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The Spanish Agency Of Medicines And Medical Devices

CERTIFICATE NUMBER: ES/066HVI/21/5

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of ESPAÑA confirms the following:

The manufacturer: Rovi Pharma Industrial Services S.A.

Site address:

Via Complutense 140, Alcala De Henares, 28805, Spain

OMS Organisation Id. / OMS Location Id.: ORG-100001250 / LOC-100004205

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. 0271 in accordance with Art. 13 of Directive 2001/20/EC and Art. 40 of Directive 2001/83/EC.

Other

(Human) artículo 63, Real Decreto Legislativo 1/2015, de 24 de julio, Real Decreto 824/2010, de 25 de junio, Directiva 2003/94/CE

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2020-02-14 , it is considered that it complies with:

The authenticity of this certificate may be verified in EudraGMDP. If it does not appear, please contact the issuing authority.

Part 2

Human Medicinal Products
Human Investigational Medicinal Products

1 MANUFACTURING OPERATIONS

1.2 Non-sterile products

   1.2.1  Non-sterile products (processing operations for the following dosage forms)
           1.2.1.8  Other solid dosage forms
           1.2.1.13  Tablets
   1.2.2  Batch certification

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.1  Capsules, hard shell
           1.5.1.8  Other solid dosage forms
           1.5.1.13  Tablets
   1.5.2  Secondary packaging

1.6 Quality control testing

1.6.2 Microbiological: non-sterility
1.6.3 Chemical/Physical

2 IMPORTATION OF MEDICINAL PRODUCTS

2.1 Quality control testing of imported medicinal products

2.1.2 Microbiological: non-sterility
2.1.3 Chemical/Physical

2.2 Batch certification of imported medicinal products

2.2.2 Non-sterile products

2.3 Other importation activities

2.3.4 Other: [HV] Importación de principios activos biológicos.(en)

Clarifying remarks (for public users):

[F/HV]1.6.3: this processing activity includes chemical release testing of mRNA vaccines.This certificate is valid up to 14/08/2024.; [I/HV]2.1.3: includes chemical/physical batch release testing of mRNA vaccines.This certificate is valid up to 14/05/2024.;

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