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Information Messages

The WDA has been withdrawn, withdrawn date is: 2024-08-27

RTF Template

Trade And Industry Inspection Agency Of State Of Lower Saxony

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products

1. Authorisation Number	:	DE_NI_03_WDA_2023_0001
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 Altona 14 A, Hollen, Hollnseth, Lower Saxony, 21769, Germany

4. Legally registered address of Authorisation Holder	:	Zevener Strasse 9, Bremervoerde, Lower Saxony, 27432
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	:	2023-02-20
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)

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

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 site plan dated 2022-08-17
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 Lageplan vom 17.08.2022
Zu 3.4: Kein Parallelimport oder Parallelvertrieb vom Arzneimittel in Funktion eines Pharmazeutischen Unternehmers i.S.d. Arzneimittelgesetzes.

Name and address of the site: HECHT Pharma GmbH

(ORG-100013585 / LOC-100019083)

, Altona 14 A, Hollen, Hollnseth, Lower Saxony, 21769, Germany

Human medicinal products

Veterinary medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

2.3. Supply

Any restrictions or clarifying remarks (for all users): According to the site plan dated 2022-08-12

To 2.2 und 2.3: Only holding and supply of human drugs on behalf of HEC Pharm GmbH

Gemäß dem Lageplan vom 12.08.2022

Zu 2.2 und 2.3 Ausschließlich Lagerung und Distribution von Arzneimitteln im Auftrag der HEC Pharm GmbH

*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

Reason for Withdrawing:

replaced by WDA DE_NI_03_WDA_2024_0005

ersetzt durch GHE DE_NI_03_WDA_2024_0005

Union Format for a Wholesale Distribution Authorisation	DE_NI_03_WDA_2023_0001
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