08/07/2019
Regulatory reforms in Greece – a comprehensive legal overview. Prepared in association with Calavros Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Greece, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? A. The recently enacted Law 4578/2018 on the “Reduction of social security contributions and other provisions” establishes under its paragraph 12 the new percentages of imposed reduction (namely “rebate”) on the…
15/02/2019
All legal aspects surrounding cannabinoid drugs, medicinal cannabis & opioid drugs in Greece. Prepared in association with Calavros Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Greece, available to purchase here for USD 99. Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? By virtue of article 1 of recent Law 4523/2018, article 2A has been introduced to Law 4139/2013 on Narcotics, providing for the possibility to obtain exceptional authorization for the production,…
Key information on patents and trademarks in Greek pharma. Prepared in association with Calavros Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Greece, available to purchase here for USD 99. 1. What are the basic requirements to obtain patent and trademark protection? Patents Currently, inventions of pharmaceutical products can be protected in Greece either by national patents, granted by Hellenic Industrial Property Organization (Greek acronym OBI) in line with Law 1733/1987 (as amended and in force)…
Need the lowdown on product liability in Greek pharma? Read on! Prepared in association with Calavros Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Greece, available to purchase here for USD 99. 1. What types of liability are recognized in your jurisdiction? Several types of liability, namely civil, administrative, criminal and disciplinary liability may be established under the national legislation in force in the event of breach of pharmaceutical laws and regulations, depending both…
The ins and outs of traditional medicines and OTC products in Greek pharma. Prepared in association with Calavros Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Greece, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Legal provisions pertaining to the regulatory requirements of the various types of medicinal products and medical devices may be found in various Interministerial Decisions and…
All about marketing, manufacturing, packaging & labeling and advertising in Greek pharma. Prepared in association with Calavros Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Greece, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Medicinal Products In line with EU legislation, four different procedures may alternatively be followed in view of obtaining marketing authorization…
The key requirements for conducting pre-clinical and clinical trials in Greece. Prepared in association with Calavros Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Greece, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. Article 9 par. 3 of Ministerial Decision Δ.ΥΓ3α/Γ.Π. 32221/Government Gazette B 1049/2013, issued in application of Directive 2001/83/EC of the European Parliament and…
A legal intro to the situation regarding regulation, pricing and reimbursement in Greek pharma. Prepared in association with Calavros Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Greece, available to purchase here for USD 99. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The National Organization for Medicines (hereinafter referred to as E.O.F.) which was established in 1983 as a public entity…
All about marketing, manufacturing, packaging & labeling and advertising in…
Regulatory reforms in Greece – a comprehensive legal overview. Prepared…
Key information on patents and trademarks in Greek pharma. Prepared…
All legal aspects surrounding cannabinoid drugs, medicinal cannabis & opioid…
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