Tomić Siniša, Filipović Sučić Anita, Ilić Martinac Adrijana
Agency for Medicinal Products and Medical Devices, Ksaverska cesta 4, Zagreb, Croatia.
Arh Hig Rada Toksikol. 2010 Dec;61(4):425-36. doi: 10.2478/10004-1254-61-2010-2035.
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.
在每个国家，人用或兽用药品制造商都必须遵守当地法规运营。在所有欧盟成员国，立法趋于一致，即它们致力于遵守相同的标准。候选国家将欧盟法律体系转化为其国内立法，包括良好生产规范（GMP）。因此，当地制造商必须严格遵守GMP和生产许可证要求，包括专门用于出口的药品。国家监管机构也发挥着至关重要的作用，在克罗地亚，由药品和医疗器械局负责颁发生产许可证、GMP证书和药品证书（CPP），并对产品进行实验室检测。GMP检查由卫生和社会福利部下属的药品检查局进行。这两个机构仅负责人用药品。仍存在一些尚未与欧盟法律体系协调一致的立法问题，但作为一个渴望加入欧盟的国家，克罗地亚应证明其行业和主管当局能够符合当前要求，从而全面融入欧洲综合监管网络。因此，加强主管当局的机构能力至关重要，因为资源不足可能会限制患者获得负担得起的治疗，从而对患者产生直接影响。
