Landesamt für Gesundheit und Soziales Mecklenburg-Vorpommern - Arzneimittelüberwachungs- und -prüfstelle
UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION
1. Authorisation Number
:
01.22/410.0410
2. Name of Authorisation Holder
Cannaphytica Biomed GmbH
(ORG-100035263 / LOC-100068740)
3. Address(es) of Site(s)
Hagenower Strasse 73, Gartenstadt, Schwerin, Mecklenburg-Western-Pommerania, 19061, Germany
4. Legally registered address of Authorisation Holder
Hagenower Strasse 73, Gartenstadt, Schwerin, Mecklenburg-Western-Pommerania, 19061
5. Scope of authorisation
ANNEX 1
6. Legal basis of authorisation
Art. 77(1) of Directive 2001/83/EC
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation
Confidential, Confidential
8. Signature
9. Date
2022-03-23
10. Annexes attached
Annex 1 Scope of wholesale distribution authorisation
Annex 2 (Optional) Address(es) of contract wholesale distribution sites and their authorisation number
Annex 3 (Optional) Name(s) of responsible person(s)
Annex 4 (Optional) Date of Inspection on which authorisation was granted
Annex 5 (Optional) Additional provisions based on national requirements
SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION
Name and address of the site: Cannaphytica Biomed GmbH
, Hagenower Strasse 73, Gartenstadt, Schwerin, Mecklenburg-Western-Pommerania, 19061, Germany
Human medicinal products
1.1. with a Marketing Authorisation in EEA country(s)
2.1. Procurement
2.3. Supply
2.4. Export
2.5. Other activities(s): Transport, storage and distribution by commissioned company (see annex 2)Transport, Lagerung und Distribution durch beauftragten Betrieb (siehe Anlage 2)
3.1.1. Narcotic or psychotropic products
Any restrictions or clarifying remarks (for all users): ref 1.1: Trade in cannabis products onlyref 3.1.1: Subject to authorisation according to para 3 German Narkotic Act
zu 1.1.: nur Handel mit Cannabisproduktezu 3.1.1: vorbehaltlich einer entsprechenden Erlaubnis nach § 3 Betäubungsmittelgesetz
Reason for Withdrawing:
The wholesale company does not fulfil the requirements of good distribution practice in accordance with Article 84 of Directive 2001/83/EC. The wholesale distribution authorisation was ordered to be suspended until 30.05.2025.
Das Großhandelsunternehmen erfüllt nicht die Anforderungen der guten Vertriebspraxis gemäß Artikel 84 der Richtlinie 2001/83/EG. Für die Großhandelserlaubnis wurde das Ruhen bis zum 30.05.2025 angeordnet.
Union Format for a Wholesale Distribution Authorisation
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