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RTF Template

Malta Medicines Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	WL047
2. Name of Authorisation Holder	:	E.J. Busuttil Ltd
3. Address(es) of Site(s)	:	Busuttil Building, Triq l-Ghadam, Zone 1 Central Business District, Birkirkara, CBD 1060, Malta

4. Legally registered address of Authorisation Holder	:	Busuttil Building, Triq l-Ghadam, Zone 1 Central Business District, Birkirkara, CBD 1060
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	:	2025-06-05
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: E. J. Busuttil Ltd.

, Busuttil Building, Triq l-Ghadam, Zone 1 Central Business District, Birkirkara, CBD 1060, Malta

Human medicinal products

1. MEDICINAL PRODUCTS

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

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

**Without prejudice to further authorisations as may be required according to national legislation.

Union Format for a Wholesale Distribution Authorisation	WL047
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