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RTF Template

Government of Upper Bavaria - Central Authority for Supervision of Medicinal Products in Bavaria (GMP/GCP)

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_BY_04_WDA_2017/ROB-55Ph-2678.Ph_3-4-3-3
2. Name of Authorisation Holder	:	ACT Medical Center GmbH
3. Address(es) of Site(s)	:	Grüntenstr. 2, Buxheim, 87740, Germany

4. Legally registered address of Authorisation Holder	:	Grüntenstr. 2, Buxheim, 87740, Germany
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2017-08-28
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: ACT Medical Center GmbH

, Grüntenstr. 2, Buxheim, 87740, Germany

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

Any restrictions or clarifying remarks (for all users): Authorisation is restricted to free-trade disinfectants and infusion solutions according to § 47 (1) 1 no. 2c German Medicinal Products Act (AMG)

Erlaubnis beschränkt sich auf freiverkäufliche Desinfektionsmittel und Infusionslösungen nach § 47 Abs. 1 Satz 1 Nr. 2 AMG

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

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

Union Format for a Wholesale Distribution Authorisation	DE_BY_04_WDA_2017/ROB-55Ph-2678.Ph_3-4-3-3
	Page 1

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