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RTF Template

Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	GIF-N-4111/53/AR/10
2. Name of Authorisation Holder	:	Poltraf Sp. z o.o. (ORG-100016279 / LOC-100025056)
3. Address(es) of Site(s)	:	Ul. Stefana Batorego 4, Pass, Blonie, 05-870, Poland

4. Legally registered address of Authorisation Holder	:	Ul. Stefana Batorego 4, Pass, Blonie, 05-870
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	:	2025-01-29
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: Poltraf Sp. z o.o.

(ORG-100016279 / LOC-100025056)

, Ul. Stefana Batorego 4, 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

2.5. Other activities(s): (please specify) *Patrz Zastrzeżenia - Uwaga 2.5

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.2. Other temperatures: (please specify) Poniżej 8° C

3.3. Other products: (please specify here or make a reference to Annex 5) 3.1.1; 3.1.2; 3.4.1; 3.4.2; 3.4.4; 3.4.5

Any restrictions or clarifying remarks (for all users): *Uwaga 2.5 Usługi logistyczno - transportowe na rzecz podmiotów odpowiedzialnych, wytwórców, importerów i hurtowni farmaceutycznych.
Punkt 3.2 – wyłącznie w zakresie transportu.
Punkt 1.3 oraz 2.4 – wyłącznie w zakresie transportu – dotyczy komór przeładunkowych: w Rzeszowie ( ul.Kapitałowa 3) oraz w Pass (Pass 28).

*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	GIF-N-4111/53/AR/10
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