CODE OF PRACTICE FOR ADVISING, INTRODUCING AND INFORMING ON PRESCRIPTION MEDICINES

as adopted by the General Assembly in Ljubljana, June 2008

Index
ADMINISTRATION OF THE CODE
INTRODUCTION
SCOPE OF CODE PROVISIONS
PROVISIONS OF THE CODE
1. MARKETING
2. PROMOTION
3. QUALITY OF INFORMATION
4. GIFTS
5. SPONSORSHIP OF HEALTCHARE                                                       PROFESSIONALS                                                                                                                                                                                                                                           6. DONATIONS AND GRANTS THAT SUPPORT HEALTHCARE OR RESEARCH
7. COMPENSATIONS FOR SERVICES
8. THE USE OF CONSULTANTS
9. NON-INTERVENTION CLINICAL TRIALS OF MEDICINES
10. PERSONS EMPLOYED IN PHARMACEUTICAL
PROMOTIONAL ACTIVITIES
11. DRUG SAMPLES
12. SANCTIONS
13. RESPONSIBILITY
14. SUPERVISION
15. COMPLAINTS
16. AMENDMENTS

ADMINISTRATION OF THE CODE

The Forum of International Research & Development Pharmaceutical companies, EIG (hereinafter: the FORUM) is establishing adequate procedures for ensuring that its member companies comply with the requirements of the European (as adopted by the European Federation of Pharmaceutical Industries and Associations (hereinafter: EFPIA) and the relevant national Code (Code of Informing and Reporting on Prescription Medicines; hereinafter: the Code) and for dealing with any complaints as to non-compliance which may be made.
For this purpose, the FORUM is establishing a Committee for the supervision of the provisions of ethical codes (hereinafter: the Committee), the members of which are independent experts in individual areas with adequate expert knowledge, and the representatives of the FORUM.
The FORUM is establishing a Committee to oversee the working of the Code and to make recommendations for any changes in the Code, or in the procedures adopted for its operation, which it considers necessary.
The FORUM has set up a Committee to evaluate drug information and which acts as a voluntary and self-regulating control body for all members of the Association.

INTRODUCTION

The main responsibility of the Pharmaceutical Industry is to develop new and efficient medicinal products, to improve existing medicinal products, and to provide reliable information about these products so that they will be of use to the individual patient.

The Industry, therefore, in addition to other marketing activities for such products, should organise professional meetings and contribute to the continuous improvement of the level of competency in the public health service. Such events are to be characterised by a high professional quality, and otherwise be of a moderate standard.

The marketing of medicinal products will be carried out in accordance with the following national and international rules:
1. All members of the FORUM have a duty to comply with the valid Medicinal Products Act and other applicable laws. All pharmaceutical companies have a duty to provide health care professionals (HCPs) with relevant, reliable and adequate information about the drugs they market.

2. The Rules are based on the set of rules adopted by the EFPIA which is the representative body for the European pharmaceutical industry and to which the FORUM is affiliated. EFPIA Code on the Promotion of Prescription-Only Medicines to, and Interactions with, Healthcare Professionals was adopted to bring them into full accord with Council Directive 2001/83/EC of November 2001, amended in 2004 by Council Directive 2004/27/EC. In addition to this, the FORUM members are obliged to respect the provisions of the valid Slovene laws for marketing, advertising and advising on medicines.

3. The FORUM encourages competition among pharmaceutical companies. The FORUM Code is not intended to restrain the promotion of medicinal products in a manner that is detrimental to fair competition. Instead, it seeks to ensure that pharmaceutical companies conduct such promotion in a truthful manner, avoiding deceptive practices and potential conflicts of interest with healthcare professionals, and in compliance with applicable laws and regulations. The FORUM Code thereby aims to foster an environment where the general public can be confident that choices regarding their medicines are being made on the basis of the merits of each product and the healthcare needs of patients.

SCOPE OF CODE PROVISIONS

The Rules apply to every form of marketing. This entails all information and sales promotion activity carried out by, or on behalf of, a manufacturer of medicinal products, and in a form that is designed to influence the prescription, turnover, sale and consumption of the company’s drugs.

The FORUM Code covers the promotion to healthcare professionals of prescription-only medicinal products. “Promotion”, as used in the FORUM Code, includes any activity undertaken, organized or sponsored by a pharmaceutical company, or with its authority, which promotes the prescription, supply, sale, administration or consumption of its medicinal product(s). The FORUM Code covers promotional activity and communication directed not only to doctors but also those directed towards any member of the medical, dental, pharmacy or healthcare professions or any other person who in the course of his or her professional activities may prescribe, purchase, supply or administer a medicine (each, a “healthcare professional”).
The FORUM Code is not intended to restrain or regulate the provision of non-promotional medical, scientific and factual information; nor is it intended to restrain or regulate activities directed towards the general public which relate solely to non-prescription only medicines.
The Rules do not apply to:
- labels and packaging enclosures, of special product descriptions approved on the issue of a marketing license;

- correspondence, and any other material of a non-marketing nature, needed to reply to specific questions about a specific pharmaceutical product;

- specific and informative public notifications concerning, for example, new packaging, warnings of possible side-effects, as well as product catalogues and price lists, provided that these do not contain any product information;
- non-promotional information relating to human health or diseases;
- activities which relate solely to non-prescription only medicinal products;
- non-promotional, general information about companies (such as information directed to investors or to current/prospective employees), including financial data, descriptions of research and development programmes, and discussion of regulatory developments affecting the company and its products.

PROVISIONS OF THE CODE
1. MARKETING

1.1. A medicinal product must not be advertised prior to the grant of the marketing authorisation.

1.2. All parts of the promotion must be consistent with the particulars listed in the summary of product characteristics and be restricted to approved indications.

1.3. Subject to applicable national laws and regulations, all promotional material must include the following information clearly and legibly:
(a) essential information consistent with the summary of product characteristics, specifying the date on which such essential information was generated or last revised;
(b) the supply classification of the product and dispensing regime.
1.4. Compliance with the provisions of clause 1.3 above is not required if the promotion material, advert or gift is only intended to serve as a reminder, provided the advert only contains the name of the product, the generic name of the components, and the name of the marketing agent.

2. PROMOTION

2.1. PROMOTION
a) Pharmaceutical information shall be exact, balanced, truthful and objective, and sufficient to enable the recipient to form an opinion about the therapeutic value of the product in question. The information should be based on the most recent evaluation of all relevant material and should clearly reflect this material. The information shall not be misleading as a result of distortions, exaggerations, incorrect assertions, omissions etc.

b The word “safe” shall never be used without making appropriate qualification.

c) The word “new” must not be used to describe any product or presentation which has been generally available or any therapeutic indication which has been generally promoted for more than one year from the date of launch to the Slovene market.

d) It shall never be claimed that a drug is free of side effects, toxic hazards or that there is no risk of addiction.

e) When marketing material makes reference to published surveys, they shall be reproduced correctly and clear reference should be given.

f) Promotion must be capable of substantiation which must be promptly provided in response to reasonable requests from healthcare professionals. In particular, promotional claims about side-effects must reflect available evidence or be capable of substantiation by clinical experience. Substantiation need not be provided, however, in relation to the validity of indications approved in the marketing authorisation.

g) Promotion must encourage the rational use of medicinal products by presenting them objectively and without exaggerating their properties. Claims must not imply that a medicinal product, or an active ingredient, has some special merit, quality or property unless this can be substantiated.
h) Any comparison made between different medicinal products must be based on relevant and comparable aspects of the products. Comparative advertising must not be misleading or disparaging.
i) All artwork, including graphs, illustrations, photographs and tables taken from published studies included in promotional material should:
- clearly indicate the precise source(s) of the artwork;
- be faithfully reproduced; except where adaptation or modification is required in order to comply with any applicable code(s), in which case it must be clearly stated that the artwork has been adapted and/or modified.
Particular care must be taken to ensure that artwork included in promotion does not mislead about the nature of a medicine (for example whether it is appropriate for use in children) or mislead about a claim or comparison (for example by using incomplete or statistically irrelevant information or unusual scales).
 

2.2. DOCUMENTATION
All information included in marketing material shall be supported by documentation which can be provided on request.
There is, however, no need to provide such documentation in respect of information that has been approved in connection with the issue of a marketing license.

Clinical data referenced to unpublished company sources should specify: “Data are available upon request at the local registered office of the company.” Sufficient information to permit evaluation of referenced data must be made available to recipients of promotional communications either as an integral part of the promotional communication, as a reference to a published report, or upon request. Sources of promotional statements shall be provided by the company within 15 days upon request.

2.3. PROMOTION OF OFF-LABEL USAGE
The promotion of a medicine must be in accordance with the terms of its marketing authorisation and must be consistent with the particulars listed in its summary of product characteristics.

The promotion of indications not covered by the marketing authorisation for a medicine is prohibited. Our members may possess or publish information regarding indications for a medicine outside the indications specified in the marketing authorisation (“off-label indications”). While representatives may provide such information in response to a request from a health professional, representatives are prohibited from using such information to promote the medicine for off-label indications.

2.4. BENEFITS
Representatives must not employ any inducement or subterfuge to gain an interview. No fee may be paid or offered for the visit or the grant of an interview.

“Inducements” should be interpreted broadly and not limited to direct financial or beneficial inducements to the health professional (e.g. the experts are not allowed to give charity in exchange for an interview when the healthcare professionals).

2.5. USE OF QUOTATIONS IN PROMOTION
Quotations from medical and scientific literature or from personal communications must be faithfully reproduced (except where adaptation or modification is required in order to comply with any applicable code(s), in which case it must be clearly stated that the quotation has been adapted and/or modified) and the precise sources identified.
 

2.6. ACCEPTABILITY OF PROMOTION
Companies must maintain high ethical standards at all times. Promotion must:
a) never be such as to bring discredit upon, or reduce confidence in the pharmaceutical industry;
b) be of a nature which recognises the special nature of medicines and the professional standing of the recipient(s);
c) not be likely to cause offence.
 

2.7. DISTRIBUTION OF PROMOTION MATERIAL a) Promotion should only be directed at those whose need for, or interest in, the particular information can reasonably be assumed;
b) Mailing lists of healthcare professionals must be kept up-to-date. Requests by healthcare professionals to be removed from promotional mailing lists must be complied with.
c) Subject to applicable national laws and regulations, the use of faxes, e-mails, automated calling systems, short text messages (SMS) and other electronic data communications for promotion is prohibited except with the prior permission, or upon the request, of the recipient.
 

2.8. TRANSPARENCY OF PROMOTION
a) Promotion and promotion material may not be disguised in order to hide the actual purpose.
b) Clinical assessments, post-marketing surveillance and experience programmes and post-authorization studies must not be disguised promotion. Such assessments, programmes and studies must be conducted with a primarily scientific or educational purpose;
c) Where a company pays for or otherwise secures or arranges the publication of promotional material in journals, such promotional material must not resemble independent editorial matter;
d) Material relating to medicines and their uses, whether promotional in nature or not, which is sponsored by a company must clearly indicate that it has been sponsored by that company.
 

2.9. NO PROMOTION TO THE GENERAL PUBLIC
a) Promotion of the following medicinal products to the general public is prohibited:
- medicinal products which are prescription-only medicinal products;
- medicinal products which contain substances defined as psychotropic or narcotic by international convention, such as the United Nations Conventions of 1961 and 1971;
- any other medicinal products which cannot legally be advertised to the general public. This prohibition does not apply to vaccination campaigns which are carried out by the pharmaceutical industry and approved by competent authorities.
b) In the case of requests from individual members of the general public for advice on personal medical matters, the enquirer should be advised to consult a healthcare professional.
 

2.10. EVENTS AND HOSPITALITY
1) All promotional, scientific or professional meetings, congresses, conferences, symposia, and other similar events (each, an “event”) organized or sponsored by a company must be held in an appropriate venue that is conducive to the main purpose of the event and may only offer hospitality when such hospitality is appropriate and otherwise complies with the provisions of any applicable code(s).
2) No company may organize or sponsor an event that takes place outside its home country (an “international event”) unless:
a) Most of the invitees are from outside of its home country and, given the countries of origin of most of the invitees, it makes greater logistical sense to hold the event in another country; or
b) Given the location of the relevant resource or expertise that is the object or subject matter of the event, it makes greater logistical sense to hold the event in another country.
3) Promotional information which appears on exhibition stands or is distributed to participants at international events may, unless prohibited or otherwise regulated by local laws and regulations, refer to medicinal products (or uses) which are not authorised in the country where the event takes place, or which are authorised under different conditions, so long as (i) any such promotional material (excluding promotional aids) is accompanied by a suitable statement indicating countries in which the product is registered and makes clear that the product or use is not authorised locally, and (ii) any such promotional material which refers to the prescribing information (indications, warnings etc.) accepted in a country or countries where the medicinal product is authorised should be accompanied by an explanatory statement indicating that conditions for obtaining marketing authorisation differ internationally.
4) Hospitality extended in connection with promotional, professional or scientific events shall be limited to travel, meals, accommodation and genuine registration fees.
5) Hospitality may only be extended to persons who qualify as participants in their own right.
6) All forms of hospitality offered to healthcare professionals shall be reasonable in level and strictly limited to the main purpose of the event.
As a general rule, the hospitality provided must not exceed what healthcare professional recipients would normally be prepared to pay for themselves.
Healthcare professional must not be provided or paid for any independent entertainment and other interest or sociable activities. Moderate (simple) entertainment (when a company organises an event and provides refreshments and/or meals, e.g. lunch or dinner, background music or local performers are allowed. Nevertheless, this does not mean that a company can finance the participation of healthcare professionals in an independent concert of such same local group, since in such case the event would not be “of secondary importance” compared to refreshments and/or meals. Moderate (simple) entertainment can be understood as prohibition to invite famous and expensive performers, e.g. a TV celebrity or pop star, while local performers, players, actors are acceptable) is allowed at meetings, which is of secondary importance compared to refreshments and/or meals.
7) Hospitality shall not include sponsoring or organizing entertainment (e.g., sporting or leisure) events. Companies should avoid using venues that are renowned for their entertainment facilities.

3. QUALITY OF INFORMATION

Marketing material shall be of a sufficient level of quality and shall not be of such a nature that it causes offence.

4. GIFTS

4.1. No gift, pecuniary advantage or benefit in kind may be supplied, offered or promised to a healthcare professional as an inducement to prescribe, supply, sell or administer a medicinal product.
4.2. Subject to a) above, where medicinal products are being promoted to healthcare professionals, gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons only if they are inexpensive and relevant to the practice of medicine or pharmacy.
4.3. Gifts may bear no more than the name and logo of the company and the name of the medicinal product, or its international non-proprietary name, where this exists, or the trademark.
4.4. Gifts for the personal benefit of healthcare professionals (such as tickets to entertainment events) should not be offered or provided.
4.5. Companies must comply with guidance concerning the meaning of the term “inexpensive”, as used in Section 4.2 and as provided in the national legislation.

5. SPONSORSHIP OF HEALTHCARE PROFESSIONALS
 

Companies must comply with criteria governing the selection and sponsorship of healthcare professionals to attend training or events as provided in, or in connection with, any Applicable Code(s). Funding must not be offered to compensate merely for the time spent by healthcare professionals in attending events. In the case of international events for which a company sponsors the attendance of a healthcare professional, if any funding is provided to such healthcare professional in accordance with the provisions of this Section 5, such funding is subject to the rules of the jurisdiction where such healthcare professional carries out his/her profession, as opposed to those in which the international event takes place. For the avoidance of doubt, this Section 5 is not intended to prohibit the extension of hospitality to healthcare professionals in accordance with Section 2.10 hereof.

6. DONATIONS AND GRANTS THAT SUPPORT HEALTHCARE OR RESEARCH (Provisions of Section 6. do not apply for discounts, rebates and free goods which are offered by member companies to institutions, organisations or associations that are comprised of healthcare professionals and/or that provide healthcare or conduct research)
 

Donations, grants and benefits in kind to institutions, organisations or associations that are comprised of healthcare professionals and/or that provide healthcare or conduct research (that are not otherwise covered by the EFPIA Code on the Promotion of Prescription-Only Medicines to, and Interactions with, Healthcare Professionals or the EFPIA Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations) are only allowed if: (i) they are made for the purpose of supporting healthcare or research; (ii) they are documented and kept on record by the donor/grantor; and (iii) they do not constitute an inducement to recommend, prescribe, purchase, supply, sell or administer specific medicinal products. Donations and grants to individual healthcare professionals and/or sole proprietors are not permitted under this section. Company sponsorship of healthcare professionals to attend international events is covered by Section 5. Companies are encouraged to make available publicly information about donations, grants or benefits in kind made by them covered in this Section 6.

7. COMPENSATIONS FOR SERVICES

Contracts between companies and institutions, organisations or associations of healthcare professionals under which such institutions, organisations or associations provide any type of services to companies (or any other type of funding not covered under Section 6 or not otherwise covered by the Code) are only allowed if such services (or other funding): (i) are provided for the purpose of supporting healthcare or research; and (ii) do not constitute an inducement to recommend, prescribe, purchase, supply, sell or administer specific medicinal products.

8. THE USE OF CONSULTANTS

8.1. It is permitted to use healthcare professionals as consultants and advisors, whether in groups or individually, for services such as speaking at and chairing meetings, involvement in medical/scientific studies, clinical trials or training services, participation at advisory board meetings, and participation in market research where such participation involves remuneration and/or travel. The arrangements that cover these genuine consultancy or other services must, to the extent relevant to the particular arrangement, fulfill all the following criteria:
(a) written contract or agreement is agreed in advance of the commencement of the services which specifies the nature of the services to be provided and, subject to clause (g) below, the basis for payment of those services;
(b) legitimate need for the services has been clearly identified in advance of requesting the services and entering into arrangements with the prospective consultants;
(c) the criteria for selecting consultants are directly related to the identified need and the persons responsible for selecting the consultants have the expertise necessary to evaluate whether the particular healthcare professionals meet those criteria;
(d) the number of healthcare professionals retained is not greater than the number reasonably necessary to achieve the identified need;
(e) the contracting company maintains records concerning, and makes appropriate use of, the services provided by consultants;
(f) the hiring of the healthcare professional to provide the relevant service may not be an inducement to recommend, prescribe, purchase, supply, sell or administer a particular medicinal product; and
(g) the compensation for the services is reasonable and reflects the fair market value of the services provided. In this regard, fictitious consultancy arrangements should not be used to justify compensating healthcare professionals.
 

8.2. In their written contracts with consultants, companies are strongly encouraged to include provisions regarding the obligation of the consultant to declare that he/she is a consultant to the company whenever he/she writes or speaks in public about a matter that is the subject of the agreement or any other issue relating to that company. Similarly, companies that employ, on a part-time basis, healthcare professionals that are still practising their profession are strongly encouraged to ensure that such persons have an obligation to declare his/her employment arrangement with the company whenever he/she writes or speaks in public about a matter that is the subject of the employment or any other issue relating to that company. The provisions of this Section 8.2 apply even though the Code does not otherwise cover non-promotional, general information about companies.
 

8.3. Limited market research, such as one-off phone interviews or mail/e-mail/internet questionnaires are excluded from the scope of this Section 8, provided that the healthcare professional is not consulted in a recurring manner (either with respect to the frequency of calls generally or of calls relating to the same research) and that the remuneration is minimal.
 

8.4. If a healthcare professional attends an event (an international event or otherwise) in a consultant or advisory capacity the relevant provisions of Section 2.10 shall apply.

9. NON-INTERVENTION CLINICAL TRIALS OF MEDICINES

9.1. A non-interventional clinical trial of a marketed medicine is defined as a trial where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial plan but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the trial. No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods shall be used for the analysis of collected data. The patients must be informed that data on them will be collected and used for trial. They must be assured that confidentiality of data will be respected.
9.2. Non-interventional studies that are prospective in nature and that involve the collection of patient data from or on behalf of individual, or groups of, healthcare professionals specifically for the trial must comply with all of the following criteria:
a) trials are conducted with a scientific purpose;

b) (i) There is a written trial plan (protocol) and (ii) there are written contracts between healthcare professionals and/or the institutes at which the trial will take place, on the one hand, and the company sponsoring the trial, on the other hand, which specify the nature of the services to be provided and, subject to clause (c) immediately below, the basis for payment of those services;

c) Any remuneration provided is reasonable and reflects the fair market value of the work performed;

d) Prior to the trial, the approval of the competent ethics committee must be obtained;

e) Local laws, rules and regulation on personal data privacy (including the collection and use of personal data) must be respected;

f) The trial must not constitute an inducement to recommend, prescribe, purchase, supply, sell or administer a particular medicinal product;

g) The trial plan must be approved by the company’s expert service and the conduct of the trial must be supervised by the company’s scientific service as described in Section 10.2.c);

h) The trial results must be analysed by or on behalf of the contracting company and summaries thereof must be made available within a reasonable period of time to the company’s service in charge of clinical trials (as described in Section 10.2.b)), which service shall maintain records of such reports for a reasonable period of time. The company shall send the summary report to all healthcare professionals who participated in the trial and shall make the summary report available to the competent medicinal ethics committee upon its request. If the trial shows results that are important for the assessment of benefit-risk, the summary report should be immediately forwarded to the relevant competent authority (the provisions also apply to trials that will end after 1 July 2008);

i) expert colleagues may only be involved in an administrative capacity and such involvement must be under the supervision of the company’s scientific service that will also ensure that the representatives are adequately trained. Such involvement must not be linked to the promotion of any medicinal product.

9.3. To the extent applicable, companies are encouraged to comply with Section 9.1 for all other types of trials covered by Section 9.1, including epidemiological studies and registries and other studies that are retrospective in nature. In any case, such trials are subject to Section 9.1.

10. PERSONS EMPLOYED IN PHARMACEUTICAL PROMOTIONAL ACTIVITIES

10.1. PHARMACEUTICAL COMPANY REPRESENTATIVES
a) Each company shall ensure that its sales representatives including personnel retained by way of contract with third parties, and any other company representatives who call on healthcare professionals, pharmacies, hospitals or other healthcare facilities in connection with the promotion of medicinal products (each, a “medical sales representative”) are familiar with the relevant requirements of the applicable code(s), and all applicable laws and regulations, and are adequately trained and have sufficient scientific knowledge to be able to provide precise and complete information on their company’s products they promote.

b) Medical sales representative shall perform their tasks ethically and responsibly.

c) Medical sales representative shall conduct their activities in conformity with the FORUM’s Code, and all applicable laws and regulations, and companies are responsible for ensuring their compliance.

d) On all visits, in accordance with applicable national laws and regulations, medical sales representative shall ensure that the HCPs visited are provided with the Summary of product characteristics for (all) the product(s) presented, or that such information is made available to them.

e) Medical sales representative shall immediately provide their company with any information they receive concerning the use of products which they have presented, and in particular information relating to side effects.

f) Medical sales representatives must ensure that the frequency, timing and duration of visits to healthcare professionals, pharmacies, hospitals or other healthcare facilities, together with the manner in which they are made, do not cause inconvenience.
g) Medical sales representatives must not use any inducement or subterfuge to gain an interview. In an interview, or when seeking an appointment for an interview, medical sales representatives must, from the outset, take reasonable steps to ensure that they do not mislead as to their identity or that of the company they represent.

10.2. OTHER EMPLOYEES
a) All employees who are in any way involved in the preparation or approval of marketing material or information directed at doctors or other health personnel shall be fully acquainted with the provisions of the Rules on the Advertising of Medicinal Products and Medical Devices.

b) All Companies shall establish a scientific service to deal with information about the company’s products. The scientific service shall comprise a doctor or a pharmacist who shall be responsible for approving any promotional material before release. Such person must certify that he or she has examined the final form of the promotional material and that in his or her belief it is in accordance with the requirements of the applicable code(s) and any applicable advertising laws and regulations, is consistent with the summary of product characteristics and is a fair and truthful presentation of the facts about the medicine. In the case of veterinary products, approval shall be given by a veterinarian or a pharmacist.
c) Each company must appoint a person who shall be responsible for supervising the compliance with the standards of the applicable code(s).

11. DRUG SAMPLES

a) In accordance with national and/or Community laws and regulations, a limited number of drug samples may be distributed to healthcare professionals qualified to prescribe drugs in order that they may become familiar with the product, provided that this takes place on the basis of a written, signed and dated request from the person in question, and other documents in accordance with the valid regulation governing the drug samples. At the same time, a complete file on the dispensed samples has to be kept on file.

b) Companies must have adequate systems of control and accountability for samples which they distribute and for all medicines handled by its representatives.
c) Each sample shall be no larger than the smallest presentation on the market.
d) Each sample must be marked ‘free medical sample – not for resale’ or words to that effect and must be accompanied by a copy of the summary of product characteristics.
e) No samples of the following medicinal products may be supplied: - medicinal products which contain substances defined as psychotropic or narcotic by international convention, such as the United Nations Conventions of 1961 and 1971;
- any other medicinal products for which the supply of samples is inappropriate, as determined by competent authorities, from time to time.

12. SANCTIONS
 

In the event that a breach is established pursuant to the procedures of its national code, each member association shall require from the offending company an immediate cessation of the offending activity and a signed undertaking by the company to prevent recurrence. Sanctions should be proportionate to the nature of the infringement, have a deterrent effect and take account of repeated offences of a similar nature or patterns of different offences. A combination of publication and fines is generally considered to be the most effective sanction; however, each member association may use any other effective sanction to enforce its national code. Each member association should consider any applicable legal, regulatory or fiscal requirements which would affect the nature of sanctions which may be imposed.

13. RESPONSIBILITY

13.1. SCOPE OF RESPONSIBILITY                                                          The responsibility for pharmaceutical information applies to information, as a whole both form and content.

13.2. PERSONS RESPONSIBLE
The responsibility for ensuring compliance with this Code rests with all FORUM members. Authorised representatives of the FORUM members are also responsible to respect this code, when the information function is managed by them.

14. SUPERVISION

The drug information provided by the industry is subject to evaluation and guidance by the Committee which is administratively attached to the FORUM.

15. COMPLAINTS

Complaints concerning breaches of these Rules shall be sent to the Committee for the Appraisal of Drug Information.

16. AMENDMENTS

Amendments or changes to the Code can be conducted on the opinion of the majority of the FORUM members. The Code may be amended several times a year:
a) upon any amendment to the EFPIA Code on the
Promotion of Prescription-Only Medicines to, and Interactions with, Healthcare Professionals
b) on the suggestion of a FORUM member or members to the Board of the FORUM, which it submits for approval to the Assembly.
For the adoption of the amendment an absolute majority of votes is necessary.