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RTF Template

Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	NZOH.5100.51.2020.MG.4
2. Name of Authorisation Holder	:	Zakłady Farmaceutyczne "Polpharma" S.A. (ORG-100038700 / LOC-100060789)
3. Address(es) of Site(s)	:	Ul. Stefana Batorego 1, Pass, Blonie, 05-870, Poland

4. Legally registered address of Authorisation Holder	:	Ul. Pelplinska 19, Starogard Gdanski, 83-200
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	:	2026-06-22
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: Zaklady Farmaceutyczne Polpharma S.A.

(ORG-100000470 / LOC-100053632)

, Ul. Stefana Batorego 1, Pass, Blonie, 05-870, Poland

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

2.2. Holding

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

3.3. Other products: (please specify here or make a reference to Annex 5) produkty krwiopochodne, immunologiczne produkty lecznicze, cytostatyczne produkty lecznicze

Any restrictions or clarifying remarks (for all users): Punkt 1.3 nie obejmuje eksportu: produktów cytostatycznych nieposiadających pozwolenia na dopuszczenie do obrotu wydanego w państwie członkowskim Unii Europejskiej lub państwie członkowskim Europejskiego Porozumienia o Wolnym Handlu (EFTA) lub pozwolenia wydanego przez Radę Unii Europejskiej lub Komisję Europejską.

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

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

Union Format for a Wholesale Distribution Authorisation	NZOH.5100.51.2020.MG.4
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