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RTF Template

Malta Medicines Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	WL138
2. Name of Authorisation Holder	:	Biocon Pharma Malta I Limited (ORG-100032201 / LOC-100066879)
3. Address(es) of Site(s)	:	Malta Life Sciences Park, Industrial Estate, San Gwann, SGN 3000, Malta

4. Legally registered address of Authorisation Holder	:	Malta Life Sciences Park, Industrial Estate, San Gwann, SGN 3000, Malta
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	:	2024-08-03
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: Biocon Pharma Malta I Limited

(ORG-100032201 / LOC-100066879)

, Malta Life Sciences Park, Industrial Estate, San Gwann, SGN 3000, 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

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

Any restrictions or clarifying remarks (for all users): No holding of medicinal products is authorised at the licensed site.
All holding is to be carried out at authorised contractors.

Union Format for a Wholesale Distribution Authorisation	WL138
	Page 1

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