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RTF Template

Landesamt für soziale Dienste Schleswig-Holstein

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_SH_01_WDA_2021_0013
2. Name of Authorisation Holder	:	Medac Gesellschaft fuer klinische Spezialpraeparate m.b.H.
3. Address(es) of Site(s)	:	Theaterstrasse 6, Wedel, Schleswig-Holstein, 22880, Germany Wilfried-Mohr-Strasse 1-5, Tornesch, Schleswig-Holstein, 25436, Germany Werner-von-Siemens-Straße 6, Elmshorn, 25337, Germany

4. Legally registered address of Authorisation Holder	:	Theaterstrasse 6, Wedel, Schleswig-Holstein, 22880, 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	:	2021-09-29
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: Medac Gesellschaft fuer klinische Spezialpraeparate m.b.H

, Theaterstrasse 6, Wedel, Schleswig-Holstein, 22880, Germany

1. MEDICINAL PRODUCTS

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

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

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): National legal basis of authorisation:
§ 52a Section 1 of German Drug Law (Arzneimittelgesetz)

Name and address of the site: Medac Gesellschaft fuer klinische Spezialpraeparate m.b.H.

, Wilfried-Mohr-Strasse 1-5, Tornesch, Schleswig-Holstein, 25436, Germany

1. MEDICINAL PRODUCTS

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

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

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): National legal basis of authorisation:
§ 52a Section 1 of German Drug Law (Arzneimittelgesetz)

Name and address of the site: Medac Gesellschaft für klinische Spezialpräparate m.b.H.

, Werner-von-Siemens-Straße 6, Elmshorn, 25337, Germany

1. MEDICINAL PRODUCTS

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

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): National legal basis of authorisation:
§ 52a Section 1 of German Drug Law (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	DE_SH_01_WDA_2021_0013
	Page 1

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