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RTF Template

Medicines Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	WL118
2. Name of Authorisation Holder	:	CHEMIE PHARMACIE HOLLAND (CPH) INTERNATIONAL Limited (ORG-100035375 / LOC-100070957)
3. Address(es) of Site(s)	:	7 Triq Il-Kbira, In-Naxxar, NXR 1800, Malta

4. Legally registered address of Authorisation Holder	:	7 Triq Il-Kbira, In-Naxxar, NXR 1800
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
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2022-07-07
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: CHEMIE PHARMACIE HOLLAND (CPH) INTERNATIONAL Limited

(ORG-100035375 / LOC-100070957)

, 7 Triq Il-Kbira, In-Naxxar, NXR 1800, Malta

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

Any restrictions or clarifying remarks (for all users): Holding operations are outsourced to Cyber Freight Amsterdam B.V. (Netherlands) and Express Trailers Ltd. (Malta)

*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	WL118
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