The Pharma Legal Handbook: Greece

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 total amount of due claims held by –among others- pharmaceutical companies and medical devices suppliers against EOPYY. The “rebate practice” allowed EOPYY to redeem long outstanding debts to pharmaceutical companies and other stakeholders of the industry by way of imposing significant discounts (ranging from 5% to 25%) on the total amount thereof. The legality of the different kinds of rebates adopted until today has been sanctioned by the Council of State and the recent provision is indeed indicative of a practice that has already become a permanent feature of the pharmaceutical and medical devices markets in Greece.

B. A new law on trademarks in application of Directive (EU) 2015/2436 is expected to be published soon. Said law, which will replace specific trademark – related provisions of Law 4072/2012 currently in force, has recently been put to public consultation. The new law will introduce novel types of trade- marks, such as the shape or packaging of goods, and even sounds and slogans under specific conditions; the fees relevant to the various procedures before the General Secretariat of Commerce will also be increased under the new law.

In addition, the draft law introduces two important innovations; namely:

1. The right of intervention of the proprietor of a later registered trade mark as defense in infringement proceedings and
2. The registration of guarantee or certification marks; this type of trademark is capable of distinguishing goods or services which are certified by the pro- prietor of the mark with respect to a specific material, mode of manufacture of goods or performance of services, quality, accuracy or other characteristics, from non – certified goods and /or services.

 

2. When are they likely to come into force?

A. Law 4578/2018 on the “Reduction of the social security contributions and other provisions” entered into force on 03.12.2018.
B. The new law on trademarks is expected to be published soon after the clo- sure of the public consultation, i.e. 25.01.2019.

 

Also from this Legal Handbook

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, possession, transport, storage and supply of the raw materials and substances derived from Cannabis Sativa L varieties with a tetrahydrocannabinol (THC) content of more than 0.2%. Authorization may equally be obtained for the installation and operation of a processing and production unit of final products of medicinal cannabis for the sole purpose of either supplying the state monopoly in view of their disposal for medical purposes or their export. Implementing Ministerial Decision Δ3(γ)52588 Government Gazette Β 2840 2018 on the Terms and Requirements for the production and marketing of final products of medicinal cannabis, provides for the particular approval procedure applicable to the marketing authorization, as well as the export or import of final products of medicinal cannabis, Final products are strictly defined in Article 2 of said Ministerial Decision as a product containing as its sole active substance, for the indications specifically and restrictively provided in article 4 of the same, a derivative of Cannabis Sativa L varieties with a tetrahydrocannabinol (THC) content of more than 0.2%, falling within the scope of L. 4523/2018.

 

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

Par. 9 of article 2A Law 4139/2013 provides for the jurisdiction of EOF regarding all matters related to the production and marketing authorization of the final products of medicinal cannabis derived from Sativa L varieties with a tetrahydrocannabinol (THC) content of more than 0.2%. The Ministry of Health retains, of course, jurisdiction over narcotics by virtue of the same law, which makes it the competent authority as regards imports of cannabinoid drugs.

 

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

Par. 9 of article 2A Law 4139/2013 provides for the application of all provisions relevant to the requirements and procedure of obtaining marketing authorization for pharmaceutical products in force as regards the production and marketing of the final products of medicinal cannabis; the above-mentioned implementing Ministerial Decision Δ3(γ)52588 Government Gazette Β 2840 2018 on the Terms and Requirements for the production and marketing of final products of medicinal cannabis specifies marketing authorization requirements for final products of medicinal cannabis, as strictly defined therein.

 

4. Which are the cannabinoid drugs that have received market approval to date?

No cannabinoid drug has received market approval by EOF yet. The Greek Ministry of Health recently approved the import of specific quantities of Sativex for the needs of the State Monopoly of Narcotics.

 

5. Who can prescribe Cannabinoid Drugs?

No exception has been provided as regards the prescription of Cannabinoid Drugs, which are regarded as medicines as far as authorization and marketing requirements are concerned; no legal basis, therefore, exists for their prescription by any other than medical doctors.

 

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

No list of doctors specifically authorized to prescribe Cannabinoid Drugs exists under Greek law.

 

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

No specific provisions related to the prescription procedure of Cannabinoid Drugs have been adopted under Greek law.

 

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

No specific provisions related to the sale and distribution of authorized Cannabinoid Drugs have yet been adopted; as is the case of all prescription medicines, Cannabinoid Drugs may be sold / distributed through pharmacies, hospitals or private clinics.

 

9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?

No specific list of authorized retailers/ distributors of Cannabinoid Drugs exists.

 

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

No specific proposals under examination have been announced, but the regulatory framework has plenty of scope to develop as the newly-adopted provisions relevant to the possibility of production, possession, transport, storage and supply of the raw materials and substances derived from Cannabis Sativa L varieties with a tetrahydrocannabinol (THC) content of more than 0.2%, as well as of production of final products based on the substance count no more than a few months’ implementation.

 

11. When are they likely to come into force?

N/A.

 

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the 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, possession, transport, storage and supply of the raw materials and substances derived from Cannabis Sativa L varieties with a tetrahydrocannabinol (THC) content of more than 0.2%. Authorization may equally be obtained for the installation and operation of a processing and production unit of final products of medicinal cannabis for the sole purpose of either supplying the state monopoly in view of their disposal for medical purposes or their export. Implementing Ministerial Decision Δ3(γ)52588 Government Gazette Β 2840 2018 on the Terms and Requirements for the production and marketing of final products of medicinal cannabis, provides for the particular approval procedure applicable to the marketing authorization, as well as the export or import of final products of medicinal cannabis, Final products are strictly defined in Article 2 of said Ministerial Decision as a product containing as its sole active substance, for the indications specifically and restrictively provided in article 4 of the same, a derivative of Cannabis Sativa L varieties with a tetrahydrocannabinol (THC) content of more than 0.2%, falling within the scope of L. 4523/2018.

 

13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?

Par. 9 of article 2A Law 4139/2013 provides for the jurisdiction of EOF regarding all matters related to the production and marketing authorization of the final products of medicinal cannabis derived from Sativa L varieties with a tetrahydrocannabinol (THC) content of more than 0.2%. The Ministry of Health has general jurisdiction over narcotics by virtue of the same law, which makes it the competent authority as regards imports of medicinal cannabis.

 

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

Par. 9 of article 2A Law 4139/2013 provides for the application of all provisions relevant to the requirements and procedure of obtaining marketing authorization for pharmaceutical products in force as regards the production and marketing of medicinal cannabis; an implementing decision by the Minister of Health following an opinion by the President of EOF specifying marketing authorization requirements is announced by virtue of the same but still pending.

 

15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

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, possession, transport, storage and supply of the raw materials and substances derived from Cannabis Sativa L varieties with a tetrahydrocannabinol (THC) content of more than 0.2%. Authorization may equally be obtained for the installation and operation of a processing and production unit of final products of medicinal cannabis for the sole purpose of either supplying the state monopoly in view of their disposal for medical purposes or their export. Said authorization is provided by virtue of an Interministerial Decision by the Minister of Finance and Development, the Minister of Health and the Minister of Rural Development and Food. Implementing Ministerial Decision Δ3(γ)52588 Government Gazette Β 2840 2018 on the Terms and Requirements for the production and marketing of final products of medicinal cannabis, provides for the particular approval procedure applicable to the marketing authorization, as well as the export or import of final products of medicinal cannabis, Final products are strictly defined in Article 2 of said Ministerial Decision as a product containing as its sole active substance, for the indications specifically and restrictively provided in article 4 of the same, a derivative of Cannabis Sativa L varieties with a tetrahydrocannabinol (THC) content of more than 0.2%, falling within the scope of L. 4523/2018. All matters related to the production and marketing authorization of the final products of medicinal cannabis fall within the jurisdiction of EOF, while the Ministry of Health having general jurisdiction over narcotics is the competent authority as regards imports of medicinal cannabis.

 

16. What approval or notifications are necessary to produce or import Medicinal Cannabis?

Implementing Interministerial Decision 51483/700/Government Gazette Β 1692 2018 on the Terms and requirements of the cultivation and processing of medicinal cannabis, provides for the specific procedure of obtaining approval, encompassing all aspects of the processing and exploitation related to the product, i.e. the single authorization for the production, possession, transport, storage, supply of raw materials and the derivative substances of Cannabis Sativa L varieties with a tetrahydrocannabinol (THC) content of more than 0.2%, the production, the import and trade of propagating material, as well as the establishment and the operation of a processing and production unit with the exclusive purpose of either the supply of the state monopoly or the disposal of final products for medicinal purposes or their export.

In order to obtain approval for the establishment of a processing and production unit, the interested party first submits its answers to the questionnaire contained in Annex I of the Interministerial Decision to the Business and Business Parks Licensing Division of the General Secretariat of Industry of the Ministry of Finance and Development; the latter must, within three (3) working days, present the interested party with a list of documents among those listed in the Interministerial Decision, required in view of the establishment and the operation of the processing and production unit under examination. The single authorization is granted by virtue of an Interministerial Decision by the Minister of Finance and Development, the Minister of Health and the Minister of Rural Development and Food within thirty (30) days of the submission of the supporting file and is issued for a validity period of five (5) years. Within fifteen (15) days of the issuance of the authorization, an on-site control of the premises is held by the Business and Business Parks Licensing Division; in case of any deviations with respect to the questionnaire and the associated supporting file, a deadline is set for the unit operator to comply with requirements; in case compliance is not possible, the authorization is revoked. The documents compiled in the supporting file of the authorization must be updated annually and submitted by 31th December of each year following the issuance of the authorization and throughout its validity period.

The Public Security Division of the Hellenic Police Headquarters is competent for the supervision and coordination of all other Hellenic Police Departments as regards safety-related matters, of both unit installations and the transport of finished products.

 

17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

Par. 9 of article 2A Law 4139/2013 provides for the application of all provisions relevant to the requirements and procedure of obtaining marketing authorization for pharmaceutical products in force as regards the production and marketing of medicinal cannabis; the above-mentioned implementing Ministerial Decision Δ3(γ)52588 Government Gazette Β 2840 2018 on the Terms and Requirements for the production and marketing of final products of medicinal cannabis specifies marketing authorization requirements for final products of medicinal cannabis, as strictly defined therein.

 

18. How can patients obtain Medicinal Cannabis?

Patients may obtain Medicinal Cannabis following prescription by a Medical Doctor.

 

19. Who can prescribe Medicinal Cannabis?

No exception has been provided as regards the prescription of Medicinal Cannabis as opposed to medicines in general; no legal basis, therefore, exists for its prescription by any other than medical doctors.

 

20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

No list of doctors specifically authorized to prescribe Medicinal Cannabis has yet been created nor is such a prospect under examination to our knowledge.

 

21. What approvals or notifications are required to prescribe Medicinal Cannabis?

No approvals or notifications are required in order to prescribe Medicinal Cannabis; possession of a license to exercise the medical profession in Greece is the sole prerequisite, as is the case regarding all medicines marketed in Greece.

 

22. Where is Medicinal Cannabis available?

Medicinal Cannabis is only available through pharmacies, as are all prescription drugs under Greek law.

 

23. Is there a list of retailers authorized to sell Medicinal Cannabis?

No, Medicinal Cannabis is only available to the public through pharmacies.

 

24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?

No specific proposals under examination have been announced, but the regulatory framework has plenty of scope to develop as the newly-adopted provisions relevant to the possibility of production, possession, transport, storage and supply of the raw materials and substances derived from Cannabis Sativa L varieties with a tetrahydrocannabinol (THC) content of more than 0.2%, as well as of production of final products based on the substance count no more than a few months’ implementation.

 

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

Opioid Drugs are regarded as narcotics falling within the scope of Law 4139/2013. They may be prescribed either in the form of pharmaceutical preparations or proprietary medicinal products under the conditions and following the procedure provided by virtue of specific Decisions by the Minister of Health following an opinion by the Narcotics Board.

 

26. What are the regulatory authorities with jurisdiction over Opioid Drugs?

Opioid Drugs being classified as narcotics fall within the general jurisdiction of the Minister of Health for the supervision of the State Monopoly. Their prescription must respect the conditions set by virtue of specific decisions by the Minister of Health.

 

27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?

All aspects relevant to the sale of narcotics, including Opioid Drugs, which is undertaken by the Special Drug Management Division of the Ministry of Health, are regulated by virtue of specific decisions by the Minister of Health. Narcotics may only be sold to pharmacies, hospitals, clinics and rural medical doctors, in regions lacking pharmacies, following approval by the Minister of Health with the consent of the Narcotics Board, specifying the exact maximum quantity per substance to be supplied annually, according to the needs of each of the above interested parties. Article 3 of Presidential Decree 148/2007 provides for the price of opium and that the retail price of State Monopoly Narcotics is set at this specific price plus 35% plus VAT. The sale price of the Narcotics belonging to the State Monopoly are set by virtue of a decision by the Minister of Health following an opinion by the Narcotics Board.

 

28. Which are the Opioid drugs that have received market approval to date?

Opioid Drugs having received market approval in Greece – not necessarily present in the Greek market today – include the following: ROMIDON/Relyo, ZIDERON/Norma (active substance: Dextropropoxyphene Hydrochloride), LONALGAL (active substances: Paracetamol – Codeine phosphate hemihydrate), LONARID-N      (active substances: Paracetamol – Codeine phosphate hemihydrate – Caffeine), MONGOL, MORFICONTIN (active substance: Morphine sulfate), NALBUPHINE (active substance: Nalbuphine hydrochloride), TRAMAL, TROPIUM, VIBRALIS (active substance: Tramadol hydrochloride), ABSTRAL, BREAKYL, DEMOGYL, DOLFEN, DUROGESIC, EFFENTORA, FENTADUR, INSTANYL, VELLOFENT (active substance: Fentanyl citrate).

 

29. Who can prescribe Opioid Drugs?

As is the case of all medicines under Greek law, only Medical Doctors may prescribe Opioid Drugs.

 

30. Is there a list of doctors authorized to prescribe Opioid Drugs?

No list of doctors specifically authorized to prescribe Opioid Drugs exists.

 

31. What approvals or notifications are required to prescribe Opioid Drugs?

Opioid Drugs must in principle be prescribed and sold at the dosage specified by Greek Pharmacopoeia as issued by EOF, even if the relevant prescription indicates an increased dosage; in the latter case, specific approval for the execution of the specific prescription must be issued by the Minister of Health, following an opinion by the Narcotics Board.

 

32. Which organizations are authorized to sell/distribute Opioid Drugs available?

Opioid Drugs may only be sold / distributed by pharmacies, hospitals, clinics and rural medical doctors, in regions lacking pharmacies. Pharmaceutical preparations based on opium are exclusively manufactured by and sold through pharmacies.

 

33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?

There is no list of retailers/distributors specifically authorized to sell Opioid Drugs; pharmacies may but are not obliged to obtain Opioid Drugs from the State Monopoly in view of selling those to the public.

 

34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?

No specific proposals for reform as regards Opioid Drugs have been announced.

 

35. When are they likely to come into force?

N/A.

 

Also from this Legal Handbook

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) or
• by European patents granted centrally by the European Patent Office (EPO) in line with Regulation (EU) No 1257/2012 implementing enhanced cooperation in the area of the creation of unitary patent protection, which establishes the issuance of European patents under the rules and procedures laid down in the Convention on the Grant of European Patents of 5 October 1973, as revised on 17 December 1991 and on 29 November 2000 (hereinafter referred to as EPC).

The procedure for granting a national patent before OBI includes the following stages:

1. Filing of the application
2. A 4-month term from the filing date for any corrections to be made or omissions to be supplemented
3. An examination, conducted by OBI in order to confirm whether the invention is “new” and involves an inventive step drafting of the search report or search report will written opinion
4. A 3-month term from the date of notification of the search report, for the applicant to comment on the search report
5. Drafting of the final search report or final search report including written opinion
6. Grant of the patent

The European procedure has not superseded the national grant procedures. So when seeking patent protection in one or more EPC contracting states one can choose between following the national procedure in each state for which he/he seeks protection and taking the European route, which in a single procedure confers protection in all contracting states.

A European patent is granted after an examination designed to establish whether the European patent application and the invention to which it relates comply with the patentability requirements of the EPC. These requirements are the basis not only for the granting of a European patent, but also for the assessment of its validity by national courts. In addition, under the EPC the extent of the protection conferred by the European patent is determined uniformly for all the contracting states.

The granting procedure is conducted by the EPO’s Receiving Section, search divisions and examining divisions. Once a European patent has been granted, there follows a nine-month period in which third parties are entitled to file a reasoned notice of opposition; and at the end of the resulting opposition proceedings, either the patent is maintained as granted or as amended or it is revoked. The decision taken in the opposition proceedings applies to all designated contracting states and can also be appealed before the EPO’s boards of appeal.

Trademarks

A trademark in Greece can either be registered

• at national level before the General Secretariat of Commerce and Consumer Protection of the Greek Ministry of Economy and Development in accordance with Law 4072/2012, as amended by Law 4155/2013, or
• at EU level as an ‘European Union trade mark’ (EUTM) at the European Union Intellectual Property Office (EUIPO) in line with Regulation (EU) 2017/1001 as supplemented by Commission Delegated Regulation (EU) 2018/625.

National and EU TMs coexist and are complementary to each other. The same trade mark can be registered at EU and/or national level through the filing of the relative application before the General Secretariat of Commerce and Consumer Protection of the Greek Ministry of Economy and Development. The EUTM system consists of one single registration procedure that grants the owner an exclusive right in all 28 EU countries.

 

2. What agencies or bodies regulate patents and trademarks?

At national level, the Hellenic Industrial Property Organization (OBI) is the only competent institution for the protection of inventions and industrial designs. The Ministry of Economy and Development’s General Secretariat of Commerce and Consumer Protection is the central authority for trademark protection.

On a European level, European Patent Office (EPO) and European Union Intellectual Property Office (EUIPO) are the competent bodies regulating European trademarks and patents respectively.

 

3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?

Patents

A patent is a legal title with duration of 20 years that can be granted for any invention having a technical character provided that it is new, involves an ‘inventive step’, and is susceptible to industrial application. An invention is considered “new” if it has not been known to the public by any means (written or oral or in any other way), before its filing date, involves an inventive step if, in an expert’s opinion, it is not based on the existing state of the art in any obvious manner and it is capable of industrial application where it can be produced and used in any field of industrial activity. It grants the owner the right to prevent others from making, using or selling the invention without permission. The invention may relate to a product, a process or an industrial application.

In each contracting state for which it is granted, a European patent gives its proprietor the same rights as would be conferred by a national patent granted in that state. If its subject-matter is a process, protection is extended to products directly obtained by that process. A published European patent application provides provisional protection which is no less than that conferred by a contracting state for a published national application and which must at least include the right to reasonable compensation in the event of wrongful infringement. The standard term of a European patent is twenty years as from the date of filing. Provided that the annual renewal fees are duly paid, patents remain in force for the maximum term.

Moreover, patents of medicinal products can be additional protected by being granted a supplementary protection certificate (SPC), in accordance with Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products. SPC constitutes an intellectual property right that serve as an extension to a patent right. It applies to specific pharmaceutical products that have been authorized by regulatory authorities. It aims to offset the loss of patent protection for pharmaceutical products that occurs due to the compulsory lengthy testing and clinical trials these products require prior to obtaining regulatory marketing approval.

An SPC can extend a patent right for a maximum of five years. A six-month additional extension is available in accordance with Regulation (EC) No 1901/2006 if the SPC relates to a medicinal product for children for which data has been submitted according to a Paediatric Investigation Plan (PIP). PIPs are required to support the authorization of medicines for children. They ensure that enough data is collected on the effects of the medicine on children. The extension compensates for the additional clinical trials and testing that PIPs require.

According to article 53 of ECP, European patents shall not be granted in respect of:

• inventions the commercial exploitation of which would be contrary to “ordre public” or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States;
• plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof;
• methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.

The same rules apply for the registration of patent on a national basis, according to article 5 of Law 1733/1987.

Trademarks

A trade mark is a sign which distinguishes the goods and services of one company from those of another. As indicators of business origin, trademarks can be words, logos, devices or other distinctive features, or a combination of these.

Pursuant to article 7 of Regulation (EU) 2017/1001, the following shall not be registered as European trademarks:

a. signs which do not conform to the requirements of Article 4;

b. trademarks which are devoid of any distinctive character;

c. trademarks which consist exclusively of signs or indications which may serve, in trade, to designate the kind, quality, quantity, intended purpose, value, geographical origin or the time of production of the goods or of rendering of the service, or other characteristics of the goods or service;

d. trademarks which consist exclusively of signs or indications which have become customary in the current language or in the bona fide and established practices of the trade;

e. signs which consist exclusively of:

1. the shape, or another characteristic, which results from the nature of the goods themselves;
2. the shape, or another characteristic, of goods which is necessary to obtain a technical result;
3. the shape, or another characteristic, which gives substantial value to the goods;

f. trademarks which are contrary to public policy or to accepted principles of morality;

g. trademarks which are of such a nature as to deceive the public, for instance as to the nature, quality or geographical origin of the goods or service;

h. trademarks which have not been authorized by the competent authorities and are to be refused pursuant to Article 6ter of the Paris Convention for the Protection of Industrial Property (‘Paris Convention’);

i. trademarks which include badges, emblems or escutcheons other than those covered by Article 6ter of the Paris Convention and which are of particular public interest, unless the consent of the competent authority to their registration has been given;

j. trademarks which are excluded from registration, pursuant to Union legislation or national law or to international agreements to which the Union or the Member State concerned is party, providing for protection of designations of origin and geographical indications;

k. trademarks which are excluded from registration pursuant to Union legislation or international agreements to which the Union is party, providing for protection of traditional terms for wine;

l. trademarks which are excluded from registration pursuant to Union legislation or international agreements to which the Union is party, providing for protection of traditional specialities guaranteed;

m. trademarks which consist of, or reproduce in their essential elements, an earlier plant variety denomination registered in accordance with Union legislation or national law, or international agreements to which the Union or the Member State concerned is a party, providing for protection of plant variety rights, and which are in respect of plant varieties of the same or closely related species.

Concerning the national trademark, article 123 of Law 4072/2012 repeats the above (a)-(g) conditions as grounds for absolute refusal of trademark registration. In addition, the following cannot be protected as trademarks:

1. Signs that consist of the flags, emblems, symbols, escutcheons, signs or hallmarks of Greece or any other state covered by Article 6ter of the Paris Convention for the Protection of Industrial Property;
2. Signs of great symbolic value and special interest, particularly religious symbols, representations and words.
3. Signs comprising geographical indications for wine and alcoholic beverages and geographical indications or appellations of origin for agricultural products that have been already registered according to the EU legislation regarding the same type of product.
4. Finally, a trademark cannot be registered if it has been filed in bad faith.

 

4. How can patents and trademarks be revoked?

Patents

At EU level, pursuant to Article 138 of the EPC, a European patent may be revoked with effect for a Contracting State only on the grounds that:

1. the subject-matter of the European patent is not patentable under Articles 52 to 57;
2. the European patent does not disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art;
3. the subject-matter of the European patent extends beyond the content of the application as filed or, if the patent was granted on a divisional application or on a new application filed under Article 61, beyond the content of the earlier application as filed;
4. the protection conferred by the European patent has been extended; or
5. the proprietor of the European patent is not entitled under Article 60, paragraph 1.

If the grounds for revocation affect the European patent only in part, the patent shall be limited by a corresponding amendment of the claims and revoked in part.

The above grounds for revocation apply accordingly for national patents pursuant to article 15 of Law 1733/1987.

Trademarks

At EU level, article 58 of Regulation (EU) 2017/1001 provides for certain conditions under which a European trademark can be revoked. More specifically the rights of the proprietor of the EU trade mark shall be declared to be revoked on application to the Office or on the basis of a counterclaim in infringement proceedings:

1. if, within a continuous period of five years, the trade mark has not been put to genuine use in the Union in connection with the goods or services in respect of which it is registered, and there are no proper reasons for non-use; however, no person may claim that the proprietor’s rights in an EU trade mark should be revoked where, during the interval between expiry of the five-year period and filing of the application or counterclaim, genuine use of the trade mark has been started or resumed; the commencement or resumption of use within a period of three months preceding the filing of the application or counterclaim which began at the earliest on expiry of the continuous period of five years of non-use shall, however, be disregarded where preparations for the commencement or resumption occur only after the proprietor becomes aware that the application or counterclaim may be filed;
2. if, in consequence of acts or inactivity of the proprietor, the trade mark has become the common name in the trade for a product or service in respect of which it is registered;
3. if, in consequence of the use made of the trade mark by the proprietor of the trade mark or with his consent in respect of the goods or services for which it is registered, the trade mark is liable to mislead the public, particularly as to the nature, quality or geographical origin of those goods or services.

It should be noted that according to paragraph 2 of said article where the grounds for revocation of rights exist in respect of only some of the goods or services for which the EU trade mark is registered, the rights of the proprietor shall be declared to be revoked in respect of those goods or services only.

At national level, pursuant to article 160 of Law 4072/2012, a national trademark can be revoked, in whole or in part, for the same reasons provided for a European trademark. The effect of the decisions ordering the revocation of a trademark commences only when the relevant decisions become final.

 

5. Are foreign patents and trademarks recognized and, if so, under what circumstances?

Regulation (EU) 1257/2012 establishes the uniform protection of the European patent within participating member states. Pursuant to article 5 of said Regulation the European patent with unitary effect shall confer on its proprietor the right to prevent any third party from committing acts against which that patent provides protection throughout the territories of the participating Member States in which it has unitary effect, subject to applicable limitations. Furthermore, according to article 7 a European patent with unitary effect as an object of property shall be treated in its entirety and in all the partici­pating Member States as a national patent of the participating Member State in which that patent has unitary effect and in which, according to the European Patent Register:

1. the applicant had his residence or principal place of business on the date of filing of the application for the European patent; or
2. where point A does not apply, the applicant had a place of business on the date of filing of the application for the European patent.

In certain Member States, it may be required to ratify the EU patent through the deposition before the competent national authority of an official translation of the claims and the design of the patent, along with the relative fees, in line with their national law on patents. In Greece, according to article 23(5) of Law 1733/1987 the holder of an EU patent must deposit to OBI an authorized greek translation of the text on the basis of which EPO granted the EU patent. Attention must be paid to the fact that if the previous conditions are not met, the EU patent does not produce its effects to Greece [article 23(6) of said Law]. Lastly, article 9 of said Law establishes an international priority procedure to be followed regarding applications that have been submitted abroad.

Trademarks

Pursuant to article 1 of Regulation (EU) 2017/1001 an EU trade mark shall have a unitary character. It shall have equal effect throughout the Union: it shall not be registered, transferred or surrendered or be the subject of a decision revoking the rights of the proprietor or declaring it invalid, nor shall its use be prohibited, save in respect of the whole Union.

Furthermore, in accordance with article 177 of Law 4072/2012 a foreign trademark shall enjoy protection in Greece upon registration with the competent Greek authority, namely Administrative Trademark Committee of the Hellenic General Secretariat of Commerce and Consumer Protection.

 

6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?

According to article 14(11) of Regulation (EC) No 726/2004, without prejudice to the law on the protection of industrial and commercial property, medicinal products for human use which have been authorized shall benefit from an eight-year period of data protection and a ten-year period of marketing protection, in which connection the latter period shall be extended to a maximum of 11 years if, during the first eight years of those ten years, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies.

In line with the above, medicines enjoy an extended data and marketing protection, along with the possible granting of supplementary protection certificate (SPC), in line with Regulation (EC) No 469/2009 (for further information on SPC protection see above).

 

7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?

The relevant Greek legislation does not provide for any further limitations on detaining patent or trademark protection of any types of medicines or devices other than those generally stipulated above under Question 60.

 

8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?

Patents

Pursuant to article 12 of Law 1733/1987, the licensor may declare before OBI that he consents to the granting of a licensing agreement upon compensation. The declaration is valid for two years and is registered with the national patent register, is published in the special report of industrial property and is recorded on the patent.

Trademarks

License agreements must be executed in writing and may be recorded on the petition of either the licensor or the licensee, duly authorized by the licensor. There is no need for the Administrative Trademark Committee to examine and approve license agreements. License agreements that have not been registered are not invalid. However, according to the leading opinion, registration is necessary in order for the licensee to claim and enforce its rights against third parties.

 

Also from this Legal Handbook

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 on the nature of the applicable provisions as well as on the nature of the person responsible, i.e. either private or public.

 

2. How do these types of liabilities apply to the manufacturers of medicines and devices?

Civil Liability

The manufacturer’s civil liability for a defective medicinal product and/or a defective medical device may be established under articles 6 and 7 of Law 2251/1994 (consumer protection Law), the provisions of which have already been coded in a single text by virtue of Ministerial Decision 5338/2018, in conjunction with the provisions of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013. Article 6 of Law 2251/1994 in particular has been amended in line with the provisions of EU Directive 85/374/EEC on liability for defective products, permitting the consumer to seek restoration of any and all damages deriving from a defective medicinal product or medical device, including nominal damage, which is specifically stipulated under article 6(7). Attention must be paid to the fact that the manufacturer’s liability under the said Law is strictly objective in the sense that the claimant is not required to claim, let alone prove the existence of the manufacturer’s fault in order to establish his/her claims. In the alternative, a claimant may also establish his/her claims under the tort liability provisions of the Greek Civil Code (articles 914 et seq.).

It is worth noting that:

• In accordance with article 6(4) of Law 2251/1994, where the producer of the (defective) product cannot be identified, each supplier of the product is treated as its producer unless he/she informs the consumer within a reasonable time of the identity of the producer or the person who supplied him with the product. Moreover, pursuant to article 7 of said Law, as recently amended by Law 4512/2018, the obligation to market safe products, including the obligation to provide sufficient information to the consumer in order to ensure safe use of a marketed product, is incumbent upon the manufacturer. The crucial definition of the manufacturer is further laid down in article 2 of Interministerial Decision Z3/2810/Government Gazette B’/2885/2004. In accordance with the specific provision, every professional who may in the course of his business affect the safety features of the product shall be deemed to be a producer. The wide scope of the manufacturer’s definition aims at the outmost protection of the consumer.

Pursuant to article 41 of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013 the granting of an authorization for the marketing of the medicinal product does not affect the civil and criminal liability of the manufacturer.

Criminal Liability

Pursuant to article 281 of the Greek Penal Code, whoever manufactures, processes or markets medicines in such a way that their use may cause damage to the user’s health or put the user’s life at risk, is punishable by imprisonment of at least 3 months and up to five years. Criminal liability, including the obligation to pay a criminal penalty, is also incurred by the persons, either Manufacturers, Representatives, Importers marketing medicinal products or Pharmacists, Doctors, Veterinaries or any distributors dispensing medicinal products in the event of repetitive infringement of either of the provisions of article 19 of Legislative Decree 96/1973 providing, in principle, for the imposition of administrative fines in cases of marketing or dispensing of medicinal products without the required authorization or while the latter has been terminated, revoked or suspended, as therein described.

Disciplinary Liability

As regards disciplinary liability, the Code of Ethics of the Hellenic Association of Pharmaceutical Companies (Hellenic acronym: SFEE), a member of EFPIA, regulates various aspects of the promotion of pharmaceutical products by its members, mirroring the EFPIA HCP and Disclosure Codes. Said Code enriches the regulatory framework on medicinal products; despite the – strictly speaking – ‘soft law’ character of its provisions, pharmaceutical companies active in Greece attach a great level of importance to compliance with its content, which constitutes, as regards several aspects of their day-to-day interaction with healthcare professionals, the only legal framework available.

Administrative Liability

Finally, in the event of breach of the provisions stipulated under Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013 and Interministerial Decision DY8d/G.P. 130648/Government Gazette B’ 2198/2009, the manufacturer may also be held administratively liable and as a result be subject to the imposition of the relevant administrative fines as initially provided by article 19 of Legislative Decree 96/1973 and amended by virtue of article 175 par. 2 of the Interministerial Decision 32221(see the section Regulatory, Pricing and Reimbursement).

 

3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees and representatives?

Article 71 of the Greek Civil Code provides for joint liability of both the natural person acting as representative of a legal entity and responsible for any acts or omissions throughout the execution of their duties establishing civil liability under the Greek Civil Code provisions and said legal entity. Administrative liability, being established on the basis of the infringement of the regulatory framework relevant to the marketing of medicinal products as set by virtue of Interministerial Decision 32221, is incurred by the legal entities or natural persons falling within its scope. Similarly, disciplinary liability on the grounds of an infringement of the Code of Ethics of SFEE is incurred by the legal entity member of the Association. Finally, criminal liability is naturally exclusively incurred by the natural persons the acts or omissions of which constitute infringements of criminal provisions.

 

4. How can a liability claim be brought?

Any individual or legal entity having suffered harm from a defective medicinal product or medical device is entitled to bring claims before civil and criminal national courts against the liable person or legal entity.

Civil law claims for positive material damage, loss of profit and/or moral damages may be brought by way of a lawsuit filed with the competent civil court.

Where criminal liability may also be established, the persons liable may be prosecuted either ex officio or following the filling of a criminal complaint by the harmed person/legal entity or report by any competent authority, namely EOF in the case of repetitive infringement of Interministerial Decision 32221 provisions.

Administrative claims are imposed by the National Medicines Organization (EOF), competent authority as regards the application of the regulatory framework relevant to the marketing of medicinal products in Greece, either following a complaint by any affected person or entity or ex officio, where any infringements are found in the context of an audit conducted by the Organization.

 

5. What defenses are available?

Defenses vary depending on the type of liability incurred and the nature (civil, criminal, administrative or disciplinary) of the specific provisions applicable, they should, therefore, be examined on a case-by-case basis. Defendant may naturally be represented before both civil and criminal courts, as well as before any disciplinary body. The civil procedure permits the defendant to file pleadings either denying the facts claimed by the claimant or raising objections against the claimant. Following initiation of the criminal procedure the defendant is required to supply either an oral or a written statement in answer to the charges brought against them; during the procedure before the criminal court, the defendant is entitled to participate either represented by a lawyer or not; where the defendant is present throughout the proceedings he is also required to answer questions raised by the court, the Public Prosecutor or the attorney of the party having initiated the criminal procedure (referred to as ‘plaintiff’) and may choose to provide a final oral statement on his own behalf, although usually this is made by the defendant’s advocate. Finally, administrative fines may be challenged before the competent administrative courts.

 

Also from this Legal Handbook

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 laws. The medicinal products which are placed on the Greek market are mainly regulated by Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B 1049/2013 (read together with Legislative Decree 96/1973 as regards traditional medicines) and by Interministerial Decision G5(a)/53625/Government Gazette B 3328/2017 relating to food supplements. Moreover, the regulatory requirements of medicinal devices are stipulated under Interministerial Decision DY8d/G.P. 130648/Government Gazette B’ 2198/2009, Interministerial Decision DY8d/130644/Government Gazette B’ 2197/2009 and Interministerial Decision DY8d/G.P. 3607/Government Gazette B’ 1060/2001.

Traditional Medicines

The definition of traditional medicines is provided by article 1(1) of Legislative Decree 96/1973 in conjunction with article 2 of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B 1049/2013. A (traditional) medicinal product is any substance or combination of substances presented for treating or preventing disease in human beings. Moreover, any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings through the exercise of pharmacological, immunological or metabolic action is likewise considered a medicinal product. The regulatory requirements of traditional medicines are stipulated in Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B 1049/2013 read together with Legislative Decree 96/1973 (see the section Regulatory, Pricing and Reimbursement).

Herbal Medicines

Pursuant to article 2(33) of the above Interministerial Decision, as herbal medicinal product is defined any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations. The specific definition is in line with Directive 2004/24/EC amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use.

A simplified registration procedure (traditional-use registration) is established for herbal medicinal products under Chapter 2a of the same Interministerial Decision. More specifically, pursuant to article 21 a simplified registration procedure is established under articles 22-28 for herbal medicinal products which fulfil all of the following criteria:

1. they have indications exclusively appropriate to traditional herbal medicinal products which, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment;
2. They may exclusively be administered at a specified strength and posology;
3. They constitute either an oral, external and/or inhalation preparation;
4. The period of traditional use as laid down in Article 23(1) has elapsed;
5. The data on the traditional use of the medicinal product is sufficient; in particular the product has proven not to be harmful in the specified conditions of use and the pharmacological effects or efficacy of the medicinal product are plausible on the basis of long-standing use and experience (of at least thirty years, a minimum of fifteen of which within the EU).

It is worth noting that according to article 22 of the same Interministerial Decision an applicant and registration holder must be established in the Community and submit an application to E.O.F.

Homeopathic Medicines

As a general remark “alternative” medicines are not recognized –and therefore authorized as such- neither by European nor by Greek legislation. The only type of alternative medicines recognized are homeopathic medicines.

Pursuant to article 2(6) of the above Interministerial Decision a homeopathic medicine is any medicinal product prepared from products, substances or compositions called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in absence thereof, by the pharmacopoeias currently used officially in the Member States. A homeopathic medicinal product may also contain a number of principles.

A special, simplified registration procedure is laid down in article 18 of Chapter 2 for the homeopathic medicines that restrictively satisfy the following conditions:

• they are administered orally or externally,
• no specific therapeutic indication appears on the labelling of the medicinal product or in any information relating thereto,
• there is a sufficient degree of dilution to guarantee the safety of the medicinal product; in particular, the medicinal product may not contain either more than one part per 10 000 of the mother tincture or more than 1/100th of the smallest dose used in allopathy with regard to active substances whose presence in an allopathic medicinal product results in the obligation to submit a doctor’s prescription.

If the above conditions are not met, the authorization process followed is the same as for traditional medicines. In any case, the relevant application must be submitted with E.O.F.

Food Supplements

The only complementary products recognized at European and national legislative level are food supplements which are regulated by Interministerial Decision G5(a)/53625/Government Gazette B 3328/2017 in line with Direction 2002/46/EC on the approximation of the laws of the Member States relating to food supplements. Pursuant to article 2 of said Interministerial Decision, food supplements’ foodstuffs fall within the competence of EOF. Their purpose must be to supplement the normal diet and must constitute concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form – namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders, designed to be taken in measured small unit quantities;

The manufacturer or the person marketing a food supplement must notify EOF of their placement on the market. Moreover, in accordance with article 4 of said Interministerial Decision, only vitamins and minerals listed in Annex I, in the forms listed in Annex II, may be used for the manufacture of food supplements and the manufacturer must obtain the relevant authorization by E.O.F.

In case a food supplement already circulates within EU and on the condition that it includes exclusively the vitamins and minerals listed in Annex I, the relevant notification to EOF shall be accompanied by an application, a sample of the label and the relevant fee, pursuant to article 10(1) of said Interministerial Decision. 

Medical Devices

According to article 1 of Interministerial Decision DY8d/G.P. 130648/Government Gazette B’ 2198/2009 as medical device is defined any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

• Diagnosis, prevention, monitoring, treatment or alleviation of disease,
• Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
• Investigation, replacement or modification of the anatomy or of a physiological process,
• Control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

Medical devices must meet the essential requirements set out in Annex I of said Interministerial Decision which apply to them (as per article 3 of said Interministerial Decision). Devices, other than devices which are custom-made or intended for clinical investigations, considered to meet the essential requirements must bear the CE marking of conformity when they are placed on the market. The CE marking of conformity, must feature in a visible, legible and indelible form on the device or its sterile pack, where practicable and appropriate, and on the instructions for use. Where applicable, the CE marking must also feature on the sales packaging (article 17 of said Interministerial Decision).

Apart from the general Interministerial Decision on medical devices, several other Interministerial and Ministerial Decisions in force govern specific types of Medical Devices, such as, indicatively, Interministerial Decision DY8d/130644/Government Gazette B’ 2197/2009 issued in application of Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices and Interministerial Decision DY8d/G.P. 3607/Government Gazette B’ 1060/2001 issued in application of Directive 98/79/EC on in vitro diagnostic medical devices. It should be noted that under European and Greek legislation the use of alternative medical devices is not authorized.

 

2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?

The advertising of traditional, herbal and homeopathic products directly to the public is subject to multiple restrictions and regulations mainly stipulated under Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B 1049/2013 (articles 118-132) jointly with legislative Decree 96/1973.

As a general rule, EOF prohibits any advertising of medicinal products which have not been granted a marketing authorization. The specific rule does not apply to homeopathic products∙ this derogation is provided for in article 132 of said Interministerial Decision. However, only the information specified in Article 94(1) may be used in the advertising of such medicinal products.

Moreover, in accordance with article 120 of said Interministerial Decision, the only medicinal products that are allowed to be advertised to the general public are those which, by virtue of their composition and purpose, are intended and designed for use without the intervention of a medical practitioner for diagnostic purposes or for the prescription or monitoring of treatment, upon advice by a pharmacist, if necessary. Pursuant to article 119 of said Decision, it is strictly prohibited to advertise medicinal products which: (a) are available on medical prescription only, (b) contain psychotropic or narcotic substances, such as those governed by the United Nations Conventions of 1961 and 1971, (c) are reimbursed by Social Security Institutions.

As regards complementary products, namely food supplements, Interministerial Decision G5(a)/53625/Government Gazette B 3328/2017 in line with Direction 2002/46/EC stipulates under articles 6-7 the two main rules to be followed:

• advertising must not attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties
• advertising shall not include any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients in general.

Finally, it should be noted that the Hellenic Association of Pharmaceutical Companies (SFEE) Code of Ethics, provides specific guidelines on the advertising of medicinal products to the public. Therefore pharmaceutical companies active in Greece must be vigilant as regards compliance with said rules.

 

3. What health, advertising and marketing claims may be made for traditional, herbal, complementary, or alternative products?

Traditional, Herbal and Homeopathic Products

In general, the infringement of the regulatory framework on marketing and advertising of traditional, herbal and homeopathic products may under certain conditions establish either civil, criminal, administrative and / or disciplinary liability as examined in Chapter 5.

It should be noted that as regards advertising in particular, pursuant to article 121 of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B 1049/2013, attention must be paid so that all advertising to the general public of a medicinal product shall:

a. Be set out in such a way that it is clear that the message is an advertisement and that the product is clearly identified as a medicinal product;

b. Include the following minimum information:

• The name of the medicinal product, as well as the common name if the medicinal product contains only one active substance,
• The information necessary for correct use of the medicinal product,
• An express, legible invitation to read carefully the instructions on the package leaflet or on the outer packaging, as the case may be.

In addition, according to article 119(3) of said Interministerial Decision, the advertising of a medicinal product shall encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties and shall not be misleading.

The non-conformity with the above rules is also subject to the sanctions examined under Chapter 5, given that the sanctions for breach of the provisions of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B 1049/2013 are uniform.

Food Supplements

In the event of infringement of the relevant regulatory provisions Interministerial Decision G5(a)/53625/Government Gazette B 3328/2017 on food supplements the sanctions stipulated under article 19 of Legislative Decree 96/1973 may be applicable, which provide, in principle, for the imposition of administrative fines. The civil, criminal, administrative and disciplinary liability of the persons in fault may also be respectively established on the grounds of claims brought by damaged persons, especially by consumers.

 

4. What are the regulatory requirements for over-the-counter (non- prescription) medications?

In general, over-the-counter medicines (hereinafter referred to as OTC medicines) are medicaments which, due to their composition and purpose, are intended and designed to be used without the intervention of a doctor for diagnosis or treatment, or in case of need, upon advice by a pharmacist.

According to article 97 of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013 , as medicinal products not subject to prescription are defined those which do not meet the criteria listed in Article 96. One must therefore examine which products are subject to medical proscription in order to be able to define the non-prescription medicines. Pursuant to article 96 of said Decision, medicinal products shall be subject to medical prescription where they:

• Are likely to present a danger either directly or indirectly, even when used correctly, if utilized without medical supervision, or are frequently and to a very wide extent used incorrectly, and as a result are likely to present a direct or indirect danger to human health, or
• Contain substances or preparations thereof, the activity and/or adverse reactions of which require further investigation, or
• Are normally prescribed by a doctor to be administered parenterally.

Furthermore, the specific article provides for further classification to subcategories of medicines subject to special medical prescription and to restricted medical prescription. The relevant classification of a medicinal product is always and exclusively conducted by EOF during the marketing authorization process. It should be noted that EOF draws up a list of prescription-only medicines which is published on its website. The list is updated annually.

In view of the above, the regulatory requirements for non-prescription medicines follow in principle the regulatory requirements examined under Chapter 1. The differentiations regarding the sale and the advertising of OTC medicines are examined below and the relevant issues on pricing under question 12 of Regulatory, Pricing and Reimbursement.

 

5. Are there any limitations on locations or channels through which OTC products may be sold?

As regards the dispensation of OTC medicinal products, a distinction must be made between the general category of OTC medicinal products and ITS subcategory of General Dispensation Medicinal Products (Greek Acronym GEDIFA).

OTC products are exclusively dispensed through pharmacies, pursuant to article 4(1) of Law 1963/1991. The retail sale of medicinal products by pharmacies is also governed by Legislative Decree 312/1992 which regulates the organization and constitution of pharmacies at national level.

Medicinal Products (GEDIFA) are products already falling within the definition and classified as OTC products, which meet cumulatively the criteria set out in article 1(a) of Ministerial Decision G5(a) 51194/ Government Gazette B’ 2219/2016 in line with article 6 of Law 4389/2016. In general, GEDIFA products are medicines taken in response to obvious symptoms e.g. headache, nausea and the interactions of which with other frequently administered therapies are minimal.

Apart from their dispensation through legally operating pharmacies, OTC medicines may also be sold, in accordance with article 5 of said Decision, through retail shops of public health interest that have been authorized to operate as supermarkets or grocery stores.

 

6. What health, advertising, and marketing claims may be made for OTC products?

Greek legislation, in line with European legislation, does not establish any special health, advertising or marketing claims for OTC products. Such claims are uniform for all medicinal products, as specified under question 46 of this Chapter.

 

7. Can OTC products be marketed or advertised directly to the public?

In line with Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013 only non-prescription (OTC) products (including herbal and homeopathic) may be advertised directly to the public, subject to the general restrictions already outlined above. The direct advertising of OTC products is jointly regulated by Ministerial Decision Y6a/2261/Government Gazette B’ 284/2002 on the advertising of medicinal products that may be administered without prescription which stipulates further specifications to be followed depending on the media used.

The same rules and processes as for the prescription-only medicinal products apply to the marketing of OTC products.

 

8. What is the mechanism by which a prescription-only product can be converted to an OTC product?

Whenever new data is brought to the attention of EOF, the latter is able to reevaluate and amend the classification of a medicine, in application of the criteria set out above under question 48.

 

9. What are the requirements for the importation of either traditional medicines or OTC products?

Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013 also regulates the importation of medicinal products (in general) under its Title IV. The importation of a medicinal product from third (non EU) countries is subject to the granting of a manufacture authorization by EOF, according to the relevant provisions applicable.

In line with Directive 2011/62/EU on the prevention of entry into the legal supply chain of falsified medicinal products, according to said Decision EOF is entitled to take appropriate measures to ensure that the import and distribution in Greece of active substances, including active substances that are intended for export, comply with good manufacturing practices and good distribution practices for active substances.

According to article 74 (1) of said Decision, importers, manufacturers and distributors of active substances who are established in the Union shall register their activity with EOF.

The registration form shall include, at least, the following information:

1. name or corporate name, permanent address and type of exercised activity;
2. the active substances which are to be imported, manufactured or distributed and the type of manufacture and control;
3. name and address of the active substance’s manufacturer and his/her GMP certificate if available
4. particulars regarding the premises and the technical equipment for their activity.
5. the countries where the active substance is distributed.

The persons referred to in paragraph 1 shall submit the registration form beforeEOF at least 60 days prior to the intended commencement of their activity.

Furthermore, pursuant to article 65(2) of said Decision, active substances shall only be imported if the following conditions are fulfilled:

1. the active substances have been manufactured in accordance following good manufacturing practice standards at least equivalent to those laid down by the Union pursuant to the third paragraph of Article 66; and
2. the active substances are accompanied by a written confirmation by the competent authority of the exporting third country of the following:

1. the standards of good manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to those laid down by the Union pursuant to the third paragraph of Article 66;
2. the manufacturing plant concerned is subject to regular, strict and transparent controls and to the effective enforcement of good manufacturing practice, including repeated and unannounced inspections, so as to ensure a protection of public health at least equivalent to that in the Union; and
3. in the event of findings relating to non-compliance, information on such findings is supplied by the exporting third country to the Union without any delay.

The requirement set out in point (b) of paragraph 2 of this Article shall not apply if the exporting country is included in the Commission’s Third Countries Assessment List.

 

Also from this Legal Handbook

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 for medicinal products in Greece, namely:

• The Centralized Procedure. Marketing authorizations granted under the “centralized procedure” allow the marketing-authorization holder to market the medicine and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorization. Such authorization is granted by the European Commission following the scientific assessment of the application by the European Medicines Agency. The centralized procedure is laid down in Regulation (EC) No 726/2004
• The mutual recognition process. This process is stipulated under articles 45-46 of the Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013. To be eligible for the mutual recognition procedure, a medicinal product must have already received a marketing authorization at least in one EU country. In this case an application for mutual recognition may be addressed to one or more EU countries. The applications submitted must be identical, and all EU countries notified accordingly. The country charged with evaluating the application or Reference Member State notifies the other Concerned Member States. The Reference Member State is then charged with deciding on the product.

This evaluation process may take up to 210 days and ends with the granting of a marketing authorization in the EU country of application. The Concerned Member States then have 90 days to acknowledge the decision of the Reference Member State, including the summary of product characteristics, labelling and packaging. National marketing authorizations are granted within 30 days.

• The decentralized procedure. This procedure introduced by Directive 2004/27 is provided for under article 47 et seq. of Interministerial Decision D.YG3α/G.P. 32221. It allows the common assessment of an application submitted simultaneously to several Member States. One of the Member States will take the lead in evaluating the application as reference Member State. At the end of the procedure, the draft assessment report, SPC, labelling and package leaflet, as proposed by the Reference Member State, are approved by the other (concerned) Member States.
• The National authorization. According to article 7 of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013, authorization to place a medicinal product on the market may also be obtained by virtue of an application to E.O.F. as national regulating authority. Said public entity is charged with ensuring all appropriate measures are taken in order for the procedure to be finalized within 210 days of the submission of a valid application (article 29 of the named Interministerial Decision).

The application shall be accompanied by a list of particulars and documents concerning the specific medicinal product, including –but not limited to- (a) name or corporate name and permanent address of the applicant and, where applicable, of the manufacturer, (b) name of the medicinal product, (c) qualitative and quantitative particulars of all the constituents of the medicinal product, with mention of the international non-proprietary name recommended by the World Health Organization where such name exists or reference to the relevant chemical name, (d) description of the manufacturing method, (e) therapeutic indications, contra-indications and adverse reactions, (f) Posology, pharmaceutical form, method and route of administration and expected shelf life, (g) If applicable, reasons for any precautionary and safety measures to be taken for the storage of the medicinal product, its administration to patients, as well as for the disposal of waste products, together with an indication of any potential risks to the environment associated with the medicinal product, (h) Description of the control methods employed by the manufacturer (i) Results of physico-chemical, biological or microbiological tests, toxicological and pharmacological tests of the product under examination etc.

With respect to biological medicinal products, article 11(4) of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013, in line with Directive 2004/27/EC provides that where a biological medicinal product which is similar to a reference biological product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or differences in manufacturing processes of the biological medicinal product and the reference biological medicinal product, the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The type and quantity of supplementary data to be provided must comply with the relevant criteria stated in Annex I and the related detailed guidelines. The results of other tests and trials from the reference medicinal product’s dossier shall not be provided.

Medical Devices

The field of medical devices is mainly regulated by Interministerial Decision DY8d/G.P. 130648/Government Gazette B’ 2198/2009, issued in application of Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Directives 98/79/EC, 2000/70/EC, 2001/104/EC, 2007/47/EC and Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003.

The general standards for the good production and control of medical devices are laid down in Decision 6209/2009 of E.O.F.’s Board of Directors (published on Government Gazette B’/199/06.02.2009).

Several Interministerial and Ministerial Decisions in force govern specific types of Medical Devices, such as, indicatively, Interministerial Decision DY8d/130644/Government Gazette B’ 2197/2009 issued in application of Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices and Interministerial Decision DY8d/G.P.3607/Government Gazette B’ 1060/2001 issued in application of Directive 98/79/EC on in vitro diagnostic medical devices.

The above Interministerial Decisions provide for the minimum requirements in view of obtaining marketing authorization for medical devices, namely the essential requirements stipulated under Annex I of Directive 93/42/EEC, 90/385/EEC and 98/79/EC accordingly. EOF is entrusted with all necessary powers in order to ensure compliance with the annexed requirements when the medical devices under examination are duly supplied and properly installed, maintained and used in accordance with their intended purpose.

However, it should be noted that on 5 April 2017, two new European Regulations on medical devices were adopted and entered into force on 25 May 2017. These Regulations will eventually replace the existing Directives as on medical devices. More specifically:

• Regulation (EU) 2017/745of the European Parliament and of the Council of 5 April 2017 on medical devices, was adopted in substitution of Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009, also repealing Council Directives 90/385/EEC and 93/42/EEC and
• Regulation (EU) 2017/746of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices repeals Directive 98/79/EC as well as Commission Decision 2010/227/EU.

The above mentioned new European legislation will become effective after a transitional period, namely 3 years following entry into force of the Regulation on medical devices (26.05.2020) and 5 years following entry into force of the Regulation on in vitro diagnostic medical devices (26.05.2022). It may be noted that the new Regulations provide for the validity of existing certificates issued under the Directives and Interministerial Decisions currently in force for a term following the progressive entry into force of the EU Regulations, as provided therein.

 

2. What is the authorization process for the marketing of generic versions of these products?

According to article 11 of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013 the applicant for the generic products marketing authorization shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which has been authorized for no less than eight years in a Member State or in the Community.

A generic medicinal product authorized pursuant to the previous provision shall not be placed on the market until ten years have elapsed since the initial marketing authorization of the reference product.

The first subparagraph shall also apply if the reference medicinal product was not authorized by EOF but by the competent authority of another Member State. In this case, the applicant shall indicate in the application form for the marketing authorization of the generic product the name of the Member State in which the reference medicinal product has been authorized.

 

3. What are the typical fees for marketing approval?

Pursuant to article 1 of Interministerial Decision DYG3(a)/171107/Government Gazette B’/2689/2008, the relevant payable fee depends on the category of the application and therefore the type of medicinal product.

A complete file of scientific documents must be submitted along with the respective fee:

• for a new or known active substance (complete file) – €20,000;
• if the license is based on related literature combined with the applicant’s studies – €20,000; and
• if the license is founded upon well-established medicinal use – €18,000.

A complete file of scientific documents is not required to be submitted (simplified application) if:

• the application for marketing authorization does not fall within the definition of ‘generic’, as opposed to the reference product – €20,000;
• the application for marketing authorization for a generic product has the same pharmaceutical form and content to the reference product and only a bioequivalence study is required – €14,000;
• the application for marketing authorization for a generic product has the same pharmaceutical form and content to the reference product without requiring a bioequivalence study – €9,000;
• the request for authorization is submitted after a concession for the use of the data of an already approved drug – €5,000.

The payable fee for a marketing authorization if the application is based on a combination of known active substances is €20,000.

 

4. What is the period of authorization and the renewal process?

According to article 40 of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013, as a general rule a marketing authorization is valid for five years and may be renewed upon application by the holder and upon new risk-benefit assessment by E.O.F. following the submission of a dossier containing the particulars listed under paragraph 2 of the same article at least nine months before the initial expiry date. After its renewal, the authorization is in principle rendered unlimited, unless otherwise justifiably decided by E.O.F.

Attention must be paid to the fact that paragraphs 4 and 5 of the same article introduce a double exception to the above general rule. These exceptions provide that the authorization is no longer valid and is ipso jure recalled by virtue of a relevant confirmatory act of E.O.F in the following circumstances, i.e. (a) if the authorized medicinal product is not placed on the market within a three-year period after the grant of its authorization or (b) if a medicinal product having been placed on the market following its authorization becomes unavailable for a consecutive three-year period.

 

5. What are the requirements, if any, for post-approval pharmacovigilance?

Pharmacovigilance rules are necessary for the protection of public health in order to prevent, detect and assess adverse reactions to medicinal products placed on the Union market, as the full safety profile of medicinal products can only be known after they have been placed on the market. EU Member States are responsible for operating a pharmacovigilance system for the fulfilment of their pharmacovigilance tasks and their participation in Union pharmacovigilance activities. The pharmacovigilance system shall be used to collect information on the risks of medicinal products as regards patients’ or public health. That information shall in particular refer to adverse reactions in human beings, arising from use of the medicinal product within the terms of the marketing authorization as well as from use outside the terms of the marketing authorization, and to adverse reactions associated with occupational exposure.

In this context, pursuant to article 136 of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013, the marketing authorization holder shall, among other things:

1. have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance;
2. maintain and make available on request a pharmacovigilance system master file;
3. operate a risk management system for each medicinal product;
4. monitor the outcome of risk minimization measures which are contained in the risk management plan or which are laid down as conditions of the marketing authorization pursuant to Articles 21a, 22 or 22a;
5. update the risk management system and monitor pharmacovigilance data to determine whether there are new risks or whether risks have changed or whether there are changes to the benefit-risk balance of medicinal products.

 

6. Are foreign marketing authorizations recognized?

No medicinal product may be placed on the market of Greece unless a marketing authorization has been granted by EOF or unless a marketing authorization has been granted in accordance with Regulation (EC) No 726/2004.

 

7. Are parallel imports of medicines or devices allowed?

Parallel imports of medicines and devices from one EU member state to another are allowed in light of the principle of free movement of goods within the EU.

 

8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?

As a general remark, pharmaceutical companies must abstain from offering any kind of incentives to healthcare professionals. More specifically, according to article 126 of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013, where medicinal products are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to their everyday practice. Moreover, hospitality services within the framework of promotional events shall always be proportionate and secondary to the main purpose of the event and must not be extended to other than health professionals. According to paragraph 3 of said article, persons qualified to prescribe or supply medicinal products shall not solicit or accept any inducement prohibited under paragraph 1 or contrary to paragraph 2 of said article.

However, pursuant to article 128 of said Decision, free samples shall be provided on an exceptional basis only to persons qualified to prescribe the same products and under the conditions strictly stipulated therein.

The Code of Ethics of the Hellenic Association of Pharmaceutical Companies (Hellenic acronym: SFEE), a member of EFPIA, regulates various aspects on the promotion of pharmaceutical products as well as on sponsorships and incentives for healthcare organizations and individual medical practitioners.

Said Code distinguishes between the organization of conferences of scientific content (Type A events) and promotional scientific events (Type B events). Each type is subject to different requirements as regards payments and benefits to healthcare professionals for their participation in either category. More specifically:

• Pursuant to article 17(3)(c) of said Code, as Type A events are defined scientific conferences, seminars and similar continuing education events held by state entities, including universities and public hospitals (clinics, laboratories, government agencies and social security organizations and health units), non-profit scientific associations, as well as non-profit scientific institutions, public or private legal entities, associations of health scientists, and scientific unions, irrespective of legal form. These can be held in Greece or abroad, their entire program is exclusively of scientific content (medical/dental/pharmaceutical/nursing/public health/health services) and have a minimum duration of four (4) hours. EOF is entitled to conduct inspections during conferences or events via its own staff or in co-operation with the competent tax authorities and, where it verifies that its approval has been infringed in case the approved provisions are not observed, may suspend the organizing entity from future events for a period of two years. The same applies to cases where the ex post financial report reveals a serious overrun of the actual costs (over 25%) compared to the approved budget. Such decisions on the part of EOF are subject to appeal. SFEE may conduct inspections in scientific Type A events via its authorized officials or external associates, in order to verify compliance of member companies with the provisions of the present Code. The inspection results will be communicated to the SFEE First Degree Committee for the Observance of the SFEE Code of Ethics, which will take action in cases of non-compliance.
• On the other hand, Type B events are events aiming to inform on pharmaceutical products or other products falling under EOF’s jurisdiction, within the framework of their promotion, organized by companies falling under EOF’s authority. Companies falling under EOF’s Authority, may not apply for the organization of this type of events in collaboration with foreign entities (Private Universities or Hospitals). Healthcare Professionals practicing in University Clinics, NHS clinics, PEDY clinics etc. may not participate in promotional events (article 11 par. 18 L. 2889/2001 as amended by article 36 L. 4272/2014). EOF Circulars on the specific requirements and procedure to be followed by companies falling under the jurisdiction of EOF in view of participation of healthcare professionals in each of the above-mentioned event categories are constantly updated.

While supporting and encouraging the participation of healthcare professionals in scientific events sponsored by its members, SFEE advises its Member companies to be vigilant of both restrictive legal provisions, such as art. 16 of LD 96/1976, of art. 126,127 of CMD 2221/2013 of the Medical Code of Ethics (L. 3418/2005), and EOF as well as SFEE guidelines as regards their transfers of value to Healthcare Professionals (HCP) and Healthcare Organizations (HCO). According to the abovementioned legislation, any transfer of value, offer or promise of gifts, monetary benefit of benefits in kind to persons entitled to prescribe or provide medicinal products closely associated with daily HCP practice is not allowed, unless if such transfer of value, offer or promise of gift, monetary benefit of benefit in kind is of insignificant value, (i.e. up to EUR 15 per item, VAT included, according to art. 14.1. of the SFEE Code of Ethics). Failure to comply with the above rules entails disciplinary sanctions in accordance with the SFEE Code enforcement procedure (article 19 of said Code).

As regards the transfer of value (ToV) to Greek HCPs / HCOs by pharmaceutical companies, the disclosure obligation of the latter is twofold, stemming both from the law and the SFEE Code of Ethics. Art. 66 par. 7 L. 4316/2014 provides for the obligation of all pharmaceutical companies to proceed to the disclosure – in principle on an individual name basis – of all transfers of value towards Healthcare Professionals / Healthcare Organisations (HCPs/HCOs) on an annual basis within six months from the closure of each calendar year; this disclosure involves any and all transfers, namely any donations, grants, sponsorships, registration costs related to congresses or scientific events of any kind, travelling and accommodation expenses as well as any other transfer, either on a contractual basis or voluntary, related to the promotion of prescription medicines.

Any transfers related to a) market research, b) meals and drinks, as well as c) objects of insignificant value, i.e. not exceeding the amount of 15 Euro including VAT, of medical and/or educational use connected to the everyday practice of HCPs/HCOs [as provided for by virtue of Ministerial Decision ΔΥΓ3α/ΓΠ 32221/2013 Gov. Gazette B’ 1049] are explicitly excluded from the disclosure obligation by virtue of the same above legal provision.

The above provision also explicitly limits the disclosure obligation relevant to a) Research and Development, as well as b) Non-interventional clinical studies (with or without medicine administration) to disclosure on an aggregate basis.

The legal obligation for disclosure involves the posting of an individual / aggregate disclosure table / list including all the above categories of transfers made throughout the previous calendar year, by the end of June of the next year, both on the website of the pharmaceutical company and the website of EOF.

The disclosure obligation of EFPIA member companies is inscribed in largely the same terms in the SFEE Code of Ethics/Chapter B: Disclosure of Transfers of Value by Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations. As per article 1.1. General Disclosure Obligation of the above Chapter B, Subject to the terms of the present Code, each Member Company shall document and disclose on their website and on the EOF website platform, within six months of the end of each calendar year at the latest, individually by name all Transfers of Value it makes, directly or indirectly, to or for the benefit of a Recipient, as described in more detail in Article 3 … Article 1.2. excludes from the scope of the disclosure obligation any transfers of value that i) are solely related to over-the-counter medicines, ii) are not listed in article 3 of the Code, such as meals and drinks, medical samples and medical utility items of insignificant value as set out in art. 14 of the Code, explicitly limiting their value to 15 Euro including VAT, iii) are part of ordinary course purchases and sales by and between pharmaceutical companies and HCPs engaging in the business of medicine trading (such as pharmacists, wholesalers) and/or HCOs, ie financial transactions within the distribution chain of medicinal products.

Article 3 of Chapter B of the Code of Ethics provides for the different categories of ToV subject to disclosure, in principle, on an individual basis. Such ToV to HCOs include Donations and Grants, Sponsorships of Events and Fees for services and consultancy, while ToV to HCPs include event-related costs, such as registration fees and travel and accommodation expenses and fees for Services and Consultancy. Any ToV related to Research and Development are exceptionally subject to Aggregate Disclosure.

 

9. How is the manufacturing of medicines and devices regulated and by which agencies?

EOF, as the competent national regulatory authority is entrusted with a significant amount of powers in order

• to ensure that the legal requirements governing the manufacturing of medicinal products and medical devices are constantly met and
• to promote the post-marketing product quality, safety and efficacy of said products.

 

10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the US Food & Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?

Local manufacturing requirements are strictly following EU legislation. As a result, the established regulatory regime in Greece is expected to meet the requirements of the European Medicines Agency which constitutes the competent regulatory authority on European level.

 

11. What is the inspection regime for manufacturing facilities?

Each pharmaceutical company is required to monitor the safety of all medicines that it markets. In addition, pursuant to article 162 et seq. of the Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013, E.O.F. is competent to perform a wide range of inspections, such as, indicatively (a) inspections of manufacturing or commercial establishments and of any laboratories entrusted by the holder of the manufacturing authorization with the task of carrying out controls of third-country imported drugs pursuant to Article 32, (b) take samples, (c) examine any documents relating to the object of the inspection and (d) inspect the establishments, archives, documents, as well as the main archives of the pharmacovigilance system of the marketing authorization holder.

 

12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?

According to article 106(1) of Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013, holders of a wholesale distribution authorization must keep the premises, installations and equipment as well as any relevant documentation, particulars or books available for inspection by the competent authorities of EOF, of the Regional Administrations and of the Ministry of Health.

 

13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?

Requirements for packaging of medicines include the requirements for its labeling, as described below. The storage by pharmaceutical warehouses is regulated by Presidential Decree 88/2004 on the organization and operational standards of pharmaceutical warehouses.

With respect to medical devices, pursuant to articles 7.2 and 8.3 of Interministerial Decision DY8d/G.P. 130648/Government Gazette B’ 2198/2009, the devices must be designed, manufactured and packed in such a way as to minimize the risk posed by contaminants and residues to the persons involved in the transport, storage and use of the devices and to the patients, taking into account the intended purpose of the product. Particular attention must be paid to the tissues exposed and to the duration and frequency of exposure. Moreover, devices delivered in a sterile state must be designed, manufactured and packed in a non-reusable pack and according to appropriate procedures to ensure that they remain sterile until the time of their intended use.

 

14. What information must be included in medicine and device labeling?

Article 77 of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B 1049/2013, provides a list of particulars which shall appear on the outer packaging of medicinal products or, where there is no outer packaging, on their immediate packaging, namely:

1. the name of the medicinal product followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults; where the product contains up to three active substances, the international non-proprietary name (INN) shall be included, or, if one does not exist, the common name; the name must also be inscribed in Braille, pursuant to art. 81 of the Interministerial Decision.
2. a statement of the active substances expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names;
3. the pharmaceutical form and the contents by weight, by volume or by number of doses of the product;
4. a list of those excipients known to have a recognized action or effect and included in the guidelines published pursuant to Article 90. However, if the product is injectable, or a topical or eye preparation, all excipients must be stated;
5. the method of administration and, if necessary, the route of administration. Space shall be provided for the prescribed dose to be indicated;
6. a special warning that the medicinal product must be stored out of the reach and sight of children;
7. a special warning, if this is necessary for the medicinal product;
8. the expiry date in clear terms (month/year);
9. special storage precautions, if any;
10. specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products, where appropriate, as well as reference to any appropriate collection system in place;
11. the name and address of the marketing authorization holder and, where applicable, the name of the representative appointed by the holder to represent him;
12. the number of the authorization for placing the medicinal product on the market;
13. the manufacturer’s batch number;
14. in the case of non-prescription medicinal products, instructions for use;
15. for medicinal products other than radiopharmaceuticals, safety features enabling wholesale distributors and persons authorized or entitled to dispense medicinal products to the public to:

• verify the authenticity of the medicinal product, and
• identify individual packs, as well as a device allowing verification of whether the outer packaging has been tampered with.

Moreover, every medicinal product that circulates on the Greek market should have a safety thread affixed, according to article 78 of said Interministerial Decision.

Devices, other than devices which are custom-made or intended for clinical trials, must bear the CE marking of conformity when they are placed on the market. The CE marking of conformity, must appear in a visible, legible and indelible form on the device or its sterile pack, where practicable and appropriate, and on the instructions for use. Where applicable, the CE marking must also appear on the sales packaging (article 17 of Interministerial Decision DY8d/G.P. 130648/Government Gazette B’ 2198/2009).

 

15. What additional information may be included in labeling and packaging?

Pursuant to article 82 of the above Decision, labeling must also include the price of the medicinal product, the legal status for supply to the patient in accordance with Title VI (prescription or non-prescription medicine), as well as the recycling marking on the outer packaging.

Apart from the particulars listed above, the inclusion of a package leaflet in the packaging of the medicinal product is considered to be an obligatory element of the packaging, in accordance with article 83.

The package leaflet shall be drawn up in accordance with the summary of the product characteristics; it shall include, in accordance with article 84 of said Interministerial Decision, the following data in the below order:

a. for the identification of the medicinal product:

1. the name of the medicinal product followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults. The common name shall be included where the product contains only one active substance and if its name is an invented name;
2. the pharmaco-therapeutic group or type of activity in terms easily comprehensible for the patient;

b. its therapeutic indications;

c. a list of information which is necessary before the medicinal product is taken, taking into account particular characteristics of certain patient groups (children, pregnant or breast-feeding women, aged persons or persons with a particular pathology), namely:

1. contra-indications;
2. appropriate precautions for use;
3. forms of interaction with other medicinal products and other forms of interaction (e.g. alcohol, tobacco, foodstuffs) which may affect the action of the medicinal product;
4. special warnings;

d. the necessary and usual instructions for proper use, and in particular:

1. the dosage,
2. the method and, if necessary, route of administration;
3. the frequency of administration, specifying if necessary the appropriate time at which the medicinal product may or must be administered; and, as appropriate, depending on the nature of the product:
4. the duration of treatment, where it should be limited;
5. the action to be taken in case of an overdose (such as symptoms, emergency procedures);
6. what to do when one or more doses have not been taken;
7. indication, if necessary, of the risk of withdrawal effects;
8. a specific recommendation to consult the doctor or the pharmacist, as appropriate, for any clarification on the use of the product;

e. a description of the adverse reactions which may occur under normal use of the medicinal product and, if necessary, the action to be taken in such a case;

f. a reference to the expiry date indicated on the label, with:

1. a warning against using the product after that date;
2. where appropriate, special storage precautions;
3. if necessary, a warning concerning certain visible signs of deterioration;
4. the full qualitative composition (in active substances and excipients) and the quantitative composition in active substances, using common names, for each presentation of the medicinal product;
5. for each presentation of the product, the pharmaceutical form and content in weight, volume or units of dosage;
6. the name and address of the marketing authorisation holder and, where applicable, the name of his appointed representatives in the Member States;
7. the name and address of the manufacturer;

g. where the medicinal product is authorised in accordance with Articles 28 to 39 under different names in the Member States concerned, a list of the names authorised in each Member State;

h. the date on which the package leaflet was last revised.

The package leaflet must also include information on possible effects of the treatment on the ability to drive or use machinery.

The package leaflet includes without exception a standard text urging patients to notify their treating physician, pharmacist or any other healthcare professional or EOF of any suspected adverse effect of the medicine making use of the national adverse effect reporting system as outlined in Part XI, Chapter 3, Section 1, art. 143 of the Interministerial Decision; the text must indicate available reporting options (e-mail, post or other) in accordance with above art. 143.

 

16. What items may not be included in labeling and packaging?

Any other particulars than those exclusively listed above.

 

17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?

The advertising of traditional, herbal and homeopathic products directly to the public is subject to multiple restrictions and regulations mainly stipulated under Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B 1049/2013 (articles 118-132) jointly with legislative Decree 96/1973.

As a general rule, EOF prohibits any advertising of medicinal products which have not been granted a marketing authorization. This specific rule does not apply to homeopathic products, asprovided for in article 132 of said Interministerial Decision. However, only the information specified in Article 94(1) may be used in the advertising of such medicinal products.

Moreover, in accordance with article 120 of said Interministerial Decision, the only medicinal products that allowed to be advertised to the general public are those which, by virtue of their composition and purpose, are intended and designed for use without the intervention of a medical practitioner for diagnostic purposes or for the prescription or monitoring of treatment, upon advice by a pharmacist, if necessary. Pursuant to article 119 of said Decision, it is strictly prohibited to advertise medicinal products which: (a) are available on medical prescription only, (b) contain psychotropic or narcotic substances, such as those governed by the United Nations Conventions of 1961 and 1971, (c) are reimbursed by Social Security Institutions.

The direct advertising of OTC products is jointly regulated by Ministerial Decision Y6a/2261/Government Gazette B’ 284/2002 on the advertising of medicinal products that may be administered without prescription which stipulates further specifications to be followed depending on the media used.

The advertising of medical devices is is mainly regulated by article 22 of Interministerial Decision DY8d/G.P. 130648/Government Gazette B’ 2198/2009 which stipulates that the advertised device must accurately correspond to the intended use of the device.

Finally, it should be noted that Code of Ethics of the Hellenic Association of Pharmaceutical Companies (SFEE) provides specific guidelines on the advertising of medicinal products to the public. Therefore pharmaceutical companies active in Greece must also be vigilant as regards compliance with said rules.

 

18. Where can medicine and devices be sold or delivered? Can medicines and devices be sold or delivered via post?

With the exception of OTC medicinal products, prescription medicinal products and medical devices are dispensed through pharmacies, pursuant to article 4(1) of Law 1963/1991. The retail sale of medicinal products by pharmacies is also governed by Legislative Decree 312/1992 which regulates the organization and constitution of pharmacies at national level.

As regards the dispensation of OTC medicinal products, a distinction must be made between the general category of OTC medicinal products and ITS subcategory of General Dispensation Medicinal Products (Greek Acronym GEDIFA).

OTC products are exclusively dispensed through pharmacies, pursuant to article 4(1) of Law 1963/1991. The retail sale of medicinal products by pharmacies is also governed by Legislative Decree 312/1992 which regulates the organization and constitution of pharmacies at national level.

Medicinal Products (GEDIFA) are products already falling within the definition and classified as OTC products, which meet cumulatively the criteria set out in article 1(a) of Ministerial Decision G5(a) 51194/ Government Gazette B’ 2219/2016 in line with article 6 of Law 4389/2016. In general, GEDIFA products are medicines taken in response to obvious symptoms e.g. headache, nausea and the interactions of which with other frequently administered therapies are minimal.

Apart from their dispensation through legally operating pharmacies, OTC medicines may also be sold, in accordance with article 5 of said Decision, through retail shops of public health interest that have been authorized to operate as supermarkets or grocery stores.

The online sale and purchase by the public of prescription-only medicinal products is strictly prohibited. The online sale of all other medicinal products is permitted provided that it is carried out by lawfully operating online pharmacies (article 116 of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B 1049/2013).

 

19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?

Ministerial Decision Y6a/2261/Government Gazette B’ 284/2002 on the advertising of medicinal products that may be administered without contains specific provisions and requirements depending on the media used.

 

20. May medicines and devices be advertised or sold directly to consumer?

Please see the section Traditional Medicines and OTC products.

 

21. How is compliance monitored?

Compliance regarding the advertising of medicinal products is monitored by EOF. Among other requirements, the marketing authorization holder shall establish, within his undertaking, pursuant to article 130 of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B 1049/2013 a scientific service in charge of information about the medicinal products which he places on the market.

The marketing authorization holder shall also:

• keep available for, or communicate to, the authorities or bodies responsible for monitoring of the advertising of medicinal products, a sample of all advertisements emanating from his undertaking together with a statement indicating the persons to whom it is addressed, the method of dissemination and the date of first dissemination,
• ensure that advertising of medicinal products by his undertaking conforms to the requirements set out in the above article 130 of the Interministerial Decision 32221,
• verify that medical sales representatives employed by his undertaking have been adequately trained and fulfill the obligations imposed upon them by Article 93(2) and (3),
• supply the authorities or bodies responsible for monitoring advertising of medicinal products with the information and assistance they require to carry out their responsibilities,
• ensure that the decisions taken by the authorities or bodies responsible for monitoring the advertising of medicinal products are immediately and fully complied with.

 

22. What are the potential penalties for noncompliance?

Apart from the civil and criminal liability established by the legislation in force, any infringement of the provisions of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013 on medicinal products for human use may lead to the imposition of administrative fines up to a maximum amount of 100.000 €, in accordance with the provisions of Legislative Decree 96/1973. Moreover, specific provisions imposing administrative fines are laid down in Interministerial Decision DY8d/G.P. 130648/Government Gazette B’ 2198/2009 on medical devices.

 

Also from this Legal Handbook

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 of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, providing for the essential content of any application in view of marketing approval before the National Medicines Organization (E.O.F.), sets no such requirement as to the clinical trials related to the use of the medicinal product under approval.

 

2. How are clinical trials funded?

Clinical trials may either be funded by a private entity, including a pharmaceutical company, or by any entity not acting, directly or indirectly, on behalf of any entity belonging in the pharmaceutical industry. In the latter case, the clinical trial is defined as non – commercial and may be sponsored by either a university, public hospital, public scientific entity, non-profit organization, patients’ organization or independent researcher, in accordance with the provisions of Ministerial Decision G5(a)/59676 Government Gazette B 4131 2016 on clinical trials conducted on humans.

 

3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?

Clinical trials to be conducted in Greece are subject to scientific approval by the National Medicines Organization (E.O.F.) according to the procedure described in article 5 of Regulation EU 536/2014 on Clinical Trials, as well as ethical approval by the National Ethics Committee, as provided in Ministerial Decision G5(a) Government Gazette 4131 2016 on clinical trials conducted on humans. Key requirements specific to Greece include the obligation to file the application, the trial protocol, the information material destined to patients, the informed consent document, the labeling of the medicines to be administered, the patients’ cards, as well as the insurance contract required in the Greek language. The remaining elements of the file may be submitted in English, subject to any request by E.O.F. for those to be filed in official translation in Greek at any given time. As far as suitability of the persons conducting the trial are concerned, the main researcher of any trial conducted in Greece must be a clinical physician holding a permit to exercise the medical profession in Greece, never having been suspended, removed or revoked in the past. The same requirement must be met by all participating researchers.

While the examination of an application by E.O.F. focuses on the scientific aspects as listed in article 6 of Regulation EU 536/2014, the examination by the National Ethics Committee focuses on the aspects listed in article 7 Regulation EU 536/2014, namely the suggested procedure relevant to obtaining the participating patients’ informed consent, the participants’ compensation terms, the suggested recruitment procedure, as well as the respect of any rules applicable to the collection and storage for future use of the participants’ biological samples.

 

4. What are the requirements for consent by participants in clinical trials?

According to article 9 of Ministerial Decision G5(a)/59676 Government Gazette B 4131 2016 on clinical trials conducted on humans, participants’ informed consent must be supplied prior to their engagement in the trial in writing; it must be dated and signed by the main researcher or any member of the research time specifically authorized by the latter. Prior to giving the required consent, the candidate must have been informed by means of an interview, equally dated and signed by an authorized research member, in a language easily understandable by the candidate, who must also have been allowed the opportunity to ask any questions, as well as sufficient time to consider his/her decision. Deaf candidates must be informed in writing and offered the opportunity to raise any questions, which must also be answered in writing, before giving consent. The same opportunities must be allowed to dumb candidates, in addition to the opportunity to ask questions in writing. In the latter two cases, a witness capable of legal action and not associated with the clinical trial in any way must be present and sign all relevant documentation. In case the candidate may neither read nor write, both the information and the consent documents may be signed by the authorized research member and two witnesses capable of legal action and not associated with the clinical trial in any way.

Alternatively, consent may be recorded on suitable audiovisual media in the presence of one witness capable of legal action and not associated with the clinical trial in any way. The information provided to the candidates must be concise and easily accessible by non-experts, as well as sufficient as regards i) the nature, purposes, potential benefits, consequences, dangers and unpleasant effects of the clinical trial, ii) the participant’s rights and the warranties in view of their protection, iii) the procedure of the clinical trial, including the expected duration of participation in the latter, iv) alternative treatments, including monitoring measures, should participation in the clinical trial be terminated. Information relevant to the insurance policy of the sponsor covering any liability associated with the clinical trial must also be included in the information provided to the candidate in view of obtaining informed consent. Article 10 of Ministerial Decision G5(a)/59676/2016 provides for minor candidates, as well as candidates incapable of legal action, whose informed consent must always be sought to the extent that they are able to realize the implications of their participation in the trial. Specifically, consent must be obtained in the cases of both minor candidates of a minimum 10 years of age and candidates incapable of legal action in a position to understand the potential benefits and dangers associated to the trial; in both cases the consent of the parents or any legal representative of the concerned candidates must also be obtained. In both cases, the express desire of the candidate not to participate in or withdraw from the clinical trial is binding.

 

5. May participants in clinical trials be compensated?

Compensation of the participants in a clinical trial is not excluded by law. However, the amount of compensation is included among the items of the application in view of approval of the trial and as such examined by the National Ethics Committee, as provided in article 20 of Ministerial Decision G5(a)/59676/2016. The latter must establish prior to approval of any compensation of the participants that no unfair influence, among others of an economic nature, has been exercised on the participants in order to participate in the clinical trial, as provided in article 28 of Regulation EU 536/2014.

 

6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?

By virtue of article 15 of Ministerial Decision G5(a)/59676/2016, the sponsor of any clinical trial must enter into an insurance contract with a trustworthy insurance company seated in an EU member state, covering any liability which might arise in the persons of the sponsor, the main researcher, as well as of the members of the research team. As far as clinical trials conducted in research centers situated in Greece are concerned, the insurance must cover any potential damages due to injuries or disabilities which may be incurred as a result of the participation therein, and shall amount to a minimum of 300,000.00 € per participant in the event of death or permanent incapacity to work.

All medicines administered, medical devices used and procedures followed throughout the clinical trial, including the diagnosis and treatment of any adverse reactions, are provided by the sponsor at no cost of the research centre, the participant or the public insurance fund of the latter. The above costs entirely undertaken by the sponsor include the cost of exceptional travel expenses incurred by participants to and from the research centre for safety reasons, travel expenses to and from specialized diagnostic centres in view of specialized diagnostic examinations either according to the trial protocol or in the event of any adverse reaction in the context of the trial. Any clause of the consent document contrary to the above is considered to be null and void regardless of any decision or note to this effect made by either E.O.F. or the National Ethics Committee in the context of examination of the approval application as to the present requirement.

 

Also from this Legal Handbook

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 of the Ministry of Health by virtue of Law 1316/1983, constitutes the main national regulatory authority with regard to medicinal products for human and veterinary use, drugs, foodstuffs intended for particular nutritional uses and food supplements, biocides, cosmetics and medical devices in Greece.

Within the framework of its mission to ensure public health and safety, E.O.F., in co-operation with the European Union, is endowed with the following powers:

• Evaluates and authorizes new, safe and efficient health – related products.
• Monitors the post-marketing product quality, safety and efficacy.
• Monitors product manufacturing procedures, clinical studies and the marketing of products, in order to ensure compliance with good manufacturing, laboratory and clinical practice, as well as with the existing legislation regarding the marketing, distribution, commercialization and advertising of the products.
• Develops and promotes medical and pharmaceutical research.
• Provides health scientists, competent authorities, and the general public with objective and useful information regarding medicines (for human or veterinary use) and other products, in order to ensure their rational use and provide an assessment of their cost-effectiveness.

 

2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?

The regulatory framework for the authorization of pharmaceutical products is mainly governed by Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B 1049/2013 issued in application of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use as in force and amended by Directive 2011/62/EU as regards the prevention of the entry into the legal supply chain of falsified medicinal products read together with Legislative Decree 96/1973, as currently in force.

Furthermore, pricing and reimbursement of pharmaceutical products falls within the scope of Ministerial Decision No. G5(a) 90552/Government Gazette B 3890/2016 on the setting of pharmaceutical prices, as amended by Ministerial Decisions G5(a) 97012/Government Gazette B 4215/2016 and G5(a) 11601/Government Gazette B 445/2017. It should be noted that in light of provision 17 of Legislative Decree 96/1973, the maximum retail, wholesale, hospital and ex-factory price, as well as any other special sale price of medicinal products – with the exception of non-prescription medicinal products- are defined by the relevant Price Bulletins, issued twice a year by the Minister of Health and uploaded to the official website of the Ministry of Health, following an opinion provided by E.O.F.

The field of medical devices is mainly regulated by Interministerial Decision DY8d/G.P. 130648/Government Gazette B’ 2198/2009, issued in application of Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Directives 98/79/EC, 2000/70/EC, 2001/104/EC, 2007/47/EC and Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003.

The general standards for the good production and control of medical devices are laid down in Decision 6209 of E.O.F.’s Board of Directors (published on Government Gazette B’/199/06.02.2009).

Several Interministerial and Ministerial Decisions in force govern specific types of Medical Devices, such as, indicatively, Interministerial Decision DY8d/130644/Government Gazette B’ 2197/2009 issued in application of Directive

90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices and Interministerial Decision DY8d/G.P. 3607/Government Gazette B’ 1060/2001 issued in application of Directive 98/79/EC on in vitro diagnostic medical devices.

However, it should be noted that on 5 April 2017, two new European Regulations on medical devices were adopted and entered into force on 25 May 2017. These Regulations will eventually replace the existing Directives as on medical devices. More specifically:

• Regulation (EU) 2017/745of the European Parliament and of the Council of 5 April 2017 on medical devices, was adopted in substitution of Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009, also repealing Council Directives 90/385/EEC and 93/42/EEC and
• Regulation (EU) 2017/746of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices repeals Directive 98/79/EC as well as Commission Decision 2010/227/EU.

The above mentioned new European legislation will become effective after a transitional period, namely 3 years following entry into force of the Regulation on medical devices (26.05.2020) and 5 years following entry into force of the Regulation on in vitro diagnostic medical devices (26.05.2022). It may be noted that the new Regulations provide for the validity of existing certificates issued under the Directives and Interministerial Decisions currently in force for a term following the progressive entry into force of the EU Regulations, as provided therein..

 

3. What are the steps to obtain authorization to develop, test, and market a product?

Manufacture Authorization

The specific procedure to be followed is mainly laid down in Interministerial Decision D.YG3α/G.P.32221/Government Gazette B’ 1049/2013 on the manufacture and marketing of medicinal products for human use. More specifically, the process of manufacture of medicinal products is stipulated under section IV of the aforesaid Interministerial Decision. By virtue of article 57 thereof, the manufacture of medicinal products in Greece is subject to a relevant authorization granted by E.O.F.

According to the same provision this manufacturing authorization shall be required notwithstanding that the medicinal products manufactured are intended for export. The minimum requirements to be met by the applicant are listed in article 58, which provides that the applicant must in particular:

1. Specify the medicinal products and pharmaceutical forms to be manufactured or imported and also the place of manufacture and the necessary controls;
2. Have at their disposal, for the manufacture or import of the above, suitable and sufficient premises, technical equipment and control facilities complying with the legal requirements as regards both manufacture and control as well as storage of medicinal products;
3. Have at their disposal the services of at least one qualified person within the meaning of Article 68. Attention must be paid to the fact that the applicant shall provide particulars in support of the above in the application.

Pursuant to article 57(3) of said Interministerial Decision, authorization referred to in the above paragraph is also required as regards imports coming from third countries into Greece.

Testing Authorization

A specific prior authorization process must also be strictly followed in view of testing, namely in order to conduct a clinical trial of the medicinal product. In accordance with the provisions of Chapter II of Regulation (EU) No 536/2014 on Clinical Trials, as well as those of Greek Interministerial Decision No. G5α/59676/Government Gazette B’ 4131/2016 on clinical trials conducted on humans, clinical trials are subject to a specific procedure of review and authorization performed by E.O.F., as described under article 3 thereof (and below under question 18 of Preclinical and Clinical Trial Requirements).

Marketing Authorization

In line with EU legislation, four different procedures may alternatively be followed in view of obtaining marketing authorization in Greece, namely:

• The Centralized Procedure. Marketing authorizations granted under the “centralized procedure” allow the marketing-authorization holder to market the medicine and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorization. Such authorization is granted by the European Commission following the scientific assessment of the application by the European Medicines Agency. The centralized procedure is laid down in Regulation (EC) No 726/2004
• The mutual recognition process. This process is stipulated under articles 45-46 of the Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013. To be eligible for the mutual recognition procedure, a medicinal product must have already received a marketing authorization at least in one EU country. In this case an application for mutual recognition may be addressed to one or more EU countries. The applications submitted must be identical, and all EU countries notified accordingly. The country charged with evaluating the application or Reference Member State notifies the other Concerned Member States. The Reference Member State is then charged with deciding on the product.

This evaluation process may take up to 210 days, and ends with the granting of a marketing authorization in the EU country of application. The Concerned Member States then have 90 days to acknowledge the decision of the Reference Member State, including the summary of product characteristics, labelling and packaging. National marketing authorizations are granted within 30 days.

• The decentralized procedure. This procedure introduced by Directive 2004/27 is provided for under article 47 et seq. of Interministerial Decision D.YG3α/G.P. 32221. It allows the common assessment of an application submitted simultaneously to several Member States. One of the Member States will take the lead in evaluating the application as reference Member State. At the end of the procedure, the draft assessment report, SPC, labelling and package leaflet, as proposed by the Reference Member State, are approved by the other (concerned) Member States.
• The National authorization. According to article 7 of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013, authorization to placea medicinal product on the market may also be obtained by virtue of an application to E.O.F. as national regulating authority. Said public entity is charged with ensuring all appropriate measures are taken in order for the procedure to be finalized within 210 days of the submission of a valid application (article 29 of the named Interministerial Decision).

The application shall be accompanied by a list of particulars and documents concerning the specific medicinal product, including –but not limited to- (a) name or corporate name and permanent address of the applicant and, where applicable, of the manufacturer, (b) name of the medicinal product, (c) qualitative and quantitative particulars of all the constituents of the medicinal product, with mention of the international non-proprietary name recommended by the World Health Organization where such name exists or reference to the relevant chemical name, (d) description of the manufacturing method, (e) therapeutic indications, contra-indications and adverse reactions, (f) Posology, pharmaceutical form, method and route of administration and expected shelf life, (g) If applicable, reasons for any precautionary and safety measures to be taken for the storage of the medicinal product, its administration to patients, as well as for the disposal of waste products, together with an indication of any potential risks to the environment associated with the medicinal product, (h) Description of the control methods employed by the manufacturer (i) Results of physico-chemical, biological or microbiological tests, toxicological and pharmacological tests of the product under examination etc.

 

4. What are the approximate fees for each authorization?

Pursuant to article 1 of Interministerial Decision DYG3(a)/171107/Government Gazette B’/2689/2008, the relevant payable fee depends on the type of application and necessarily of the concerned medicinal product.

A complete file of scientific documents must be submitted along with the respective fee:

• For a new or known active substance (complete file) – €20,000;
• If the license is based on related literature combined with the applicant’s studies – €20,000; and
• If the license is founded upon well-established medicinal use – €18,000.

A complete file of scientific documents is not required to be submitted (simplified application) if:

• The application for marketing authorization does not fall within the definition of a ‘generic’, with reference as opposed to the so-called product reference product – €20,000;
• The application for marketing authorization for a generic product has the same pharmaceutical form and content to the reference product and only a bio-equal potentiality study is required – €14,000;
• The application for marketing authorization for a generic product has the same pharmaceutical form and content to the reference product without requiring a bio-equal potentiality study – €9,000;
• The request for authorization is submitted following concession for the use of the data of an already approved drug – €5,000.
• The payable fee for a marketing authorization if the application is based on a combination of known active substances is €20,000.

 

5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?

According to article 40 of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013, as a general rule a marketing authorization is valid for five years and may be renewed , on application by the holder and upon new risk-benefit assessment by E.O.F. following the submission of a dossier containing the particulars listed under paragraph 2 of the same article at least nine months before the initial expiry date. After its renewal, the authorization is in principle rendered unlimited, unless otherwise justifiably decided by E.O.F.

Attention must be paid to the fact that paragraphs 4 and 5 of the same article introduce a double exception to the above general rule. These exceptions provide that the authorization is no longer valid and is ipso jure recalled by virtue of a relevant confirmatory act of E.O.F in the following circumstances, i.e. (a) if the authorized medicinal product is not placed on the market within a three-year period after the grant of its authorization or (b) if a medicinal product having been placed on the market following its authorization becomes unavailable for a consecutive three-year period.

 

6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?

Regarding generic products, the Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013 provides for a procedure slightly different from the standard authorization process as described above. More specifically, in derogation of article 9 (3) (i) and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of preclinical and clinical trials if he can demonstrate that the product is generic of a reference product which was granted marketing authorization within the EU at least 8 years ago. However, the generic product is not authorized to be marketed before the lapse of a ten-year period as of the authorization date of the reference product.

The definitions of both generic and reference products are provided by the Interministerial Decision itself. If a product does not fall within the scope of the respective stipulated definition in light of the bioequivalence study data available and required to be submitted in support of the application, the applicant must prove bioequivalence on the basis of data obtained through appropriate preclinical and clinical trials.

The marketing authorization process does not differ between local and foreign-owned manufacturers as long as they are established in the European Union. More specifically, according to article 9(2) of the above Interministerial Decision, marketing authorization may only be granted to an applicant established in the European Community.

 

7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug +biologic + device) regulated?

According to Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013 the definition of medicinal product covers any substance or combination of substances suitable for treating or preventing disease in human beings. Furthermore, the definition of substance refers to any matter irrespective of origin which may be either human, e.g. human blood and human blood products; animal, e.g. micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products; vegetable, e.g. micro-organisms, plants, parts of plants, vegetable secretions, extracts or chemical, e.g. elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis.

Given the wide scope of the above definitions, the combination products of drug + drug and drug + biologic are governed by the aforesaid Interministerial Decision D.YG3α/G.P. 32221. Moreover, the combination products that include medical devices are in addition regulated by the above mentioned Interministerial Decision DY8d/G.P. 130648/Government Gazette B’ 2198/2009 on medical devices, Interministerial Decision DY8d/130644/Government Gazette B’ 2197/2009 on active implantable medical devices and Interministerial Decision DY8d/G.P. 3607/Government Gazette B’ 1060/2001 on in vitro diagnostic medical devices.

 

8. How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?

As Greece constitutes an EU Member State, the Greek regulatory regime is expected to meet the requirements of the European Medicines Agency. E.O.F. as the competent national regulatory authority is entrusted with a significant amount of powers in order to ensure that the legal requirements governing medicinal products are constantly met and to promote the post-marketing product quality, safety and efficacy.

Each pharmaceutical company is required to monitor the safety of all medicines that it markets. In addition, pursuant to article 162 et seq. of the Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013, E.O.F. is competent to perform a wide range of inspections, such as, indicatively (a) inspections of manufacturing or commercial establishments and of any laboratories entrusted by the holder of the manufacturing authorization with the task of carrying out controls of third-country imported drugs pursuant to Article 32, (b) take samples, (c) examine any documents relating to the object of the inspection and (d) inspect the establishments, archives, documents, as well as the main archives of the pharmacovigilance system of the marketing authorization holder.

Moreover, E.O.F. is charged with taking all appropriate steps to ensure that (a) the manufacturing processes adopted in view of the manufacture of immunological products are properly validated and attain batch-to-batch consistency and (b) the holder of the marketing authorization for a medicinal product and, where appropriate, the holder of the manufacturing authorization, furnish proof of the controls carried out on the medicinal product and/or the ingredients and of the controls carried out at an intermediate stage of the manufacturing process, in accordance with the methods laid down in Article 9(3)(h).

Lastly, according to articles 168-169 of the aforesaid Interministerial Decision, E.O.F. is entitled (a) to suspend or revoke or modify an authorization to place a medicinal product on the market and (b) to prohibit the supply of a medicinal product and withdraw a medicinal product from the market under the specific conditions alternatively stipulated therein.

 

9. What is the potential range of penalties for noncompliance?

Apart from the civil and criminal liability established by the legislation in force, any infringement of the provisions of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013 on medicinal products for human use may lead to the imposition of administrative fines up to a maximum amount of 100,000 €, in accordance with the provisions of Legislative Decree 96/1973.

Moreover, specific provisions imposing administrative fines are laid down in Interministerial Decision DY8d/G.P. 130648/Government Gazette B’ 2198/2009 on medical devices, Interministerial Decision DY8d/130644/Government Gazette B’ 2197/2009 on active implantable medical devices, as well as Interministerial Decision DY8d/G.P. 3607/Government Gazette B’ 1060/2001 on in vitro diagnostic medical devices.

 

10. Is there a national healthcare system? If so, how is it administered and funded?

The Greek national health system was intended to guarantee the provision of healthcare services through a network of public/state providers and contracted private providers of primary, hospital and ambulatory health care with the aim to ensure disease prevention and the promotion, preservation, improvement, recovery and protection of citizens’ health. The presence of private providers is stronger in primary health care, especially as regards the provision of diagnostic services, but also as regards the provision of medical services by independent physicians and private clinics, either contracted by the National Healthcare Services Provider (EOPYY) or not.

The system is co-financed by means of the State, social insurance contributions and private payments. EOPYY (Greek acronym for National Organization for the Provision of Healthcare Services) was established in 2012 by virtue of Law 3918/2011 (article 17) and is under the control of the Greek Ministry of Health. EOPYY is exclusively responsible for negotiating, contracting and remunerating public/state and private contracted healthcare providers, covering the healthcare costs for over 95% of the population including the vulnerable social groups such as the unemployed and uninsured, refugees etc.

Additionally, EOPYY holds a number of statutory designations at EU level, namely, as the Greek liaison body for the reimbursement of sickness benefits in kind according to the Regulation (EC) 883/2004, the competent institution of the place of stay or residence, is a member of the European Healthcare Fraud and Corruption Network (EHFCN) and works closely with EU agencies and authorities on various health issues.

Primary Healthcare is provided by:

• EOPYY-contracted private healthcare providers (doctors, diagnostic centers, private clinics, chronic hemodialysis units)
• PEDΙ (National Primary Healthcare Network) Units
• State hospitals, health centers, rural and regional medical units of the National Health System (Greek acronym: ESY)
• Purely private healthcare professionals, not contracted with EOPYY but paid entirely by patients.

Hospital Healthcare is provided by:

• EOPYY – contracted private clinics.
• State hospitals of the National Healthcare System (ESY), free of charge as regards healthcare services within the national health benefits basket.
• Private hospitals and clinics.

 

11. How does the government (or public) healthcare system function with private sector healthcare?

The National Organization for the Provision of Healthcare Services (Greek acronym: EOPYY) negotiates contracts and remunerates healthcare professionals on the basis of a Health Benefits Regulation (Greek acronym EKPY) prescribing the benefits basket for the beneficiaries of the system.

The healthcare benefits basket includes, under various specific conditions:

• medical treatment
• diagnostic/laboratory/clinical tests
• dental treatment
• physiotherapy, occupational therapy, speech therapy, psychotherapy
• medication, consumables, dietary supplements, medical devices
• hospital treatment
• supplementary healthcare (orthopedics, eyeglasses, hearing aids, prosthetics etc)
• long-term care
• obstetric care and ivf
• healthcare abroad
• vaccination programs

Contracted private doctors must respect a limit of 200 patients’ visits per month, which may be remunerated by EOPYY, so one will be required to pay privately when visiting a contracted doctor who has reached the 200-consultation ceiling for the particular month.

Any doctor may provide referral for hospital treatment. Although healthcare within the framework of the national healthcare benefits basket is provided free of charge by the public/state providers, the insured patient is expected to participate in the charge, paying for a certain varying percentage of the total cost when opting for contracted private hospital healthcare providers.

 

12. Are prices of drugs and devices regulated and, if so, how?

Prescription Medicinal Products

Pricing and reimbursement of pharmaceutical products falls within the scope of Ministerial Decision No. G5 (a) 90552/Government Gazette B 3890/2016 on the setting of pharmaceutical prices, as amended by Ministerial Decisions G5 (a) 97012/Government Gazette B 4215/2016 and G5(a) 11601/Government Gazette B 445/2017. According to Article 5 of MD 90552/2016 prices of all medicinal products are revised twice a year and the price bulletins are issued in May and November of each year. Such price bulletins setting the maximum prices of medicinal products, are issued by the Minister of Health, following the recommendation of E.O.F.

Prior to its recommendation to the Minister of Health, EOF posts the Price Bulletin on its website. Anyone having legitimate interest may submit comments on the Price Bulletin before EOF in the event of a manifest error, within 3 business days as of the following day of the post of the Price Bulletin on EOF’s website. Following this, EOF conducts a 5-day consultation and finally submits its proposal to the Minister of Health. The Price Bulletin is issued by the Minister of Health and posted on the website of the Ministry of Health. Anyone having legitimate interest may appeal the decision of the Minister of Health within 5 days as of the following day of the issuance of said decision and its post on the Ministry’s website. Such an appeal is submitted before EOF. By virtue of a Ministerial Decision, following EOF’s opinion, the appeals submitted are rejected or accepted and a revised Price Bulletin is issued, which is posted on the Ministry’s website and enters into force as of the day of its post, as regards its amended part. 

OTC Medicinal Products

Unlike prescription medicines, the pricing of the non-prescription medicines or the so-called “over-the-counter medicinal products” (hereinafter referred to as “OTC medicinal products”) has recently been released to a certain extent. More specifically, according to article 2(3) of Interministerial Decision G5(a) 38152/Government Gazette B 1761/2017, the indicative retail price of OTC medicines, determined on the basis of the average of the three lowest prices of the same medicinal product in three EU member states, is not compulsory for those entitled to market the OTC product. As a result, the latter can freely determine their pricing policy as to the OTC medicinal products, despite the fact that the indicative –but non-compulsory- retail price is determined according to the above criteria. For the determination of prices for reference medicinal products, EOF’s competent department conducts a research with EU member states’ competent authorities, or other official and reputable State or European institutions providing similar data,. Moreover, it should be noted that pursuant to article 5(5) of Law 4558/2018 which recently entered into force, the indicative retail price of OTC medicinal products should no longer appear on the packaging of the product∙ this measure may be regarded as a further step towards the liberalization of OTC medicinal products’ prices.

 Medical Devices

Pricing of medical devices is accordingly regulated pursuant to article 108 of Law 4461/2017, as amended by Law 4472/2017. More specifically, according to said provision, the maximum price of the medicinal product is determined on the basis of the average of the three lowest prices in EU member states. The importer-manufacturer-representative of each medicinal product must submit a statement with E.O.F. solemnly declaring the above.

 

13. How are drugs and devices used by patients paid for? What roles do public and private payers play?

As a general note, pursuant to article 38 of Law 4025/2011 patient undertakes a participation of 25% price of the medicinal product, when the latter is prescribed by EOPYY – contracted private doctors or hospitals.

However, certain patients’ groups, such as –indicatively- the chronically ill, pregnant women, vulnerable groups, patients with a maximum taxable income of 1,200 € are entitled to receive medicines free of charge or pay a reduced participation. Pursuant to article 26 of Law 4549/2018 the contribution of patients belonging to the above –mentioned vulnerable groups may be reduced to none if the patient is supplied with a generic product.

 

14. Who dispenses drugs and devices to patients and how are those dispensers compensated?

With the exception of OTC medicinal products, prescription medicinal products and medical devices may be prescribed to patients by either EOPYY – contracted private doctors, private doctors or hospital doctors and they are dispensed through pharmacies, pursuant to article 4(1) of Law 1963/1991. The retail sale of medicinal products by pharmacies is also governed by Legislative Decree 312/1992 which regulates the organization and constitution of pharmacies at national level.

In this regard, it should also be noted that:

• The retail sale through pharmacies of medicinal products and medical devices other than those exclusively listed in article 1(1) and 1(2) of the above Legislative Decree or in any other specific provisions of law and/or Ministerial Decisions is strictly prohibited.
• In line with Ministerial Decision D3(a) 46627/Government Gazette B 2285/2018 every pharmacy should possess stock of at least one package of generic product per each therapeutic class containing the active substances listed at the beginning of each year by IDIKA S.A.

As regards the dispensation of OTC medicinal products and of the so-called Products of General Dispensation (which constitute a sub-category of OTC products – Greek Acronym: ΓΕΔΙΦΑ) – see the section Traditional Medicines and OTC products.

Furthermore, the pharmacies’ reimbursement is covered partly by the patients’ contribution of (as a general rule) 25% of the product’s price and partly by the competent Social Insurance Institution covering the patients’ insurance, also contracted with the pharmacy, according to Law 3918/2011.

 

15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?

The Hellenic Code of Pharmaceutical Ethics provides for numerous professional and legal responsibilities borne by pharmacists. Among others, according to article 21 thereof a pharmacist must check whether the prescribed product to be dispensed meets legal specifications. Furthermore, while dispensing a medicinal product a pharmacist must provide the patient with clear directions for its use and reassure the avoidance of possible errors throughout its use, in line with article 20 of said Code.

It is acknowledged that dispensing patients with medicinal products alone does not suffice in order to achieve the goals of the adopted treatment. To address these medication – related needs, pharmacists must embrace their key role behind a successful treatment, as well as their responsibility in providing patients with enhanced services. According to the Code of Pharmaceutical Ethics, a pharmacist must provide any patient with assistance to the extent of his/her knowledge∙ it is therefore clear that the pharmacist’s contribution in guaranteeing high public health standards is of great importance.

In the event of non – compliance a pharmacist’s disciplinary liability may be established pursuant to article 34 of said Code of Ethics. Moreover, according to the same article a pharmacist may also be liable at civil, administrative and criminal level, in accordance with the legislation in force.