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RTF Template


National Institute of Pharmacy and Nutrition

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

HU-D-MMHC

2. Name of Authorisation Holder

:

Messer Medical Home Care Hungary Kft.

(ORG-100041096 / LOC-100067678)

3. Address(es) of Site(s)

:

Vaci Ut 117, Budapest IV, 1044, Hungary 

Repteri Ut 7, Gyor, 9027, Hungary 

Letai Ut 120, Debrecen, 4034, Hungary 

Verseny Utca 15, Pecs, 7622, Hungary 




4. Legally registered address of Authorisation Holder

:

Vaci Ut 117, Budapest IV, 1044

5. Scope of authorisation (complete for each site under 4)

:

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 wholesaling authorisation

:

Confidential, Confidential

8. Signature

:


9. Date

:

2022-03-07

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: Messer Medical Home Care Hungary Kft.

(ORG-100041096 / LOC-100067678)

, Vaci Ut 117, Budapest IV, 1044, Hungary   



Human medicinal products


1. MEDICINAL PRODUCTS

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

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

   1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 

   2.4. Export 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.2. Medicinal gases 




Any restrictions or clarifying remarks (for all users):  Additional provisions based on national requirements
Name of responsible person                 diploma No :
dr. Szűrös-Ritoók Emese                           72/2001 (pharmacist)
Vadasné dr. Takács Timea                         86/1988 (pharmacist)


Name and address of the site: Messer Medical Home Care Hungary Kft.

(ORG-100041096 / LOC-100068687)

, Repteri Ut 7, Gyor, 9027, Hungary   



Human medicinal products


1. MEDICINAL PRODUCTS

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

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

   1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 

   2.4. Export 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.2. Medicinal gases 




Any restrictions or clarifying remarks (for all users):  Additional provisions based on national requirements
Name of responsible person                 diploma No :
dr. Szűrös-Ritoók Emese                           72/2001 (pharmacist)
Vadasné dr. Takács Timea                         86/1988 (pharmacist)


Name and address of the site: Messer Medical Home Care Hungary Kft.

(ORG-100041096 / LOC-100068686)

, Letai Ut 120, Debrecen, 4034, Hungary   



Human medicinal products


1. MEDICINAL PRODUCTS

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

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

   1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 

   2.4. Export 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.2. Medicinal gases 




Any restrictions or clarifying remarks (for all users):  Additional provisions based on national requirements
Name of responsible person                 diploma No :
dr. Szűrös-Ritoók Emese                           72/2001 (pharmacist)
Vadasné dr. Takács Timea                         86/1988 (pharmacist)


Name and address of the site: Messer Medical Home Care Hungary Kft.

(ORG-100041096 / LOC-100068685)

, Verseny Utca 15, Pecs, 7622, Hungary   



Human medicinal products


1. MEDICINAL PRODUCTS

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

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

   1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 

   2.4. Export 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.2. Medicinal gases 




Any restrictions or clarifying remarks (for all users):  Additional provisions based on national requirements
Name of responsible person                 diploma No :
dr. Szűrös-Ritoók Emese                           72/2001 (pharmacist)
Vadasné dr. Takács Timea                         86/1988 (pharmacist)



*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

HU-D-MMHC


Page 1





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