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RTF Template

Medicines Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	WL141 (4th variation)
2. Name of Authorisation Holder	:	Macure Healthcare Limited (ORG-100034427 / LOC-100054552)
3. Address(es) of Site(s)	:	62 Archlight Building, Triq L-Gharbiel, Is-Swieqi, SWQ 3251, Malta

4. Legally registered address of Authorisation Holder	:	7 Business House Suite, Triq L-Arcisqof Pietru Pace, Rabat, VCT 2504
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	:	2023-01-12
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: Macure Healthcare Limited

(ORG-100034427 / LOC-100069059)

, 62 Archlight Building, Triq L-Gharbiel, Is-Swieqi, SWQ 3251, Malta

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

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): This site is not licensed for holding of human 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	WL141 (4th variation)
	Page 1

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