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RTF Template

Medicines Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	WL072
2. Name of Authorisation Holder	:	Ing Karl Farrugia f/Central Procurement and Supplies Unit
3. Address(es) of Site(s)	:	UB002 Industrial Estate, San Gwann SGN 3000, Freezers 4,5,6 - Centre for Molecular Medicines and Biobanking(freezer storage only), Basement Floor, University of Malta, Msida MSD 2080, ., ., Malta

4. Legally registered address of Authorisation Holder	:	UB002 Industrial Estate, San Gwann, SGN3000, Malta
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2020-12-24
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: Central Procurement and Supplies Unit

, UB002 Industrial Estate, San Gwann SGN 3000, Freezers 4,5,6 - Centre for Molecular Medicines and Biobanking(freezer storage only), Basement Floor, University of Malta, Msida MSD 2080, ., ., Malta

1. MEDICINAL PRODUCTS

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

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.1.4. Radiopharmaceuticals (including radionuclide kits)

3.2. Medicinal gases

3.3. Cold chain products(requiring low temperature handling)

*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	WL072
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