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RTF Template

Landesdirektion Sachsen

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_SN_01/L24.2-5117/163
2. Name of Authorisation Holder	:	AKULA-Medizintechnik Annaberg GmbH
3. Address(es) of Site(s)	:	Barbara-Uthmann-Ring 156, Annaberg-Buchholz, 09456, Germany

4. Legally registered address of Authorisation Holder	:	Barbara-Uthmann-Ring 156, Annaberg-Buchholz, 09456, 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	:	2017-12-18
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: AKULA-Medizintechnik Annaberg GmbH

, Barbara-Uthmann-Ring 156, Annaberg-Buchholz, 09456, 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

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Medicinal gases

Any restrictions or clarifying remarks (for all users): This authorisation does not apply to wholesale distribution of medicinal products which need to be stored under cool, cold and freezer conditions.

Diese Erlaubnis gilt nicht für den Großhandel mit kühl und tiefgekühlt zu lagernden Arzneimitteln.

*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_SN_01/L24.2-5117/163
	Page 1

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