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RTF Template

Landesamt für Gesundheit und Soziales Mecklenburg-Vorpommern

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	01.20/410.5408
2. Name of Authorisation Holder	:	O'ZOO GmbH
3. Address(es) of Site(s)	:	Am Industriegelände 5, Ludwigslust, Mecklenburg-Vorpommern, D-19288, Germany

4. Legally registered address of Authorisation Holder	:	Am Industriegelände 5, Ludwigslust, Mecklenburg-Vorpommern, D-19288, Germany
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2020-10-02
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: O'ZOO GmbH

, Am Industriegelände 5, Ludwigslust, Mecklenburg-Vorpommern, D-19288, 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

2.5. Other activities(s): Storage and logistics additionally by an authorised company (see Appendix 2)Lagerung und Logistik zusätzlich durch einen beauftragten Betrieb (siehe Anlage 2)

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: drop shipments, trade in products in accordance of § 1 of the animal vaccines regulation Streckengeschäfte, Handel mit Mitteln i. S. d. § 1 Tierimpfstoff-Verordnung

Any restrictions or clarifying remarks (for all users): ref 2.5:
external storage and logistics at warehousing and logistics service providers:
NextPharma Logistics Gmbh, Stieghorster Straße 62, 33605 Bielefeld, Niederlassungen Eichenbusch 1, 59368 Werne und Daimlerstraße 16, 85748 Garching

zu 2.5:
Lagerung und Logistik durch
NextPharma Logistics Gmbh, Stieghorster Straße 62, 33605 Bielefeld, Niederlassungen Eichenbusch 1, 59368 Werne und Daimlerstraße 16, 85748 Garching

Union Format for a Wholesale Distribution Authorisation	01.20/410.5408
	Page 1

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