Medical Cannabis CuraçaoApplication procedureMINISTRY OF HEALTH, ENVIRONMENT & NATURESEPTEMBER 2019

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Before you start:Have a good definition of your core activities and product;Having an high level experienced agriculture expert is a must for licenses to cultivate medicinal cannabis; In case of research: Bear in mind that a medicinal cannabis production license requires always a research license. When applying for an Opium Ordinance license for conducting scientific or analytical-chemical research, the need for the license must be demonstrated. If there are alternative options - that is, the goal can reasonably be achieved without using cannabis - the necessity has not been demonstrated in principle. In the case of applications for scientific or analytical chemical research, the aim must be scientifically substantiated (for example by means of a scientific research protocol for a clinical study or for plant breeding). If applicable, various quality requirements or various certification standards (for example ISO and NEN) must be met. If this cannot be met (yet), this must be justified. If test subjects are involved in the study, a statement must be submitted stating that the study design has been tested with a positive result by an authorized medical ethics committee. A standardized preparation (standardization on, for example, one or more ingredients) must be used. It must be stated how the preparation is prepared and from whom this preparation will be obtained;Alternatively, an approved sample of an existent product might be submitted for approval in case of manufacturing of a (generic) product;In case of manufacturing: According to the Decree on Packaged Medicines: The preparation of packaged medicines by a manufacturer may only take place under the supervision of a pharmacist who has not been suspended or has not been deprived of his authority.

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1 Design Business Case

Design Business Plan: Product, production

processes, people and Organization, Safety and Security, Financing and

Financial statements

(1) Establish Legal Entity;

(2) Register at Chamber of Commece;

(3) Get Vestigings-vergunning;

(4) Get Proof of Funds

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Input and resources:Ordinance on Medicinal Cannabis and Opium OrdinanceNational Ordinance on Medicines;National Decree on Packaged Medicines;WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants;Guidelines on good manufacturing practices for the manufacture of herbal medicinesRead voorschriften voor de verbouw van cannabis voor medicinale doeleinden

Contract with Pharmacist

(1) Acquire Application Form (2) Fill in Form and include attachments, (3)

Pay Application fee

Submit Application Form and

attachments to OMCC

Acquire Proof of Good Conduct 3

Submit Contract to Inspector

Receive Notice of Preliminary Approval and Indicative Production Plot

Submit: (1) Application Form

Medicinal Wholesaler License;

(2) Application for Building Permit;

(3) Application for Nuisance License

Receive Notice of Application

Submission 4

2 D 28 D

Complete Application Form

Receive: (1) Medicinal

Wholesaler License (MWL)

(2) Nuisance License (NuiL)

(3) Building Permit (BP)

5Submit MWL, NuiLand BP to MHEN

42 D

Pay Licenses Fees

Receive Notice of Licenses Application

Approval

6Submit Proofs of Fee Payments to OMCC

14 D

Submit: (1) Sales Contract(s) with ultimate

buyer (2) Production Plan, (3) Label and Packaging design and contract(s) to

OMCC

(1) Start Building Process;

(2) Recruit and train personnel;(3) Find/Define

Buyers

7

Receive Notice of Approval of Sales

Contract(s) and Production Plans and

Sign Contract w/ OMCC

14 D

Start Production and Notify OMCC

Submit Samples for Lab Testing 8Receive Payment for

Sold Products

Submit Authenticated Certificates to OMCC and

Submit Final Product Samples for Lab Test

Deposit Payment for Sold Products on Government

Acct.

9Notify OMCC of Final Production

Acquire Certificate of Export and

Certificate of Import from

Buyer

Receive Notice of Delivered Goods

Notify OMCC of Delivery of Sold

Goods and Deliver Sold

Goods to OMCC

Receive payment for Delivered Sold Goods