Certificates

Updated 28 October 2020

The Danish Medicines Agency issues a certificate when an inspection has been successfully completed. The certificate confirms that a cannabis-producing company with a relevant licence complies with the national rules on manufacturing of cannabis products in the pilot programme. The certificate also confirms that the company complies with “good manufacturing practice” for medicines (GMP). 

If a company obtains a licence under the pilot programme to manufacture cannabis bulk or cannabis primary products/cannabis intermediate products, the company is not required to satisfy additional requirements to obtain a certificate.

The Danish Manufacturing executive order on cultivation, production and distribution of cannabis bulk and production of cannabis primary products provides that companies must comply with GMP. This means that apart from adhering to the rules of the pilot programme, they must also adhere to the detailed guidelines on good manufacturing practice for medicines, intermediate products and active substances published by the European Commission in the Good Practice (GMP) guidelines.

Neither the pilot programme nor the underlying administrative framework establishes any rules for the issue of certificates to companies with a licence to manufacture cannabis products. However, the absence of such rules does not prevent the Danish Medicines Agency from preparing a certificate for cannabis manufacturers that want to export Danish cannabis products. Importing countries can choose to include the certificate in their assessment of whether to allow the import of Danish cannabis products from the company concerned. However, other countries are not bound to recognise the certificates issued by the Danish Medicines Agency, the reason being that the rules in the cannabis area have not been harmonised in the EU or internationally.

The certificates will be issued in a national format and will not use the common European format used for pharmaceutical manufacturers under EU law and published in the EudraGMDP database. However, when the Danish Medicines Agency issues either European GMP certificates for medicines or nationally-prepared certificates for cannabis-producing companies in the pilot programme, it means that the Danish Medicines Agency in capacity as the national competent authority has inspected the company and verified that it complies with the applicable GMP rules.

Name

Certificate by licence type

Number of sites

Certificate number

Date

Guidelines

Medican A/S
Licence to produce cannabis bulk
1 DK CBF 00112029
22.10-2020  
Aurora Nordic Cannabis A/S
Licence to produce cannabis intermediate products (Cannabis primary products based on Danish-grown cannabis)
1 DK CBF 00112028
15.09.2020
GACP
EU GMP, vol. 4, Part I
EU GMP, vol. 4, Part II
Aurora Nordic Cannabis A/S
Licence to produce cannabis bulk
1 DK CBF 00112027
22.04.2020
GACP
EU GMP, vol. 4, Part I
EU GMP, vol. 4, Part II

Schroll Medical ApS

Licence to produce cannabis bulk

1

DK CBF 00112025

29.10.2019

GACP
EU GMP, vol. 4, Part I
EU GMP, vol. 4, Part II

Schroll Medical ApS

Licence to produce cannabis intermediate products (Cannabis primary products based on Danish-grown cannabis)

1

DK CMF 00112025

29.10.2019

GACP
EU GMP, vol. 4, Part I
EU GMP, vol. 4, Part II

Canopy Growth Denmark ApS

Licence to produce cannabis bulk

1

DK CBF 00112026

30.10.2019

GACP
EU GMP, vol. 4, Part I
EU GMP, vol. 4, Part II

Canopy Growth Denmark ApS

License to produce cannabis intermediate products (Cannabis primary products based on Danish-grown cannabis)

1

DK CBF 00112026

30.10.2019

GACP
EU GMP, vol. 4, Part I
EU GMP, vol. 4, Part II


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