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RTF Template

Bezirksregierung Arnsberg

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_NW_01_WDA_2025/24.05.06-067/02
2. Name of Authorisation Holder	:	GTI Medicare GmbH (ORG-100019491 / LOC-100028263)
3. Address(es) of Site(s)	:	Beuler Hoehe 36, Hattingen, 45525, Germany

4. Legally registered address of Authorisation Holder	:	Beuler Hoehe 36, Hattingen, 45525
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	:	2025-07-17
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: GTI Medicare GmbH

(ORG-100019491 / LOC-100028263)

, Beuler Hoehe 36, Hattingen, 45525, 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) Medicinal gases Medizinische Gase

Any restrictions or clarifying remarks (for all users): This authorisation covers only wholesale distribution with medicinal gases (gaseous form, in cylinders) and decanting of liquefied oxygen into portable containers.

Die Großhandelserlaubnis umfasst ausschließlich den Großhandel mit medizinischen Gasen (gasförmig, in Flaschen) und das Umfüllen von flüssigen Sauerstoff in tragbare Behälter.

Union Format for a Wholesale Distribution Authorisation	DE_NW_01_WDA_2025/24.05.06-067/02
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