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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	:	479D
2. Name of Authorisation Holder	:	FARMACEUTICA REMEDIA DISTRIBUTION & LOGISTICS S.R.L.
3. Address(es) of Site(s)	:	Sat Livezeni, Comuna Livezeni, Str. Lungă nr.106, Comuna Livezeni, Jud. Mureş, cod poştal 547365, Romania Calea Severinului nr. 46, Mun. Craiova, Jud. Dolj, cod poştal 200610, Romania Sat Valea Lupului nr.4, DN 28, Comuna Valea Lupului, Jud. Iaşi, cod poştal 707410, Romania Str. Zizinului nr. 109 BIS, Mun. Braşov, Jud. Braşov, cod poştal 500414, Romania B-dul Nicolae Bălcescu nr. 2, Mun. Deva, Jud. Hunedoara, cod poştal 330040, Romania B-dul Metalurgiei nr. 78, Mun. Bucureşti, sector 4, cod poştal 041836, Romania B-dul Nicolae Bălcescu nr. 138A, Mun. Piteşti, Jud. Argeş, cod poştal 110101, Romania Str. Lozoveni nr. 115, Mun. Galaţi, Jud. Galaţi, cod poştal 800156, Romania Calea Lugojului nr. 134/7, parter, Sat Ghiroda, Com. Ghiroda, Jud. Timiş, cod poştal 307200, Romania

4. Legally registered address of Authorisation Holder	:	B-dul Nicolae Bălcescu nr.2, Deva, Hunedoara, Cod poştal 330040, 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	:	2021-12-20
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: FARMACEUTICA REMEDIA DISTRIBUTION & LOGISTICS SRL

, Sat Livezeni, Comuna Livezeni, Str. Lungă nr.106, Comuna Livezeni, Jud. Mureş, cod poştal 547365, 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

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)

Name and address of the site: FARMACEUTICA REMEDIA DISTRIBUTION & LOGISTICS SRL

, Calea Severinului nr. 46, Mun. Craiova, Jud. Dolj, cod poştal 200610, 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

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)

3.4. Other products: custody Custodie

Any restrictions or clarifying remarks (for all users): In addition, the transportation is performed bySC 2A FARM SRL, according to the concluded transportation services agreement.

Activitatea de transport se efectuează şi de către SC 2A FARM SRL, conform contractului de transport încheiat.

Name and address of the site: FARMACEUTICA REMEDIA DISTRIBUTION & LOGISTICS SRL

, Sat Valea Lupului nr.4, DN 28, Comuna Valea Lupului, Jud. Iaşi, cod poştal 707410, 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

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)

Name and address of the site: FARMACEUTICA REMEDIA DISTRIBUTION & LOGISTICS SRL

, Str. Zizinului nr. 109 BIS, Mun. Braşov, Jud. Braşov, cod poştal 500414, 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

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)

Name and address of the site: FARMACEUTICA REMEDIA DISTRIBUTION & LOGISTICS SRL

, B-dul Nicolae Bălcescu nr. 2, Mun. Deva, Jud. Hunedoara, cod poştal 330040, 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

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 Ahead Translog Solutions SRL which are using an transit storage transportation hub in Cluj county, and Pharma ExpertSpedition SRL which are using an transit storage transportation hubs in Alba, Cluj and Timiș counties.

Activitatea de transport se efectuează şi de către beneficiarii de contract Ahead Translog Solutions SRL care utilizează un nod de transport în judeţul Cluj, respectiv de către Pharma ExpertSpedition SRL care utilizează noduri de transport în județele: Alba, Cluj, Timiș.

Name and address of the site: FARMACEUTICA REMEDIA DISTRIBUTION & LOGISTICS SRL

, B-dul Metalurgiei nr. 78, Mun. Bucureşti, sector 4, cod poştal 041836, 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

2.4. Export

2.5. Other activities(s): custody,custodie

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)

Name and address of the site: FARMACEUTICA REMEDIA DISTRIBUTION & LOGISTICS SRL

, B-dul Nicolae Bălcescu nr. 138A, Mun. Piteşti, Jud. Argeş, cod poştal 110101, 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

3.3. Cold chain products(requiring low temperature handling)

Name and address of the site: FARMACEUTICA REMEDIA DISTRIBUTION & LOGISTICS SRL

, Str. Lozoveni nr. 115, Mun. Galaţi, Jud. Galaţi, cod poştal 800156, 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

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 Ahead Translog Solution SRL which are using an transportation hub in Buzau county, according to the concluded transportation services agreement.

Activitatea de transport se efectuează şi de către SC Ahead Translog Solutions SRL care utilizează un nod de transport în Jud. Buzău, conform contractului de transport încheiat.

Name and address of the site: FARMACEUTICA REMEDIA DISTRIBUTION & LOGISTICS SRL

, Calea Lugojului nr. 134/7, parter, Sat Ghiroda, Com. Ghiroda, Jud. Timiş, cod poştal 307200, 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

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 transportation is performed by Pharma Expertspedition SRL, according to the concluded transportation services agreement.

Activitatea de transport se efectuează şi de către Pharma Expertspedition SRL, conform contractului de transport încheiat.

*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	479D
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