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RTF Template

National Agency for Medicines and Medical Devices of Romania

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	177D
2. Name of Authorisation Holder	:	SOLACIUM PHARMA S.R.L.
3. Address(es) of Site(s)	:	B-dul Theodor Pallady nr.50, Clădirea Administraţie, C15, et.3, zona A, Mun. Bucureşti, sectorul 3, cod poştal 032266, Romania

4. Legally registered address of Authorisation Holder	:	B-dul Theodor Pallady nr.50, Clădirea Administraţie, C15, et.3, zona A, Mun. Bucureşti, Sectorul 3, Cod poştal 032266, Romania
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	:	2021-03-09
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: SOLACIUM PHARMA SRL

, B-dul Theodor Pallady nr.50, Clădirea Administraţie, C15, et.3, zona A, Mun. Bucureşti, sectorul 3, cod poştal 032266, Romania

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

Any restrictions or clarifying remarks (for all users): The current WDA is valid only if the terms of the storage and logistical services agreement (storage, handling, ) signed with FM Romania S.R.L are complied with.

Prezenta Autorizaţie de distribuţie angro este validă numai respectându-se prevederile contractului de custodie şi prestări servicii logistice (depozitare, manipulare) încheiat cu FM Romania S.R.L

*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	177D
	Page 1

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