Rules about relationships applicable to companies

Rules about relationships applicable to companies comprised by the pilot programme

Companies comprised by the medicinal cannabis pilot programme or the scheme for cultivation, production, etc. are bound by notification and information obligations when they establish a relationship with a proprietary pharmacist or a doctor.

Important things for companies to know:

1. Companies covered by the rules

The notification and information obligations concern companies

• holding an authorisation under section 9(1) of the Act on a Medicinal Cannabis Pilot Programme, permitting them to cultivate, manufacture or distribute cannabis primary products or cannabis intermediate products or to cultivate, process, control, etc. cannabis in Denmark (Danish title: Lov om forsøgsordning med medicinsk cannabis).

2. Companies have an information obligation

When a company comprised by the pilot programme or the scheme for cultivation, production, etc. of medicinal cannabis establishes a relationship with a proprietary pharmacist or a doctor, they must inform this health professional that he or she must notify the Danish Medicines Agency of the relationship or apply for permission thereof, including that the Danish Medicines Agency’s publishes this information.

3. Companies must report their relationships on an annual basis

Companies comprised by the pilot programme must report information about their established relationships with proprietary pharmacists and doctors to the Danish Medicines Agency.

The details to be included in the report are: company name and central business registration number ((CVR no.) to be entered on the form), the full names of the connected proprietary pharmacists and doctors, their primary workplace, private address or email address and authorisation ID or civil registration number (CPR no.) as well as the time period of the relationship.

The information is to be entered in this template (Excel). In the column Cpr-nr. (column G), either write the civil registration number (CPR no.) or the authorisation ID.

The report is to be submitted using this encrypted form to which the Excel file should be attached. You have 20 minutes to complete and submit the form after you have opened it. If you exceed this time limit, we will not receive your form. The form is submitted using digital employee signature.

Tell proprietary pharmacists and doctors about the submitted report

At the time of submitting the report to the Danish Medicines Agency, the company must inform the concerned proprietary pharmacists and doctors of the report content (the information that has been submitted about the person to the Danish Medicines Agency).

Legislation

The Act on a Medicinal Cannabis Pilot Programme and on a Scheme for Cultivation, Production, etc. of Medicinal Cannabis provides the legal framework for the companies’ notification and information obligations when they establish relationships with proprietary pharmacists and doctors.

List of companies

The Danish Medicines Agency publishes a list of companies comprised by the pilot programme and thus the rules on relationships.