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RTF Template

Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	GIF-N-411/1016/1-6/TL/16
2. Name of Authorisation Holder	:	Adamed Pharma S.A. (ORG-100001178 / LOC-100018448)
3. Address(es) of Site(s)	:	44 A, Radonice, MAZOWIECKIE, 05-870, Poland

4. Legally registered address of Authorisation Holder	:	Ul. Mariana Adamkiewicza 6a, Pienkow, Czosnow, 05-152, Poland
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	:	2024-12-10
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: Hurtownia Farmaceutyczna Adamed Pharma S.A.

, 44 A, Radonice, MAZOWIECKIE, 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

3.2. 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) 3.4.1 Cytotoxic medicinal products, 3.4.4 Medicinal products with very strong

Any restrictions or clarifying remarks (for all users): Obrót hurtowy na terytorium Rzeczypospolitej Polskiej ograniczony wyłącznie do produktów leczniczych, dla których podmiotem odpowiedzialnym albo przedstawicielem podmiotu odpowiedzialnego jest Adamed Pharma S.A. z siedzibą w Pieńkowie, przy ul. Adamkiewicza 6A. Obrót hurtowy pozostałymi produktami leczniczymi wyłącznie z podmiotami zagranicznymi. Powyższe ograniczenia nie dotyczą produktów nieposiadających pozwolenia na dopuszczenie do obrotu na terytorium Rzeczypospolitej Polskiej, a dopuszczonych czasowo do obrotu na terytorium Rzeczypospolitej Polskiej przez ministra właściwego do spraw zdrowia (tj. produktów pochodzących z importu interwencyjnego).

*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-411/1016/1-6/TL/16
	Page 1

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