Professional paper
https://doi.org/10.2478/10004-1254-61-2010-2035
Good Manufacturing Practice: The Role of Local Manufacturers and Competent Authorities
Siniša Tomić
; Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
Anita Filipović Sučić
; Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
Adrijana Ilić Martinac
; Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
Abstract
In every country, a manufacturer of medicinal products for either human or veterinary use is required to operate in compliance with local legislation effect that they are committed to abide by the same standards. The candidate countries transpose the acquis into their national legislation, including the good manufacturing practice (GMP). Consequently, the local manufacturer is required to strictly comply with GMP and the manufacturing licence, including for medicinal products exclusively intended for export. A vital role is also played by national regulatory authorities, in Croatia by the Agency for Medicinal Products and Medical Devices which issues the manufacturing licence, GMP certifi cate, and the Certifi cate of a Pharmaceutical Product (CPP) and conducts laboratory control of
products. GMP inspection is carried out by the Pharmaceutical Inspectorate with the Ministry of Health and Social Welfare. Both authorities are responsible only for human medicines. There are legislative issues not yet harmonised with the acquis, but as a country aspiring for the EU membership, Croatia is expected
to demonstrate that its industry and competent authorities are able to conform to current requirements and thus fully adhere to the integrated European regulatory network. Hence the importance of strengthening the institutional capacity of the competent authorities, as insuffi cient resources may have a direct bearing
on patients by limiting their access to affordable treatment.
Keywords
inspection; medicinal product; production; quality assurance; quality control; qualified person
Hrčak ID:
62470
URI
Publication date:
21.12.2010.
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