Tepnel has been inspected in connection with Manufacturing and/or Marketing Authorisation(s) listing the company as a site of QC testing, in accordance with Art. 111 (1) of Directive 2001/83/EC (or Article 80(1) of Directive 2001/82/EC) transposed in the following national legislation: For human medicines 'The Medicines Act 1968 as amended'; for veterinary medicines 'The current Veterinary Medicines Regulations'; for investigational
medicinal products 'The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031)' and is authorised for;
- MANUFACTURING OPERATIONS:
Quality control testing
Microbiological: sterility testing
Microbiological: non-sterility testing
Chemical/Physical testing
Biological testing
- IMPORTATION OF MEDICINAL PRODUCTS:
Quality control testing of imported medicinal products
Microbiological: sterility testing
Microbiological: non-sterility testing
Chemical/Physical testing
Biological testing
Veterinary Medicinal Products
Tepnel has been inspected in connection with Manufacturing and/or Marketing Authorisation(s) listing the company as a site of QC testing, in accordance with Art. 111 (1) of Directive 2001/83/EC (or Article 80(1) of Directive 2001/82/EC) transposed in the following national legislation: For human medicines 'The Medicines Act 1968 as amended'; for veterinary medicines 'The current Veterinary Medicines Regulations'; for investigational
medicinal products 'The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031)' and is authorised for:
- MANUFACTURING OPERATIONS:
Quality control testing
Microbiological: sterility testing
Microbiological: non-sterility testing
Chemical/Physical testing
Biological testing
- IMPORTATION OF MEDICINAL PRODUCTS:
Quality control testing of imported medicinal products
Microbiological: sterility testing
Microbiological: non-sterility testing
Chemical/Physical testing
Biological testing