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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-08-13

RTF Template

Staatliches Gewerbeaufsichtsamt Lueneburg

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products

1. Authorisation Number	:	DE_NI_03_WDA_2024_0005
2. Name of Authorisation Holder	:	HECHT Pharma GmbH (ORG-100013585 / LOC-100019348)
3. Address(es) of Site(s)	:	Zevener Strasse 9, Bremervoerde, Lower Saxony, 27432, Germany

4. Legally registered address of Authorisation Holder	:	Zevener Strasse 9, Bremervoerde, Lower Saxony, 27432, 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	:	2024-08-26
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: HECHT Pharma GmbH

(ORG-100013585 / LOC-100019348)

, Zevener Strasse 9, Bremervoerde, Lower Saxony, 27432, 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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: Parallel distribution Parallelvertrieb

Any restrictions or clarifying remarks (for all users): According to the site plan dated 2022-08-17
To: 1.2 Import of medical products on request from pharmacies acc. section 73 (3) AMG
To: 3.4 No parallel import and parallel distribution of human drugs in function as "Pharmazeutischer Unternehmer" related to german medicinal products act

Gemäß dem vorliegenden Lageplan vom 17.08.2022
Zu: 1.2 Durchführung des Verbringens nach § 73 Abs. 3 AMG
Zu: 3.4 Kein Parallelimport oder Parallelvertrieb von Arzneimittel in Funktion eines Pharmazeutischen Unternehmers i. S. d. Arzneimittelgesetzes

Reason for Withdrawing:

replaced by WDA: DE_NI_03_WDA_2025_0005

ersetzt durch GHE: DE_NI_03_WDA_2025_0005

Union Format for a Wholesale Distribution Authorisation	DE_NI_03_WDA_2024_0005
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