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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	:	480145
2. Name of Authorisation Holder	:	Richter Pharma AG (ORG-100000500 / LOC-100004589)
3. Address(es) of Site(s)	:	Feldgasse 19, Wels, Upper Austria, 4600, Austria

4. Legally registered address of Authorisation Holder	:	Feldgasse 19, Wels, Upper Austria, 4600, 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	:	2003-09-23
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: Richter Pharma AG

(ORG-100000500 / LOC-100004589)

, Feldgasse 19, Wels, Upper Austria, 4600, Austria

Human medicinal products

Veterinary 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*

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) Lagerung von Arzneimitteln bei -80°C bis -60°C und -25°C bis -15°C Lagerung von Arzneimitteln bei -80°C bis -60°C und -25°C bis -15°C

3.2.2. Other temperatures: (please specify) 80°C bis -60°C und -25°C bis -15°C 80°C bis -60°C und -25°C bis -15°C

Any restrictions or clarifying remarks (for all users): Richter Pharma AG; Ad 1.2: eingeschränkt auf das Produkt "Acemap" / restricted to the medicinal product "Acemap"

Richter Pharma AG; Ad 1.2: eingeschränkt auf das Produkt "Acemap" / restricted to the medicinal product "Acemap"

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

Union Format for a Wholesale Distribution Authorisation	480145
	Page 1

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