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Bezirksregierung Koeln

CERTIFICATE NUMBER: DE_NW_04_GMP_2026_0041

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER(1) , (2)

Part 1

Issued following an inspection in accordance with
Art. 111(5) of Directive 2001/83/EC as amended

The competent authority of Germany confirms the following:

The manufacturer: Zenabis Ltd.

Site address:

12 Comeau Avenue, Atholville, Nb, E3N 4G2, Canada

OMS Organisation Id. / OMS Location Id.: ORG-100039213 / LOC-100105872

Has been inspected in connection with marketing authorisation(s) listing manufacturers located outside of the European Economic Area in accordance with Art. 111(4) of Directive 2001/83/EC transposed in the following national legislation:Sect. 72a para 1 sent. 1 No. 2 in conjunction with sent. 3 No. 1 German Medicinal Product Act (import certificate).

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2026-07-31 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572. (3)

This certificate reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. Updates to restrictions or clarifying remarks can be identified through the EudraGMDP website (https://eudragmdp.ema.europa.eu/). This certificate is valid only when presented with all pages and both Parts 1 and 2.

The authenticity of this certificate may be verified in EudraGMDP. If it does not appear, please contact the issuing authority.

__________________________________________________________________________________________________________________________

(1) The certificate referred to in paragraph Art. 111(5) of Directive 2001/83/ECis also applicable to importers.
(2) Guidance on the interpretation of this template can be found in the Interpretation of the Union format for GMP certificate.
(3) These requirements fulfil the GMP recommendations of WHO.

Part 2

Human Medicinal Products

1 MANUFACTURING OPERATIONS

1.2 Non-sterile products

1.2.1 Non-sterile products (processing operations for the following dosage forms)
1.2.1.17 Other: cannabis flowers(en)

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.17  Other non-sterile medicinal products: cannabis flowers(en)
   1.5.2  Secondary packaging

Clarifying remarks (for public users):

This certificate was issued following an inspection request of the company Enua Pharma GmbH Vitalisstraße 67 50827 Köln on 24th February 2025 in order to obtain a confirmation according to paragraph 64 Abs. 3f and 72a Abs. 1 Medicinal Product Act, German Drug Law (Arzneimittelgesetz - AMG). Contrary to the statement on page 1 there is no marketing authorisation according to paragraph 21 AMG issued for cannabis flowers. The GMP certificate applies exclusively to flowers from plants cultivated at the companys own premises located at 12 Comeau Avenue, Atholville NB, E3N 4G2, Canada.

The EudraGMDP database is maintained and operated by the EMA. Access to the general public is granted in order to enhance availability of information related to the EMA mandate. The content of the database is provided by the National Competent Authorities (NCA) of the EEA. For this reason, the EMA accepts no responsibility or liability whatsoever (including but not limited to any direct or consequential loss or damage it might occur to you and/or any other third party) arising out of or in connection with the information on this database. Any questions about the content should be addressed to the relevant NCA. Please click here to get list of NCA's.

For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

Documents issued by UK authorities up to and including 31 December 2020 remain available for consultation in EudraGMDP. However, they are no longer included or updated from 1 January 2021, with the exception of the documents pertaining to sites located in Northern Ireland.