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RTF Template

Bezirksregierung Duesseldorf

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_NW_03_WDA_2023_0051/24.05.05.01-CAELO
2. Name of Authorisation Holder	:	Caesar und Loretz GmbH (ORG-100001709 / LOC-100007602)
3. Address(es) of Site(s)	:	Herderstrasse 31, Hilden, North Rhine-Westphalia, 40721, Germany

4. Legally registered address of Authorisation Holder	:	Herderstrasse 31, Hilden, North Rhine-Westphalia, 40721
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC § 52a AMG
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2023-12-18
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: Caesar und Loretz GmbH

(ORG-100001709 / LOC-100007602)

, Herderstrasse 31, Hilden, North Rhine-Westphalia, 40721, Germany

Human 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

Any restrictions or clarifying remarks (for all users): to 1.1: Wholesale is limited to herbal drugs according to standard authorisation.
to 1.2: Cannabis flowers and cannabis extracts
to 3.1.1: Subject to a corresponding permit pursuant to Section 3 BtMG

Zu 1.1: Der Handel ist auf pflanzliche Drogen gem. Standardzulassung beschränkt.
Zu 1.2: Cannabisblüten und Cannabisextrakte
Zu 3.1.1: Vorbehaltlich einer entsprechenden Erlaubnis nach § 3 BtMG

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

**Without prejudice to further authorisations as may be required according to national legislation.

Union Format for a Wholesale Distribution Authorisation	DE_NW_03_WDA_2023_0051/24.05.05.01-CAELO
	Page 1

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