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RTF Template

Bezirksregierung Düsseldorf

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_NW_03_WDA_2020_0020/ 24.05.05.01-Paesel & Lorei
2. Name of Authorisation Holder	:	Paesel & Lorei GmbH & Co. KG Biochemika, Diagnostika und Pharmazeutika
3. Address(es) of Site(s)	:	Nordring 11, Rheinberg, Nordrhein-Westfalen, 47495, Germany

4. Legally registered address of Authorisation Holder	:	Nordring 11, Rheinberg, Nordrhein-Westfalen, 47495, 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	:	2020-08-24
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: Paesel & Lorei GmbH & Co. KG Biochemika, Diagnostika und Pharmazeutika

, Nordring 11, Rheinberg, Nordrhein-Westfalen, 47495, Germany

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation 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

3.1.1. Narcotic or psychotropic products

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): To 1.2: cannabis flowers and cannabis extract from EU/EWR-states
To 3.1.1: subject to a corresponding authorisation under § 3 BtMG
To 3.1.2: no blood plasma

Zu 1.2: Cannabisblüten und -extrakte aus EU/EWR-Staaten
Zu 3.1.1: vorbehaltlich einer entsprechenden Erlaubnis nach § 3 BtMG
Zu 3.1.2: keine Blutplasmen

*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_NW_03_WDA_2020_0020/ 24.05.05.01-Paesel & Lorei
	Page 1

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