Abstract
In every country, a manufacturer of medicinal products for either human or veterinary use is required to operate in compliance with local legislation. In all EU Member States, legislation is approximated to the 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 certificate, and the Certificate 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 insufficient resources may have a direct bearing on patients by limiting their access to affordable treatment.
Highlights
In every country, a manufacturer of medicinal products for either human or veterinary use is required to operate in compliance with local legislation
A vital role is played by national regulatory authorities, in Croatia by the Agency for Medicinal Products and Medical Devices which issues the manufacturing licence, good manufacturing practice (GMP) certificate, and the Certificate of a Pharmaceutical Product (CPP) and conducts laboratory control of products
Since the output is a human medicine, quality assurance and quality control (QA/quality control (QC)) procedures monitor and test the production process carefully to ensure that no patients will be harmed [5]
Summary
A manufacturer of medicinal products for either human or veterinary use is required to operate in compliance with local legislation. A vital role is played by national regulatory authorities, in Croatia by the Agency for Medicinal Products and Medical Devices which issues the manufacturing licence, GMP certificate, and the Certificate of a Pharmaceutical Product (CPP) and conducts laboratory control of products. The Croatian manufacturers and competent authorities are implementing the acquis which has been adopted into national legislation In this pre-accession period there are still discrepancies in terms of the roles of manufacturers and the Agency responsible for medicines locally produced and those produced in other countries, including the EU [6]. According to Croatian legislation [10] a qualified person for batch release in cases of the manufacture of specific medicinal products (biologics, radiopharmaceuticals, medical gases) and pharmaceutical forms may graduated in medicine, veterinary medicine, chemistry, biology and other scientific disciplines, but should possess at last five-year experience in pharmaceutical quality control. Premises and equipment used in production are critical for product quality and they should be properly qualified and validated [12]
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