Rules about relationships to companies

Updated 08 March 2018
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Rules about relationships applicable to companies comprised by the pilot programme

The companies comprised by the medicinal cannabis pilot programme have a reporting obligation and a duty to inform when they establish a relationship with a proprietary pharmacist or a doctor.

Three important things for companies to know:

1. Companies covered by the rules

The reporting obligation and the duty to inform concern companies

  • authorised to import, manufacture or distribute cannabis primary products or cannabis intermediate products (cf. section 9(1) of the act on the medicinal cannabis pilot programme),
  • permitted to cultivate, manufacture, control, etc. cannabis in Denmark (cf. section 6 of the act on the medicinal cannabis pilot programme and any rules issued pursuant to this act ).

2. Companies have a duty to inform

When a company comprised by the pilot programme establishes a relationship with a proprietary pharmacist or a doctor, it must inform the person that he or she has a duty to notify or apply for permission of the relationship to the Danish Medicines Agency and that the Danish Medicines Agency will publish information about the relationship.

I forhold til apotekere og læger, som er påbegyndt en tilknytning til virksomheden før den 1. januar 2018, gælder dog, at I skal informere disse om reglerne senest den 15. januar 2018.

3. Companies must report relationships annually

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

The first report, covering the 2018 calendar year, must be submitted no later than 31 January 2019.

The details to be included in the report are: company name and central business registration number (CVR no.) (these are entered in the form), the names of the connected proprietary pharmacists and doctors, their primary workplace, private 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.

Inform proprietary pharmacists and doctors about the 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 contents of the report (the information that has been submitted about the person to the Danish Medicines Agency).

Legislation

The act on the medicinal cannabis pilot programme provides the legal framework for the companies’ reporting obligation and duty to inform when they establish a relationship 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

.

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