporary suspension of licence 17. (1) The Minister may in the public interest require the temporary suspension of a licence for such period as he or she may determine. (2) Where the Minister suspends a licence in terms of subsection (1), he or she shall forthwith notify the licensee of the reasons therefor and call upon the licencee to show cause why the licence should not be suspended. Reinstatement of suspended licence 18. The Minister shall, by notice to the licensed producer, reinstate a licence, in respect of any or all activities or substances affected by the suspension, if the licensed producer demonstrates to the Minister that— (a) the failure that gave rise to the suspension has been rectified; or (b) the suspension was unfounded. Cancellation of licence following suspension Page 14 of 43 19. (1) The Minister shall cancel a licence if the licensed producer fails to comply with the decision of the Minister to suspend the licence under section 17 or if the failure that gave rise to the suspension is not rectified. (2) The Minister shall give notice thereof in writing to the licensed producer of the intended cancellation. (3) A notice given in terms of subsection (2) shall— (a) specify the grounds on which the opinion of the Minister is based; and (b) indicate that the person to whom it is directed may within seven days after the receipt thereof submit to the Minister any comments he may wish to put forward in connection with the matter failure of which the Minister shall proceed with the cancellation. Cancellation on other grounds 20. The Minister shall cancel a producer’s licence in the following circumstances — (a) the Minister has reasonable grounds to believe that the licence was issued on the basis of false or misleading information submitted in, or false or falsified documents submitted with, the application; (b) the licensed producer has, since the issuance of the licence, contravened a provision of the Act or its regulations or a condition of their licence or of an import or export permit issued under this Part; (c) the licensed producer is no longer eligible under section 4; (d) information received from an inspector, a competent authority or the United Nations raises reasonable grounds to believe that the licensed producer has been involved in the diversion of a controlled substance or precursor to an illicit market or use; or (e) any of the persons referred to in section 7(1)(i) does not hold a security clearance. Notice of cessation of activities 21. (1) A licensed producer who intends to cease conducting activities at their site, whether before or on the expiry of their licence shall submit to the Minister a written notice to that effect at least thirty days before ceasing those activities. (2) A notice referred to in subsection (1) shall be signed and dated by the licensed producer in charge and shall contain the following information — (a) the expected date of the cessation of activities at the site; (b) a description of the manner in which any cannabis remaining on the site as of the date referred to in paragraph (a) will be dealt with by the licensed producer, including — (i) if some or all of it will be sold or provided to another licensed producer who will be conducting activities at the same site, the name of that producer; Page 15 of 43 (ii) if some or all of it will be sold or provided to another licensed producer or a licensed dealer, the name of that producer and the address of their site or the name of that dealer and the address of their premises; and (iii) if some or all of it will be destroyed, the date on which and the location at which the destruction is to take place; (c) the address of the location at which the licensed producer’s records, books, electronic data and other documents will be kept after activities have ceased; and (d) the name, address, telephone number, mobile number and, if applicable, the email address of a person whom the Minister may contact for further information after activities have ceased. (3) After having ceased the activities, the licensed producer shall submit to the Minister a detailed update of the information referred to in paragraphs (2) (a) to (d), if it differs from what was set out in the notice submitted under subsection (1 and such update shall be signed and dated by the licensed producer in charge. (4) If the activities cease before the expiry of the licence, the licensed producer shall return to the Minister the original of the licence and the Minister shall then revoke the licence. PART III SECURITY MEASURES PART A –PERIMETER OF SITE Compliance with security measures 22. A licensed producer shall ensure that the security measures set out in this Part are carried out. Unauthorised access 23. A licensed producer’s site shall be designed in a manner that prevents unauthorised access. Visual monitoring of the Perimeter of Site 24. (1) The perimeter of the licensed producer’s site shall be visually monitored at all times by visual recording devices to detect any attempted or actual unauthorised access. (2) The devices referred to in subsection (1) shall, in the conditions under which they are used, be capable of making a visible recording of any attempted or actual unauthorised access. Intrusion detection system of the perimeter of site 25. The perimeter of the licensed producer’s site shall be secured by means of an intrusion detection system that operates at all times and that allows for the detection of any attempted or actual unauthorised access to or movement in the site or tampering with the system. Page 16 of 43 Monitoring by personnel of the perimeter of site 26. (1) The intrusion detection system shall be monitored at all times by personnel who shall determine the appropriate steps to be taken in response to the detection of any occurrence referred to in section 24 or 25. (2) If any such occurrence is detected, the personnel shall make a record of— (a) the date and time of the occurrence; and (b) the measures taken in response to it and the date and time when they were taken. PART B – AREAS WHERE CANNABIS IS HANDLED Restricted access 27. (1) Access to areas within a site where cannabis is present shall be restricted to persons whose presence in those areas is required by their work responsibilities. (2) The responsible person in charge or, if applicable, the alternate responsible person in charge shall be physically present while other persons are in those areas. (3) A record shall be made of the identity of every person entering or exiting those areas. Physical barriers 28 A holder of a producer’s licence shall include physical barriers that prevent unauthorised access within a site where cannabis is present. Visual Monitoring 29. (1) A holder of a producer’s licence shall ensure that areas where cannabis is present are visually monitored at all times by visual recording devices to detect illicit conduct. (2) The devices referred to in subsection (1) shall, in the conditions under which they are used, be capable of making a visible recording of illicit conduct. Intrusion detection system 30. A licensed producer shall ensure that areas where cannabis is present are secured by means of an intrusion detection system that operates at all times and that allows for the detection of any attempted or actual unauthorised access to or movement in those areas or tampering with the system. Filtration of air 31. A licensed producer shall ensure that areas where cannabis is present are equipped with a system that filters air to prevent the escape of odours and, if present, pollen. Monitoring by personnel Page 17 of 43 32. (1) The intrusion detection system referred to in section 30 shall be monitored at all times by personnel who shall determine the appropriate steps to be taken in response to the detection of any occurrence referred to in section 29 or 30. (2) If any such occurrence is detected, the personnel shall make a record of— (a) the date and time of the occurrence; and (b) the measures taken in response to it and the date and time when they we. PART IV GENERAL CONDITIONS OF PRODUCTION Good Production Practices 33. (1) A licensed producer shall ensure that standard operating procedures are developed and implemented for all activities during production of cannabis. (2) The procedures referred to in subsection (1) shall be in accordance with the Good Agricultural Practices and Good Manufacturing Practices. Cultivation of cannabis 34. Good Agricultural Practices shall be applied in the cultivation of cannabis, as determined by the Ministry responsible for agriculture. Soil and Fertilisers 35. (1) Cannabis shall be grown on soil not contaminated with sludge, heavy metals, pesticide residues or other chemicals. (2) The chemicals and quantities used for production shall be justified. (3) Monitoring of soil contamination shall be performed and reported on. (4) Manure applied shall be thoroughly composted and shall devoid of human faeces. (5) Fertilisers shall be used in such a way that leaching is reduced to a Minimum level. Irrigation 36. (1) Irrigation shall be controlled to ensure quality cultivation of the cannabis plant. (2) The quality of the irrigation water shall be controlled to ensure minimum contaminants, including faeces, heavy metals, herbicide, pesticides and toxicologically hazardous substances. (3) All tillage operations shall be adapted to plant growth and requirements. Page 18 of 43 Pest control products 37. (1) Fresh or dried cannabis or cannabis plants or seeds shall not be treated with a pest control product unless the product is authorised or registered for use under the Plant Pests and Diseases Act [Chapter 19:08] or is otherwise authorised for use under that Act. (2) The use of herbicides and pesticides shall be avoided as far as possible. Harvesting 38. Good harvesting practices with appropriate procedures, as determined by the Ministry responsible for agriculture shall be followed to ensure that the appropriate quality product is obtained for the intended use. Drying 39. (1) A licensed producer shall ensure that there is a uniform drying speed of the crops and prevention of mould growth by applying appropriate measures. (2) In cases where cannabis is dried in open air, the cannabis shall be spread in a thin layer, to ensure good air circulation of the drying rakes placed at sufficient distance from the drying surface. (3) Where cannabis is not dried in open air optimal drying conditions, i.e. temperature and drying time shall be followed and recorded. Microbial and chemical contaminants 40. The microbial and chemical contaminants of fresh or dried cannabis or cannabis oil shall be within generally accepted tolerance limits for herbal medicines for human consumption. Disintegration of capsules 41. A capsule or similar dosage form of cannabis oil that is intended to be swallowed whole or used as a suppository shall meet the requirements of a disintegration test that is applicable to the formulation of the capsule or similar dosage form. Maximum yield quantity— cannabis oil 42. (1) Cannabis oil shall not exceed a maximum yield quantity of 30 mg of delta-9 tetrahydrocannabinol per millilitre of the oil in the immediate container, taking into account the potential to convert delta-9-tetrahydrocannabinolic acid into delta-9-tetrahydrocannabinol. (2) If cannabis oil is in a capsule or similar dosage form, each capsule or unit of the dosage form shall not exceed a maximum yield quantity of 10 mg of delta-9-tetrahydrocannabinol, taking into account the potential to convert delta-9-tetrahydrocannabinolic acid into delta-9 tetrahydrocannabinol. Page 19 of 43 Solvents 43. Cannabis oil shall not contain residues of solvents other than Class 3 solvents listed in the Guidance Document — Impurities: Guideline for Residual Solvents, ICH Topic Q3C(R5), as amended from time to time. (2) Those residues shall not exceed the limits established under that document. Analytical testing 44. Analytical testing for the following shall be conducted using validated methods— (a) the disintegration referred to in section 41; (b) the residues of solvents referred to in section 43; and (c) the content of delta-9-tetrahydrocannabinol, delta-9-tetrahydrocannabinolic acid, cannabidiol and cannabidiolic acid. Premises 45. (1) Fresh or dried cannabis, cannabis oil or cannabis plants or seeds shall be produced, packaged, labelled and stored in premises that are designed, constructed and maintained in a manner that permits those activities to be conducted under sanitary conditions, and in particular that— (a) permits the premises to be kept clean and orderly; (b) permits the effective cleaning of all surfaces in the premises; (c) permits the substance to be stored or processed appropriately; (d) prevents the contamination of the substance; and (e) prevents the addition of an extraneous substance to the substance. (2) The substances referred to in subsection (1) shall be stored under conditions that will maintain their quality. Equipment 46. Fresh or dried cannabis, cannabis oil or cannabis plants or seeds shall be produced, packaged, labelled and stored using equipment that is designed, constructed, maintained, operated and arranged in a manner that — (a) permits the effective cleaning of its surfaces; (b) permits it to function in accordance with its intended use; (c) prevents the contamination of the substance; and (d) prevents the addition of an extraneous substance to the substance. Sanitation program Page 20 of 43 47. Fresh or dried cannabis, cannabis oil or cannabis plants or seeds shall be produced, packaged, labelled and stored in accordance with a sanitation program that sets out — (a) procedures for effectively cleaning the premises in which those activities are conducted; (b) procedures for effectively cleaning the equipment used in those activities; (c) procedures for handling any substance used in those activities; and (d) all requirements, in respect of the health, hygienic behaviour and clothing of the personnel who are involved in those activities, that are necessary to ensure that those activities are conducted in sanitary conditions. Standard operating procedures 48. Fresh or dried cannabis, cannabis oil or cannabis plants or seeds shall be produced, packaged, labelled and stored in accordance with standard operating procedures that are designed to ensure that those activities are conducted in accordance with the requirements of this Part. Recall 49. (1) A licensed producer shall establish and maintain a system of control that permits the rapid and complete recall of every lot or batch of fresh or dried cannabis, cannabis oil or cannabis plants or seeds that has been made available for sell. (2) The procedure for recall shall be in accordance with the provisions set out in the Fourth Schedule. Recall reporting 50. Before commencing a recall of fresh or dried cannabis, cannabis oil or cannabis plants or seeds, a licensed producer shall provide the Minister with the following information in respect of the substance to be recalled— (a) its brand name; (b) the number of each lot or batch to be recalled; (c) if known by the licensed producer, the name and address of each licensed producer who imported or produced any of it; (d) the reasons for commencing the recall; (e) the quantity that was produced or imported into Zimbabwe by the licensed producer; (f) the quantity that was sold or provided in Zimbabwe by the licensed producer; (g) the quantity remaining in the possession of the licensed producer; (h) the number of persons to whom it was sold or provided by the licensed producer; and (i) a description of any other action that the licensed producer is taking in respect of the recall. Page 21 of 43 Quality assurance 51. (1) A licensed producer shall employ a quality assurance person who — (a) is responsible for assuring the quality of the fresh or dried cannabis, cannabis oil or cannabis plants or seeds before they are made available for sale, and (b) has the training, experience and technical knowledge relating to the activity conducted and the requirements of this Part; and (c) investigates every complaint received in respect of the quality of those substances and, if necessary, takes corrective and preventative measures. (2)The substances shall be produced, packaged, labelled and stored using methods and procedures that, prior to their implementation, have been approved by a quality assurance person. (3) Every batch of the substances shall be approved by a quality assurance person before it is made available for sell. (4) Any of fresh or dried cannabis, cannabis oil, or cannabis plant or seeds that are sold or provided and subsequently returned to the licensed producer shall not be resold or provided again. Sample of lot or batch 52. (1) Subject to subsection (3), if the Minister has reasonable grounds to believe that a lot or batch of fresh or dried cannabis, cannabis oil or cannabis plants or seeds made available for sale or provision by a licensed producer, may by reason of the manner in which the substance was produced, packaged, labelled or stored, pose a risk to the health of a person who obtains the substance for their own medical purposes, the Minister may require the licensed producer to provide the Minister with a sample of that lot or batch. (2) A sample referred to in subsection (1) shall be of sufficient quantity to enable a determination of whether the lot or batch meets the requirements of sections 40 and 41 and, if applicable, sections 42, 43 and 44. (3) The Minister shall not require a sample to be provided if more than one year has elapsed after the expiry date or provision of any portion of the batch. PART V PACKAGING, LABELLING AND SHIPPING Packaging 53. (1) A licensed producer who sells or provides fresh or dried cannabis or cannabis oil shall ensure that— (a) the substance is packaged in an immediate container— Page 22 of 43 (i) that is in direct contact with the substance or, in the case of a substance in a capsule or similar dosage form, that is in direct contact with the capsules or units of that dosage form; (ii) that prevents the contamination of the substance and, in the case of dried cannabis, keeps it dry; (iii) that has a security feature that provides reasonable assurance to consumers that the container has not been opened prior to receipt, and (iv) that is a child resistant package; and (b) not more than the equivalent of 30 g of dried cannabis is in the immediate container. (2) A licensed producer who sells or provides cannabis seeds shall ensure that they are packaged in a container that — (a) is in direct contact with the seeds; (b) keeps them dry and prevents their contamination; and (c) has a security feature that provides reasonable assurance to consumers that the container has not been opened prior to receipt. (3) A licensed producer who sells or provides cannabis plants shall ensure that they are sold or provided in a package that has a security feature that provides reasonable assurance to consumers that the package has not been opened prior to receipt. Accuracy of weight 54. (1) A licensed producer who sells or provides fresh or dried cannabis or cannabis oil shall ensure that the net weight of the substance in the immediate container is not less than 95% and not more than 105% of the net weight specified on the label in accordance with section 56. (2) A licensed producer who sells or provides cannabis oil shall ensure that the net volume of the oil in the immediate container is not less than 95% and not more than 105% of the net volume specified on the label in accordance with section 56. (3) A licensed producer who sells or provides cannabis oil in a capsule or similar dosage form shall ensure that number of capsules or units in the container is the same as the number specified on the label in accordance with section 56. (4) A licensed producer who sells or provides cannabis seeds shall ensure that the number of seeds in the immediate container is the same as the number specified on the label in accordance with section 57 Accuracy on number of plants 55. A licensed producer who sells or provides cannabis plants shall ensure that the exact number of plants in the package referred to in section 53(3) is indicated on the package. Product label for cannabis or cannabis oil 56. (1) In this section— Page 23 of 43 “w/w” means weight in weight (2) A licensed producer who sells or provides fresh or dried cannabis or cannabis oil shall ensure that a label that contains the following information and the information set out in subsection (3), (4) or (5), as applicable, is affixed to the immediate container— (a) the name, telephone number, physical and email address of the licensed producer; (b) the words “Fresh cannabis”, “Dried cannabis” or “Cannabis oil” (or the equivalent term “Cannabis oil”), as applicable; (c) in respect of the substance in the container— (i) its brand name, (ii) its batch number, (iii) its recommended storage conditions, (iv) its packaging date, and (v) either— A. its expiry date established in accordance with section 60, or B. a statement that no expiry date has been determined; (d) the symbol “N” set out in the upper left quarter of the label in a colour contrasting with the rest of the label or in type not less than half the size of any other letters used on the label; (e) the warning “KEEP OUT OF REACH OF CHILDREN.” (3) In the case of fresh or dried cannabis , the label shall also contain the following information in respect of the cannabis in the container— (a) its net weight in grams; (b) the percentage of delta-9-tetrahydrocannabinol w/w, followed by the word “delta-9 tetrahydrocannabinol”; (c) the percentage of delta-9-tetrahydrocannabinol w/w that the cannabis could yield, taking into account the potential to convert delta-9-tetrahydrocannabinolic acid into delta-9 tetrahydrocannabinol; (d) the percentage of cannabidiol w/w, followed by the word “cannabidiol”; (e) the percentage of cannabidiol w/w that the cannabis could yield, taking into account the potential to convert cannabidiolic acid into cannabidiol; and (f) in the case of fresh cannabis, the dried cannabis equivalency factor determined under section 73. (4) In the case of cannabis oil that is not sold in a capsule or similar dosage form, the label shall also contain the following information in respect of the oil in the container— (a) its net weight in grams; (b) its net volume in millilitres; Page 24 of 43 (c) the quantity of delta-9-tetrahydrocannabinol, in milligrams per millilitre; (d) the quantity of delta-9-tetrahydrocannabinol, in milligrams per millilitre, that the oil could yield, taking into account the potential to convert delta-9-tetrahydrocannabinolic acid into delta-9-tetrahydrocannabinol; (e) the quantity of cannabidiol, in milligrams per millilitre; (f) the quantity of cannabidiol, in milligrams per millilitre, that the oil could yield, taking into account the potential to convert cannabidiolic acid into cannabidiol; (g) the dried cannabis equivalency factor determined under section 73; (h) the carrier oil used; and (i) in the case of cannabis oil that is intended for topical use only, the warning “FOR TOPICAL USE ONLY. DO NOT INGEST.”. (5) In the case of cannabis oil that is sold in a capsule or similar dosage form, the label shall also contain the following information in respect of the oil in the container— (a) the number of capsules or units of that dosage form; (b) the net weight in grams as well as the net volume in millilitres of each capsule or unit; (c) the quantity of delta-9-tetrahydrocannabinol, in milligrams, in each capsule or unit; (d) the quantity of delta-9-tetrahydrocannabinol, in milligrams, that each capsule or unit could yield, taking into account the potential to convert delta-9-tetrahydrocannabinolic acid into delta-9-tetrahydrocannabinol; (e) the quantity of cannabidiol, in milligrams, in each capsule or unit; (f) the quantity of cannabidiol, in milligrams, that each capsule or unit could yield, taking into account the potential to convert cannabidiolic acid into cannabidiol; (g) the dried cannabis equivalency factor determined under section 73; (h) the carrier oil used; and (i) in the case of cannabis oil that is intended for topical use only, the warning “FOR TOPICAL USE ONLY. DO NOT INGEST.” Product label for cannabis seeds 57. A licensed producer who sells or provides cannabis seeds shall ensure that a label that contains the following information is affixed to the immediate container— (a) the name, telephone number, mobile number, physical and email address of the licensed producer; (b) the words “Cannabis seeds”; (c) in respect of the seeds in the container— (i) the number of seeds, Page 25 of 43 (ii) their brand name, (iii) their batch number, (iv) their recommended storage conditions, and (v) their packaging date; and (d) the information required by section 56 (2) (d) and (e) Product label for cannabis plants 58. A licensed producer who sells or provides cannabis plants shall ensure that each plant bears a label that contains the following information— (a) the name, telephone number, mobile number, physical and email address of the licensed producer; (b) the words “Cannabis plant” ; (c) in respect of the plant— (i) its brand name, (ii) its batch number, (iii) its packaging date; and (d) (d) the information required by section 56 (2)(d) and (e) . Presentation of information on label 59. (1) All information that is required under section 56 and as applicable, to appear on a label shall be — (a) in English and any other language that may be approved by the Minister; (b) clearly and prominently displayed on the label. (2) All information in a document that is required under section 56 shall be in English and in any other language that may be approved by the Minister and readily discernible under the customary conditions of use. Expiry date 60. (1) A licensed producer shall not include an expiry date on a label referred to in section 56 unless — (a) the licensed producer has submitted data to the Minister that establishes the stability period during which, after the fresh or dried cannabis or cannabis oil is packaged in Page 26 of 43 accordance with section 53 and when it is stored under its recommended storage conditions referred to in section 57(c)(iv) (b) the substance maintains not less than 80% and not more than 120% of its delta-9 tetrahydrocannabinol content and cannabidiol content; and (c) the microbial and chemical contaminants of the substance remain within the limits referred to in section 40;and (d) in the Minister’s opinion the data submitted by the licensed producer meets the requirements of paragraph (a) and the Minister has notified the producer to that effect. (2) For the purposes of subsection (1) and section 57(c)(iv), expiry date means the date, expressed at minimum as a year and month, that is the end of the stability period. Reference to Act or Regulations 61. It is prohibited to include a reference, direct or indirect, to the Act or any regulations made under the Act on a label of or in an advertisement for fresh or dried cannabis, cannabis oil or cannabis plants or seeds unless the reference is a specific requirement of either of the Act or those regulations. Shipping 62. (1) A licensed producer who ships fresh or dried cannabis or cannabis oil to any person shall — (a) transport the substance in only one shipment per order; (b) prepare the package in a manner that ensures the security of its contents, such that — (i) it will not open or permit the escape of its contents during handling and transportation; (ii) it is sealed so that it cannot be opened without the seal being broken; (iii) it prevents the escape of cannabis odour; and (iv) it prevents its contents from being identified without it being opened; (c) use a transporting method that ensures the tracking and safekeeping of the package during transportation; and (d) ship it only to the following address — (i) in the case of an authorised recipient or an individual who is responsible for that, the shipping address specified and (ii) in the case of any other person, the shipping address indicated in the order referred to in section 71; and (e) in the case of a client or an individual who is responsible for that client, ship the substance in a quantity that does not exceed the equivalent of 150 g of dried cannabis. Page 27 of 43 (2) A licensed producer who ships cannabis seeds to any person referred shall— (a) comply with the requirements of subsection (1)(a) to (c); and (b) ship the package only to the following— (i) the shipping address indicated in the order referred to in section 71; and (ii) the address of the site for the production of cannabis plants or the site for the storage of cannabis that is specified in the person’s registration with the Minister made under Part II. (3) A licensed producer who ships cannabis plants to any person shall — (a) prepare the package in a manner that ensures the security of its contents, such that — (i) it will not open or permit the escape of its contents during handling and transportation, (ii) it is sealed so that it cannot be opened without the seal being broken, and (iii) it prevents its contents from being identified without it being opened; (b) use a shipping method referred to in subsection (1)(c); and (c) ship it to the address referred to in subsection (2)(b). (4) A licensed producer who ships cannabis to any person shall— (a) use a shipping method referred to in subsection (1)(c); and (b) ship it only to the shipping address indicated in the order referred to in section 71. Import and Export 63. A licensed producer who wishes to import or export cannabis shall, upon payment of fees specified in the First Schedule, submit an application to the Minister in terms of Section 44 of the Dangerous Drugs Regulations, 1975, published in Rhodesia Government Notice 1111 of 1975. Persons authorised to handle cannabis 64. (1) Any of following persons, namely— (a) a person licensed to do so under the Medicines and Allied Substances Control Act [Chapter 15:03]; (b) any medical practitioner, dental practitioner or veterinary surgeon; (c) any pharmaceutical chemist licensed in terms of the Medicines and Allied Substances Control Act [Chapter 15:03] or pharmaceutical chemist or other person— (i) employed in a hospital, clinic, dispensary or like institution administered by the State or by a local authority, or in any other hospital, clinic, dispensary or like institution approved by the Minister responsible for health; or dps://1503/ dps://1503/ dps://1503/ dps://1503/ Page 28 of 43 (ii) employed in any medical store of the State; (d) any person in charge of a laboratory used for the purposes of research or instruction and attached to— (i) a university, a recognised university college or other educational institution; or (ii) any hospital referred to in subparagraph (i) of paragraph (c); (e) any analyst employed by the State; or (f) any inspector appointed in terms of the Medicines and Allied Substances Control Act [Chapter 15:03]; or (g) any other person prescribed by the Minister responsible for justice by notice in a statutory instrument after consultation with the Minister; may, in that capacity and so far as is necessary for the practice or exercise of that person’s profession, function or employment, lawfully acquire, possess and supply, cannabis (2) A qualified nurse— (a) in charge of a ward, theatre or out-patients’ department in any hospital referred to in subsection (1)(c)(i); or (b) who— (i) is employed in a supervisory capacity over two or more wards in any hospital referred to in subsection (1) (c)(i); and (ii) has been appointed by the medical practitioner in charge of the hospital to be responsible at any time for the distribution of Part I scheduled drugs within the hospital; may, in that capacity and so far as is necessary for the practice of that nurse’s profession, function or employment, lawfully acquire, administer, possess and supply a Part I scheduled drug. PART VI RECORD KEEPING Record keeping by licensed producers 65. (1) Except in the case referred to in section 70, a licensed producer who receives cannabis shall record the following information— (a) the name of the person from whom it was received; (b) the address of the site at which it was received; (c) the date on which it was received; and (d) an indication of which substance was received, as well as the following information— (i) in the case of fresh or dried cannabis or cannabis oil, the quantity and, if applicable, brand name, or dps://1503/ dps://1503/ dps://#161.1.c dps://#161.1.c Page 29 of 43 (ii) in the case of cannabis other than cannabis referred to in subparagraph (i), its quantity, description, intended use and, if applicable, brand name. (2) A licensed producer who imports cannabis shall retain a copy of the export permit issued by a competent authority in the country of export. (3) A licensed producer who exports cannabis shall retain a copy of the import permit issued by a competent authority in the country of final destination. Record keeping by authorised persons 66. An authorised person shall keep records which shall include the following information — (a) if applicable, the given name, surname and date of birth of the authorised recipient for whom the order is placed; (b) the given name and surname of the individual placing the order; (c) the quantity, brand name and lot number of the fresh or dried cannabis cannabis oil or cannabis plants or seeds sold or provided; (d) the date on which the order was received; (e) the date on which the substance was shipped; and (f) the address to which the substance was shipped. Manner of keeping records 67. (1) A licensed producer shall ensure that the records, documents and information referred to in this Part are kept in a manner that will enable an audit of them to be made in a timely manner and are available at their site. (2) A licensed producer shall retain the records, documents and information for the following periods— (a) in the case of a notice that the producer is required to provide or send under this Part, for a period of five years after the day on which the notice is provided or sent; (b) in the case of information that the producer is required to record under sections 65, and sections 66, 69 and 70, for a period of five years after the day on which the information is recorded; (c) in the case of the visual recordings or the records referred to in Part III, for a period of five years after the day on which they were made; (d) in the case of the records demonstrating that each batch of fresh or dried cannabis, cannabis oil or cannabis plants or seeds, for a period of five years after the date of the last sale or provision of any portion of the batch of fresh or dried cannabis, cannabis oil or cannabis plants or seeds. Page 30 of 43 (e) in the case of a document for the period during which it is current and for an additional period of five years after the day on which it is replaced by a new version; (f) in the case of a document detailing the description of the qualifications of the quality assurance person for the period during which the quality assurance person acts in that capacity and for an additional period of five years after the day on which the person ceases to do so; (g) in the case of the records of complaint, for a period of five years after the day on which the complaint was recorded; (h) in the case of the records of any testing conducted by or on behalf of the licensed producer for a period of five years after the date of the last sale or provision of any portion of the batch, other than a sale or provision for destruction; (i) (i) in the case of the records of the information that the licensed producer is required by section 50 to provide to the Minister in respect of recall of cannabis, for a period of five years after the day on which the substance was recalled; (j) in the case of the information concerning the method referred to in section 73, for a period of five years after the day on which the information is recorded; (k) in the case of the records and documents referred to in section 76, for a period of five years after the day on which the cannabis was destroyed; (l) in the case of a document or record of a request received from a licensing authority, for a period of five years after the day on which the information was provided to the licensing authority; (3) A licensed producer shall retain the serious adverse reaction case reports and the summary reports referred to in section 50, respectively, for a period of twenty-five years after the day on which they were made. Preservation of records 68. Every licensed producer shall keep or cause to be kept a record of such production for a period of five years and shall preserve such record on the premises in which the production takes place: Provided that where the premises cease to be used or licensed such person shall make arrangements, acceptable to the Minister, for the preservation or destruction of such records. Cannabis Inventory 69. (1) A licensed producer shall keep a record of the net weight of each of the following in an inventory at their site at the end of each quarter of the calendar year — (a) cannabis seeds, other than cannabis seeds referred to in paragraph (h); (b) harvested cannabis, other than cannabis referred to in paragraphs (e) and (f), that is not to be subjected to a drying process; (c) harvested cannabis, other than cannabis referred to in paragraphs (e) and (g), in respect of which the drying process has not been completed; Page 31 of 43 (d) harvested cannabis, other than cannabis referred to in paragraphs (e) and (g), in respect of which the drying process has been completed; (e) cannabis that is destined for destruction; (f) packaged fresh cannabis; (g) packaged dried cannabis; (h) packaged cannabis seeds; and (i) cannabis or cannabis oil, with an indication of the name and net weight of each of the substances in question. (2) A licensed producer shall keep a record of the number of cannabis plants destined to be sold or provided that are in inventory at their site at the end of each quarter of the calendar year. (3) A licensed producer shall keep a record of the net weight of each of the following that are in inventory at their site at the end of each quarter of the calendar year— (a) cannabis oil that has not been packaged, other than cannabis oil referred to in paragraph (c); (b) packaged cannabis oil, other than cannabis oil referred to in paragraph (c); and (c) cannabis oil that is destined for destruction. Returned substance 70. A licensed producer who receives fresh or dried cannabis, cannabis oil or cannabis plants or seeds that are returned shall record the following information— (a) the given name and surname of the person who returned the substance or on behalf of whom the substance was returned; (b) the address of the site at which it was received; (c) the name of the substance, its quantity and brand name; (d) the date on which it was received; and (e) reason of the return. Order for export 71. (1) A licensed producer who fills an order for export shall record the following information — (a) the name of the person to whom the substance was sold or provided; (b) the shipping address; (c) an indication of which substance was ordered, as well as the following information— (i) in the case of fresh or dried cannabis or cannabis oil, its quantity and, if applicable, brand name, or (ii) in the case of cannabis other than cannabis referred to in subparagraph (i), its quantity, description; if applicable, brand name; and Page 32 of 43 (d) the date on which the substance was shipped; (e) the number and date of the import certificate; and (f) the authority by whom such certificate is issued. (2) A licensed producer who refuses to fill an order for export shall retain a copy of the written notice of refusal to fill the order. Security Inventory 72. A licensed producer shall keep — (a) the visual recordings referred to in sections 24 and 29; (b) the records referred to in sections 26(2) and 32(2); and (c) the record referred to in section 27(3). Dried cannabis equivalency factor 73. A licensed producer shall keep a record of the information concerning the method that they have used to determine the dried cannabis equivalency factor. Batch reconciliation 74. (1) A licensed producer shall keep a record of the following information concerning each batch of cannabis that they propagate, sow, harvest, dry, package or destroy — (a) the date on which cannabis plants are propagated by means other than sowing seeds and the number of new plants propagated in this manner; (b) the date on which cannabis seeds are sown and their net weight on that date; (c) the date on which cannabis is harvested and its net weight on that date; (d) the date on which the drying process for cannabis is completed, if any, and its net weight on that date; (e) the date on which cannabis is packaged and its net weight on that date; and (f) the date on which cannabis is destroyed and its net weight on that date, before the destruction. (2) A licensed producer shall keep a record of the following information concerning each lot or batch of cannabis oil that they produce, package or destroy — (a) the date on which the oil is produced and its net weight or volume on that date; (b) if applicable, the date on which the oil is put into a capsule or other similar dosage form and the number of capsules or units of that dosage form; (c) in respect of the cannabis that was used to produce the oil, its description, its net weight or volume, its lot or batch number and the date on which it was produced; (d) the date on which the oil is packaged and its net weight or volume on that date; and Page 33 of 43 (e) the date on which the oil is destroyed and its net weight or volume on that date, before the destruction. Research and development 75. Every licensed producer shall keep a record of the following information concerning cannabis that they use in a research and development activity — (a) its description, the quantity used, its lot or batch number and, if applicable, its brand name; (b) the date on which it was used in that activity; (c) the purpose and a brief description of that activity; (d) in respect of any product or compound containing that cannabis that they have made or assembled in the course of that activity — (i) its description; (ii) the date on which it was made or assembled and the quantity made or assembled; (iii) if applicable, the date on which it was used for testing and the quantity used; (iv) if applicable, the date on which it was placed in inventory and the quantity placed in inventory; (e) any other details permitting the reconciliation of the quantity of cannabis referred to in paragraph (a) and the quantities of products or compounds referred to in paragraph (d). Destroyed cannabis 76. (1) A licensed producer shall keep, for each instance in which they destroy cannabis, a record of the following information— (a) the date on which the cannabis was destroyed, the name of the substance destroyed and its net weight on that date, before the destruction; (b) the location at which it was destroyed; (c) a brief description of the method of destruction; (d) the names of the witnesses to the destruction and the basis on which they are qualified to be witnesses; and (e) if applicable, the name of the person who accompanied the cannabis to the location at which it is to be destroyed. (2) A licensed producer shall keep, for each instance in which they destroy cannabis, a statement signed and dated by each of the witnesses referred to in subsection (1) (d) stating that they have witnessed the destruction and that the cannabis was destroyed in accordance with a method that complies with environmental legislation applicable to the location at which it is to be destroyed. Disposal of cannabis Page 34 of 43 77 (1) Where cannabis requires to be destroyed the licensed producer shall notify the Minister who shall give directions as to the disposal of the cannabis. (2) For the purposes of subsection (3) there is hereby established a panel comprising of a police officer of or above rank of a superintendent designated by the Commissioner of Police, a senior customs officer designated by the Commissioner General of the Zimbabwe Revenue Authority, the Director-General of the Medicines Control Authority of Zimbabwe or an inspector designated by him or her and a senior official of the Ministry responsible for justice designated by the Attorney General or any person appointed by the Minister in the destruction of any cannabis. (3) On a date and time appointed by the Minister, the panel referred to in subsection (2) shall attend to the destruction by appropriate means of the cannabis concerned in the full view and presence of each other and shall immediately thereafter, subscribe to and sign a joint declaration attesting to the total destruction of such cannabis, which shall be forwarded forthwith to the Minister. Adverse reactions 78.(1) In this section— “adverse reaction” means a noxious and unintended response to fresh or dried cannabis or cannabis oil; “case report” means a detailed record of all relevant data associated with the use of fresh or dried cannabis or cannabis oil by a person; “serious adverse reaction” means a noxious and unintended response to fresh or dried cannabis or cannabis oil that requires in-patient hospitalisation or a prolongation of existing hospitalisation, that causes congenital malformation, that results in persistent or significant disability or incapacity, that is life threatening or that results in death. (2) A licensed producer who sells or provides fresh or dried cannabis or cannabis oil or any person referred to in section 64 shall provide the Minister with a case report for each serious adverse reaction to the substance, within fifteen days after the day on which the producer becomes aware of the reaction. (3) A licensed producer who sells or provides fresh or dried cannabis or cannabis oil shall prepare annually and maintain a summary report that contains a concise and critical analysis of all adverse reactions to the substance that have occurred during the previous twelve months. (4) If, after reviewing a case report provided under subsection (1) or after reviewing any other safety data relating to the fresh or dried cannabis or cannabis oil, the Minister has reasonable grounds to believe that it may, by reason of the manner in which it was produced, packaged, labelled or stored, pose a risk to the health of a person who in accordance with these Regulations obtains it for their own medical purposes, the Minister may request that, within thirty days after the day on which the request is received, the licensed producer— (a) provides the Minister with a copy of any summary report prepared under subsection (2); or Page 35 of 43 (b) prepares and provides the Minister with an interim summary report containing a concise and critical analysis of all adverse reactions to the substance that have occurred since the date of the most recent summary report prepared under subsection (2). Destruction of cannabis after change in production area 79. If a registration is amended or at the time of the renewal to reflect a change in the production area, the person authorised to produce cannabis shall destroy — (a) any cannabis plants under production that are in excess of the maximum number of plants that may be produced under the registration, as amended; and (b) any cannabis that they are storing that is in excess of the equivalent of the maximum quantity of dried cannabis that may be stored under the registration, as amended. Advertisement of Cannabis 80. No person shall publish, distribute or in any other manner whatsoever bring to the notice of the public or cause or permit to be published or distributed or to be so brought to the notice of the public any advertisement concerning cannabis without the authority of the Minister. PART VII GENERAL Fees 81. The fees payable in terms of these regulations shall be the appropriate fee opposite the appropriate item specified in the first column of the First Schedule. Penalties 82. Any person who contravenes the provisions of these regulations shall be guilty of an offence and liable to a fine not exceeding level twelve or to imprisonment for a period not exceeding one year or to both such fine and such imprisonment. Appeals 83. (1) Any person who is dissatisfied by any decision made in terms of these regulations may, within thirty days, appeal to the Minister. (2) Upon receiving the appeal noted in terms of subsection (1), the Minister may, within thirty days, confirm, vary or set aside the decision appealed against. (3) Any person who is dissatisfied by the decision of the Minister may, within twenty-one days, appeal to the Administrative Court. Page 36 of 43 FIRST SCHEDULE (Sections 2, 4(1)(a), 14(1)(a), 63 and 81) FEES Item Fee US $ 1. Application for a licence to produce cannabis 50 000 2. Application for a licence to conduct research on cannabis 5 000 3. Application for renewal of licence to produce cannabis 20 000 4. Application for renewal of a licence to conduct research on cannabis 2 500 5. Application for variation or amendment of a licence 2 500 6. Application for import/export licence 5 000 7. Inspection 2 500 8. Annual return fees 15 000 Page 37 of 43 SECOND SCHEDULE (Section 4(1)) FORM DANGEROUS DRUGS ACT [CHAPTER 15:02] APPLICATION FOR ISSUE OF A LICENCE FOR PRODUCTION OF CANNABIS This form is submitted in terms of Section 5 (1) of the Dangerous Drugs (Production of Cannabis for Medicinal and Scientific Use) Regulations, 2017. (To be submitted in duplicate) PART A (To be completed by individuals and sole traders) 1. Full name………………………………………………………………. 2. Date and place of birth…………………………………………………… 3. Gender…………………………………………………………….. 4. Address (Home)………………………………………………………….. 5. Email address…………………………………………………………… 6. Mobile phone number………………………………………………………….. 7. Present place of employment………………………………………….. 8. Position of applicant at place of employment (e.g. owner, manager, etc.) PART B (To be completed by companies) 9. If a company: Name of company ……………………………………. (a) Physical address…………………………………………………….. (b) Registered Office……………………………………………………. (c) Email Address……………………………………………………… (d) State shareholders or distribution of shares ……… 10.PARTICULARS OF DIRECTORS: (a) Full names………………………………………………………… (b) Address…………………………………………………………………… (c) Citizenship……………………………………………………………….. (d) Date of Birth……………………………………………………………… (e) Gender…………………………………………………………………… PART C (To be completed by all applicants) Page 38 of 43 11. Name under which business is conducted……………………………. 12. Physical address of premises to be licensed…………………………... ………………………………………………………………………………. 13. Postal address of business………………………………………………. ………………………………………………………………………………. 14. Telephone/Mobile number of proposed site……………………………………………………….. 14A. Email address………………………………………………………… 15.PARTICULARS OF AUTHORISED PERSON (a) Full name………………………………………………………………. (b) Date and place of birth…………………………………………………… (c) Gender…………………………………………………………….. 16.PARTICULARS OF RESPONSIBLE PERSON (a) Full name………………………………………………………………. (b) Date and place of birth…………………………………………………… (c) Gender ………………………………………………………………………. 17. State the proposed activities…………………………………………………… 18. The substances in respect of which each activity is to be conducted…………………………………………………………………………………… 19. State the building/s within the site where the proposed activities are to be conducted (if applicable) ………………………………………………………………………………………………… ………………………………………………………………………………………………… 20. Have you previously held a licence to produce cannabis? YES / NO*……………………………………… If YES, give details………………………………………………………… 21. Has any application made by you for a licence been refused or cancelled? YES/NO*……………………………………………………… If YES, give details……………………………………………………….. 22. Name and address of nearest police station……………………… 23. Name and approximate distance of nearest residence from premises to be licensed………………………………………… 24. Particulars and date of any trading or other licence held by the applicant or business…………………………………………. 25. If an individual: (a) are you a citizen of, or ordinarily resident in Zimbabwe? YES/NO*; (b) if YES supply proof thereof; (e) Have you within the preceding ten years of this application been convicted inside or outside Zimbabwe of an offence involving the wrongful dealing in or supply or possession of Page 39 of 43 cannabis, or of an offence involving dishonesty? YES/NO* (Attach affidavit) (f) If YES state details……………………………………………………. 26. If a company: (a) Are the directors of the company or a majority thereof citizens or ordinarily resident in Zimbabwe? YES/NO*................................................... (b) If YES supply proof thereof; (c) If NO supply proof of exemption by the Minister; (d) Has the company or any of the directors of the company within the preceding ten years of this application been convicted inside or outside Zimbabwe of an offence involving the wrongful dealing in or supply or possession of cannabis, or of an offence involving dishonesty? YES/NO*(Attach Affidavit)………………………… (e) If YES state details……………………………………………… *Delete the inapplicable NOTE: 1. Plans of the premises, the appropriate fee, proof of citizenship, residency or an exemption by the Minister, etc, are required to be attached to the application. 2. Copies of original documents must be properly certified. 3. If any plan document or fee required to be attached is not attached, the application cannot be accepted. 4. If insufficient space is provided in the application, attach a sheet of paper with the additional information. I enclose the proof of payment of the fee of ……………………………………………………………. I do hereby declare that the facts herein are fully within my knowledge and to the best of my knowledge are true and correct. Signature of applicant …………… Date…………………… ………………………………………………………. Name and position of person in the company DANGEROUS DRUGS ACT [CHAPTER 15:02] Page 40 of 43 LICENCE FOR SITE PRODUCTION OF CANNABIS FOR MEDICINAL AND SCIENTIFIC USE Licence No Receipt No File No 1. Licensee: 2. In the case of a company Names of Directors Citizenship 3. Type of site licensed: 4. Description of licensed site: 5. Location of site: 6. Name of person carrying on business on licensed site: 7. Name of business: 8. Conditions of renewal imposed by the Minister: 9. The site shall, for the purposes of section of the, be under the supervision of the following person (s): Name (Licence number) Date of renewal of licence: Expiry date of licence: Date: Minister Page 41 of 43 THIRD SCHEDULE (Section 4(4)) Security Clearance Requirements Upon an application made in terms of section 4(4), an applicant is required to provide the security requirements for the authorised persons and shall include the information set out below. 1. Date and place of birth 2. Gender 3. Height 4 Certified copy of National Identity Document 5Address (Home) 6 The addresses of all locations at which each of the stated persons resided during the years preceding the application 7An identification of the stated person(s) activities during the five years preceding the application, including the names and addresses of the persons’ employers and any post-secondary educational institutions attended. 8 The stated persons’ fingerprints taken by the Zimbabwe Republic Police. 9 The full names of the persons or spouses Page 42 of 43 FOURTH SCHEDULE (Section 49(2)) RECALL A process for withdrawing or removing cannabis or cannabis product from the distribution chain because of defects in the product, complaints of serious adverse reactions to the product and/ or concerns that the product is or may be counterfeit. The recall might be initiated by the producer or the Minister. Classification of Recalls Recalls are classified according to the following system: 3.2.1 Class I recall Occur when products are potentially life-threatening or could cause a serious risk to health. Examples of Class I Defects - Wrong Product (label and contents are different products) Correct product but wrong strength, with serous medical consequences - Microbial contamination of sterile injection or ophthalmic product - Chemical contamination with serious medical consequences - Mix up of some products with more than one container involved Wrong active ingredient in a multi-component product with serious medical consequences - Lack of effectiveness for a life threating condition. 3.2.2 Class II recall Occur when product defects could cause illness or mistreatment, but are not Class I. Examples of Class II Defects - Mislabeling e.g. wrong or missing text or figures - Missing or incorrect information- leaflets or inserts - Microbial contamination of non-injectable, non-ophthalmic sterile product with medical consequences - Chemical/ physical contamination (significant impurities, cross contamination, particulates) - Mix up of products in containers - Non compliance with specification (e.g. assay, stability, fill/ weight or dissolution) - Insecure closure with serious medical consequences (e.g. cytotoxics, child resistant containers, potent products) Lack of efficacy/effectiveness for medical condition that is not life threatening. 3.2.3 Class III recall Occur when product defects may not pose a significant hazard to health ie low risk to health but recall may be initiated for other reasons, due to quality, safety or efficacy concerns. Examples of Class III Defects - Faulty packaging e.g. wrong or missing batch number or expiry date. Class I or Class II recalls are considered to be urgent safety-related recalls. They must be reported to the MCAZ for further evaluation and investigation. Class III recalls are considered to be minimum risk to public health but should however still be reported to the MCAZ. Note: Each recall is a unique exercise and there may be occasions when the scope of a recall can be narrowed to particular customer groups. The classification is determined by the MCAZ. Expert advice might be sought where the nature of the hazard or its significant is not clear. Decision made by other stringent regulatory authorities internationally will also be considered. The Guidelines do not apply to the recall of a medicine, vaccine or medical device related to regulatory issues such as cancellation of registration due to non-payment of retention fees, approved change of applicant, manufacturer, labeling, package insert or other registered particulars. Regulatory issues in which there is lack of compliance to cGMP may lead to a recall and/or a cancellation of registration. Page 43 of 43 3.3 Levels of recall As with classification, the level (or depth) of a recall is to be assigned in agreement with the MCAZ. In determining the recall level, the principal factors to be considered are the significance of the hazard (if any), the channels by which the medicine, vaccine or medical device pharmaceutical products have been distributed, and the level to which distribution has taken place. Again, expert opinion may be necessary to determine the significance of the hazard or risk. There are three levels of recall: wholesale, retail and consumer. 3.3.1 Wholesale level Includes all parties involved in wholesale distribution and may include wholesalers and retail pharmacies. 3.3.2 Retail level Includes: - All public and private hospital pharmacies; - Retail pharmacies; Clinical investigators and the institutions in which clinical investigations are performed; Medical, dental and other health care practitioners; - Nursing homes and other related institutions; - Other retail outlets e.g. medicine shops, supermarkets and health food stores; NB: In the case where consumers that are known to be in possession of the affected products, a plan should be put in place where specific telephone calls are made to these consumers or recall letters sent to arrange for return of the recalled product. 3.3.3 Consumer level. Includes patients and other consumers. The following stages shall be followed when initiating a recall: Recall Stages Section 1. Notification to the Minister Receipt of Cannabis or Cannabis Product Problem Report 1 Information on problem of cannabis or cannabis products 2. Initiation of a Recall 2 Information Required for Assessment of Recall Information on product, problem and distribution is required 3. Assessment of Recall 3 The classification, level and strategy of recall are determined depending on the potential hazard of the defective product and the extent of product distribution. 4. Recall 4 Letters and press release (if required) are dispatched to relevant firms for notifying on the recall. 5. Progress of Recall and Report 5 Progress reports and final report are submitted to the Minister. 6. Evaluation of the Recall 6 The effectiveness of the recall is monitored by the Minister 7. Reinstatement of Supply