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    Frequently asked questions

    28.04.2017
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    The frequently asked questions concerning the advertising of medicinal products are based on the questions asked from the State Agency of Medicines. The answers presented here are an interpretation of the Medicinal Products Act by the State Agency of Medicines.

    Q1: One person may be provided with five samples of authorized medicinal products no larger than the smallest presentation on the market, and the amount of samples provided per year should not exceed 300. If the smallest presentation on the market is registered as a package containing 10 pellets then is it allowed to hand out special sample packages containing 2 pellets?
    A1: According to section 85 subsection 5 of the Medicinal Products Act one person may be provided with five samples of authorized medicinal products no larger than the smallest presentation on the market per year. So, if the package containing 2 pellets does not have a marketing authorization it is forbidden to hand it out as a sample.

    Q2: Is it allowed to make informational materials for patients regarding their disease and treatment? The material is based on the information on the package information leaflet and the information about the disease.
    A2: Informational materials are allowed but only about the disease. The material must not contain any names of medicinal products and may even not imply to a medicinal product. Otherwise the material may be considered an advertisement. The State Agency of Medicines interprets the regulation in a way so that if the informational material contains information about all the therapeutic indications with equal thoroughness then the active ingredient of the medicinal product may be mentioned.

    Q3: Can medicinal products be advertised over the Internet? If so, does the warning notice have to be marked on the advertisement on the Internet?
    A3: According to the amendment of the Medicinal Products Act which entered into force on the 18th of April 2010 the advertising of medicinal products to the general public is allowed over the Internet. When advertising medicinal products over the Internet all requirements for advertising of medicinal products to the general public apply. Thus, the advertisement of medicinal product that is published over the Internet must contain the warning notice according to section 84 subsection 3 clause 3 of the Medicinal Products Act.
    The advertising of medicinal products subject to medical prescription over the Internet is permitted only if access to the information is limited to persons qualified to prescribe medicinal products, dispensing chemists and pharmacists (section 85 subsection 11 of the Medicinal Products Act) and the advertisement complies with the conditions set out in section 85 subsection 9 of the Medicinal Products Act or it contains the summary of product characteristics because it is not transferable by personal communication with the aforementioned persons or by printed matter sent by post.

    Q4: If the requirements for advertising that are stated in section 85 subsection 10 of the Medicinal Products Act are written, for example, on a cup or on a pen then is it in accordance with the Medicinal Products Act?
    A4: Yes, the requirements in section 85 subsection 10 of the Medicinal Products Act have to be printed on the object that is shared by personal communication. The distributed objects are considered to be gifts according to the Medicinal Products Act and their value must not exceed 6,40 euros.

    Q5: Are all pecuniary gifts prohibited according to section 86 subsection 1 of the Medicinal Products Act? What is meant by pecuniary gifts?
    A5: Primarily the State Agency of Medicines regards money, gift cards etc as pecuniary gifts.

    Q6: Do the gifts for persons qualified to prescribe medicinal products, dispensing chemists and pharmacists have to be associated with their professional activities and must not be associated with the sale of a certain medicinal product or the sale of medicinal products or issuing medical prescriptions by a certain manufacturer of medicinal products?
    A6: Yes, the gifts have to be associated with professional activities and gifts should not be given with the aim to influence the persons qualified to prescribe medicinal products according to the wishes of the marketing authorization holder.

    Q7: Is advertising medicinal products subject to medical prescription allowed in publications published by a publishing house “X”?
    A7: The advertising of medicinal products not subject to medical prescription is allowed and it has to meet the general requirements for advertising set in the Advertising Act and to the requirements from sections 83 and 84 of the Medicinal Products Act. According to section 84 subsection 1 it is prohibited to advertise medicinal products subject to medical prescription to the general public. So it is not allowed to advertise medicinal products subject to medical prescription in a publication if it is not specifically directed to persons qualified to prescribe them, dispensing chemists and pharmacists.

    Q8: The slogan of the advertisement states that the medicinal products of the holder of the marketing authorization X are cheaper until the end of the month or good and cheap in all pharmacies. Is the described slogan in conflict with the Medicinal Products Act?
    A8: The Medicinal Products Act does not prohibit discounts of medicinal products. When forwarding the described advertisement one has to distinguish between the advertising of medicinal products to the general public and advertising of medicinal products to persons qualified to prescribe them, dispensing chemists and pharmacists so the advertising of medicinal products subject to medical prescription would be excluded. For example, when advertising to the general public, the advertisement should say: “Medicinal products not subject to medical prescription of the holder of the marketing authorization X are cheaper!”

    Q9: In the summary of product characteristics of some medicinal products there is a commonly used sentence which says that clinical trials of medicinal products have shown that this certain medicinal product has some kind of a specific effect. Can the advertisement of this medicinal product refer to a study that is included in the clinical part of the documentation of the marketing authorization but to what the summary of product characteristics does not refer to?
    A9: It is not allowed because according to section 83 subsection 3 of the Medicinal Products Act the advertisement has to be in full compliance with the information specified in the summary of product characteristics of the medicinal product.

    Q10: Can CHMP publish a press release when a marketing authorization is issued?
    A10: No, press release is an advertisement if its contain reference to the medicinal product and describes the positive feature of the product and has to meet all the requirements set to the specific type of advertising of medicinal product.

    Q11: When package information leaflets are considered to be an advertisement?
    A11: The package leaflet is an advertisement if its content and appearance differs from the package information leaflet approved by the State Agency of Medicines. For example, a package leaflet that features the brand sign of the marketing authorization holder or if its design has been changed then it is considered to be an advertisement of a medicinal product.

    Q12: Is it allowed to make treatment agendas to the patient about a medicinal product subject to medical prescription (the physician gives out the treatment agenda with the prescription)?
    A12: Giving informational materials to the patient about the medicinal products subject to medical prescription is considered to be an advertisement of medicinal products subject to medical prescription. According to the section 84 subsection 1 of the Medicinal Products Act the advertising of medicinal products subject to medical prescription to the general public is prohibited. The treatment agenda may be given to a patient but it must not contain a reference to the medicinal product.

    Q13: Is putting discount rates on printed publications allowed?
    A13: According to the amendment of the Medicinal Products Act that entered into force on the 18th of April 2010 the usage of discount rates is allowed in advertisements.

    Q14: The advertising of medicinal products subject to medical prescription is allowed in pre-reviewed medical or pharmaceutical journals. Eesti Arst is a pre-reviewed medical journal in Estonia but the advertisements of medicinal products subject to medical prescription may be found in Lege Artis, Meditsiiniuudised etc?
    A14: Lege Artis and such journals are considered to be (on the basis of section 82 subsection 3 clause 3 of the Medicinal Products Act) sending printed matter to a specific person in which the advertising of medicinal products subject to medical prescription is allowed.

    Q15: Based on section 85 subsection 1 of the Medicinal Products Act is using quotations taken from scientific works allowed when advertising medicinal products subject to medical prescription to persons qualified to prescribe them if the quotations are presented without amendments and are supplied with references to the source documents?
    A15: Yes, it is allowed but one has to keep in mind the general requirements for advertising of medicinal products and the requirement that the advertising of a medicinal product has to be in full compliance with the information specified in the summary of product characteristics of the medicinal product. Such advertisements may include claims supplementing the information referred to in SmPC, provided that the claims confirm or clarify and are compatible with SmPC, do not distort it and are consistent with the requirements; shall encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties; shall not be misleading; shall be accurate, up-to-date, verifiable and sufficiently complete to enable the recipient to, form his or her own opinion of the therapeutic value of the, medicinal product concerned; also quotations as well as tables and other illustrative matter taken from medical journals or other scientific works for use in the documentation shall be faithfully reproduced and the precise sources indicated.

    Q16: Do I understand correctly, that if we used the content of scientific articles (the information about clinical trials of medicinal products that is not mentioned in the confirmed SPC) published in pre-reviewed medical or pharmaceutical journals in our advertising, then it is not allowed because the advertising of medicinal products has to be based on the approved summary of product characteristics?
    A16: Yes, the advertisement of medicinal products has to be in full compliance with the summary of product characteristics. So you can only refer to the articles in which the content is in compliance with the summary of product characteristics of the medicinal product (also A15).

    Q17: Is it allowed to distribute an article published in a scientific work in its unaltered form to persons qualified to prescribe medicinal products? The information in the article (from clinical trials of medicinal products) is not included in the summary of product characteristics.
    A17: According to the section 82 subsection 2 clause 4 of the Medicinal Products Act copies of scientific articles published in pre-reviewed medical or pharmaceutical journals without any amendments or comments thereto forwarded to persons qualified to prescribe medicinal products, dispensing chemists and pharmacists are not deemed to be advertising of medicinal products. If the distributed article corresponds with these characteristics then it is not considered as an advertisement of medicinal products in the light of the Medicinal Products Act and the copies of the articles may be distributed to aforementioned persons.

    Q18: If we wish to present a Russian translation in an advertisement directed to the general public then is it allowed to add the warning notice to the bottom of the page and refer to it with an asterisk if we advertise multiple medicinal products?
    A18: No. If you want to present the translation of the advertisement in Russian then the exact translation of the advertisement must be displayed, including the warning notice: “„Tähelepanu! Tegemist on ravimiga ....“. Since the purpose of the warning notice is to draw attention to the fact that the advertised product is a medicinal product and using the medicinal product entails certain risks then the warning notification has to be present in all languages next to the advertised medicinal product.

    Q19: According to section 85 subsection 10 clause 6 of the Medicinal Products Act the contact information of the marketing authorization holder’s representation in Estonia has to be presented in the advertisement. If the company does not have a representation in Estonia but has concluded a contract of cooperation with an Estonian company then does the advertisement directed to a physician have to contain the contact information of the foreign representation or does the material distributed in Estonia have to contain a note about some contact information in Estonia?
    A19: The purpose of section 85 subsection 10 clause 6 of the Medicinal Products Act is to give the physician a possibility to get additional information about the medicinal product if necessary. So the provision is created with the aim that the marketing authorization holder would have a representative who is properly authorized and able to provide additional information about the medicinal product.

    Q20: If a marketing authorization is granted to a medicinal product but one of the package sizes of the medical product is granted a marketing authorization as a medicinal product not subject to medical prescription and the other a marketing authorization as a medicinal product subject to medical prescription then is it allowed to advertise the medicinal product not subject to medical prescription to the public?
    A20: Yes, it is allowed to advertise the medicinal product that was granted the marketing authorization as a medicinal product not subject to medical prescription to the general public but the size of the package has to be shown in the advertisement to rule out the possibility of advertising of medicinal products subject to medical prescription to the general public.

    Q21: If the advertisement of a medicinal product is two-sided and in the pharmacy it is hanged to the shelf where the information about the product (the name of the product, the active ingredients, therapeutic indications etc) is on the first side of the advertisement but since there is no room for the warning notice it is put on the back side of the advertisement. Is this in accordance with the Medicinal Products Act?
    A21: The Advertising Act and the Medicinal Products Act do not directly regulate this kind of a situation but the State Agency of Medicines finds that when the information presented about the medicinal product is put on one side then this side is considered to be the advertisement and the information published in the advertisement has to meet the requirements set for advertising of medicinal products. Therefore the advertisement (the side with the information about the product) has to include the warning notice. The purpose of the warning notice is to draw attention to the fact that the advertised product is a medicinal product and it is necessary to read the package information leaflet. The warning notice has to be presented with the advertisement and the consumer should not have to make a special effort to find the warning notice (e.g. to turn the other page etc.)

    Q22: If a homoeopathic preparation does not have a therapeutic indication then can the package information leaflet for the specialist include information about what the homoeopathic preparation is used?
    A22: The advertisement of medicinal products has to meet the general requirements for the advertising of medicinal products and the specified requirements for the corresponding type of advertisement. According to section 83 subsection 3 of the Medicinal Products Act the advertisement has to be in full compliance with the information specified in the summary of product characteristics of the medicinal product. If the homoeopathic preparation does not have a summary of product characteristics then only the information that is presented on the package information leaflet can be used in the advertisement.
    So when advertising homoeopathic preparations to persons qualified to prescribe medicinal products subject to medical prescription, dispensing chemists and pharmacists it is not allowed to attribute qualities to the preparation that have not been approved by the State Agency of Medicines. If the homoeopathic preparation was not given a therapeutic indication when issuing the marketing authorization then it is prohibited to use an indication about the preparation in the advertisement.

    Q23: Is it necessary in the television advertising of medicinal products to show the active ingredient of the medicinal product on the screen every time the medicinal product is shown? And is it required if the name of the medicinal product is simply read out?
    A23: The wording of section 83 subsection 5 of Medicinal Products Act suggests that the name of the active ingredient of the medicinal product has to be added any time the name of the medicinal product is mentioned. This applies for cases when the name of the medicinal product is mentioned in speech.

    Q24: Can the advertisement of medicinal products subject to medical prescription (with all the necessary information provided) be sent to physicians via e-mail?
    A24: The State Agency of Medicines finds that the manners of transmitting the advertisements of medicinal products subject to medical prescription are exhaustively listed in section 82 subsection 3 of the Medicinal Products Act. If the advertising of medicinal products is transmitted in another manner then it is deemed to be advertising of medicinal products to the public (subsection 4). If it is made certain beforehand that the e-mail address belongs to a physician then it is allowed to send advertisements via e-mail with the approval form the physician. In that case the advertisement is considered to be sending printed matter to a specific person (the section 82 subsection 3 clause 3).
    It has to be kept in mind that hyperlinks added to the advertisement become a part of the advertisement of medicinal products.

    Q25: Is it allowed to give persons qualified to prescribe medicinal products samples of antivirus substances for systematic usage?
    A25: The section 85 subsection 6 of the Medicinal Products Act prohibits supplying samples of medicinal products containing narcotic drugs and psychotropic substances, and antibiotics. The purpose of the regulation is to limit the extensive and unreasonable use of anti-infection medicinal products and to keep the resistance that derives from this under control. The resistance is not only a problem concerning bacteria but also viruses, fungus and parasites and is relevant all over the world. Resistance may lead to a situation where there will be no medicinal products to function when dealing with pathogens. So there is not a universal restriction for supplying samples of antivirus substances in the Medicinal Products Act. The State Agency of Medicines still finds it very important that no samples of antivirus, anti-fungus and anti-parasite medicinal products are not distributed in light of the need to protect the public health.

    Q26: Can medicinal products not subject to medical prescription be sold to the general public in a gift bag with the symbol of the medicinal product? Does the gift bag have to meet the requirements set to advertising of medicinal products?
    A26: Section 84 subsection 8 of the Medicinal Products Act states that it is prohibited to persons not qualified to prescribe medicinal products to offer items connected to medicinal products. The State Agency of Medicines finds that gift bags with the symbol of the medicinal product are items connected to medicinal products and therefore their distribution by a person not qualified to prescribe medicinal products is not allowed. It does not make any difference if the gift bag meets the requirements for advertising of medicinal products.

    Q27: Does the advertisement of medicinal products directed to the general public have to include the contact information of the holder of the marketing authorization or the contact information of its representative in Estonia?
    A27: There are no requirements set in the Medicinal Products Act about mentioning the holder of marketing authorization in advertising that is directed to the general public. The general requirements of the Advertisement Act have to be considered. Section 3 subsection 2 of the act states that advertising shall contain the clearly distinguishable name, the trade mark or domain name of the person who commissions advertising which is under registration or has been registered in Estonia or the European Community.

    Q28: What kind of additional information has to be written on a pen that advertises a medicinal product subject to medical prescription?
    A28: Since the advertising of medicinal products subject to medical prescription is allowed only to persons qualified to prescribe them, dispensing chemists and pharmacists then the information has to meet the requirements for advertising of medicinal products subject to medical prescription to persons qualified to prescribe them, dispensing chemists and pharmacists. An advertisement of a medicinal product subject to medical prescription handed over in the course of personal communication (the pen) has to meet the requirements of section 85 subsection 10 of the Medicinal Products Act.

    Q29: Is advertising medicinal products allowed in outdoor advertising?
    A29: Yes, the Medicinal Products Act allows advertising medicinal products not subject to medical prescription in outdoor advertising. The advertising of medicinal products subject to medical prescription to the general public remains prohibited.

    Q30: Is it allowed to give objects such as pens, mugs and towels to persons qualified to prescribe medicinal products subject to medical prescription, dispensing chemists and pharmacists if the advertisement of medicinal product is printed on them?
    A30: The gifts for persons qualified to prescribe medicinal products subject to medical prescription, dispensing chemists and pharmacists have to be relevant to the corresponding professional practice of the persons and must not be connected to the sale or prescription of specific medicinal products or medicinal products manufactured by a specific manufacturer and the value of the gift can not exceed 6,40 euros (section 86 subsection 1 of the Medicinal Products Act). 
    This means that when the gift is relevant to the professional practice of the physician and the value of the gift is under 6,40 euros, it is allowed. If there is an advertisement printed on the gift, it has to meet the requirements for the advertising of medicinal products to persons qualified to prescribe them, dispensing chemists and pharmacists (if the advertisement is handed over in the course of personal communication it has to meet the standards of section 85 subsection 10 of the Medicinal Products Act).

    Q31: Some of the medicinal products that contain the active ingredient X also contain for example, the excipient lactose. Medicinal product A does not contain that excipient. Is it allowed to publish such information in the advertisement of the medicinal product A with the purpose to inform people who are lactose intolerant?
    A31: If it is a comparative advertisement then the State Agency of Medicines does not find that it is prohibited. In case of using comparisons in the advertisements one has to follow the rules in section 5 of the Advertising Act.

    Q32: If we wish to give a physician a bag which she may use for shopping, for example, then what information has to be on the bag in addition to the name of the medicinal product, active ingredient and the information about the holder of the marketing authorization? Does it have to contain a warning notice if the gift is meant for a physician?
    A32: It is allowed to give persons qualified to prescribe medicinal products subject to medical prescription gifts that are relevant to the corresponding professional practice and not connected to the sale or prescription of specific medicinal products or medicinal products manufactured by a specific manufacturer and the value of the gift does not exceed 6,40 euros (section 86 subsection 1 of the Medicinal Products Act). In this case one has to consider whether the described bag is used in the professional practice of the physician. Although the bag is given to the person who prescribes medicinal products the purpose of the usage of the item should be considered when advertising. If it is an item that is shown in public (for example a bag or an umbrella) then the advertisement has to meet the requirements for advertising medicinal products to general public (section 84 of the Medicinal Products Act).

    Q33: Is advertising a medicinal product allowed in a way where two actors (the “cough” and the “physician”) communicate directly with the people visiting a supermarket? People are handed informational booklets with all necessary warnings and contact information of the holder of the manufacturing authorization.
    A33: The described activity has to be considered as advertising medicinal products. When advertising medicinal products in the described way all the requirements for the advertising of medicinal products to the general public have to be met, among them the requirement stated in section 84 subsection 3 clause 1 according to which the advertising has to be set out in such a way that it is clear that the message is advertising and that the product is a medicinal product.

    Q34: Can hyperlinks be added when the advertisement of the medicinal products is published over the Internet?
    A34: Yes, they can be added but the State Agency of Medicines points out that hyperlinks added to the advertisement become a part of the advertisement of medicinal products and therefore have to meet the requirements for advertising medicinal products.

    Q35. How is the advertising of medicinal products not subject to medical prescription regulated when it is transmitted by directly communicating with the general public?
    A35: The regulation for advertising medicinal products to the general public by the holder of the manufacturing authorization is the same as it is for advertising medicinal products to the general public. There are no specific requirements for the described type of advertising. So, when advertising medicinal products thorough direct communication one has to guarantee the implementation of general rules for advertising (from the Advertising Act), the general rules for advertising medicinal products (section 83 of the Medicinal Products Act) and rules for advertising medicinal products to general public (section 84 of the Medicinal Products Act).

    Q36: Are sponsorship announcements and product placement by the marketing authorization holder permitted according to the Media Services Act?
    A36: The section 30 subsection 8 of the Media Services Act gives the undertakings whose activities include the sale and manufacturing of medicinal products the right to promote the name or the image of the undertaking but does not allow the promotion of medical treatments available only by medical prescriptions. According to terms stated in section 31 of the Media Services Act product placement of medicinal products is allowed but according to subsection 6 the product placement is prohibited regarding specific medicinal products or medical treatments available only on a medical prescription.
    The State Agency of Medicines points out that according to section 25 subsection 1 of the Media Services Act sponsorship announcements and product placement are considered to be commercial communication. According to the section 25 subsection 3 of the same act the requirements set for advertising in the provisions of the Advertising Act and other acts apply to business communications as well. Therefore considering product placement and sponsorship announcements one has to keep in mind the general requirements set in the Advertising Act as well as the requirements for advertising of medicinal products subject to medical prescription and advertising of medicinal products to general public set out in the Medicinal Products Act.