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RTF Template

Freie und Hansestadt Hamburg, Ministry of Health and Consumer Protection

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_HH_01_WDA/517-02.13/01,0102
2. Name of Authorisation Holder	:	Pure Pharma u. Chemikalien Import-Export GmbH
3. Address(es) of Site(s)	:	Albert-Einstein-Ring 13, Hamburg, Hamburg, 22761, Germany

4. Legally registered address of Authorisation Holder	:	Albert-Einstein-Ring 13, Hamburg, Hamburg, 22761, 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	:	2018-12-28
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: Pure Pharma u. Chemikalien Import-Export GmbH

, Albert-Einstein-Ring 13, Hamburg, Hamburg, 22761, Germany

1. MEDICINAL PRODUCTS

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

2.4. Export

2.5. Other activities(s): Holding is outsourced, see annex 5 of the official documentLagerung bei einem beauftragten Betrieb, siehe Anlage 5 der Urkunde

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Ref. 1.2: no finished dosage forms

zu 1.2: keine Fertigarzneimittel

*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_HH_01_WDA/517-02.13/01,0102
	Page 1

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