New Framework in Greece to Combat Falsified Medicines and Protect Public Health
New Framework in Greece to Combat Falsified Medicines and Protect Public Health
March 2025
Irene Kyriakides, Partner, Victoria Mertikopoulou, Partner, Aithra Antoniadou, Associate, and Anastasia Iliopoulou, Associate
Kyriakides Georgopoulos Law Firm
Background
The rise of falsified medicines in the European Union presents a serious threat to public health. These counterfeit drugs may have incorrect packaging, labeling, or ingredients — or even falsified distribution records making their way into the market not just through illegal channels but also within the legal supply chain.
To enhance safeguards, the EU introduced Commission Delegated Regulation (EU) 2016/161 (“Regulation”), setting stringent safety feature requirements for medicinal packaging.
New Regulations in Greece
With the February 9th, 2025 deadline for implementing the Regulation, Greece has introduced Ministerial Decision Δ3(α) 6030 (ΦΕΚ 407 B’ 07.02.2025), amending existing laws [Joint Ministerial Decision Δ.ΥΓ3α/Γ.Π. 32221/29.4.2013 (ΦΕΚ 1049 B’ 29.04.2013)] governing the manufacturing and circulation of medicinal products. These new provisions, effective from 9 February 2025, strengthen safety measures to ensure alignment with EU standards.
Scope
Medicinal products marketed in Greece must now comply with the EU’s safety feature requirements:
- Prescription medicines must bear safety features unless excluded by relevant EU catalogs.
- Over-the-counter (OTC) medicines are generally exempt unless specifically included due to a high risk of falsification.
- Reimbursed medicines (whether prescription or OTC) must include safety features.
Key Changes
(a) Labeling Requirements
Medicines must now display their legal status regarding prescription requirements and include a recycling mark on the outer packaging.
Notably, the obligation to indicate the product’s price on the label has been abolished.
(b) Enhanced Safety Features on Packaging
To strengthen security, medicines covered by the new regulations (see above under the section “Scope”) must include verifiable safety features, allowing wholesalers and suppliers to confirm authenticity and detect tampering.
OTC medicines will now carry the unique National Medicinal Product Identification Number (“EOF Unique Code”) printed on their outer packaging in both human-readable format and barcode. By 8 August 2025, all OTC medicines must display an authenticity strip with the EOF Unique Code.
In addition, medicines procured by public hospitals and institutions must bear the label “STATE PRODUCT” («ΚΡΑΤΙΚΟ ΕΙΔΟΣ»), while those distributed within private clinic pharmacies must be marked “PHARMACY OF A PRIVATE CLINIC” («ΦΑΡΜΑΚΕΙΟ ΙΔ. ΚΛΙΝΙΚΗΣ»).
(c) Repackaging and Safety Features Replacement
Repackaging of medicinal products will be allowed only under strict conditions. Before removing or covering safety features, the Marketing Authorization Holder (“MAH”) must verify the identification product’s and authenticity comply with and good manufacturing practice, under EOF’s supervision.
Replacement of safety features is possible if the replacing safety features are considered equivalent, i.e., if they meet the requirements set out in the Regulation and are equally effective for verifying the authenticity and identification of medicinal products, as well as for providing evidence of falsification of the medicinal product.
(d) Market Monitoring and Risk Assessment
EOF, being interconnected with the Hellenic Medicines Verification Organization (“HMVO”) according to Joint Ministerial Decision Δ3(α) 41169/19/2020 (GG 6124 Β’ 31.12.2020), closely monitors the pharmaceutical market through the Hellenic Medicines Verification System (“HMVS”) for the purposes of tracking falsification risks, overseeing compliance, and supporting pharmacovigilance efforts.
Additionally, EOF will conduct risk assessments to prevent falsification based on several factors, including product price, sales volume, past falsification incidents, the severity of diseases treated, and potential public health risks. These evaluations will help determine which products require additional safety measures.
(e) Obligations for wholesalers
Wholesalers must now verify the authenticity of medicinal products by checking their safety features before distribution. Additionally, wholesalers must decommission the EOF Unique Code before supplying certain institutions, such as veterinary clinics, prisons, schools, nursing homes, and other authorized entities.
In light of the aforementioned obligations, EOF recently issued the Circular under no. 21036/20.02.2025 outlining the following implementation measures:
- For medicinal products that either bear safety features or are exempt from them, specifically for those that will no longer bear authenticity stripes, a new electronic system was introduced on 27.02.2025. This system facilitates the submission and monitoring of data related to these medicinal products intended for intra-Community distribution and exports via EOF’s online portal.
- For medicinal products packaging that continues to bear an authenticity stripe and is subject to intra-Community distribution or export, the applicable provisions and obligations on authenticity stripes, including the deactivation of the serial numbering of the authenticity stripes, remain in force.
- For medicinal products packaging that includes both safety features and an authenticity stripe, only the authenticity stripe shall be deactivated in the EOF system.
Therefore, all wholesalers involved in intraCommunity distribution and/or exports of medicinal products, whether they bear safety features or are exempt from them, must report the following information in real time through the designated system on the EOF portal, under the section “Authenticity Stripe Inventory System – Intra-Community Distribution and Exports”, before proceeding with distribution or export:
- The National Medicinal Identification Number (barcode);
- The quantity in packaging units;
- The batch number;
- The batch expiration date;
- The destination country.
(f) Penalties for Non-Compliance
Possession of medicines with deactivated safety features is now prohibited to all participants in the supply chain of medicinal products, unless explicitly permitted under the law. Violators may face penalties of up to EUR 44,000.00 along with potential confiscation of medicinal products, subject to EOF’s discretion.
Conclusions
Greece’s new legislation marks a major leap forward in the fight against falsified medicines, enhancing patient safety and reinforcing regulatory oversight. By aligning with EU standards, these measures guarantee that any medicine — prescription or OTC — is fully traceable and verifiable, minimizing the risk of counterfeit products reaching consumers.
March 2025
Irene Kyriakides, Partner, Victoria Mertikopoulou, Partner, Aithra Antoniadou, Associate, and Anastasia Iliopoulou, Associate
Kyriakides Georgopoulos Law Firm
Background
The rise of falsified medicines in the European Union presents a serious threat to public health. These counterfeit drugs may have incorrect packaging, labeling, or ingredients — or even falsified distribution records making their way into the market not just through illegal channels but also within the legal supply chain.
To enhance safeguards, the EU introduced Commission Delegated Regulation (EU) 2016/161 (“Regulation”), setting stringent safety feature requirements for medicinal packaging.
New Regulations in Greece
With the February 9th, 2025 deadline for implementing the Regulation, Greece has introduced Ministerial Decision Δ3(α) 6030 (ΦΕΚ 407 B’ 07.02.2025), amending existing laws [Joint Ministerial Decision Δ.ΥΓ3α/Γ.Π. 32221/29.4.2013 (ΦΕΚ 1049 B’ 29.04.2013)] governing the manufacturing and circulation of medicinal products. These new provisions, effective from 9 February 2025, strengthen safety measures to ensure alignment with EU standards.
Scope
Medicinal products marketed in Greece must now comply with the EU’s safety feature requirements:
- Prescription medicines must bear safety features unless excluded by relevant EU catalogs.
- Over-the-counter (OTC) medicines are generally exempt unless specifically included due to a high risk of falsification.
- Reimbursed medicines (whether prescription or OTC) must include safety features.
Key Changes
(a) Labeling Requirements
Medicines must now display their legal status regarding prescription requirements and include a recycling mark on the outer packaging.
Notably, the obligation to indicate the product’s price on the label has been abolished.
(b) Enhanced Safety Features on Packaging
To strengthen security, medicines covered by the new regulations (see above under the section “Scope”) must include verifiable safety features, allowing wholesalers and suppliers to confirm authenticity and detect tampering.
OTC medicines will now carry the unique National Medicinal Product Identification Number (“EOF Unique Code”) printed on their outer packaging in both human-readable format and barcode. By 8 August 2025, all OTC medicines must display an authenticity strip with the EOF Unique Code.
In addition, medicines procured by public hospitals and institutions must bear the label “STATE PRODUCT” («ΚΡΑΤΙΚΟ ΕΙΔΟΣ»), while those distributed within private clinic pharmacies must be marked “PHARMACY OF A PRIVATE CLINIC” («ΦΑΡΜΑΚΕΙΟ ΙΔ. ΚΛΙΝΙΚΗΣ»).
(c) Repackaging and Safety Features Replacement
Repackaging of medicinal products will be allowed only under strict conditions. Before removing or covering safety features, the Marketing Authorization Holder (“MAH”) must verify the identification product’s and authenticity comply with and good manufacturing practice, under EOF’s supervision.
Replacement of safety features is possible if the replacing safety features are considered equivalent, i.e., if they meet the requirements set out in the Regulation and are equally effective for verifying the authenticity and identification of medicinal products, as well as for providing evidence of falsification of the medicinal product.
(d) Market Monitoring and Risk Assessment
EOF, being interconnected with the Hellenic Medicines Verification Organization (“HMVO”) according to Joint Ministerial Decision Δ3(α) 41169/19/2020 (GG 6124 Β’ 31.12.2020), closely monitors the pharmaceutical market through the Hellenic Medicines Verification System (“HMVS”) for the purposes of tracking falsification risks, overseeing compliance, and supporting pharmacovigilance efforts.
Additionally, EOF will conduct risk assessments to prevent falsification based on several factors, including product price, sales volume, past falsification incidents, the severity of diseases treated, and potential public health risks. These evaluations will help determine which products require additional safety measures.
(e) Obligations for wholesalers
Wholesalers must now verify the authenticity of medicinal products by checking their safety features before distribution. Additionally, wholesalers must decommission the EOF Unique Code before supplying certain institutions, such as veterinary clinics, prisons, schools, nursing homes, and other authorized entities.
In light of the aforementioned obligations, EOF recently issued the Circular under no. 21036/20.02.2025 outlining the following implementation measures:
- For medicinal products that either bear safety features or are exempt from them, specifically for those that will no longer bear authenticity stripes, a new electronic system was introduced on 27.02.2025. This system facilitates the submission and monitoring of data related to these medicinal products intended for intra-Community distribution and exports via EOF’s online portal.
- For medicinal products packaging that continues to bear an authenticity stripe and is subject to intra-Community distribution or export, the applicable provisions and obligations on authenticity stripes, including the deactivation of the serial numbering of the authenticity stripes, remain in force.
- For medicinal products packaging that includes both safety features and an authenticity stripe, only the authenticity stripe shall be deactivated in the EOF system.
Therefore, all wholesalers involved in intraCommunity distribution and/or exports of medicinal products, whether they bear safety features or are exempt from them, must report the following information in real time through the designated system on the EOF portal, under the section “Authenticity Stripe Inventory System – Intra-Community Distribution and Exports”, before proceeding with distribution or export:
- The National Medicinal Identification Number (barcode);
- The quantity in packaging units;
- The batch number;
- The batch expiration date;
- The destination country.
(f) Penalties for Non-Compliance
Possession of medicines with deactivated safety features is now prohibited to all participants in the supply chain of medicinal products, unless explicitly permitted under the law. Violators may face penalties of up to EUR 44,000.00 along with potential confiscation of medicinal products, subject to EOF’s discretion.
Conclusions
Greece’s new legislation marks a major leap forward in the fight against falsified medicines, enhancing patient safety and reinforcing regulatory oversight. By aligning with EU standards, these measures guarantee that any medicine — prescription or OTC — is fully traceable and verifiable, minimizing the risk of counterfeit products reaching consumers.
