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RTF Template

Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	W11642/00001
2. Name of Authorisation Holder	:	PTC Therapeutics International Limited (ORG-100001436 / LOC-100000823)
3. Address(es) of Site(s)	:	Unit 1, 52-55 Sir John Rogerson's Quay, Dublin 2, D02 NA07, Ireland

4. Legally registered address of Authorisation Holder	:	70 Sir John Rogerson's Quay, Dublin 2, D02 R296, Ireland
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	:	2024-08-26
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: PTC Therapeutics International Limited

(ORG-100001436 / LOC-100092122)

, Unit 1, 52-55 Sir John Rogerson's Quay, Dublin 2, D02 NA07, 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*

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

3.3. 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 products3.3.4 Unauthorised medicinal products3.3.12 Biological products3.3.13 Advance Therapeutic Medicinal productsNot all of the contract wholesale distribution sites listed in Annex 2 are appropriately authorised to hold all of the medicinal product categories listed in Annex 1.The site of Arvato SE additionally includes the house number Gottlieb-Daimler-Strasse 2 per the clarifying remarks on the site's WDA.

*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	W11642/00001
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