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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	:	115D
2. Name of Authorisation Holder	:	S.C. GLAXOSMITHKLINE (GSK) S.R.L.
3. Address(es) of Site(s)	:	Str. Costache Negri nr. 1-5, Opera Center One, et. 5 şi 6 (zona 1), Mun. Bucureşti, sector 5, cod poştal 050552, Romania

4. Legally registered address of Authorisation Holder	:	Str. Costache Negri nr. 1-5, Opera Center One, et. 5 şi 6 (zona 1), Mun. Bucureşti, sector 5, cod poştal 050552, 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	:	2021-02-02
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: GLAXOSMITHKLINE (GSK) S.R.L.

, Str. Costache Negri nr. 1-5, Opera Center One, et. 5 şi 6 (zona 1), Mun. Bucureşti, sector 5, cod poştal 050552, Romania

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: medicines for clinical investigation medicamente pentru investigaţie clinică

Any restrictions or clarifying remarks (for all users): The current WDA is valid only if the terms of the storage and logistical services agreement signed with SC Europharm Holding S.A. are complied with.

Prezenta Autorizaţie de distribuţie angro este validă numai respectându-se prevederile contractului de custodie şi prestări servicii logistice încheiat cu SC Europharm Holding S.A.

*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	115D
	Page 1

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