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RTF Template

Apothekerkammer Niedersachsen

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_NI_05_WDA_2022_0054
2. Name of Authorisation Holder	:	Arkaden-Apotheke Mark Herold e.K. (ORG-100039640 / LOC-100062718)
3. Address(es) of Site(s)	:	Salzdahlumer Strasse 196, Brunswick, Lower Saxony, 38126, Germany

4. Legally registered address of Authorisation Holder	:	Salzdahlumer Strasse 196, Brunswick, Lower Saxony, 38126
5. Scope of authorisation (complete for each site under 4)	:	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 wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2022-11-17
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: Arkaden-Apotheke Mark Herold e.K.

(ORG-100039640 / LOC-100062718)

, Salzdahlumer Strasse 196, Brunswick, Lower Saxony, 38126, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): The new permit was issued on the basis of the 09.11.2022 inspection.
The permit is valid for the premises indicated with date of 10.11.2021 (according to room plan 11/2021).

Die neue Erlaubnis wurde aufgrund der Inspektion vom 09.11.2022 erteilt.
Die Erlaubnis gilt für die mit Datum vom 10.11.2021 (gemäß Raumplan 11/2021) angezeigten Betriebsräume.

*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_NI_05_WDA_2022_0054
	Page 1

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