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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	:	195D
2. Name of Authorisation Holder	:	PHARMA VISION PLUS S.R.L.
3. Address(es) of Site(s)	:	B-dul Metalurgiei nr. 130E, Mun. Bucureşti, Sectorul 4, Cod poştal 041837, Romania

4. Legally registered address of Authorisation Holder	:	B-dul Metalurgiei nr. 130E, etaj 2, Camera 19, Mun. Bucureşti, Sectorul 4, Cod poştal 041837, 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	:	2020-12-14
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 VISION PLUS S.R.L.

, B-dul Metalurgiei nr. 130E, Mun. Bucureşti, Sectorul 4, Cod poştal 041837, Romania

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.5. Other activities(s): CustodyCustodie

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): In addition, the transportation is performed by Pharma Expertspedition SRL which are using an transportation hub in IŞ, DJ, AB, TM, CJ, CT, BV, BR, BC şi SV.counties, according to the concluded transportation services agreement.

Activitatea de transport se efectuează numai de către beneficiarul de contract Pharma Expertspedition SRL care utilizează noduri de transport în judeţele: IŞ, DJ, AB, TM, CJ, CT, BV, BR, BC şi SV.

*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	195D
	Page 1

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