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RTF Template

National Agency for Medicines and Medical Devices

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	365D
2. Name of Authorisation Holder	:	S.C. PHARMA PROMOTION S.R.L.
3. Address(es) of Site(s)	:	Str. Dimitrie Gusti, nr. 8, Mun. Bucureşti, sectorul 1, cod poştal 010894, Romania

4. Legally registered address of Authorisation Holder	:	Str. Dimitrie Gusti, nr. 8, Mun. Bucureşti, sectorul 1, cod poştal 010894, 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	:	2018-04-24
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: PHARMA PROMOTION S.R.L.

, Str. Dimitrie Gusti, nr. 8, Mun. Bucureşti, sectorul 1, cod poştal 010894, 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

3.3. Cold chain products(requiring low temperature handling)

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 Nucleos Logistics S.R.L. and transportation services agreement signed with Direct Pharma Logistics SRL are complied with.

Prezenta Autorizaţie de distribuţie angro este validă numai respectându-se prevederile contractului de custodie şi prestări servicii logistice încheiat cu SC Nucleos Logistics S.R.L. si prevederile contractului de prestari servicii de transport incheiat cu Direct Pharma Logistics SRL.

*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	365D
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