Certificates

The Danish Medicines Agency issues a certificate on completion of a satisfactory inspection. The certificate will attest that the cannabis manufacturer with a relevant authorisation complies with the national rules governing the production of cannabis products. The certificate will also attest the company’s compliance with good manufacturing practice for medicinal products (GMP). 

The executive order on the manufacture of cannabis bulk and cannabis primary products (Danish title: bekendtgørelse om fremstilling af cannabisbulk og cannabisudgangsprodukter) provides that the company must comply with GMP. This means that in addition to the rules of the pilot programme, the company must also adhere to the detailed guidelines on good manufacturing practice for medicinal products, intermediate products and active substances published by the European Commission in the Good Manufacturing Practice (GMP) guidelines.

Neither the pilot programme nor its underlying administrative framework provides any rules on the issuance of certificates to companies that are authorised to produce cannabis products. But this does not prevent the Danish Medicines Agency from drawing up a certificate for cannabis manufacturers that want to export Danish cannabis products. The importing country can decide to include the certificate in their assessment of whether to allow the import of cannabis products from the company concerned. But the certificates issued by Danish Medicines Agency have no binding effect on other countries since there are no harmonised rules in the cannabis area, neither at the EU level or the international level.

Certificates will be issued in a national format, not in the common European format that is used for pharmaceutical manufacturers under EU legislation. Nor will the certificates be transferred to the EudraGMDP database since this database is for certificates issued pursuant to the pharmaceutical legislation. When the Danish Medicines Agency, which is the competent authority for medicinal cannabis, issues a certificate, it attests that the company has been inspected and found to be compliant with the rules in force, including the GMP rules. The validity of the certificates can be confirmed at any time by contacting the Danish Medicines Agency.

The validity of certificates issued with expiry on 31 December 2021 are automatically renewed until 31 December 2023.

The Danish Medicines Agency has issued certificates to the following companies: 

CF – Authorisation to manufacture cannabis bulk and cannabis primary products (new authorisation type from 1 January 2022)
CBF – Authorisation to manufacture cannabis bulk (authorisation type issued in the period of 2018 to 2021)
CMPF – Authorisation to manufacture cannabis intermediate products (until 1 January 2022, the manufacture of cannabis primary products was based on Danish-grown cannabis comprised by this authorisation type)