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RTF Template

Landesamt für Gesundheit und Soziales Mecklenburg-Vorpommern

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	01.18/410.0401
2. Name of Authorisation Holder	:	HELIOS Kliniken Schwerin GmbH
3. Address(es) of Site(s)	:	Wismarsche Straße 393 - 397, Abteilung Transfusionsmedizin, Haus 47, Ebene 0, Räume 47.0.17, 47.0.17a und 47.0.17b, Schwerin, Mecklenburg-Vorpommern, D-19049, Germany

4. Legally registered address of Authorisation Holder	:	Wismarsche Straße 393 - 397, Schwerin, Mecklenburg-Vorpommern, D-19049, 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	:	2018-10-12
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: HELIOS Kliniken Schwerin GmbH

, Wismarsche Straße 393 - 397, Abteilung Transfusionsmedizin, Haus 47, Ebene 0, Räume 47.0.17, 47.0.17a und 47.0.17b, Schwerin, Mecklenburg-Vorpommern, D-19049, 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.2. Medicinal products derived from blood

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): ref 1.1: only trade in medicinal products derived from blood

Zu 1.1: Nur Handel mit Arzneimitteln aus Blut

*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	01.18/410.0401
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