Pharmaceuticals

European Legislation

• Directive 2001/83/EC (“Directive”) on the Community code relating to pharmaceutical products for human use, as amended and in force.

National Legislation

• Legislative Decree 96/1973 (Government Gazette A’ 172/3/8.8.1973) on the trading of pharmaceutical and cosmetic products.
• Law 1316/1983 (Government Gazette A’ 3/11/11.1.83) on the establishment, organisation and competence of the National Organization for Medicines (EOF, as per its Greek acronym).
• Joint Ministerial Decision DYG 3a/32221/2013 (“JM Decision”) (Government Gazette Β’ 1049/29.04.2013) on the implementation of Directive 2001/83/EC of the European Parliament and the European Council on the Community Code relating to pharmaceutical products for human use.

Medical Devices

European Legislation

• Regulation (EU) 2017/745 of the European Parliament and Council of 5 April 2017 on medical devices (“MDR”).
• Regulation (EU) 2017/746 of the European Parliament and Council of 5 April 2017 on in vitro diagnostic medical devices (“IVDR”).

National Legislation

• Joint Ministerial Decision DY8d/130648/2009 on “Medical Devices” (Government Gazette Β’ 2198/02.10.2009), for the harmonisation of national legislation with the provisions of Directive 93/42/EEC “on Medical Devices”, as amended by Directives 98/79/EC, 2000/70/EC, 2001/104/EC, 2007/47/EC and Regulation (EC) 1882/2003.
• Joint Ministerial Decision DY8d/130644/2009 on “Active Implantable Medical Devices” (Government Gazette Β’ 2197/2.10.2009), for the harmonisation of national legislation with the provisions of Directive 90/385/EEC “on the approximation of the laws of the Member States relating to Active Implantable Medical Devices”, as amended by Directives 93/42/EEC, 93/68/EC, 2007/47/EC and Regulation (EC) 1882/2003.
• Joint Ministerial Decision DY8d/3607/892/2001 on “In Vitro Diagnostic Medical Devices” (Government Gazette Β’ 1060/10.8.2001), for the harmonisation of national legislation with the provisions of Directive 98/79/EC of the European Parliament and of the of 27 October 1998 “on In Vitro Diagnostic Medical Devices”.

Regulatory Bodies

The competent national authority with regulatory oversight over pharmaceutical products and medical devices is EOF, established by Law 1316/1983 (Government Gazette A’ 3/11/11.1.83) as an entity of public law.

Within the framework of its mission, EOF is responsible for:

• receiving and approving applications for marketing authorisations;
• receiving and approving applications for clinical trials and monitoring clinical trials;
• approving and monitoring manufacturing facilities in order to ensure compliance with Good Manufacturing Practices (GMP);
• monitoring the quality, safety and efficacy of products within its competency;
• receiving applications for pricing of pharmaceutical products and proposing pricing to the Ministry of Health; and
• approving and monitoring wholesale facilities. 

EOF, in the scope of its mission, is autonomous, and the Ministry of Health can only revoke its decisions based on a legally justifiable basis.

Pharmaceuticals

When a marketing authorisation for a pharmaceutical product is rejected, the applicant can appeal to the Committee for Medicinal Products for Human Use (under Article 49 of the JM Decision). The Committee will issue a decision on the appeal within 60 days of the submission. If the applicant’s appeal is denied, they can further contest this decision by appealing to the Administrative Court of First Instance.

Additionally, objections to the price bulletin issued by the Ministry of Health can be raised through a petition for annulment submitted to the Conseil d’État (Council of State (ΣτΕ)).

Objections against the decision of the Ministry of Health for non-inclusion in the Reimbursement List may be raised by a petition of annulment before the Three-Member Administrative Court of Appeal.

Medical Devices

In Greece, the EOF is responsible for overseeing the marketing of medical devices. This includes ensuring that these devices comply with the legal requirements outlined in the Joint Ministerial Decision DY8d/130648/2009, as amended by Ministerial Decision YA A4g/88159/2017. This framework appoints the EOF as the authority overseeing medical devices in Greece and outlines the applicability of the MDR and IVDR within the country. The relevant legal provisions also include Article 2, Paragraph 2; Article 3, Paragraph 1; and Article 6, Paragraph 2 of Law 1316/1983 (Government Gazette A’ 3/11/11.1.83), along with the applicable provisions of the MDR and IVDR.

If EOF decides to withdraw a medical device from the market, the manufacturer has the right to appeal this decision at the Administrative Court of First Instance for annulment.

Pharmaceuticals

Prescription-only medicines require a doctor’s prescription for purchase, are dispensed by pharmacies, and are subject to stricter regulations regarding their distribution and marketing.

Following their approval, OTC products can be sold without a prescription.

Medical Devices

The MDR and the Joint Ministerial Decision DY8d/130648/2009 (Article 9 and Annex IX) classify medical devices as follows: 

• Class I requires only self-certification by the manufacturer; 
• Class IIa involves a notified body for conformity assessment;
• Class IIb requires the involvement of a notified body and a more rigorous assessment (eg, clinical evaluation and performance data are required); and
• Class III requires a full assessment from the notified body (including design dossier review, robust clinical data requirement, and clinical trials).

Pharmaceuticals

The legal framework applicable to clinical trials in Greece is laid down in the Regulation (EU) No 536/2014 (“CTR”) on clinical trials on pharmaceuticals for human use.

The provisions of the CTR were transposed in the Greek legislation by the Joint Ministerial Decision G5a/59676/2016 (Government Gazette Β’ 4131/22.12.2016).

In order to conduct a clinical trial in Greece, prior approval from EOF is required following an application submitted via the EU portal. 

The application, the clinical trial protocol, the information material addressed to patients, the informed consent form, the labelling, the patient cards, and the insurance contract must be submitted in Greek. The rest of the file documentation may be submitted in English.

Medical Devices

The legal framework applicable to clinical investigations (or performance studies in the case of in vitro diagnostic medical devices) is set out in Section VI of the MDR, as well as in Section VI of the IVDR on in vitro diagnostic medical devices, as the case may be. In Greece, the MDR and the IVDR are directly applicable in conjunction with the Joint Ministerial Decision DY8d/130648/2009 (Article 15 of the said Decision specified the clinical-related rules).

Pharmaceuticals

Clinical trials are subject to scientific and ethical evaluation and are approved in accordance with Article 8 of the CTR. The EOF conducts a scientific evaluation of the clinical trial. If EOF has been granted the status of ‘reporting’ member state, it notifies the sponsor and other member states concerned via the EU portal within six days of submitting the application file (Article 5 of the CTR).

Ethical evaluation is carried out by the National Ethics Committee, which drafts an assessment report in accordance with the procedure laid down in Article 7 of the CTR.

A positive scientific (by EOF) and ethical (by National Ethics Committee) assessment of the clinical trial is required for its approval.

Medical Devices

According to articles 62 of the MDR and 58 of the IVDR, both clinical investigations and performance studies are subjected to an authorisation by the Member State in which the clinical investigation or the performance study is to be conducted, following a scientific and ethical review, the latter being performed by an ethics committee, according to the national law. As per above, competent authorities are EOF and the National Ethics Committee.

Greece has no national database for clinical trials of medicines or medical devices. A central European database (EudraCT) exists, as provided in article 80 of the CTR.

In Greece, there are no explicit restrictions on the use of online tools in clinical trials. However, the use of these tools must comply with both national and European legislation. This includes the CTR, Ministerial Decision No G5α/59676/2016 on Clinical Trials, and EU Regulation 2016/679 (General Data Protection Regulation – GDPR), along with its implementation of Greek Law 4624/2019. Additionally, guidance from EOF must be followed to ensure the protection of clinical trial participants’ data privacy rights.

More specifically, Ministerial Decision No. G5α/59676/2016 (Articles 8, 13 and 24) describes the processes throughout the clinical trial course in Greece and the obligations assigned to sponsors and clinical research organisations (CROs) regarding protecting the participant’s data, including using appropriate security measures.

In addition, a Data Protection Impact Assessment has to be conducted; appropriate privacy-related information must be provided to individuals concerned, and data processing agreements (DPAs) are required between sponsors, investigators, and tool providers. The Hellenic Data Protection Authority (HDPA) oversees the enforcement of data protection regulations in Greece. While the HDPA has not issued specific guidance on the use of online tools in clinical trials, sponsors and investigators must ensure that any digital platforms used for recruitment or monitoring purposes implement appropriate technical and organisational measures. 

Data from clinical trials is classified as sensitive health-related information regarding an individual’s past, present, or future physical and mental health (Article 4(15) GDPR).

Transferring clinical trial data to third parties or affiliates is allowed under specific conditions:

• Within the EU/EEA – It is allowed, provided that clinical trial participants have been duly informed through the informed consent form and processing is in accordance with the trial’s approved protocol.
• Outside the EU/EEA (International Transfers) – If data is transferred to a third country (eg, the US), additional safeguards are required:
1. the recipient country must have an adequacy decision from the European Commission (eg, under the EU-US Data Privacy Framework);
2. if no adequacy decision exists, Standard Contractual Clauses (SCCs) or Binding Corporate Rules (BCRs) must be used; and
3. additional security measures (eg, encryption, pseudonymisation) may be required.

To ensure compliance, before transferring clinical trial data to third parties or affiliates, the sponsor must execute a Data Processing Agreement (DPA) (along with the execution of the appropriate Standard Contractual Clauses if applicable for international transfer) with third-party vendors or enter into an intragroup data transfer agreement with its affiliates.

Below, you will find requirements applying to the creation of database containing personal or sensitive data (in accordance with GDPR and Law 4624/2019).

A Data Protection Impact Assessment (DPIA) (GDPR art. 35) is mandatory if the processing of personal data is likely to result in a high risk to individuals’ rights. For example, this will be the case if:

• there is large-scale processing of special categories of data;
• there is involvement of high-risk data processing; or
• there are systematic and extensive processing activities, including profiling.

Adherence to data protection principles such as the data minimisation and purpose limitation principles is required, as the database should only contain the minimum amount of data necessary for the specific purposes for which it was created (Articles 5-11 GDPR).

Appropriate security and access controls (eg, encryption & pseudonymisation, access restrictions, data retention policies, and rules to protect data from unauthorised access, breaches, or leaks) must be implemented.

The appropriate legal basis must be assessed (as per Articles 6 & 9 of the GDPR for plain and special categories of personal data such as health-related).

It is essential to provide relevant information to the individuals involved. This information should include the purposes for processing their data, the identity and contact details of the data controller, any recipients or categories of recipients who will receive the personal data, and the privacy-related rights of the individuals, among other necessary details.

If third parties access the database, data processing agreements must be executed, along with Standard Contractual Clauses (SCCs), as applicable for international transfers.

In case the database involves automated processing of personal data, prior consultation with the Hellenic Data Protection Authority (HDPA) may be required. The HDPA may also review international data transfers or secondary uses of the data.

The process for classifying a product as either a pharmaceutical or a medical device depends on its intended use, primary mode of action and composition. The primary distinction is their mode of action. Pharmaceuticals exert their effects through chemical or biological mechanisms, while medical devices operate primarily via physical or mechanical means.

Pharmaceuticals

Pharmaceuticals are governed by Directive and relevant national laws, such as Legislative Decree 96/1973 and Law 1316/1983 in Greece. The approval process for pharmaceuticals involves submitting an application to the regulatory authority (EOF in Greece), including information about composition, manufacturing standards, and pharmacovigilance practices. Once approved, marketing authorisation holders (MAHs) must comply with stringent post-marketing obligations, including pharmacovigilance reporting.

Medical Devices

The MDR and the IVDR regulate medical devices. National Joint Ministerial Decisions, along with guidance issued by the EOF, provide additional oversight. Medical devices are designed to assist bodily functions and can operate mechanically, physically, or through software without producing direct pharmacological effects. Examples include surgical instruments and diagnostic software. Manufacturers must complete a conformity assessment to demonstrate compliance with safety and performance standards. The product obtains CE marking through a notified body or the national authority before it can be marketed. Devices are classified based on their risk level and intended purpose, with post-marketing vigilance responsibilities ensuring continued safety and effectiveness. In Greece, the responsible notified body for the conformity assessment and the CE marking (granting of CE 0653 in Greece, which shows compliance with the applicable legislation) of medical devices is the National Evaluation Center of Quality and Technology in Health (EKAPTY).

In Greece, biologic medicinal products require marketing authorisation through either the national procedure (EOF) or, more commonly, the centralised procedure under Regulation (EC) No 726/2004, where approval is granted at the EMA level.

There are no differences in the approval process between pharmaceutical (chemical) and biological products.

Biosimilars, or generic biological products, must be similar but not identical to the reference product. This contrasts with traditional chemical pharmaceuticals, which require identical characteristics for approval.

Validity and Renewal

Pharmaceuticals

Marketing authorisations are valid for five years from the date of approval. If a renewal is approved, the authorisation lasts indefinitely unless further safety monitoring is necessary, in which case the renewal is for an additional five-year period.

Medical devices

A CE certificate necessary for the marketing of medical devices is issued by a notified body for a five-year term (as per Article 56 paragraph 2 of the MDR). Manufacturers must provide updated clinical evaluations, performance data, and post-market surveillance reports to renew the CE certificate. The said CE certificate is issued by a notified body (ie, the organisation responsible for the CE certification issuance and conformity assessment procedures as per Article 1, paragraph 2ie), Article 11 and 16 of the Joint Ministerial Decision DY8d/130648/2009 – their specific requirements are set out in Annex VII of the MDR, in Greece, Ministry of Health is responsible for their compliance as per Article 3 of the Ministerial Decision A4g/88159/2017).

Revocation, Variation, Suspension or Withdrawal

Revocation by EOF or EMA if:

• the product is not placed on the market within three years of authorisation;
• the product is not marketed for a continuous period of three years; or
• if new pharmacovigilance data show an unacceptable risk-benefit ratio.

Modification of a marketing authorisation is applicable if new data on safety or efficacy is discovered.

Temporary suspension is applied in case of unresolved safety issues.

For medical devices, the CE marking certification can be:

• revoked if the device is not placed on the market within three years from the issuance of the certificate;
• suspended or withdrawn if there is an increase in adverse events and the risk level is high; and
• modified if additional safety measures are needed.

Obtaining an Authorisation

Pharmaceuticals

The regulatory process for national marketing authorisation by EOF is outlined in detail in the JM Decision (Article 7 et seq), and it is fully aligned with the centralised process (marketing authorisation from EMA) provided for in the Regulation (EC) No 726/2004. The application for a national marketing authorisation for a medicinal product intended for human use is submitted to EOF.

Medical devices

The manufacturer of medical devices is required to submit all relevant data to the EOF for the identification of these products before they are marketed (including the CE marking and the instructions for use). This requirement is outlined in Article 14 of Joint Ministerial Decision DY8d/130648/2009, Article 10a of Joint Ministerial Decision DY8d/130644/2009, and Article 10 of Joint Ministerial Decision DY8d/3607/892/2001.

The rules regarding conformity assessment and CE marking of medical devices also depend on their classification as category I, category IIa, category IIb and category III medical devices, made-on-order medical devices or active implantable medical devices. In particular, every manufacturer of category I or on-order medical devices that sells in the Greek market under its name or via an authorised representative based in Greece (when the manufacturer’s registered office is outside the EU) is registered in the Register of Manufacturers of the EOF, to affix the CE marking on the medical devices (Article 14 of Joint Ministerial Decision DY8d/130648/2009).

Every manufacturer of category IIa, IIb, and III medical devices, of active implantable medical devices, as well as of in vitro diagnostic medical devices, submits a technical dossier of the products to a Notified Body within the EU, which assesses their compliance with the legal requirements and issues a CE marking certificate (Article 16 and Annex XI of Joint Ministerial Decision DY8d/130648/2009, Article 9 and Annex II of Joint Ministerial Decision DY8d/130644/2009, as well as Article 9 and Annex II of Joint Ministerial Decision DY8d/3607/892/2001).

Variation of an Authorisation

Pharmaceuticals

According to Article 43 of the JM Decision, any changes to an existing marketing authorisation are determined by the EOF. An application providing a specific form that follows the template set by the EMA must be submitted to the EOF to initiate a variation.

Variations are categorised based on their impact on safety, quality, and efficacy, and the process aligns with EU rules for minor and major variations (EU Regulation 1234/2008). Minor changes may require just EOF’s notification (eg, change in labelling – such as a font size change), moderate changes require EOF’s approval before implementation (eg, change of labelling which is linked with safety), major changes necessitate an evaluation before implementation (eg, change in therapeutic indication, formulation).

Medical devices

EOF has not made publicly available a template form to be submitted for variations concerning specifically medical devices; however, based on the rules and guidance provided by EMA,  the following details are expected to be requested:

• device(s) identification and classification;
• name of the device and brief description;
• intended purpose;
• classification;
• serial number;
• manufacturer details;
• notified body details;
• proof of fee paid; and
• details regarding the variation.

Transfer of an Authorisation

Pharmaceuticals

The process involves a joint transfer application to EOF, which includes:

• details about the product concerned
• details about the existing and the new MAH;
• confirmation that there are no changes to the product; and
• description of the pharmacovigilance system.

Medical devices

For medical devices, the rights regarding the CE marking can be transferred by:

• updating the CE certificate holder details with the Notified Body;
• ensuring continued compliance with the MDR and EOF’s guidance by the new holder; and
• updating EOF’s registration regarding the new owner’s details.

Pharmaceuticals

Compassionate use programmes: In Greece, compassionate use programmes are regulated by the Joint Ministerial Decision DYG3(a) 85037/10/2011, which provides early access/ compassionate use of medicinal products which either constitute the subject of a marketing authorisation application before EOF or EMA or are at stage III of clinical trials and more specifically at the stage of analysis of clinical trial data. Conditions are:

• approval by EOF; and
• certification from a doctor of the respective speciality that the existing treatments do not exist.

Two types of programmes may be approved:

• a group early access; and
• an individual early access,
• with a maximum duration of one year for both programmes.

In the first case, the applicant is the applicant for the marketing authorisation before the competent authority or the sponsor of the clinical trial, while in the second case, the applicant is the treating physician.

Emergency and public health exceptions

EOF can authorise a temporary supply of unapproved medicines as follows.

• According to paragraph 5 of Article 8 of Legislative Decree 96/1973, EOF may, in case of a public health emergency, proceed with the import of any pharmaceutical product with no limitations in terms of quantity and quality.
• According to paragraph 6 of Article 8 of Legislative Decree 96/1973, EOF may permit importing unapproved medicinal products in limited quantities and for specific purposes.

Medical Devices

According to Article 59 of the MDR and as per Article 11 paragraph 13 of the Joint Ministerial Decision DY8d/130648/2009, any competent authority (EOF for Greece) may authorise the import of a specific device for which the procedures for placement in the market have not been carried out but the use of which is in the interest of public health or patient safety or health.

Pharmaceuticals

MAH’s ongoing obligations are described in Article 36, 38, 39 and 40 of the JM Decision.

Article 36 of the JM Decision provides that EOF may impose on MAH the obligation to conduct either:

• a post-marketing safety study, if there are issues relating to the risks of a medicinal product; or
• a post-marketing efficacy study when the knowledge of the disease or the clinical methodology suggests that previous efficacy assessments may need a significant revision.

Furthermore, according to Article 38 of the JM Decision, the MAH immediately informs EOF of any prohibition or restriction imposed by the competent authorities of any other country and any new information that might influence the pharmaceutical product’s risk-benefit balance.

Article 39 of the JM Decision provides that the MAH notifies EOF of the exact date of the placement of the medicinal product in the Greek market. The MAH notifies EOF of any discontinuation (temporary or permanent) of commercialisation of the product at least three months before discontinuation.

Article 12A of the Legislative Decree 96/1973 (Government Gazette A’ 172/3/8.8.1973) provides that any MAH  of medicinal products shall ensure the adequate and continuous supply of products to the market in order to meet the needs of patients in Greece.

The electronic submission of individual case safety reports (ICSRs) in the Eudravigilance database is mandatory for MAHs either through the centralised procedure of Regulation 726/2004 or through the national procedure of Directive, as well as for clinical trial sponsors.

Medical Devices

Post-marketing vigilance. The competent authority in Greece, the EOF, has adopted the White Card system. Manufacturers are obliged to report to EOF all serious adverse events taking place in Greece by submitting in English the following two types of reports:

• the Manufacturers Incident Report (MIR) form; and
• the Field Safety Corrective Action (FSCA) form. The following are reportable to EOF:
1. any malfunction or deterioration in the characteristics and/or performance of a product, as well as any deficiency in the labelling or instructions for use, which may cause or have caused the death or serious deterioration in the health of a patient; and
2. any technical or medical event relating to the characteristics or performance of a product which has led to the manufacturer’s systematic withdrawal from the market.

Pending Applications

Third parties have limited access to information in pending marketing authorisation applications. The information included in the application dossier (such as proprietary formulations, clinical trial data, regulatory status or information that might reveal competitive strategies) is not publicly accessible unless there is an overriding public interest in disclosure (Article 81, paragraph 5 of the CTR).

For medical devices, no public registry of pending applications exists.

Granted Authorizations

Pharmaceuticals

The following information becomes public:

• product name & active substance;
• MAH;
• summary of product characteristics;
• public assessment report;
• approval date and therapeutic indications; and
• package leaflet & labelling.

Medical devices

EOF may release basic registration details (eg, name of the manufacturer, general device use, approval date), but full technical documentation remains confidential. Article 20 of the Joint Ministerial Decision DY8d/130648/2009 sets out what is considered non-confidential information. Moreover, the National Electronic Registry of Medical Devices (GREMDIS) can only be accessed if there are dedicated credentials and is not publicly available, while for EUDAMED (the EU medical device database), in order to check for device registration/certifications, specific fields need to be completed (eg, manufacturer; notified body; certificate number and status; risk class; device type, etc).

Refused Authorisations

Pharmaceuticals

EMA publishes details of refused, withdrawn, or suspended authorisations, including the reasons for refusal. Information on national refusals (EOF decisions) is not published but can be obtained upon request.

Medical devices

If a CE certification is refused, the manufacturer is not obligated to disclose it.

Rules on Protecting Commercially Confidential Information and Personal Data

There are confidentiality obligations regarding commercially confidential information (eg, manufacturing processes, regulatory strategies, proprietary research) and the protection of personal data (eg, clinical trial participants’ personal data and individual adverse event reports) as set out in EU legislation (eg, Regulation EU 1049/2001 – Access to EU Documents, 679/2016 GDPR, Regulation EU 1725/2018 for processing of personal data by the Union institutions, bodies, offices and agencies; Directive, etc).

Pharmaceuticals

EMA provides mechanisms such as accelerated assessment (Regulation 726/2004 Article 14 paragraph 9 and Directive) and conditional marketing authorisations (Regulation 726/2004 Article 14a in conjunction with Regulation 507/2006 and Directive) for products that address unmet medical needs or serious conditions. For accelerated assessment, the authorisation application is assessed in 150 days instead of 210 days, and the applicant submits a full set of clinical data and data proving that the medicine is of major interest to public health. 

Conditional marketing authorisation allows approval of the product before full submission of the clinical trial results, provided that the benefit of the immediate availability on the market outweighs the risk when additional data are still required.

Medical Devices

For medical devices, Article 11 paragraph 13 of the Joint Ministerial Decision DY8d/130648/2009 and Article 59 of the MDR provide expedited pathways in specific cases where any competent authority may authorise, on a duly justified request, the placing of a specific device on the market, the use of which is in the interest of public health. EOF may grant temporary emergency use authorisation or national exemption before EU-wide approval.

Pharmaceuticals

EU-based reliance

If a medicine has received a marketing authorisation from EMA, it is automatically valid in all EU member states, including Greece.

If another EU national competent authority grants an authorisation via Mutual Recognition Procedure or Decentralised Procedure, EOF relies on that decision and does not reassess the application dossier.

Non-EU reliance

EOF may consider World Health Organization (WHO) pre-qualification medicines in case of global health emergencies.

EOF does not automatically accept non-EU approvals (eg, FDA, MHRA, etc), however:

• companies can submit foreign regulatory approvals as supportive data;
• EOF may expedite the local review.

Medical Devices

If a device is already CE-certified by an EU Notified Body, EOF does not conduct an additional review. Registration with EOF is still required for local market entry. In general, as per Article 20, paragraph 1 of the MDR, medical devices in conformity with the rules of the MDR bear the CE marking of conformity, which means that they can be marketed in all member states.

EOF does not automatically accept non-EU approvals (eg, FDA), but companies can submit foreign approvals to strengthen applications.

Pharmaceuticals

Manufacturing facilities must obtain a manufacturing 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 manufactured, as well as the place of manufacture;
• ensure suitable and adequate premises, technical 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 manufacturing 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 compliance 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 implementation of a quality system. As per Article 3 of the said decision, among others, the manufacturer of a medical device must have the following 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 distribution 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 Ministerial Decision DY8d/130648/2009.

Manufacturing licenses for pharmaceuticals and medical devices typically remain valid indefinitely, 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 circumstances 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).

Wholesalers must obtain a wholesale license issued by EOF. Application to EOF includes company details, warehouse location, description of storage and handling facilities, list of medicinal products to be handled and responsible person certificate.

Upon evaluation and on-site inspection to verify GDP standards, EOF grants a wholesale license, which gives the right to procure, store, distribute and supply pharmaceuticals/devices to pharmacies and hospitals.

Pharmaceuticals

The Wholesale License is issued for a specific region and is valid for five years. If MAH or its local representative has a manufacturing license, no wholesale license is needed to distribute and sell products.

The conditions for granting a wholesale license are outlined in Article 105 of the JM Decision and the Presidential Decrees 194/1995 and 88/2004.

According to Article 105 of JM Decision, the applicant must:

• have appropriate and sufficient premises and equipment;
• employ staff, including a qualified person (QP) who meets the requirements set forth in the applicable legislation;
• fulfil the obligations outlined in Article 106 of JM Decision; and
• satisfy the remaining conditions of Presidential Decree 88/2004, “Organization and Operating Specifications of a Pharmaceutical Warehouse.”

Medical Devices

For medical devices, the validity period is not explicitly set under MDR/IVDR, but compliance with regulations is continuously monitored, and EOF may revoke the authorisation if the wholesaler fails to comply with regulatory obligations. Any certification which verifies compliance with regulatory standards must be renewed every three years.

The classifications are described in the Directive (Directive Title VI), national laws (3457/2006 & 3816/2010), and JM Decision (Article 95). According to Article 70 of the Directive and Article 95 of the abovementioned Decision, pharmaceuticals are classified as:

• a pharmaceutical subject to medical prescription; and
• a pharmaceutical not subject to medical prescription.

Based on the above, in Greece, the classification of pharmaceuticals is as follows:

• Prescription-only medicines (POM) require a prescription from a licensed healthcare professional and are dispensed in pharmacies. Furthermore, according to Directive Article 70 paragraph 2, EOF has to classify further when labelling the following pharmaceuticals:
1. pharmaceuticals subject to a medical prescription;
2. pharmaceuticals subject to special medical prescription; and
3. pharmaceuticals subject to a “restricted” medical prescription reserved for use in hospitals.
• Over-the-counter (OTC) medicines can be purchased without a prescription. Regulated under EOF guidelines and still subject to quality & safety controls.

Pharmaceuticals

Directive 2001/83 (IV Section) along with the JM Decision and EU Directive 2011/62 along with Joint Ministerial Decision D3(α)41169/19/8-7-2020 (for the prevention of the entry into the legal supply chain of falsified medicinal products) set out the rules for importation and exportation of pharmaceuticals.

Medical Devices

MDR is the legal framework for importing and exporting medical devices, while IVDR is the legal framework for in vitro diagnostic medical devices.

Competent Bodies

• EOF is the competent authority.
• To ensure an adequate supply of products in the market, the EOF has banned the export of certain medicines. Additionally, through Circular No 66718/2011, the EOF requires wholesalers to submit monthly intra-EU export data. In line with this, the Greek Customs Code (Law 2960/2001) and the EU Customs Code (Regulation (EU) No 952/2013) have introduced a monitoring system, as outlined in Circular No 24151/2012, to track the domestic distribution of pharmaceuticals at the customer level for all wholesalers.
• In response to COVID-19 supply chain challenges, EOF, in coordination with EMA, imposed temporary bans on parallel exports and intra-EU distribution.
• Greek Customs Authority (Independent Authority for Public Revenue – AADE):
1. controls import duties, VAT, and customs clearance;
2. works with EOF to intercept counterfeit or illegal imports; and
3. ensures compliance with tariff codes and EU single market rules.

In Greece, an importer can be:

• a MAH;
• manufacturers with import licenses (if importing their own products); and
• licensed wholesale distributors of medicines and medical devices.

IFET (the national Greek public wholesaler) handles the import of medicines that are not commercially available in Greece and require special approval for pharmacies and hospitals

Pharmaceuticals

According to the JM Decision (Government Gazette B’ 1049/29-04-2013), which aligns Greek law with the Directive, an importation licence from EOF is required. Obtaining the licence requires filing an application, which must include the specific medicines to be imported, the place of their production, the relevant premises, technical equipment, and control capabilities for the importation process. Additionally, the application must designate at least one qualified individual responsible for these activities, as outlined in the aforementioned Ministerial Decision.

Key requirements:

• Import Permit by EOF for controlled substances (pharmaceuticals containing narcotics);
• Wholesale Distribution Authorisation from EOF;
• Marketing Authorisation or Parallel Import License; and
• Customs Registration & VAT Compliance (AADE & Greek Customs Authority).

Medical Devices

According to guidance issued by EOF, importers of medical devices are required to notify their details to the National Electronic Registry of Medical Devices GREMDIS. Required documents are:

• CE Marking Certificate (for high-risk medical devices) or certificate of the competent authority of the EU Member State where the products were registered (for low-risk Categories);
• manufacturer’s Declaration of Conformity;
• outer packaging;
• and
• instructions for use.

Key requirements:

• registration with EOF as an importer;
• CE Marking & Declaration of Conformity from the manufacturer
• quality compliance certification (eg, ISO 13485); and
• Customs and VAT Registration (AADE & Greek Customs Authority).

In Greece, the importation of pharmaceuticals and medical devices requires prior authorisation from the National Organization for Medicines (EOF). Import licenses are necessary only for products brought in from non-EU countries. This is in accordance with the EOF Circular on the Import and Distribution of Pharmaceuticals (EG-18013-2013) and the regulation allowing the free movement of goods within the EU (DYG 3a 82161/12, Article 40).

Importation of Pharmaceuticals

According to the JM Decision (Government Gazette B’ 1049/29-04-2013), an importation license from EOF is required as follows.

• Import Capability License:
1. company application with requested forms;
2. operating license from Authorities;
3. layout of required spaces; and
4. list of microbiological/chemical lab instruments (if self-testing).
• Pharmaceutical Product Import License:
1. application specifying manufacturer, packaging, control site, origin, formulation, strength, and packaging;
2. Import Capability License for the requested form;
3. marketing authorisation; and
4. GMP Certificate issued by an EU/EEA Authority for the product or manufacturer.

Importation of Medical Devices

Distinction between based on CE mark:

• CE-Marked Medical/In Vitro Diagnostic Devices (MDR/IVDR compliant); the importer must be registered with EOF; and
• 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 requirements 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 Medical Devices GREMDIS of their details. Required documents are:

• CE Marking Certificate (for higher-risk medical 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;
• outer packaging; and
• instructions for use.

Exceptions

Personal use

Patients can import small quantities of prescription medicines for personal use, but the provision of the doctor’s prescription and patient declaration to customs is mandatory.

Emergency public health situations

During pandemics, disasters, or shortages, pharmaceutical products may be imported following a decision of EOF (Paragraph 5 of Article 8 of Legislative Decree 96/1973)

Named patient programmes & compassionate use

Importation of unapproved medicines for individual patients or for a group of patients following EOF decision. For individual patients, the treating physician proposes (and EOF issues) an individual decision. 

In Greece, non-tariff regulations and restrictions on the importation of pharmaceuticals and medical devices are imposed based on their regulatory category and classification under the Combined 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 (Regulation (EU) No 952/2013), provides that if the pharmaceutical product or the medical device meets the requirements of the applicable legislation for its manufacturing and production, it may be imported into Greece or any other European jurisdiction.

Pharmaceuticals, governed by Directive, implemented in Greece through JM Decision, require authorisation from the EOF. Products must meet provided qualitative and quantitative composition 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 restrictions are outline below.

• Greek Customs Code (Law 2960/2001) – Establishes the general import framework.
• EU Customs Code (Regulation (EU) No 952/2013) – Sets import procedures across the EU.
• Directive & JM Decision – Regulates pharmaceutical imports.
• MDR & IVDR – control medical device imports.

Greece is a member of the European Union (EU), which operates as a trade bloc and has established multiple Free Trade Agreements (FTAs) and Mutual Recognition Agreements (MRAs) with third countries.

The EU’s FTAs with Japan (EPA), South Korea, and the UK (TCA) provide duty-free access for pharmaceutical exports, eliminating tariffs entirely. In the case of the FTA with Canada (CETA), 99% of tariffs on pharmaceuticals have been abolished. The EU also has an FTA with Switzerland, where pharmaceutical trade benefits from tariff-free movement due to Switzerland’s participation in the EU Single Market. Once ratified, the pending EU-MERCOSUR trade agreement is expected to bring tariff reductions for pharmaceutical exports.

As a member of the World Trade Organization (WTO) since 1995, Greece adheres to global trade rules that promote transparency, fair market access, and lower trade restrictions. Its participation in the WTO FTA reduces shipping times and administrative costs, which benefits pharmaceutical exports.

Mutual Recognition Agreements (MRAs) with Canada, Switzerland and the UK facilitate market access by eliminating duplicate testing, expediting regulatory approvals, and accelerating entry into highly regulated markets.

Pharmaceuticals

According to Legislative Decree 96/1973 and Ministerial Decisions D3(a)/6295/2024 and D3(a) 59308/2024, the maximum prices for prescription-only medicinal products – specifically the retail price, wholesale price, hospital sale price, and ex-factory price – are determined using Price Bulletins issued by the Minister of Health. This process follows a proposal by the EOF, as stated in Article 17 of Legislative Decree 96/1973 (Government Gazette A’ 172/3/8.8.1973), and requires an application from the Marketing Authorization Holder (MAH). OTC medicinal products are excluded from this pricing structure.

Original medicinal products are priced in accordance with a median of the two lowest prices of the two Member States of the Eurozone. The same applies to off-patent medicinal products (original products following the expiration of their market exclusivity). Generic products are priced at 65% of the original product’s price, while biosimilars are priced using the same method as their originals (the two lowest prices in the Eurozone). Non-prescribed pharmaceutical products (OTC) are priced in accordance with a median of three lowest prices of three EU Member States, and this price is indicative for pharmacies but mandatory for sales to hospitals. The final price of all the above categories of products is the ex-factory price on which the wholesale margin and the retail margin are added when the product is sold through a pharmacy. When the products are sold to a hospital, the ex-factory price is reduced by 8.74%.

Medical Devices

There is no legislation in Greece controlling their prices. EOPYY (National Organization for Health Care Services) sets maximum reimbursement limits for certain categories of devices. Prices are primarily controlled through hospital tenders and reimbursement policies rather than direct price caps.

Pharmaceuticals

Original medicinal products are priced in accordance with a median of the two lowest prices of the two Member States of the Eurozone.

The same applies to off-patent medicinal products (original products following the expiration of their market exclusivity).

Generic products are priced at 65% of the original product’s price, while biosimilars are priced with the same method as their originals (the two lowest prices in the Eurozone).

OTCs are priced in accordance with a median of the three lowest prices of the three EU Member States. This price is not obligatory for the retail channel (pharmacies) but is mandatory when sales are made to public hospitals.

Medical Devices

For medical devices, Greek legislation does not explicitly tie their price to other countries under general pricing rules but relies on EOPYY reimbursement rules considering costs across the EU.

Pharmaceuticals

According to Article 1 (paragraph 2) of Law 3457/2006 (Government Gazette Α 93/8.5.2006), the medicinal products that are classified as OTC are not reimbursed by social security funds. The reimbursement rules regarding prescription-only products are contained in Article 12 of Law 3816/2010 (Government Gazette Α’ 6/26.01.2010), as well as in Article 247 et seq of Law 4512/2018 (Government Gazette Α’ 5/17.01.2018).

For the latter products to be reimbursed, they need to be approved on the positive list of reimbursed products (Article 12 of Law 3816/2010). The inclusion of a medicinal product requires a Decision of the Minister of Health, following the opinion of the Committee for the Evaluation and Reimbursement of Medicinal Products for Human Use (Evaluation Committee – Article 247 of Law 4512/2018), which opinion is issued following an application from the MAH.

The Evaluation Committee, in order to evaluate the cost-effectiveness ratio and the impact on the state budget, refers for an opinion to the Drug Price Negotiation Committee (Negotiation Committee) and is responsible for negotiating the prices or discounts of medicinal products which are going to be reimbursed (and often concludes separate agreements including further discounts).

The Negotiation Committee initiates and concludes the negotiation process for the medicinal product by issuing a justified opinion. The Evaluation Committee takes into account the justified opinion of the Negotiation Committee for its final opinion.

Medical Devices

The reimbursement of medical devices is regulated under Article 108 of Law 4461/2017 (Government Gazette Α’ 38/28.03.2017). In particular, for the reimbursement of medical devices for special medical purposes (FSMPs), the importer/manufacturer/representative of these products must submit to EOPYY a declaration stating that:

• the items are registered in the registers of EOF and in the registers of reimbursable products of EOPYY if the product is registered in the latter; and
• that the product is marketed in at least three countries of the European Union.

The reimbursement price of the product is determined by a maximum of the average of the three lowest prices in the countries of the European Union.

In Greece, Health Technology Assessment (HTA) plays a significant role in reimbursing pharmaceuticals and medical devices.

Currently, the country has established the Committee for Assessment and Reimbursement of Medicines for Human Use, effectively functioning as an HTA body, which evaluates new products as follows (Article 245 of Law 4512/2018):

• clinical benefit – assessing the therapeutic value and efficacy of the medicine;
• comparison with existing therapies – evaluating how the new medicine compares to treatments already available and reimbursed;
• data reliability – ensuring the robustness and credibility of the submitted clinical and economic data;
• cost-effectiveness – analysing the economic value of the medicine in relation to its therapeutic benefits; and
• budget impact – estimating the financial implications of including the medicine in the reimbursement list.

The assessment process begins with the MAH submitting a dossier. For products receiving a positive initial assessment, the Pricing Negotiation Committee (as per Article 254 of Law 4512/2018) evaluates their budget impact and negotiates pricing and discounts with the MAH. 

Prescription and Dispensing by Physicians

According to Law 3892/2010, physicians are required to issue prescriptions through the Electronic Prescription System, a centralised platform managed by IDIKA SA (e-Government Center for Social Security Services). IDIKA S.A. maintains a database of all insured individuals in all social insurance funds based on the unified Social Security Registry Number (AMKA Registry). This system monitors prescribing practices and ensures compliance with national guidelines.

According to the provisions of Laws 4052/2012 and 4093/2012, doctors must prescribe exclusively based on the active substance’s International Nonproprietary Name (INN). Doctors are required to select the appropriate medication in compliance with the therapeutic protocols of EOF. Also, physicians are legally obligated not to exceed prescription limits for patients.

Pharmacy Sales

Pharmacies, according to law 4316/2014, are required to dispense the pharmaceutical product with the lowest retail price for each active substance from the drugs listed in the positive list unless the consumer insists on a brand-name drug and pays the price difference in addition to a co-payment which is typically 0%-25% of the drug cost.

Also, pharmacies are linked to the national e-prescription system, ensuring real-time tracking.

Law 4052/2012, as amended, provides for a claw-back mechanism imposing a specific budget for pharmaceutical sales to public healthcare entities. As a result, any amount exceeding the budget is recovered by the payors from the MAHs of pharmaceutical products.