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RTF Template

Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	GIF-N-411/327/MSH/11
2. Name of Authorisation Holder	:	Lek S.A. (ORG-100004145 / LOC-100008089)
3. Address(es) of Site(s)	:	Ul. Stefana Batorego 1, Pass, Blonie, 05-870, Poland

4. Legally registered address of Authorisation Holder	:	Ul. Podlipie 16, Strykow, 95-010
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	:	2026-05-06
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: Lek S.A.

(ORG-100004145 / LOC-100041666)

, 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)

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) immunologiczne produkty lecznicze, cytostatyczne produkty lecznicze

Any restrictions or clarifying remarks (for all users): Zakres zastrzeżeń jest zbyt obszerny i przekracza wielkość niniejszej rubryki. Zastrzeżenia należy sprawdzać w Rejestrze Hurtowni Farmaceutycznych lub bezpośrednio w decyzji udzielającej zezwolenia na prowadzenie hurtowni farmaceutycznej.

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

Union Format for a Wholesale Distribution Authorisation	GIF-N-411/327/MSH/11
	Page 1

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