Pharmacovigilance
COOPER SA has a well-equipped analytical laboratory (Physicochemical-Biological-Microbiological) that meets the requirements of cGLPs, in which exercises strict control over all stages of the production process from raw ingredients and packaging materials, in-process controls, to the final product.
COOPER SA follows written procedures drawn up in accordance with international standards and GMP guidelines, as well as the ISO 9001:2015, ISO 13485:2016, standard and supervises all production processes as well as the reliability of installations, equipment, systems and all testing and production proceedures.
It also applies the principles and guidelines governing correct practice for storage and distribution of Medical Products and Devices, in accordance with Ministerial Decision DY8/1348/2004, and holds the relevant certificate from the competent certification agency, the Research Center for Biomaterials (EKΑPTY SA).
COOPER SA collects and monitors the safety data for all medicinal products marketed, in accordance with the guidelines governing Pharmacovigilance internationally.
For any report of an adverse event/reaction or a quality complaint about a COOPER SA product you can call at +30 2103462108 or send an email to the following address:
pharmacovigilance@koper.gr
For the needs of pharmacovigilance, the company collects personal data, based on the current legislation related to the safety of medicines. Data is stored for a period defined in the current legislation. Sending information or personal data to the above-mentioned email address, indicates your consent about data processing.
For FRESENIUS KABI products you can call at +30 210 6542 909 or send an email to the following address: FKHinfo@fresenius-kabi.com
COOPER SA follows written procedures drawn up in accordance with international standards and GMP guidelines, as well as the ISO 9001:2015, ISO 13485:2016 standard and supervises all production processes as well as the reliability of installations, equipment, systems and all testing and production proceedures.
It also applies the principles and guidelines governing correct practice for storage and distribution of Medical Products and Devices, in accordance with Ministerial Decision DY8/1348/2004, and holds the relevant certificate from the competent certification agency, the Research Center for Biomaterials (EKΑPTY SA).
COOPER SA collects and monitors the safety data for all medicinal products marketed, in accordance with the guidelines governing Pharmacovigilance internationally.
For any report of an adverse event/reaction or a quality complaint about a COOPER SA product you can call at +30 2103462108 or send an email to the following address:
pharmacovigilance@koper.gr
For the needs of pharmacovigilance, the company collects personal data, based on the current legislation related to the safety of medicines. Data is stored for a period defined in the current legislation. Sending information or personal data to the above-mentioned email address, indicates your consent about data processing.
For FRESENIUS KABI products you can call at +30 210 6542 909 or send an email to the following address: FKHinfo@fresenius-kabi.com
