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RTF Template

State Institute for Drug Control

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	sukls296909/2019
2. Name of Authorisation Holder	:	GALMED a.s.
3. Address(es) of Site(s)	:	PHARMOS a.s., Theodor 28, Pchery, 273 08, Czechia PHARMOS a.s., Slánská 79, Brandýsek, 273 41, Czech Republic PHARMOS a.s.,Vožická 605, Tábor, 390 02, Czech Republic PHARMOS a.s., Kladská 1192/65a, Hradec Králové, 500 03, Czechia

4. Legally registered address of Authorisation Holder	:	Těšínská ul. 1349/296, Ostrava - Radvanice, 716 00, Czech Republic
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2019-11-22
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: GALMED a.s.

, PHARMOS a.s., Theodor 28, Pchery, 273 08, Czechia

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

Name and address of the site: GALMED a.s.

, PHARMOS a.s., Slánská 79, Brandýsek, 273 41, Czech Republic

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

Name and address of the site: GALMED a.s.

, PHARMOS a.s.,Vožická 605, Tábor, 390 02, Czech Republic

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

Name and address of the site: GALMED a.s.

, PHARMOS a.s., Kladská 1192/65a, Hradec Králové, 500 03, Czechia

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

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

Union Format for a Wholesale Distribution Authorisation	sukls296909/2019
	Page 1

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