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RTF Template

Malta Medicines Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	WL154
2. Name of Authorisation Holder	:	Reges (Malta Branch) (ORG-100052078 / LOC-100091635)
3. Address(es) of Site(s)	:	Susan Court B1, Triq Il-Prinjolata, Ta Xbiex, XBX 1131, Malta

4. Legally registered address of Authorisation Holder	:	Susan Court B1, Triq Il-Prinjolata, Ta Xbiex, XBX 1131, 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	:	2024-10-31
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: Reges (Malta Branch)

(ORG-100052078 / LOC-100091635)

, Susan Court B1, Triq Il-Prinjolata, Ta Xbiex, XBX 1131, Malta

Human medicinal products

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*

1.3. without a Marketing Authorisation or registration 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

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Any restrictions or clarifying remarks (for all users): This site is not authorised for the holding of medicinal products.

*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

Union Format for a Wholesale Distribution Authorisation	WL154
	Page 1

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