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RTF Template

Regierung Von Oberbayern

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BY_04_WDA_2026/ ROB-55Ph-2678.Ph_3-304-7-23
2. Name of Authorisation Holder	:	Zimeda GmbH & Co. KG (ORG-100040264 / LOC-100065594)
3. Address(es) of Site(s)	:	Dr.-Emil-Brichta-Strasse 3, Kohlbruck, Passau, 94036, Germany

4. Legally registered address of Authorisation Holder	:	Dr.-Emil-Brichta-Strasse 3, Kohlbruck, Passau, 94036
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	:	2026-01-12
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: Zimeda GmbH & Co. KG

(ORG-100040264 / LOC-100065594)

, Dr.-Emil-Brichta-Strasse 3, Kohlbruck, Passau, 94036, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Other products: (please specify here or make a reference to Annex 5) Medical gases, medicines requiring cold chain storage

Any restrictions or clarifying remarks (for all users): The range of medicinal products is limited to disinfectants and (infusion) solutions in accordance with Section 47 (1) of the German Medicines Act (AMG), medical gases and nutritional solutions as medicinal products. Deliveries are made to public pharmacies, hospitals and doctors in Germany and Austria.

das Arzneimittelsortiment beschränkt sich auf Desinfektionsmittel und (Infusions-)lösungen nach § 47 Abs. 1 AMG, medizinische Gase sowie ERnährungslösungen als Arzneimittel. Die Lieferung erfolgt an öffentl. Apotheken sowie Krankehäuser und Ärzte in Deutschland und Österreich

Union Format for a Wholesale Distribution Authorisation	DE_BY_04_WDA_2026/ ROB-55Ph-2678.Ph_3-304-7-23
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