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Information Messages

The WDA has been withdrawn, withdrawn date is: 2026-02-05

RTF Template

Regierungspraesidium Tuebingen Leitstelle Arzneimittelueberwachung Baden-Wuerttemberg

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products

1. Authorisation Number	:	DE_BW_01_WDA_2019_0001_Glatt Pharmaceutical
2. Name of Authorisation Holder	:	Glatt Pharmaceutical Services GmbH & Co. KG (ORG-100011667 / LOC-100018538)
3. Address(es) of Site(s)	:	Werner-Glatt-Str. 1, Binzen, 79589, Germany Im Entenbad 4, Brombach, Loerrach, Baden-Wuerttemberg, 79541, Germany

4. Legally registered address of Authorisation Holder	:	Werner-Glatt-Str. 1, Binzen, 79589, Germany
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	:	2019-10-29
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: Glatt Pharmaceutical Services GmbH & Co. KG

(ORG-100011667 / LOC-100018538)

, Werner-Glatt-Str. 1, Binzen, 79589, Germany

Human medicinal products

Veterinary medicinal products

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

1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

2.5. Other activities(s): order management, financial processing, reportings, balancing

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.3. Cold chain products(requiring low temperature handling)