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RTF Template

Malta Medicines Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	WL156 (1st variation)
2. Name of Authorisation Holder	:	Pharmadox Healthcare Limited (ORG-100012142 / LOC-100018944)
3. Address(es) of Site(s)	:	KW20A Kordin Industrial Park, Paola, PLA 3000, Malta Kkw46 Kordin Industrial Park, Paola, PLA 3000, Malta Hhf 303 Hal Far Industrial Estate, Hal Far, Birzebbuga, BBG 3000, Malta

4. Legally registered address of Authorisation Holder	:	KW20A Kordin Industrial Park, Paola, PLA 3000
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	:	2026-06-02
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: Pharmadox Healthcare Limited

(ORG-100012142 / LOC-100018944)

, KW20A Kordin Industrial Park, Paola, PLA 3000, Malta

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

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Name and address of the site: Pharmadox Healthcare Limited

(ORG-100012142 / LOC-100067754)

, Kkw46 Kordin Industrial Park, Paola, PLA 3000, Malta

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

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Name and address of the site: Pharmadox Healthcare Limited

(ORG-100012142 / LOC-100102924)

, Hhf 303 Hal Far Industrial Estate, Hal Far, Birzebbuga, BBG 3000, Malta

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

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Union Format for a Wholesale Distribution Authorisation	WL156 (1st variation)
	Page 1

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