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RTF Template

Austrian Agency For Health And Food Safety

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products

1. Authorisation Number	:	480355
2. Name of Authorisation Holder	:	Herba Chemosan Apotheker AG (ORG-100016631 / LOC-100025426)
3. Address(es) of Site(s)	:	06.Bez.:Jakomini, Petersgasse 42, Graz, 8010, Austria

4. Legally registered address of Authorisation Holder	:	Haidestrasse 4, Simmering, Vienna, 1110
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	:	1996-12-13
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: Herba Chemosan Apotheker AG

(ORG-100016631 / LOC-100041217)

, 06.Bez.:Jakomini, Petersgasse 42, Graz, 8010, 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

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

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

3.2.2. Other temperatures: (please specify) -90 °C bis -60 °C und -25 °C bis -15 °C / -90 °C to -60 °C and -25 °C to -15 °C -90 °C bis -60 °C und -25 °C bis -15 °C / -90 °C to -60 °C and -25 °C to -15 °C

Any restrictions or clarifying remarks (for all users): Herba Chemosan Apotheker AG; Betreffend Verfahren INS-480355-104771226 Probebetrieb bis zum / regarding inspection case INS-480355-104771226 valid until: 31.03.2030

Herba Chemosan Apotheker AG; Betreffend Verfahren INS-480355-104771226 Probebetrieb bis zum / regarding inspection case INS-480355-104771226 valid until: 31.03.2030

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

Union Format for a Wholesale Distribution Authorisation	480355
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