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RTF Template

Malta Medicines Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	WL126
2. Name of Authorisation Holder	:	Ferro Pharma Europe Limited (ORG-100035559 / LOC-100056341)
3. Address(es) of Site(s)	:	Administration Building Level 0, Ta Maggi Industrial Park, Triq San Leonardu, Xghajra, XJR 2306, Malta

4. Legally registered address of Authorisation Holder	:	Administration Building Level 0, Ta Maggi Industrial Park, Triq San Leonardu, Xghajra, XJR 2306, Malta
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	:	2024-04-30
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: Ferro Pharma Europe Limited

(ORG-100035559 / LOC-100056341)

, Administration Building Level 0, Ta Maggi Industrial Park, Triq San Leonardu, Xghajra, XJR 2306, Malta

Human medicinal products

1. MEDICINAL PRODUCTS

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

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

3.1.1. Narcotic or psychotropic products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Site is not authorised for holding of medicinal products

*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	WL126
	Page 1

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