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RTF Template

Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	W12472/00001
2. Name of Authorisation Holder	:	Merck Sharp & Dohme Ireland (Human Health) Limited (ORG-100004346 / LOC-100004889)
3. Address(es) of Site(s)	:	Red Oak North, South County Business Park, Dublin 18, D18 X5K7, Ireland

4. Legally registered address of Authorisation Holder	:	South County Business Park, Red Oak North, Dublin 18, D18 X5K7
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	:	2025-07-03
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: Merck Sharp & Dohme Ireland (Human Health) Limited

(ORG-100004346 / LOC-100004889)

, Red Oak North, South County Business Park, Dublin 18, D18 X5K7, Ireland

Human medicinal products

1. MEDICINAL PRODUCTS

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

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

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 products3.3.5 Vaccines3.3.12 Biological products

*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

Union Format for a Wholesale Distribution Authorisation	W12472/00001
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