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RTF Template

Landesamt Fuer Soziales Jugend Und Versorgung

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_RP_01_WDA_2026/3112-0192/261002
2. Name of Authorisation Holder	:	phi Pharma International GmbH & Co. KG (ORG-100038309 / LOC-100060282)
3. Address(es) of Site(s)	:	Carl-Zeiss-Strasse 31, Hechtsheim, Mainz, Rhineland-Palatinate, 55129, Germany

4. Legally registered address of Authorisation Holder	:	Carl-Zeiss-Strasse 31, Hechtsheim, Mainz, Rhineland-Palatinate, 55129
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	:	2026-10-02
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

ANNEX 1

SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION

Name and address of the site: phi Pharma International GmbH & Co. KG

(ORG-100038309 / LOC-100060282)

, Carl-Zeiss-Strasse 31, Hechtsheim, Mainz, Rhineland-Palatinate, 55129, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation or registration in EEA country(s)

1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*

1.3. without a Marketing Authorisation or registration in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

2.5. Other activities(s): (please specify) Activities within the scope of Sect 73 para 2, no. 2, 2a, 3, 3a AMG and Sect 73 para 3 AMG |Tätigkeiten im Rahmen des § 73 Abs. 2 Nr. 2, 2a, 3, 3a AMG und § 73 Abs. 3 AMG

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.3. Other products: (please specify here or make a reference to Annex 5) Medicinal products derived from blood; immunological medicinal prod. acc. to Art. 83 of 2001/83/EC | Arzneimittel aus Blut, immunologische Arzneimittel entsprechend Art. 83 der Richtlinie 2001/83/EC

Any restrictions or clarifying remarks (for all users): Archiving is also performed in the 2th upper floor within the building Carl-Zeiss-Strasse 26, 55129 Mainz.
To 3.1.: Wholesale activities cover also the wholesale with the following products:
Cannabis Flos, standardized Cannabis Extract and finished medicinal products, which are covered by MedCanG.
---

Die Archivierung erfolgt zusätzlich in den Räumlichkeiten im 2. Obergeschoss der Carl-Zeiss-Straße 26, 55129 Mainz.
Zu Punkt 3.1.: Die Großhandelstätigkeit umfasst auch den Handel mit folgenden Produkten: Cannabis Flos, eingestellter Cannabisextrakt und Fertigarzneimittel, die unter das MedCanG fallen.

*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

**Without prejudice to further authorisations as may be required according to national legislation.

Union Format for a Wholesale Distribution Authorisation	DE_RP_01_WDA_2026/3112-0192/261002
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