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RTF Template

State Office of Health and Social Affairs Berlin

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	5373/1-Medios Individual GmbH/2
2. Name of Authorisation Holder	:	Medios Individual GmbH
3. Address(es) of Site(s)	:	Ringbahnstrasse 10/14, Berlin, Berlin, 12099, Germany

4. Legally registered address of Authorisation Holder	:	Ringbahnstrasse 10/14, Berlin, Berlin, 12099, 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	:	2018-07-26
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: Medios Individual GmbH

, Ringbahnstrasse 10/14, Berlin, Berlin, 12099, 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

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): only medicinal products authorised in germany for parenteral use, which could be used as starting material for the manufacturer's authorisation

ausschließlich im Geltungsbereich des AMG zugelassene Arzneimittel zur parenteralen Anwendung, die als Ausgangsstoffe im Rahmen der bestehenden Herstellungserlaubnis nach § 13 AMG zum Einsatz kommen können

*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	5373/1-Medios Individual GmbH/2
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