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RTF Template

National Authority Of Medicines And Medical Devices Of Romania

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	444D
2. Name of Authorisation Holder	:	Marcos Provit S.A. (ORG-100040361 / LOC-100065976)
3. Address(es) of Site(s)	:	Aleea Industriilor Nr. 25, Maracineni, 127325, Romania
3.a. Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations)	:	Completed address: Aleea Industriilor nr.25, nr. cadastral 36816, Sat Măracineni, Comuna Mărăcineni, Jud. Buzău, cod poștal 127325

4. Legally registered address of Authorisation Holder	:	Strada Urziceni Nr 35, Buzau, 120226
4.a. Additional details on units inspected of registrant's legal address (optional)	:	Completed address: Str. Urziceni nr. 35, Mun. Buzău, Jud. Buzău, cod poştal 120226
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2025-07-03
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: Marcos Provit S.A.

(ORG-100040361 / LOC-100095813)

, Aleea Industriilor Nr. 25, Maracineni, 127325, Romania

Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations): Completed address: Aleea Industriilor nr.25, nr. cadastral 36816, Sat Măracineni, Comuna Mărăcineni, Jud. Buzău, cod poștal 127325

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Any restrictions or clarifying remarks (for all users): In addition, the transportation is performed by Evofarm Logistic SRL which are using an transit storage transportation hub in MS and IF county.

Activitatea de transport se efectuează şi de către beneficiarul de contract Evofarm Logistic SRL care utilizează un nod de transport în jud. MS și IF.

**Without prejudice to further authorisations as may be required according to national legislation.

Union Format for a Wholesale Distribution Authorisation	444D
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