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Swedish Medical Products Agency

CERTIFICATE NUMBER: 6.2.1-2023-055194

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of Sweden confirms the following:

The manufacturer: Rechon Life Science AB

Site address:

Soldattorpsvagen 5, Limhamn, 216 13, Sweden

OMS Organisation Id. / OMS Location Id.: ORG-100000620 / LOC-100003401

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. 6.2.1-2023-055194 in accordance with Art. 40 of Directive 2001/83/EC.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2023-09-22 , 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

1 MANUFACTURING OPERATIONS

1.1 Sterile products

   1.1.1  Aseptically prepared (processing operations for the following dosage forms)
           1.1.1.4  Small volume liquids
                  Special Requirements:
                   7  Other: Hormones or substances with hormonal activity(en)
   1.1.2  Terminally Sterilised (processing operations for the following dosage forms)
           1.1.2.3  Small volume liquids
   1.1.3  Batch certification

1.3 Biological medicinal products (list of product types)

   1.3.1  Biological medicinal products (list of product types)
           1.3.1.2  Immunological products
           1.3.1.5  Biotechnology products
           1.3.1.6  Human or animal extracted products
   1.3.2  Batch Certification (list of product types)
           1.3.2.2  Immunological products
           1.3.2.5  Biotechnology products
           1.3.2.6  Human or animal extracted products

1.5 Packaging

1.5.2 Secondary packaging

1.6 Quality control testing

   1.6.2  Microbiological: non-sterility
   1.6.3  Chemical/Physical
   1.6.4  Biological

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

   2.2.1  Sterile products
           2.2.1.1  Aseptically prepared
           2.2.1.2  Terminally sterilised
   2.2.3  Biological medicinal products
           2.2.3.2  Immunological products
           2.2.3.5  Biotechnology products
           2.2.3.6  Human or animal extracted products

2.3 Other importation activities

2.3.1 Site of physical importation
2.3.3 Biological active substance

Clarifying remarks (for public users):

1.3.1.2, 1.3.1.5, 1.3.1.6 formulation, sterile filtration, aseptic fill/finish, visual inspection, packaging and container-closure testing.

Withdrawal comments in English: Replaced by certificate number SE-H-GMP-24-055298.

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