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RTF Template

Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	W11497/00001
2. Name of Authorisation Holder	:	Duelchem Limited
3. Address(es) of Site(s)	:	Unit 7, Purcellsinch Business Park, Dublin Road, Kilkenny, -, -, Ireland

4. Legally registered address of Authorisation Holder	:	Unit 7, Purcellsinch Business Park, Dublin Road, Kilkenny, -, -, Ireland
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2019-09-12
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: Duelchem Limited

, Unit 7, Purcellsinch Business Park, Dublin Road, Kilkenny, -, -, Ireland

1. MEDICINAL PRODUCTS

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

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.4. Other products: Please see restrictions or clarifying remarks (for all users).

Any restrictions or clarifying remarks (for all users): 3.4.1 Prescription only medicinal products3.4.2 Medicinal products for general sale3.4.3 Over the counter medicinal products for sale through pharmacies only3.4.6 Parallel imported medicinal products authorised by Parallel Product Authorisation (PPA)3.4.7 Parallel imported medicinal product authorised by Dual Pack Registration (DPR)3.4.8 Parallel distributed centrally authorised medicinal products3.4.9 Traditional herbal medicinal products3.4.10 Homeopathic medicinal products (HOR and HOA)3.4.11 Exempt medicinal products

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

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

Union Format for a Wholesale Distribution Authorisation	W11497/00001
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