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RTF Template

Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	GIF-N-411/1034/1-4/MP/16
2. Name of Authorisation Holder	:	Ziaja Dystrybucja Duda Marcin Piotr (ORG-100038726 / LOC-100060818)
3. Address(es) of Site(s)	:	Ul. Augustow 97 C, Augustow, Kowala, Mazowieckie, 26-624, Poland

4. Legally registered address of Authorisation Holder	:	Ul. Augustow 97 C, Augustow, Kowala, Mazowieckie, 26-624
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	:	2024-05-08
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: Ziaja Dystrybucja Duda Marcin Piotr

(ORG-100038726 / LOC-100060818)

, Ul. Augustow 97 C, Augustow, Kowala, Mazowieckie, 26-624, 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

3.3. Other products: (please specify here or make a reference to Annex 5) 3.4.2 Dangerous medicinal products, 3.4.4 Medicinal products with very strong effects.

Any restrictions or clarifying remarks (for all users): Produkty lecznicze, dla których podmiotem odpowiedzialnym jest Ziaja Ltd Zakład Produkcji Leków sp. z o.o., ul. Jesienna 9, 80-298 Gdańsk.

Union Format for a Wholesale Distribution Authorisation	GIF-N-411/1034/1-4/MP/16
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