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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-05-02

RTF Template

Austrian Federal Office For Safety In Health Care

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products

1. Authorisation Number	:	483078
2. Name of Authorisation Holder	:	G.L. Pharma GmbH (ORG-100000592 / LOC-100004168)
3. Address(es) of Site(s)	:	Gansterergasse 9-13, Ottakring, Vienna, 1160, Austria

4. Legally registered address of Authorisation Holder	:	Schlossplatz 1, Lannach, Styria, 8502, Austria
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC Art. 99 of Regulation (EU) 2019/6
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2020-07-06
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: G.L. Pharma GmbH

(ORG-100000592 / LOC-100003326)

, Gansterergasse 9-13, Ottakring, Vienna, 1160, Austria

Human medicinal products

Veterinary medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

2.3. Supply

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

Any restrictions or clarifying remarks (for all users): G.L. Pharma GmbH; INS-483078-103728019 Probebetrieb bis zum: / Regarding inspection case INS-483078-103728019 valid until: 31.05.2026

G.L. Pharma GmbH; INS-483078-103728019 Probebetrieb bis zum: / Regarding inspection case INS-483078-103728019 valid until: 31.05.2026

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

Reason for Withdrawing:

The licence issued in accordance with § 63 para 1 or § 63a para 2 or 3 or § 65 para 1 shall become void if the operating licence holder relinquishes it (austrian medicinal products act).

Union Format for a Wholesale Distribution Authorisation	483078
	Page 1

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