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RTF Template

Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	NZOH.5100.77.2022.AKE.6
2. Name of Authorisation Holder	:	Dospiro Sp. z o.o. (ORG-100045258 / LOC-100076249)
3. Address(es) of Site(s)	:	Ul. Pojezierska 90a, Lodz, 91-341, Poland

4. Legally registered address of Authorisation Holder	:	Ul. Zbaszynska 3, Lodz, 91-342
5. Scope of authorisation (complete for each site under 4)	:	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 wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2022-12-22
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: Dospiro Sp. z o.o.

(ORG-100045258 / LOC-100074651)

, Ul. Pojezierska 90a, Lodz, 91-341, Poland

Human medicinal products

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

1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: 3.4.1, 3.4.2, 3.4.3, 3.4.4, 3.4.5

Any restrictions or clarifying remarks (for all users): W zakresie produktów objętych punktem 1.3 bez cytostatycznych produktów leczniczych, produktów leczniczych niebezpiecznych, w tym łatwopalnych, lotnych i żrących, produktów leczniczych silnie wonnych, w tym
cuchnących oraz produktów leczniczych bardzo silnie działających, określonych we właściwej Farmakopei.

*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	NZOH.5100.77.2022.AKE.6
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