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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	:	615D
2. Name of Authorisation Holder	:	POFTIM FARMAGRUP S.R.L.
3. Address(es) of Site(s)	:	Str. Vlad Ţepeş nr. 878, Sat Comana, Com. Comana, Jud. Giurgiu, Cod poştal 087055, Romania

4. Legally registered address of Authorisation Holder	:	Str. Occidentului nr.69, bl.2, sc.A, demisol, ap.5, Oraş Popeşti Leordeni, Jud. Ilfov, Cod poştal 077160, 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	:	2019-09-03
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: POFTIM FARMAGRUP S.R.L.

, Str. Vlad Ţepeş nr. 878, Sat Comana, Com. Comana, Jud. Giurgiu, Cod poştal 087055, 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

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

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 Pi Pharma M&D 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 Pi Pharma M&D 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	615D
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