Chapter 578 – Production of Cannabis for Medicinal and Research Purposes Act

PRODUCTION OF CANNABIS FOR MEDICINAL AND RESEARCH PURPOSES

CHAPTER 578

PRODUCTION OF CANNABIS FOR MEDICINAL AND RESEARCH PURPOSES ACT An Act to provide for the production of cannabis for medicinal and research purposes.

17th April, 2018 ACT X of 2018 Arrangement of Act Article

Part I

Preliminary 1-2

Part II

Administration

Part III

General Provisions

Part IV

Operational Requirements

Part V

Appeals 6-10

Part VI

Miscellaneous Provisions 11-14

PART I

PRELIMINARY

Art. 1

The short title of this Act is the Production of Cannabis for Medicinal and Research Purposes Act.

Art. 2

In this Act, unless the context otherwise requires:

Interpretation. "Board" means the Licensing Appeals Board established by article 5; "cannabis" means: (a) fresh or dried cannabis; (b) cannabis oil; (c) cannabis plant or seeds; (d) derivatives of cannabis derivatives; and, or (e) any substance and, or product set out in guidelines issued by the regulatory authority, excluding Short title. synthetic all of the foregoing to be used exclusively for manufacturing of products for medicinal and, or research purposes;

Cap. 31 Cap. 101. PRODUCTION OF CANNABIS FOR MEDICINAL AND RESEARCH PURPOSES "drugs laws" means the Medical and Kindred Professions Ordinance, the Dangerous Drugs Ordinance and the Drug Dependence (Treatment not Imprisonment) Act; "letter of intent" means a letter issued by Malta Enterprise which shall constitute a preliminary approval and may include inter alia the regulating of assistance under the Malta Enterprise laws, and a letter of intent that includes assistance under the Malta Enterprise laws shall be subject to the provisions of the Malta Enterprise laws, which shall, mutatis mutandis, apply; "licence" means the approval given by the regulatory authority or any other authority as may from time to time be prescribed;

Cap. 325. "Malta Enterprise laws" means the Business Promotion Act and the Malta Enterprise Act; "Minister" means the Minister responsible for the Medicines Authority save for the purposes of article 3 and article 5(2) where it shall mean the Minister responsible for industry; "premises" means the industrial premises where the production of products derived from cannabis, for medicinal and, or research purposes, is to be carried out; "prescribed" means prescribed by regulations made under the powers conferred by this Act; "prescribed form" means a form as from time to time published by Malta Enterprise;  "public health" has the same meaning as is assigned to it by article 2 of the Public Health Act;  "public health emergency" has the same meaning as is assigned to it by article 2 of the Public Health Act;  "public health risk" has the same meaning as is assigned to it by article 2 of the Public Health Act;  "regulatory authority" means the authority as established by article 4 of the Medicines Act; "research" means research for pharmaceutical, pharmacological and, or clinical purposes; and  "superintendent" means the Superintendent of Public Health as established by article 3 of the Public Health Act.

PRODUCTION OF CANNABIS FOR MEDICINAL AND RESEARCH PURPOSES

PART II

ADMINISTRATION

Art. 3

Administration.

Provided that the Superintendent shall have the functions and powers vested in him by virtue of: (a) the Public Health Act, in relation to matters of public health, public health emergency and public health risk; (b) the Medicines Act. 

PART III

GENERAL PROVISIONS

Art. 4

Provided that an approval, authorisation, licence and, or permit may only be granted where the intended use of cannabis and, or products deriving therefrom is for medicinal and, or research purposes:

Provided further that cultivation that does not form an integral part of a production process intended for production of products for medicinal and, or research purposes is expressly prohibited.

Malta Enterprise shall ensure that the proposed activity is solely a production process;

Prohibitions.

PRODUCTION OF CANNABIS FOR MEDICINAL AND RESEARCH PURPOSES    (c) comply with all regulations, including international obligations resulting from a treaty to which Malta may from time to time be a party, as may be applicable; (d) comply with all regulations relating to the production and quality standards of products for medicinal and, or research purposes, as the case may be, as applicable under the Medicines Act and with any other relevant regulations; (e) obtain a licence from the regulatory authority; (f) comply with any other relevant regulations as shall, from time to time, be promulgated under this Act or any other applicable law.

PART IV

OPERATIONAL REQUIREMENTS Operational requirements.

Art. 5

Provided that the regulatory authority may at its own discretion request additional information as may be necessary for the evaluation of the application.

PRODUCTION OF CANNABIS FOR MEDICINAL AND RESEARCH PURPOSES Provided that Malta Enterprise may at its own discretion request additional information as may be necessary for the evaluation of the application.

PART V

APPEALS

Art. 6

Licensing Appeals Board.

Provided that the Minister may appoint a substitute secretary in the following cases: (a) in cases of urgency if the designated secretary is in any way not available to perform his duties; and    PRODUCTION OF CANNABIS FOR MEDICINAL AND RESEARCH PURPOSES (b) Right of appeal. in cases where the designated secretary abstains himself for the same reasons that a member of the Board may abstain himself as mentioned above.

Art. 7

In determining an appeal under this article the Board may: (a) dismiss the appeal; (b) annul the decision, and refer the matter to the regulatory authority.

Art. 8

Art. 9

Appeal to the Court of Appeal.   

Art. 10

The effect of a decision to which an appeal relates shall not, except where the Board or the Court of Appeal, as the case may be, so orders, be suspended in consequence of the filing of the appeal.

Suspension of effects of a decision pending appeal.

PART VI

MISCELLANEOUS PROVISIONS

Art. 11

The Minister may make regulations for the purpose of regulating the use of cannabis for the production of products for medicinal and, or research purposes, but without prejudice to the generality of this provision, he may make regulations for all or any of the following purposes: (a) for prescribing the conditions under which the licence and authorisations may be granted, renewed, suspended, transferred or cancelled; (b) for providing the manner in which applications for the grant, renewal, suspension, transfer or cancellation of the license and authorisation, or of any one or more categories or classes thereof are to be made; (c) for providing the manner in which applications for such licence, authorisations and approvals as may be prescribed are to be publicised and for providing the manner in which any person, who may be prejudiced by such licence, authorisations and approvals may make an objection or representation thereon; (d) for establishing the duration of the validity of the licence and authorisations or of any one or more categories or classes thereof;

Power to make regulations.

PRODUCTION OF CANNABIS FOR MEDICINAL AND RESEARCH PURPOSES   (e) for establishing the qualifications that certain key personnel involved in or with the premises may be required to possess; (f) for regulating inspections to be carried out at the premises; (g) for prescribing the inventory controls, registers, records or databases that have to be kept by the licence holder at the premises and any financial guarantees which the licence holder shall have to give; (h) for the establishment of quality controls and quality assurances other than those under the Medicines Act and any matter in relation to any activity carried on or any premises or by any person licensed under this Act; (i) for establishing the fees leviable in respect of the letter of intent, licence, authorisations and approvals or of any one or more categories or classes thereof, either by direct determination or by reference to the manner in which such fees are to be reckoned; and to make provision for fees leviable in respect of broken periods:

Provided that regulations made under this paragraph may establish the minimum and the maximum of any fee leviable in respect of the letter of intent, licence, authorisations and approvals or of any one or more categories or classes thereof; (j) for establishing the penalties or administrative sanctions to which any offender against the provisions of this Act or any regulations made thereunder shall be liable, except where anything done constitutes an offence under the drugs laws, which administrative penalties shall not exceed one hundred thousand euro (€100,000) and one thousand euro (€1,000) for every day during which an offence or a default subsists.

Power to issue guidelines.

Art. 12

Malta Enterprise and the regulatory authority may issue guidelines and, or directives for prescribing any matter, including high level of security considered necessary or expedient for the better carrying out of any of the provisions of this Act.

Monitoring.

Art. 13

Art. 14

Terms of exemption from drugs laws.