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RTF Template

Landesdirektion Sachsen LDS

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products

1. Authorisation Number	:	DE_SN_01_WDA_2024_0004
2. Name of Authorisation Holder	:	Noweda GmbH & Co. KG (ORG-100024835 / LOC-100055226)
3. Address(es) of Site(s)	:	Apothekerstrasse 1, Oberrossau, Rossau, Saxony, 09661, Germany

4. Legally registered address of Authorisation Holder	:	Pfalzgraf-Otto-Strasse 40, Mosbach, Baden-Wuerttemberg, 74821
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC Art. 99 of Regulation (EU) 2019/6
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-02-20
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: Noweda GmbH & Co. KG

(ORG-100024835 / LOC-100034015)

, Apothekerstrasse 1, Oberrossau, Rossau, Saxony, 09661, Germany

Human medicinal products

Veterinary medicinal products

1. MEDICINAL PRODUCTS

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

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Other products: (please specify here or make a reference to Annex 5) see under „Any restrictions or clarifying remarks (for all users)": siehe unter „Etwaige Einschränkungen oder klärende Bemerkungen (für alle Nutzer)":

Any restrictions or clarifying remarks (for all users): The wholesale distribution authorisation dated 20 February 2024, issued by the Landesdirektion Sachsen, with the no. DE_SN_01_WDA_2024_0004, currently contains the following scope for no. 3:

'3.1 Medicinal products according to Art. 83 of Directive 2001/83/EC:
3.1.1 Narcotics or psychotropic substances;
3.1.2 medicinal products derived from blood,
3.1.3 immunological medicinal products;
veterinary medicinal products
3.1.5 Narcotics or psychotropic substances;
3.1.6 medicinal products for food-producing animals;
3.1.7 prescription-only veterinary medicinal products
3.2 Medical gases;
3.3 Medicinal products subject to cold chain requirements (storage and transport at low temperatures).'

Die Großhandelserlaubnis vom 20. Februar 2024, ausgestellt von der Landesdirektion Sachsen,
mit der Nr. DE_SN_01_WDA_2024_0004, enthält aktuell folgenden Umfang zu Nr. 3.:

"3.1 Arzneimittel entsprechend Art. 83 der Richtlinie 2001/83/EG:
3.1.1 Narkotika oder psychotrope Stoffe;
3.1.2 Arzneimittel aus Blut,
3.1.3 immunologische Arzneimittel;
Tierarzneimittel
3.1.5 Narkotika oder psychotrope Stoffe;
3.1.6 Arzneimittel für Lebensmitteltiere;
3.1.7 verschreibungspflichtige Tierarzneimittel
3.2 Medizinische Gase;
3.3 Kühlkettenpflichtige Arzneimittel (Lagerung und Transport bei niedrigen Temperaturen)."

*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

Union Format for a Wholesale Distribution Authorisation	DE_SN_01_WDA_2024_0004
	Page 1

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