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RTF Template

Department of Occupational Health and Safety, Customer Protection and Health

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_BB_01_WDA_2020/ G3 – 6300.GH/ M1_Aesthetics /03/22.12.2020
2. Name of Authorisation Holder	:	M1 Aesthetics GmbH
3. Address(es) of Site(s)	:	Lilienthalstr. 3 a, Schönefeld, OT Waltersdorf, Brandenburg, 12529, Germany Lilienthalstr. 3 b, Schönefeld, OT Waltersdorf, Brandenburg, 12529, Germany

4. Legally registered address of Authorisation Holder	:	Lilienthalstr. 3 a, Schönefeld, OT Waltersdorf, Brandenburg, 12529, 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	:	2020-12-22
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: M1 Aesthetics GmbH

, Lilienthalstr. 3 a, Schönefeld, OT Waltersdorf, Brandenburg, 12529, Germany

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

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 office of M1 Aesthetics GmbH is located in 12529 Schönefeld, Lilienthalstr. 3 a, according to the present ground plan of 12.12.2014.

Der Sitz (Büroräume) der Firma M1 Aesthetics GmbH befindet sich in 12529 Schönefeld, Lilienthalstr. 3 a, gemäß dem vorliegenden Grundrissplan vom 12.12.2014.

Name and address of the site: M1 Aesthetics GmbH

, Lilienthalstr. 3 b, Schönefeld, OT Waltersdorf, Brandenburg, 12529, Germany

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

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): Storage and logistics are carried out in the rooms of Haemato Pharm GmbH, Lilienthalstr. 3 b, 12529 Schönefeld in accordance with the present floor plan of 03.12.2015.

According to the terms of the responsibility agreement of 03.07.2014, the storage / logistics are carried out using the rooms and personnel of Haemato Pharm GmbH.

Die Lagerung und Logistik wird in den Räumen der Haemato Pharm GmbH, Lilienthalstr. 3 b, 12529 Schönefeld gemäß dem vorliegenden Grundrissplan vom 03.12.2015 durchgeführt.

Gemäß dem Verantwortungsabgrenzungsvertrag vom 03.07.2014 erfolgt die Lagerung/Logistik unter Nutzung der Räume und des Personals der Haemato Pharm GmbH.

Union Format for a Wholesale Distribution Authorisation	DE_BB_01_WDA_2020/ G3 – 6300.GH/ M1_Aesthetics /03/22.12.2020
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