GREECE Law and Practice Contributed by: Angela Livgieri, Danai Panopoulou and Iliana Andronou, ALG Manousakis Law Firm
• Non-CE-Marked Devices (not registered in Greece): EOF must provide specific import approval. Custom-made medical devices (eg, prosthetics) may be exempted from standard import require- ments but must still be registered with EOF. In order to place their products on the Greek market, medical device importers are required to notify the National Electronic Registry of Medi- cal Devices GREMDIS of their details. Required documents are: • CE Marking Certificate (for higher-risk medi- cal devices) or Certificate of the competent authority of the EU Member State where the products were registered (for low-risk medical devices); • Manufacturer’s Declaration of Conformity;
treating physician proposes (and EOF issues) an individual decision. 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports In Greece, non-tariff regulations and restrictions on the importation of pharmaceuticals and medi- cal devices are imposed based on their regula- tory category and classification under the Com- bined Nomenclature (CN) Code, which is based on the Harmonized System (HS) Code. The Greek Customs Code (Law 2960/2001), in alignment with the EU Customs Code (Regu- lation (EU) No 952/2013), provides that if the pharmaceutical product or the medical device meets the requirements of the applicable legisla- tion for its manufacturing and production, it may be imported into Greece or any other European jurisdiction. Pharmaceuticals, governed by Directive, imple- mented in Greece through JM Decision, require authorisation from the EOF. Products must meet provided qualitative and quantitative com- position standards, and batch testing may be required upon their termination. Medical devices are regulated under MDR and IVDR for in vitro diagnostic devices. All imported devices must bear the CE mark and be registered in the EUDAMED database. Customs authorities check for technical documentation, conformity assessments, and labelling compliance. Additionally, specific restrictions from countries on specific products may be provided in the EU TARIC database, which determines additional requirements, restrictions, or prohibitions. Laws and Regulations governing these restric- tions are outline below.
• outer packaging; and • instructions for use. Exceptions Personal use
Patients can import small quantities of prescrip- tion medicines for personal use, but the provi- sion of the doctor’s prescription and patient dec-
laration to customs is mandatory. Emergency public health situations
During pandemics, disasters, or shortages, pharmaceutical products may be imported fol- lowing a decision of EOF (Paragraph 5 of Article
8 of Legislative Decree 96/1973) Named patient programmes & compassionate use
Importation of unapproved medicines for indi- vidual patients or for a group of patients follow- ing EOF decision. For individual patients, the
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