Marketing, Manufacturing, Packaging & Labeling, Advertising
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?
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.
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:
- have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance;
- maintain and make available on request a pharmacovigilance system master file;
- operate a risk management system for each medicinal product;
- 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;
- 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:
- 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.
- 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;
- the pharmaceutical form and the contents by weight, by volume or by number of doses of the product;
- 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;
- the method of administration and, if necessary, the route of administration. Space shall be provided for the prescribed dose to be indicated;
- a special warning that the medicinal product must be stored out of the reach and sight of children;
- a special warning, if this is necessary for the medicinal product;
- the expiry date in clear terms (month/year);
- special storage precautions, if any;
- 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;
- the name and address of the marketing authorization holder and, where applicable, the name of the representative appointed by the holder to represent him;
- the number of the authorization for placing the medicinal product on the market;
- the manufacturer’s batch number;
- in the case of non-prescription medicinal products, instructions for use;
- 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:
- 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;
- 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:
- appropriate precautions for use;
- 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;
- special warnings;
d. the necessary and usual instructions for proper use, and in particular:
- the dosage,
- the method and, if necessary, route of administration;
- 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:
- the duration of treatment, where it should be limited;
- the action to be taken in case of an overdose (such as symptoms, emergency procedures);
- what to do when one or more doses have not been taken;
- indication, if necessary, of the risk of withdrawal effects;
- 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:
- a warning against using the product after that date;
- where appropriate, special storage precautions;
- if necessary, a warning concerning certain visible signs of deterioration;
- 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;
- for each presentation of the product, the pharmaceutical form and content in weight, volume or units of dosage;
- the name and address of the marketing authorisation holder and, where applicable, the name of his appointed representatives in the Member States;
- 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.