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RTF Template

Landesamt für Soziales, Jugend und Versorgung

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_RP_01_WDA_54.2_2018_005
2. Name of Authorisation Holder	:	Pharma International Apothekerin Cordula Messer
3. Address(es) of Site(s)	:	Carl-Zeiss-Str. 31, Mainz, 55129, Germany

4. Legally registered address of Authorisation Holder	:	Carl-Zeiss-Str. 31, Mainz, 55129, 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	:	2018-09-24
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: Pharma International Apothekerin Cordula Messer

, Carl-Zeiss-Str. 31, Mainz, 55129, Germany

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation in EEA country(s)

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

1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): ____________________________________________________________
The authorisation includes wholesale distribution activities with products according to Art. 67 of 2001/82/EC.

____________________________________________________________
Translation in national language:
Die Erlaubnis umfasst auch den Großhandel mit Tierarzneimitteln entsprechend Art. 67 der Richtlinie 2001/82/EG.

*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_RP_01_WDA_54.2_2018_005
	Page 1

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