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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	:	10D
2. Name of Authorisation Holder	:	Fildas Trading S.R.L (ORG-100017573 / LOC-100039743)
3. Address(es) of Site(s)	:	Strada Rodnei 3-7, Cluj-Napoca, 400393, Romania Strada Banat Nr 2, Pitesti, 110406, Romania Strada Wolfgang Amadeus Mozart N 6, Dumbravita, 307160, Romania Industrial Park, Sura Mica, 557270, Romania Strada Ghiocelului 18-20, Targu Mures, 540038, Romania Sat Blejoi Sos Buda Nr. 6, Blejoi, 107070, Romania Cladirea C Celula 4, Unitatea Hala C Modulul 5, Strada Buiacului Nr. 2, Mogosoaia, 077135, Romania Com Miroslava, Strada Principala Nr 37e, Bratuleni, 707307, Romania Ghercesti Comm, Strada Aviatorilor (Zona Aeroport) Nr 2a, Craiova, 200786, Romania Strada Botizului Nr 177, Satu Mare, 440110, Romania Bulevardul Vlaicu Aurel Nr 125, Lot 9/1, Constanta, 900154, Romania Strada Bucegi 3a, Brasov, 500053, Romania Strada Alexandru Ioan Cuza Nr 12, Nicolae Balcescu, 607355, Romania Strada Brailei 308a, Galati, 800628, 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: Str. Banat nr. 2, C1, Mun. Piteşti, Jud. Argeş, cod poştal 110406 Completed address: Str. W.A. Mozart nr.6, Com. Dumbrăviţa, Jud. Timiş, cod poştal 307160 Completed address: Com. Şura Mică, în cadrul Parcului Industrial Sibiu - Şura Mică, Jud. Sibiu, cod poştal 557270 Completed address: Com. Blejoi, Sat Blejoi, Șos. Buda nr. 6, Jud. Prahova, cod poştal 107070

4. Legally registered address of Authorisation Holder	:	Strada Banat Nr 2, Pitesti, 110406, Romania
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	:	2024-12-19
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: Fildas Trading S.R.L

(ORG-100017573 / LOC-100063154)

, Strada Rodnei 3-7, Cluj-Napoca, 400393, Romania

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

Name and address of the site: Fildas Trading S.R.L

(ORG-100017573 / LOC-100039743)

, Strada Banat Nr 2, Pitesti, 110406, 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: Str. Banat nr. 2, C1, Mun. Piteşti, Jud. Argeş, cod poştal 110406

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

Name and address of the site: Fildas Trading S.R.L

(ORG-100017573 / LOC-100063155)

, Strada Wolfgang Amadeus Mozart N 6, Dumbravita, 307160, 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: Str. W.A. Mozart nr.6, Com. Dumbrăviţa, Jud. Timiş, cod poştal 307160

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

Name and address of the site: Fildas Trading S.R.L

(ORG-100017573 / LOC-100063136)

, Industrial Park, Sura Mica, 557270, 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: Com. Şura Mică, în cadrul Parcului Industrial Sibiu - Şura Mică, Jud. Sibiu, cod poştal 557270

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

Name and address of the site: Fildas Trading S.R.L

(ORG-100017573 / LOC-100063148)

, Strada Ghiocelului 18-20, Targu Mures, 540038, Romania

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

Name and address of the site: Fildas Trading S.R.L

(ORG-100017573 / LOC-100084352)

, Sat Blejoi Sos Buda Nr. 6, Blejoi, 107070, 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: Com. Blejoi, Sat Blejoi, Șos. Buda nr. 6, Jud. Prahova, cod poştal 107070

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

Name and address of the site: Fildas Trading S.R.L

(ORG-100017573 / LOC-100054668)

, Cladirea C Celula 4, Unitatea Hala C Modulul 5, Strada Buiacului Nr. 2, Mogosoaia, 077135, Romania

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

Name and address of the site: Fildas Trading S.R.L

(ORG-100017573 / LOC-100063151)

, Com Miroslava, Strada Principala Nr 37e, Bratuleni, 707307, Romania

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

Name and address of the site: Fildas Trading S.R.L

(ORG-100017573 / LOC-100063137)

, Ghercesti Comm, Strada Aviatorilor (Zona Aeroport) Nr 2a, Craiova, 200786, Romania

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

Name and address of the site: Fildas Trading S.R.L

(ORG-100017573 / LOC-100063153)

, Strada Botizului Nr 177, Satu Mare, 440110, Romania

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

Name and address of the site: Fildas Trading S.R.L

(ORG-100017573 / LOC-100065326)

, Bulevardul Vlaicu Aurel Nr 125, Lot 9/1, Constanta, 900154, Romania

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

Name and address of the site: Fildas Trading S.R.L

(ORG-100017573 / LOC-100068602)

, Strada Bucegi 3a, Brasov, 500053, Romania

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

Name and address of the site: Fildas Trading S.R.L

(ORG-100017573 / LOC-100068597)

, Strada Alexandru Ioan Cuza Nr 12, Nicolae Balcescu, 607355, Romania

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

Name and address of the site: Fildas Trading S.R.L

(ORG-100017573 / LOC-100094854)

, Strada Brailei 308a, Galati, 800628, Romania

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

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

Union Format for a Wholesale Distribution Authorisation	10D
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