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RTF Template

Landesamt für Gesundheit und Soziales Mecklenburg-Vorpommern

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	01.18/410.5802
2. Name of Authorisation Holder	:	Medizintechnik Jürgen K. Kranz GmbH
3. Address(es) of Site(s)	:	Bellevue 1 - 3, Gägelow, Mecklenburg-Vorpommern, D-23968, Germany

4. Legally registered address of Authorisation Holder	:	Bellevue 1 - 3, Gägelow, Mecklenburg-Vorpommern, D-23968, 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	:	2018-10-11
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: Medizintechnik Jürgen K. Kranz

, Bellevue 1 - 3, Gägelow, Mecklenburg-Vorpommern, D-23968, 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

3.2. Medicinal gases

Any restrictions or clarifying remarks (for all users): ref 1.1: only skin and hand disinfectants, medicinal gases and infusion solutions regulated in section 47 subsection 1 number 2c Medicinal Products Act

Zu 1.1: nur Haut- und Händedesinfektionsmittel, medizinische Gase sowie Infusionslösungen gemäß § 47 Abs. 1 Nr. 2c Arzneimittelgesetz

*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	01.18/410.5802
	Page 1

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