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RTF Template

Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	NZOH.5100.67.2020.MG.11
2. Name of Authorisation Holder	:	Pfizer Trading Polska Sp. z o.o. (ORG-100037799 / LOC-100059650)
3. Address(es) of Site(s)	:	Ul. Lugowa 85, Mszczonow, 96-320, Poland

4. Legally registered address of Authorisation Holder	:	Ul. Zwirki I Wigury 16b, Warsaw, 02-092
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	:	2024-05-24
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: Pfizer Trading Polska Sp. z o.o.

(ORG-100037799 / LOC-100066149)

, Ul. Lugowa 85, Mszczonow, 96-320, Poland

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.2. Other temperatures: (please specify) Poniżej 8 stopni 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

Any restrictions or clarifying remarks (for all users): Obrót produktami leczniczymi ograniczony do produktów leczniczych, dla których podmiotem odpowiedzialnym lub przedstawicielem podmiotu odpowiedzialnego jest Pfizer Polska Sp. z o.o. Obrót produktami leczniczymi niebezpiecznym i zimnego łańcucha dostaw ograniczony do produktów leczniczych Torisel i Prostin VR.

Union Format for a Wholesale Distribution Authorisation	NZOH.5100.67.2020.MG.11
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