GREECE Law and Practice Contributed by: Angela Livgieri, Danai Panopoulou and Iliana Andronou, ALG Manousakis Law Firm
5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices Pharmaceuticals Manufacturing facilities must obtain a manufac- turing license from EOF. According to Article 58 of the JM Decision, each manufacturing facility has to obtain a manufacturing license, which is granted under the following conditions: • specify the medicinal products to be manu- factured, as well as the place of manufacture; • ensure suitable and adequate premises, tech- nical equipment, and control facilities; and • appoint at least one qualified person. Furthermore, according to Articles 9 of both Joint Ministerial Decision DYG3a/7567/2008 and Joint Ministerial Decision YA D3(a)/14709/2018, the manufacturer must ensure that manufactur- ing plants and equipment are sited, designed, constructed and maintained in such a way that they perform the functions for which they are intended. Additionally, they must be arranged and used in such a way as to minimise the risk of error and to permit effective maintenance in order to avoid direct and cross-contamination and any undesirable effect on product quality. EOF conducts on-site inspections to verify com- pliance with EU GMP standards. Medical Devices For medical devices, the decision issued by EOF 0−1016/22nd/15.12.2008 (Ministerial Decision 6209/2009) sets out the rules regarding good manufacturing and control rules for medical devices in order to ensure appropriate imple- mentation of a quality system. As per Article 3
of the said decision, among others, the manu- facturer of a medical device must have the fol- lowing in place: • appropriately qualified and trained personnel; • adequate facilities and premises; • appropriate equipment and services; • appropriate materials, containers and labels; • approved procedures and instructions; • appropriate storage; and • written records of manufacture and distribu- tion with which the history of the batch can be traced. Following the approval of the application, EOF grants the manufacturing authorisation for the medical device as per Article 2 of the Joint Min- isterial Decision DY8d/130648/2009. Manufacturing licenses for pharmaceuticals and medical devices typically remain valid indefinite- ly, provided that the manufacturer complies with ongoing regulatory requirements. These include: • adherence to GMP rules and issuance of a relevant GMP certificate of compliance, which is valid for three years unless specific circum- stances reduce or increase this period; and • adherence to relevant quality management standards (eg, ISO 13485 for medical devices that must be renewed every three years). 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices Wholesalers must obtain a wholesale license issued by EOF. Application to EOF includes com- pany details, warehouse location, description of storage and handling facilities, list of medicinal
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