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RTF Template

Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	W11878/00001
2. Name of Authorisation Holder	:	Janssen Sciences Ireland Unlimited Company (ORG-100006406 / LOC-100023444)
3. Address(es) of Site(s)	:	Barnahely, Ringaskiddy, P43 FA46, Ireland

4. Legally registered address of Authorisation Holder	:	Barnahely, Ringaskiddy, Co. Cork, P43 FA46
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	:	2025-12-18
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: Janssen Sciences Ireland Unlimited Company

(ORG-100006406 / LOC-100023444)

, Barnahely, Ringaskiddy, P43 FA46, Ireland

Human medicinal products

1. MEDICINAL PRODUCTS

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

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

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) Please see remarks

3.3. Other products: (please specify here or make a reference to Annex 5) Please see restrictions or clarifying remarks (for all users).

Any restrictions or clarifying remarks (for all users): 3.3.1 Prescription only medicinal products3.3.3 Over the counter medicinal products for sale through pharmacies only3.3.5 Vaccines3.3.11 Exempt medicinal products3.3.12 Biological products3.3.13 Advance Therapeutic Medicinal products

**Without prejudice to further authorisations as may be required according to national legislation.

Union Format for a Wholesale Distribution Authorisation	W11878/00001
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