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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

:

A013/06/H/001/2006

2. Name of Authorisation Holder

:

Laboratório BA Farma, Lda.

3. Address(es) of Site(s)

:

Rua Pé de Mouro, n.º 9005, Polígono Empresarial Pé de Mouro, Armazém 21, Capa Rota, Sintra, 2710-335 Sintra, Portugal 




4. Legally registered address of Authorisation Holder

:

Rua Pé de Mouro, n.º 9005, Polígono Empresarial Pé de Mouro, Armazém 21, Capa Rota, Sintra, 2710-335 Sintra, 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

:

2006-04-18

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: Laboratório BA Farma, Lda.

, Rua Pé de Mouro, n.º 9005, Polígono Empresarial Pé de Mouro, Armazém 21, Capa Rota, Sintra, 2710-335 Sintra, Portugal   




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 

   2.4. Export 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.3. Cold chain products(requiring low temperature handling) 




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

Registration of the Wholesale Distribution Authorisation n.º A013/06/H/001/2006, of 2006-04-18 in favour of the the insolvent estate, by a final court decision, of 2017-08-30 in the context of the judicial process number 13983/17.2T8SNT.



*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

A013/06/H/001/2006


Page 1





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