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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-06-23

RTF Template

State Institute for Drug Control

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	sukls261246/2020
2. Name of Authorisation Holder	:	Simply You Pharmaceuticals a.s.
3. Address(es) of Site(s)	:	warehouse is in Pharmazet Group s.r.o., Třtinová 260/1, Praha 9 - Čakovice, 196 00, Czechia

4. Legally registered address of Authorisation Holder	:	Třtinová 260/1, Praha 9 - Čakovice, 196 00, Czechia
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2020-11-09
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: Simply You Pharmaceuticals a.s.

, warehouse is in Pharmazet Group s.r.o., Třtinová 260/1, Praha 9 - Čakovice, 196 00, 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

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Reason for Withdrawing:

annulment

Union Format for a Wholesale Distribution Authorisation	sukls261246/2020
	Page 1

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