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RTF Template

State Institute for Drug Control

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	sukls107386/2021
2. Name of Authorisation Holder	:	Bracco Imaging Czech s.r.o.
3. Address(es) of Site(s)	:	warehouse is in Alliance Healthcare s.r.o., Podle Trati č.p. 624/7, Praha 10 - Malešice, 108 00, Czech Republic warehouse is in LACOMED, spol. s r.o., Vodárenská 699, Kralupy nad Vltavou - Lobeček, 278 01, Czechia

4. Legally registered address of Authorisation Holder	:	Novodvorská 994/138, Praha 4- Braník, 142 00, Czechia
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	:	2021-06-02
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: Bracco Imaging Czech s.r.o.

, warehouse is in Alliance Healthcare s.r.o., Podle Trati č.p. 624/7, Praha 10 - Malešice, 108 00, Czech Republic

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

Name and address of the site: Bracco Imaging Czech s.r.o.

, warehouse is in LACOMED, spol. s r.o., Vodárenská 699, Kralupy nad Vltavou - Lobeček, 278 01, 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

1.3. without a Marketing Authorisation 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

3.1.4. Radiopharmaceuticals (including radionuclide kits)

3.3. Cold chain products(requiring low temperature handling)

*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	sukls107386/2021
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