Certificates

Certificate ISO 9001:2008 for Galenika a.d.
Parapharmaceuticals Plant
For: development, manufacturing and sales of pharmaceutical products in all pharmaceutical forms, dental products, medical dressings, dietary supplements and skin care products.

Certificate EN ISO 13485:2003/AC:2007 for Galenika a.d.
Parapharmaceuticals Plant
For: manufacturing and sales of medical devices for wound treatment

EC certificate for Galenika a.d.
Parapharmaceuticals Plant
Manufacturing Quality Assurance System
(Annex V to MDD 93/42/EEC)
For: adhesive dressings, sterile packaging

Certificate: HACCP system for Galenika a.d.
Parapharmaceuticals Plant
For: manufacturing and sales of dietary supplements

Certificate EN ISO 13485:2003/AC:2007 for Galenika a.d.
Dental Products Plant: development, manufacturing and sales of medical devices for dentistry use

EC certificate for Galenika a.d.
Dental Products Plant
Full Quality Assurance System
(Annex II, Article 3 to MDD 93/42/EEC)
For: dental products/medical devices

GMP certificate for Galenika a.d.
Solid Dosage Forms Plant
Certificate №: 70

GMP certificate for Galenika a.d.
Solid Dosage Forms Plant
Certificate №: 76

Certificate on validation of information system for Galenika a.d.
Certificate on validation of company MRP II BAMCS (Business And Manufacturing Control System) information system