S.L. 578.1 Art. 2Interpretation. 

In these regulations, unless the context otherwise requires –

''the Act'' means the Production of Cannabis for

Medicinal and Research Purposes Act;

"Contribution" means a payment per unit product marketed, made to the Regulatory Authority for corresponding research and education activities;

"clock-stop" means any period during which the Regulatory Authority is awaiting the applicant’s submission of documents or information it has formally requested

''distribution'' includes activities consisting of procuring, holding or supplying, apart from distributing to the public, medicinal preparations of cannabis in the authorised product pack size;

''GMP certificate'' has the same meaning as ''GMP

certificate'' in article 2 of the Medicines Authority (Fees) Regulations;

''Licensing Authority'' means the authority established by article 3 of the Medicines Act;

"preceding year" means the period of twelve (12) consecutive months commencing on the date an annual fee becomes due and ends on the day immediately preceding the next annual fee due date:

Provided that for the purpose of calculating the first annual fee, the twelve (12) month period shall be deemed to commence on the date on which the license is officially granted in accordance with the Act and these regulations;

''Regulatory Authority'' means the authority established by article 4 of the Medicines Act; and RESEARCH PURPOSES (FEES)

''Unit product'' means the final product pack as authorised for release, which pack shall in any case not exceed one (100) hundred grams in weight or four (400) hundred millilitres in volume, or as otherwise approved by the Regulatory Authority taking into consideration composition and intended market.