infarmed
Autoridade Nacional do Medicamento
e Produtos de Saude, I.P.
INFARMED - Autoridade Nacional do Medicamento e Produtos de Saude,
J.P.
Issued following an inspection in accordance with:
Art. 111(5) of Directive 2001/83/EC as amended
The competent authority of Portugal confirms the following:
The manufacturer: LaboratOrios JlitOria,S.A.
Site address: Rua Elias Garcia, n. 028, Amadora, 2700-320, Portugal
Has been inspected under the national inspection programme in connection with manufacturing
authorisation no. in accordance with Art. 40 of Directive 200 1/83/EC transposed in the following national
legislation:
Art. 55.0 of Decree-Law n. 0 176/2006, 30 of August
From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on
2008-11-13 , it is considered that it complies with:
• The principles and guidelines of Good Manufacturing Practice laid down in Directive 2003/94/EC
This certificate reflects the status of the manufacturing site at the time of the inspection noted above and
should not be relied upon to reflect the compliance status if more than three years have elapsed since the date
of that inspection, after which time the issuing authority should be consulted. The authenticity of this
certificate may be verified with the issuing authority.
Part 2
I Human
Medicinal Products
- authorised manufacturing
packaging or presentation),
operations include total and partial manufacturing
batch release and certification,
(including various processes of dividing up,
storage and distribution of specified dosage forms unless informed to the
contrary;
- quality control testing and/or release and batch certification activities without manufacturing
operations should be specified under
the relevant items;
- if the company is engaged in manufacture
penicillin,
of products with special requirements
sulphonamides,cytotoxics,cephalosporins,substances
e.g. radiopharmaceuticals
or products containing
with hormonal activity or other potential hazardous active
ingredients this should be stated under the relevant produce type and dosage fonn;
Signatory: Prof Helder Mota Filipe
Helder Mota Fillpe
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INFARMED
INSPEC(,'AO
DIRECCAO
E
UCENCIAMENrOS
DE
INFARMED - Autoridade
Nacional do Medicamento
e Produtos de Saude, I.P.
Parque de Saude de Lisboa - Avenida do Brasil, S3
Tel: +3S1 217987100
1749-004 Lisboa - Portugal
Fax: +3S1 217987316
Website: www.infarmed.pt
Email: [email protected]
infarmed
Autoridade
e Produtos
1.1
Sterile Products
1.1.1 Aseptically prepared (list of dosage forms)
1.1.1.4 Small volume liquids
1.1.2
Terminally Sterilised (list of dosage forms)
1.1.2.3
1.2
Nacional
Small volume liquids
Non-sterile products
1.2.1 Non-sterile products (list of dosage forms)
1.2.1.1
1.2.1.12
1.2.1.13
1.2.1.17
Capsules, hard shell
Suppositories
Tablets
Other: Outros(pt)
1.5
Packaging only
1.5.2 Secondary packing
1.6
Quality control testing
1.6.1 Microbiological: sterility
1.6.2
Microbiological: non-sterility
1.6.3
Chemical/Physical
Name and signature of the authorised person ofthe
Competent Authority of Portugal
Prof Helder Mota Filipe
INFARMED - Autoridade
Produtos de Saude, J.P.
Tel: +351 21 798 7117
Fax: +35121 798 7106
!NFAHMED
INSPEC<;;AO
E
DIRECCAo
DE
UCENCIAMENTOS
INFARMED - Autoridade
Nacional do Medicamento
Nacional do Medicamento
e Produtos de Saude.I.P
Parque de Saude de Lisboa - Avenida do Brasil, S3
1749-004 Lisboa - Portugal
rei:
+ 3S 1 217987 100 Fax: + 351 217 987 316 Website: www.infarmed.pt
Email: [email protected]
do Medicamento
de Saude, I.P.
e