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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_2018_0046/24.05.05.01-HAL
2. Name of Authorisation Holder	:	HAL Allergie GmbH (ORG-100001935 / LOC-100002483)
3. Address(es) of Site(s)	:	Poststr. 5-6, Düsseldorf, 40213, Germany

4. Legally registered address of Authorisation Holder	:	Poststrasse 5-6, Karlstadt, Duesseldorf, North Rhine-Westphalia, 40213
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2018-12-17
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: HAL Allergie GmbH

, Poststr. 5-6, Düsseldorf, 40213, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.3. Other products: (please specify here or make a reference to Annex 5) immunological human medicinal products immunologische Arzneimittel

Any restrictions or clarifying remarks (for all users): Annex 2 - Storage:
HAL Allergy B.V., J.H. Oortsweg 15 in 2333 CH Leiden, Netherlands

Anlage 2 - Lagerung:
HAL Allergy B.V., J.H. Oortsweg 15 in 2333 CH Leiden, Niederlande

Union Format for a Wholesale Distribution Authorisation	DE_NW_03_WDA_2018_0046/24.05.05.01-HAL
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