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RTF Template


National Authority of Medicines and Health Products, I.P.

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


1. Authorisation Number

:

A023/98/H/004/2021

2. Name of Authorisation Holder

:

F.H.C. - Farmacêutica, S.A.

3. Address(es) of Site(s)

:

Parque Industrial Manuel Lourenço Ferreira, Lotes 2, 10 e 11, Mortágua, 3450-232 Mortágua, Portugal 




4. Legally registered address of Authorisation Holder

:

Parque Industrial Manuel Lourenço Ferreira, Lote 2, Mortágua, 3450-232 Mortágua, Portugal

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

:

2021-04-01

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: F.H.C. - Farmacêutica, S.A.

, Parque Industrial Manuel Lourenço Ferreira, Lotes 2, 10 e 11, Mortágua, 3450-232 Mortágua, Portugal   




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

     3.1.1. Narcotic or psychotropic products 

     3.1.2. Medicinal products derived from blood 

     3.1.3. Immunological medicinal products 

     3.1.4. Radiopharmaceuticals (including radionuclide kits) 

   3.2. Medicinal gases 

   3.3. Cold chain products(requiring low temperature handling) 

   3.4. Other products: Medicines with preservation conditions that require refrigeration and ultra-refrigeration




Any restrictions or clarifying remarks (for all users):  National legal basis of authorisation: Art. 94.º of Decree-law 176/2006, of 30th August.

WDA scope activity - Wholesale Distributor and 3 PL (Third Party Logistics Providers).

Updating of the Annex 1 regarding the inclusion of the medicines with preservation conditions that require refrigeration and ultra-refrigeration.

The Authorisation number A023/98/H/004/2021 replaces the previous one with the Authorisation number A023/98/H/003/2019, of 2019-09-27.



*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

A023/98/H/004/2021


Page 1





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