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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

:

87D

2. Name of Authorisation Holder

:

Alliance Healthcare Romania S.R.L.

(ORG-100034371 / LOC-100059174)

3. Address(es) of Site(s)

:

Strada Balastierei 10, Apahida, 407035, Romania 

Comuna Miroslava, Str. Mihail Sadoveanu Nr. 3, Bratuleni, Iasi, 707307, Romania 

Strada Calea Ploiesti Nr. 53 Corp C10 Depozitul 3, Spatiul De Depozitare A Si B Parter Si Spatiul De Birouri Parter Si Etajul 1, Aricestii Rahtivani, Prahova, 107025, Romania 

Intrarea Panduri Nr 12, Rudeni, Ilfov, 077046, Romania 

Dn 59/a Km 6+300 Stanga, Timisoara, Timis, 030737, Romania 

De 307 Km 0, Parter 400, Ghimbav, Brașov, 507075, 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)

:

Complet address: Str. Balastierei nr.10, Sat Apahida, Com. Apahida, Jud. Cluj, cod poştal 407035 

 

Complet address: Sat Ariceştii Rahtivani, Com. Ariceştii Rahtivani, Calea Ploiești nr. 53, Corp C10, Depozitul 3, Spațiul de Depozitare A și B, Parter și Spațiul de Birouri, Parter și Etajul 1, Jud. Prahova, cod poştal 107025 

 

 

Complet address: Oraş Ghimbav, DE 307, Km 0+400, Parter, Jud. Braşov, cod poştal 507075 




4. Legally registered address of Authorisation Holder

:

Strada Sandulescu C. Amilcar Nr 7, Bucharest, 060859

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

:

2025-11-24

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: Alliance Healthcare Romania S.R.L.

(ORG-100034371 / LOC-100062620)

, Strada Balastierei 10, Apahida, 407035, Romania   


Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations): Complet address: Str. Balastierei nr.10, Sat Apahida, Com. Apahida, Jud. Cluj, cod poştal 407035


Human medicinal products


1. MEDICINAL PRODUCTS

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

   1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*


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 

   3.3. Other products: (please specify here or make a reference to Annex 5) Special needs medicines Medicamente pentru nevoi speciale




Any restrictions or clarifying remarks (for all users):  In addition, the transportation is performed by Transcom SRL, Romcargo Express and Alex Internaţional Transport'94 SRL which are using transit storage transportation hubs in BM şi SM counties.

Activitatea de transport se efectuează şi de către beneficiarii de contract Transcom SRL, Romcargo Express și  Alex Internaţional Transport'94 SRL care utilizează noduri de transport în judeţele BM şi SM.


Name and address of the site: Alliance Healthcare Romania S.R.L.

(ORG-100034371 / LOC-100095861)

, Comuna Miroslava, Str. Mihail Sadoveanu Nr. 3, Bratuleni, Iasi, 707307, Romania   



Human medicinal products


1. MEDICINAL PRODUCTS

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

   1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*


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 

   3.3. Other products: (please specify here or make a reference to Annex 5) Special needs medicines Medicamente pentru nevoi speciale




Any restrictions or clarifying remarks (for all users):  In addition, the transportation is performed by Alex Internaţional Transport'94 SRL which are using transit storage transportation hubs in BT, NT, SV counties.

Activitatea de transport se efectuează şi de către beneficiarul de contract Alex Internaţional Transport'94 SRL care utilizează noduri de transport în judeţele: BT, NT, SV.


Name and address of the site: Alliance Healthcare Romania S.R.L.

(ORG-100034371 / LOC-100097368)

, Strada Calea Ploiesti Nr. 53 Corp C10 Depozitul 3, Spatiul De Depozitare A Si B Parter Si Spatiul De Birouri Parter Si Etajul 1, Aricestii Rahtivani, Prahova, 107025, Romania   


Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations): Complet address: Sat Ariceştii Rahtivani, Com. Ariceştii Rahtivani, Calea Ploiești nr. 53, Corp C10, Depozitul 3, Spațiul de Depozitare A și B, Parter și Spațiul de Birouri, Parter și Etajul 1, Jud. Prahova, cod poştal 107025


Human medicinal products


1. MEDICINAL PRODUCTS

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

   1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*


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 

   3.3. Other products: (please specify here or make a reference to Annex 5) Special needs medicines medicamente pentru nevoi speciale




Any restrictions or clarifying remarks (for all users):  In addition, the transportation is performed by Transcom SRL, Romcargo Express and Alex Internaţional Transport'94 SRL which are using transit storage transportation hubs in Braila, Buzau and Vrancea counties.

Activitatea de transport se efectuează şi de către beneficiarii de contract Transcom SRL, Romcargo Express și Alex Internaţional Transport'94 SRL care utilizează noduri de transport în judeţele: BR, BZ, VN.


Name and address of the site: Alliance Healthcare Romania S.R.L.

(ORG-100034371 / LOC-100054482)

, Intrarea Panduri Nr 12, Rudeni, Ilfov, 077046, Romania   



Human medicinal products


1. MEDICINAL PRODUCTS

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

   1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 

   2.4. Export 

   2.5. Other activities(s): (please specify) Custody, counter-samples and drugs for clinical investigationCustodie contraprobe şi medicamente pentru investigaţie clinică


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 

   3.3. Other products: (please specify here or make a reference to Annex 5) auxiliary drugs used in clinical trials, drugs for clinical investigation; Special needs medicines medicamente auxiliare utilizate în studii clinice, medicamente pentru investigaţie clinică; medicam




Any restrictions or clarifying remarks (for all users):  The invoicing operation is carried out at the headquarters located at: Str. Amilcar C. Săndulescu no.7, Corp C1, space S2B, et.1, Municipality of Bucharest, postal code 060859. The transport activity is also carried out by the contract beneficiary Alex Internaţional Transport'94 SRL which uses transport nodes in the counties: CL, CT, DJ, IL, TR, AG, VL, OT, GJ as well as by the other contract beneficiaries qualified for the transport activity.

Operaţia de facturare se efectuează la sediul situat la adresa: Str. Amilcar C. Săndulescu nr.7, Corp C1, spaţiul S2B, et.1, Mun. Bucureşti, cod poştal 060859. Activitatea de transport se efectuează şi de către beneficiarul de contract Alex Internaţional Transport'94 SRL care utilizează noduri de transport în judeţele: CL, CT, DJ, IL, TR, AG, VL, OT, GJ cât şi de către ceilalţi beneficiari de contract calificaţi pentru activitatea de transport.


Name and address of the site: Alliance Healthcare Romania S.R.L.

(ORG-100034371 / LOC-100067656)

, Dn 59/a Km 6+300 Stanga, Timisoara, Timis, 030737, Romania   



Human medicinal products


1. MEDICINAL PRODUCTS

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

   1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*


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 

   3.3. Other products: (please specify here or make a reference to Annex 5) auxiliary drugs used in clinical trials, drugs for clinical investigation; Special needs medicines medicamente auxiliare şi medicamente utilizate în studii clinice; medicamente pentru nevoi speciale




Any restrictions or clarifying remarks (for all users):  In addition, the transportation is performed by Alex Internaţional Transport'94 SRL which are using transit storage transportation hubs in AR, HD, BH counties.

Activitatea de transport se efectuează şi de către beneficiarul de contract Alex Internaţional Transport'94 SRL care utilizează noduri de transport în judeţele: AR, HD, BH.


Name and address of the site: Alliance Healthcare Romania S.R.L.

(ORG-100034371 / LOC-100067788)

, De 307 Km 0, Parter 400, Ghimbav, Brașov, 507075, Romania   


Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations): Complet address: Oraş Ghimbav, DE 307, Km 0+400, Parter, Jud. Braşov, cod poştal 507075


Human medicinal products


1. MEDICINAL PRODUCTS

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

   1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*


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 

   3.3. Other products: (please specify here or make a reference to Annex 5) Special needs medicines Medicamente pentru nevoi speciale




Any restrictions or clarifying remarks (for all users):  In addition, the transportation is performed by Transcom SRL, Romcargo Express SRL and Alex Internaţional Transport'94 SRL which are using transit storage transportation hubs in HR, AB, SB, MS counties.

Activitatea de transport se efectuează şi de către beneficiarii de contract Transcom SRL, Romcargo Express SRL și Alex Internaţional Transport'94 SRL care utilizează noduri de transport în judeţele: HR, AB, SB, MS.



*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

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













Union Format for a Wholesale Distribution Authorisation

87D


Page 1





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