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RTF Template

Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	W12964/00001
2. Name of Authorisation Holder	:	SHORLA PHARMA Limited (ORG-100043572 / LOC-100072068)
3. Address(es) of Site(s)	:	Questum Acceleration Center, Ballingarrane Science And Technology Park, Ballingarrane, Clonmel, E91 V329, Ireland

4. Legally registered address of Authorisation Holder	:	Ballingarrane Science & Technology Park, Questum Acceleration Centre, Clonmel, E91 V329
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	:	2025-08-01
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: Shorla Pharma Limited

(ORG-100043572 / LOC-100072068)

, Questum Acceleration Center, Ballingarrane Science And Technology Park, Ballingarrane, Clonmel, E91 V329, Ireland

Human medicinal products

1. MEDICINAL PRODUCTS

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): 3.4.1 Prescription only medicinal products3.4.4 Unauthorised medicinal products

Union Format for a Wholesale Distribution Authorisation	W12964/00001
	Page 1

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