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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

:

46D

2. Name of Authorisation Holder

:

S.C. PHARMA S.A.

3. Address(es) of Site(s)

:

Str. Aeroportului, tarla 6, parcela 69, Com. Cârcea, Jud. Dolj, cod poştal 207206, Romania 

Str. Sfântul Andrei nr. 23, Sat Sânandrei, Com. Sânandrei, Jud. Timiş, cod poştal 307375, Romania 

Str. Clujului nr. 97A, Sat Sânnicoară, Com. Apahida, Jud. Cluj, codul p, codul poştal 407042, Romania 

Şos. Bucium nr. 73E, Mun. Iaşi, Jud. Iaşi, cod poştal 700278, Romania 

Str. Verde nr. 31, Mun. Constanţa, Jud. Constanţa, cod poștal 900328, Romania 

Str. Principală nr. 962 A, Sat Filipeştii de Pădure, Com. Filipeştii de Pădure, Jud. Prahova, cod poştal 107245, Romania 




4. Legally registered address of Authorisation Holder

:

Şos. Bucium, nr. 73 E, Mun. Iaşi, Jud. Iaşi, cod poştal 700278, 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

:

2021-03-25

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 S.A.

, Str. Aeroportului, tarla 6, parcela 69, Com. Cârcea, Jud. Dolj, cod poştal 207206, 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: PHARMA S.A.

, Str. Sfântul Andrei nr. 23, Sat Sânandrei, Com. Sânandrei, Jud. Timiş, cod poştal 307375, 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: PHARMA S.A.

, Str. Clujului nr. 97A, Sat Sânnicoară, Com. Apahida, Jud. Cluj, codul p, codul poştal 407042, 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: PHARMA S.A.

, Şos. Bucium nr. 73E, Mun. Iaşi, Jud. Iaşi, cod poştal 700278, 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) 




Name and address of the site: PHARMA S.A.

, Str. Verde nr. 31, Mun. Constanţa, Jud. Constanţa, cod poștal 900328, 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: PHARMA S.A.

, Str. Principală nr. 962 A, Sat Filipeştii de Pădure, Com. Filipeştii de Pădure, Jud. Prahova, cod poştal 107245, 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) 





*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

46D


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