Guideline of the National Institute of Pharmacy and Nutrition on the right choice of names for medicinal products for human use

Transcription

1 Guideline of the National Institute of Pharmacy and Nutrition on the right choice of names for medicinal products for human use 1. INTRODUCTION 2. LEGAL BACKGROUND 3. CONFORMITY CRITERIA FOR MEDICINE NAMES 3.1 Medicine safety criteria Mix-up with other invented names Misleading invented names 3.2 Similarity with international non-proprietary names Similarity between an invented name and an existing INN Invented names containing an INN stem 3.3 Other invented names of public health concern Use of abbreviations, qualifiers Use of promotional qualifiers Special age groups 3.4 Issues relating to invented names for certain types of medicines Vaccines Biological medicines Non-prescription medicines Fix combinations Co-packaged preparations Names of generic, hybrid- and similar biological medicines Use of common name or scientific name Names of generic medicinal products referring to a centrally authorized medicinal product 3.5 Braille requirements for name on product label 4. UMBRELLA TRADE NAMES 5. REGULATORY ASPECTS RELATED TO PROPOSED MEDICINE NAMES 6. PRIOR OPINION ON MEDICINE NAMES 1/18 12 August 2015

2 1. INTRODUCTION Under the available legal framework the National Institute of Pharmacy and Nutrition (hereinafter: OGYÉI) makes all efforts to guarantee patients safe access to medicines, at the same time to try to effectively foster a law-abiding conduct by drug market stakeholders. Made in this spirit this guideline intends to provide assistance to drug market stakeholders for choosing the right names for their medicinal products for human use by introducing them to the principles that OGYÉI consistently enforces upon the adjudication of medicine names. Upon assessment of proposed medicine names OGYÉI first of all looks at whether the suggested name raises public health and within that medicine safety concerns. The aim of the name scrutiny is to find out whether or not the proposed name can potentially be mistaken with other medicine names and/or whether a potential names mix up endangers safe use of the products bearing that name. As a consequence thereof - and because of the lack of explicit competence intellectual property rights, first of all trademarks, do not at all constitute the subject matter of the marketing authorization, OGYÉI does not and cannot take this factor into account when looking at the acceptability of the proposed names. Moreover all information supplied by applicants and marketing authorization holders in respect of medicine names is a business secret by operative legislation and also by OGYÉI internal - confidentiality rules, and is to be treated as such. The below principles regarding the assessment of medicine names shall be used in new marketing authorization applications, applications for the renewal of a marketing authorization as well as in variation procedures concerning name changes starting after the publication of this guideline. Applicants are being requested to please follow the contents of this guideline when deciding on the names for their medicinal products! 2/18 12 August 2015

3 2. LEGAL BACKGROUND 1. Section 1.13 of Act XCV of 2005 on Medicinal Products for Human Use and on the Amendment of Other Regulations Related to Medicinal Products (hereinafter: Medicine Law) says: The name of a medicinal product shall be the name given in the marketing authorization, which can be an invented name not to be mistaken with the common name, or any common or scientific name which is used together with the trademark or with the name of the marketing authorization holder 2. This definition according to the Medicine Law is in conformity with Article 1(20) of the European Parliament and Council Directive 2001/83/EC (6 November 2001) on the Community Code of Medicinal Products for Human Use (hereinafter: Directive), which says: The name of a medicinal product may be an invented name - not to be mistaken with the common name - or any common or scientific name which is used together with the trademark or with the name of the marketing authorization holder. 3. Article 1(21) of the Directive says: The common name is the international non-proprietary name given in accordance with the recommendation of the World Health Organization (WHO), failing which the generally used common name. 4. Subsection (5) of Section 5 of MoH decree 52/2005 (XI. 18.) on the marketing authorization of medicinal products for human use says: The name of the medicinal product in paragraph b) of Section (2) cannot be the same as the name of another medicinal product already authorized for marketing and cannot resemble the name of another medicinal product already authorized for marketing so closely that the medicinal products concerned may be mixed up with each other. 3/18 12 August 2015

4 3. CONFORMITY CRITERIA FOR MEDICINE NAMES 3.1 Medicine safety criteria Based on legal regulation in effect a medicine s name can have one of the below structures: - Invented name in itself; - INN together with the MAH s name; or - INN and trademark together. Although a medicine s name, according to existing legal rules, is always to be shown on the packaging and in the patient information leaflet together with the strength and the dosage form, these three categories need to be discussed in separate chapters. This guideline describes only the principles applying to medicine names without the strength and dosage form. Regarding the acceptability of medicine names OGYÉI primarily looks at whether the suggested name tends to cause public health relevant complications. OGYÉI always examines medicine names individually, relative to the given medicinal product, and the aim is to minimize the risk of mix up with another medicinal product. Applicants must bear in mind the contents of this guideline whenever choosing a name for their medicinal products. First we describe the governing principles for invented names, they being the most important category of medicine names Mix-up with other invented names A medicine s invented name should consist of at least 3 letters that should possibly form a single word. An invented name must differ from the name of an earlier authorized medicinal product. According to this rule an earlier authorized medicinal product is: - A medicinal product that has been authorized for marketing and put on sale; - A medicinal product that has been authorized for marketing but not actually put on sale, or is not sold at the time of the assessment of the application; - A medicinal product, the marketing authorization of which has been withdrawn within an OGYÉI-specified period (but at least 5 years earlier), depending on the circumstances of the case. - A medicinal product that is the subject matter of an earlier started ongoing at the time of the submission of the application - procedure. An invented name is not to be mistaken with the invented name of another medicinal product, be it in - Printed form, - Handwritten form, - Phonetic form or - In the list of medicine names in user software containing medicine names (e.g. pharmacy and prescription writing softwares). 4/18 12 August 2015

5 OGYÉI uses the following points to assess a potential mix up: - The number of common letters in similar medicine names and their position within the words; - Phonetic resemblance of the names; - Use of prefixes and suffixes in the name; - Risk of mix up with other products in the case of handwritten prescriptions; - Indication(s) - Patient group(s); - Pharmaceutical form(s); - Route(s) of administration; - Strength(s); - Posology; - Pharmacovigilance profile; - Legal status/classification (prescription only medicines non-prescription medicines, medicines bound to special prescription, etc.). More principles used in the assessment of a mix up: In spite of the fact that an invented name had been registered as a trademark, it still remains required that the invented name cannot be mixed up with the name of an already existing medicine; An invented name is not allowed to contain any reference to any therapeutic area; An invented name is not allowed to carry individual numbers, letters or symbols for they might have misleading meaning for posology, strength or treatment duration. This rule, however, does not apply to vaccines, radioactive medicines and immunological preparations; Characters like,, etc. are not allowed to constitute part of a medicine s name; The use of symbols (+, -, =, *, &, /, # etc.) is not acceptable in invented names; The use of small or capital letters in an invented name is irrelevant from the point of acceptability, but printed characters must by all means be displayed legibly in Latin letters; Any invented name or part of an invented name used in another language has to be translated and changed by all means if the meaning in Hungarian is obscene, pejorative, or abusive; Qualifier of an invented name that refers to a therapeutic area should always be translated to avoid misinterpretation by consumers (for example: FANTASY Cough syrup - FANTASY Köhögés elleni szirup ); An invented name is not allowed to include Hungarian family and Christian names including the name of the inventor of the medicine, and is not allowed to have religious, historic, geographic or just an abusive meaning. Exception to this rule is that an invented name can include a registered trademark or the name of the marketing authorization holder; A medicinal product s name should not begin with the name of the marketing authorisation holder or the trademark in order to make sure that the lists containing the names of medicinal products are transparent (e.g. lists of softwares used in pharmacies or for prescribing medicines). The ability to spell the name in Hungarian is a general principle during assessment; An invented name cannot be identical with the name of another category of products (e.g. paramedicines, cosmetics, food supplements, nutrients, etc.) earlier put on the market. Exception to this rule is, if the requirements relating to umbrella trade names are fulfilled, but this should be examined on a case-by-case basis. 5/18 12 August 2015

6 During the development of an invented name attention must be paid to the legal requirement of having to display the medicine name in Braille too; Standard terms of the pharmaceutical form (gel, ointment etc.) are not allowed to form part of an invented name; The invented name may be used on the summary of product characteristics, patient information leaflet, label, and during commercial practice, and the marketing authorization holder is responsible for the use Misleading invented names An invented name cannot be misleading as to therapeutic effects and/or pharmaceutical connotation and/or composition. Based on the aforesaid the following flow chart is used to demonstrate decision-making process on the acceptability of an invented name: INVENTED NAME Reference in the name to therapeutic or pharmaceutical meanings YES NO Reference in the name to the medicine s composition YES NO In written and printed form or verbally it can be mistaken with the invented name of another medicinal product already on the market YES NO Similar pharmaceutical form and/or similar route of administration and/or similar legal status/classification Invented name acceptable YES NO Invented name not acceptable Invented name acceptable 6/18 12 August 2015

7 3.2 Similarity with international non-proprietary names According to Section 1.13 of the medicine law - and Articles 1(20) and 1(21) of the Directive an invented name should not be mistaken with the common name. The common name is the international non-proprietary name given in accordance with the recommendation of the World Health Organization (WHO), failing which the generally used common name. Here is to mention WHO resolution No. WHA46.19, which says invented names should not be derived from the International Non-proprietary Name (hereinafter: INN), neither is the use of INN stems desirable in invented names. Accordingly, concurrence with international non-proprietary names is likely to occur in the following two cases Similarity between an invented name and an existing INN In the event where there is similarity between a proposed invented name and an existing INN OGYÉI shall use the following criteria to assess the acceptability of the invented name: - The degree of similarity with own or other INN in writing or phonetically; - Similarity between the areas of use for the concerned products; - Similarity between the classification of the products e.g. need for specific prescription; - Similarity between the route(s) of administration and wherever possible, between pharmaceutical forms. Applicants are advised to check in advance any similarity with INN-s before filing their application and wherever needed submit an in-depth explanation to substantiate acceptability for the planned invented name. OGYÉI uses the following flow chart to decide on the acceptability of an invented name: INVENTED NAME Similarity with own or other INN Closeness in writing and/or speech keeping in mind the similarity between medical setting and/or condition of use and/or route of administration YES NO Invented name not acceptable Invented name acceptable More information about INN is available on the following WHO homepage: 7/18 12 August 2015

8 3.2.2 Invented names containing an INN stem The use of INN stems in invented names might give the impression for healthcare professionals that it is a new active substance and not an invented name. So there is good reason to avoid using INN stems in invented names. If the proposed invented name happens to include an INN stem earlier published by WHO OGYÉI assesses the acceptability of the invented name in consideration of the following circumstances: - Similarity between the INN stem and the therapeutic class of the medicinal product; - The place of the INN stem in the invented name according to the WHO recommendation on the placement of the INN stems; - Similarity between the indication of the products concerned; - Similarity between the classification of the products e.g. need for specific prescription; - Similarity between the route(s) of administration and wherever possible, between pharmaceutical forms. Applicants are advised to check in advance the occurrence of INN stems in the proposed invented name before filing their application and wherever needed submit an in-depth explanation to substantiate acceptability for the planned invented name. OGYÉI uses the following flow chart to decide on the acceptability of an invented name: Invented name containing an INN stem YES As per WHO stem location recommendation NO Same therapeutic class Different therapeutic class Can public health concern be identified? Similar medical setting and/or condition of use and/or route of administration YES NO YES NO Invented name not acceptable Invented name acceptable Invented name not acceptable Invented name acceptable Invented name acceptable More information on INN stems and the list of published INN stems is available on the following WHO homepage: 8/18 12 August 2015

9 3.3 Other invented names of public health concern Use of abbreviations, qualifiers The use of qualifiers (such as Rapid, Forte, Kombi, Plus, Mite, etc.) and abbreviations in invented names is theoretically acceptable but the use of numbers is approved only in certain cases for example to indicate the number of serotypes in a vaccine. Submissions of such type of invented names must in every case be furnished with an explanation. Qualifiers used in medicine invented names must be informative on the first place. OGYÉI uses the following points to assess names containing abbreviations or qualifiers: - Does the qualifier/abbreviation carry added information on the properties of the medicinal product (such as patient group, route of administration, composition, etc.) or does it offer assistance for healthcare professionals and/or patients in the choice or prescription of the right medicine; and - The rate of public health concerns potentially caused by doctors mistakes due to a qualifier/abbreviation relative to the risks caused by more complex names with negative impact on the ability to memorize or spell or prescribe the medicine. The use of qualifiers, adverbials consisting of 1 or 2 letters or (Arabic or Roman) numbers is not recommended in any case - this is particularly true for combinations of letters covering the strength, because this will make it easy to mix it up with dosage form and/or dosing. For example: Gyorsanható, Rapid (including derived qualifiers) is acceptable only in that case if the data in the summary of product characteristics do really substantiate a faster action or the faster action has relevance to therapy; PLUS Plusz is acceptable only in that case if the medicine includes an added active substance that appreciably contributes to therapeutic efficacy; Co- Ko- prefix is acceptable for combinations in which a new active substance is added to an already existing product; Forte / Mite qualifiers may be used in that case if the product includes an active substance which has greater/smaller strength compared to an already existing product; Maximum, the abbreviation thereof, Max or Maximum strength may only be used for preparations where the medicinal product actually contains the maximum permissible quantity of the active substance per unit of dose; Duo Kettő is to be used only when two active substances are used in one preparation; Original, Classic Klasszikus, Klasszik is acceptable only where the medicinal product is available in more than one presentations on the market and the qualifier is used to differentiate the product first authorized for marketing from the later variations; Tastes ( strawberry, menthol ) and fragrances ( eucalyptus ) are to be indicated in Hungarian only, in harmony with the product s composition and with a prior explanation. The use of superlatives should be avoided in all names. 9/18 12 August 2015

10 3.3.2 Use of promotional qualifiers Invented names are not allowed to convey any message of promotional nature implying therapeutic and/or pharmacological properties or composition of a medicinal product Special age groups If a medicine exclusively targets one age group ( Junior, Baby, Adult, For children etc.), this has to be indicated on the package. The age group definition should follow the age classification in the Formulae Normales VII/General Information, Section IX. 3.4 Issues relating to invented names for certain types of medicines Vaccines In the case of vaccines constituted from several serotypes the original name should be kept upon the addition of a new serotype; the name is to be followed by the number of serotypes and the dosage form. For example: Invented name X (serotype) suspension for injection. The same procedure applies to the addition of new antigens. Differentiation between the medicinal products has particular importance in cases when two vaccines are available parallel in the market Biological medicines If a change in the manufacture results in the birth of a new version of a biological medicine that is a substitute of the old one (e.g. line extension), OGYÉI assesses the former invented name according to the individual circumstances of that particular case. But if the former biological medicine has its properties changed (for example through the addition of a new adjuvant) the use of a new invented name or a prefix or suffix added to the old invented name may become necessary. In this case the prefix or suffix has to convey clear meaning for the consumer Non-prescription medicines In the case of medicines available without medical prescription attention should be paid to the special position of these types of medicines. The use of qualifiers/abbreviations should facilitate easy selection, identification of the medicine by the patient and its differentiation from other medicines. Hence the restrictions in Sections and need not necessarily to be applied in such case. To promote self-medication it is acceptable that non-prescription medicine names convey positive meaning and/or informative message. We insist that Applicants in each case thoroughly explain the use of the planned qualifier. 10/18 12 August 2015

11 3.4.4 Fix combinations Invented names for fix combination products should be selected in such a way that the name duly differs from the names of active substances that constitute the medicine and/or from the names of other fix combination products containing the same active substance(s). A way of doing so is the use of qualifiers, e.g. Diovan HCT, Pritor Plus, Aspirin Complex. The use of a completely new invented name is another possibility. A general principle is to rule out mix up when several fix combinations exist parallel, for example: Tuttiname, Tuttiname Forte, Tuttiname Ind, Tuttiname Forte Ind, Tuttiname Rosu, Tuttiname Forte Rosu, Tuttiname Ind Forte Rosu. Making up the name of a fix combination from the invented names of the products constituting it is not acceptable, e.g. Tuttiname + Muky Co-packaged preparations If two medicinal products are packed in a common box (so-called kombi-pack or copackaged product ) the name has to be well distinguished from: - the names of products not co-packed; - the names of other co-packaged products; and - the names of other fix combination products. Acceptable is a name structure such as full name of the co-packaged preparations + a qualifier referring to co-packaging, e.g.: Tuttiname FORTE 20 mg/10 mg hard capsule + Muky 5 mg film-coated tablet Kombi-pack. The use of an entirely new invented name is also acceptable Names of generic, hybrid- and similar biological medicinal products The same criteria apply to generic, hybrid and other similar biological medicines as to any other medicinal product regarding the invented name. 11/18 12 August 2015

12 3.4.7 Use of common name or scientific name Apart from Section 3.2 if Applicant wants to use a common name or a scientific name in place of the invented name together with the trademark or the name of the marketing authorization holder - the following should be kept in mind: - Where there is a WHO-recommended INN for the given active substance, it must be shown in the medicine s name exactly as it had been published, without abbreviations and omissions. Any linguistic variations of the INN should be regarded as one name. If there is no such name the generally used common name is to be used; - Where there is a WHO-recommended Modified INN (hereinafter: INNM) for the given active substance, it must be shown in the medicine s name exactly as it had been published, without abbreviations and omissions; - Where the active substance is an INNM which had never been published before, the medicine s name can only be a version adopted together by the users of the INN (pharmacopoeia committees, regulatory authorities, stakeholders), in accordance with WHO /3 INNM working document which is available on the following link: - The name of the marketing authorization holder or, if need be, the trademarked name should be put right after the common name with or without a hyphen but in any case before the strength and the pharmaceutical form. For example: INN - MAH / TRADEMARK + STRENGTH + PHARMACEUTICAL FORM INN MAH / TRADEMARK + STRENGTH + PHARMACEUTICAL FORM Please note that only one of the above two combinations is allowed for a medicinal product with a given active substance, a given strength and pharmaceutical form. Each further name has to be an invented name; - The INN and the marketing authorization holder s name cannot be combined to form a single word (e.g.: pravastatinx); - The trademark to be used with the INN should be a trademark that the trademark owner has agreed to; - If the trademark to be used with the INN is already an invented name of a marketing authorized medicinal product, the trademark is not allowed to be used (e.g. Imodium; Diphenoxylate-Imodium); - OGYÉI does not accept names structured as INN + qualifier + MAH, or INN + MAH + qualifier because the qualifier must be part of the invented name. Renewals are the only exception, if cannot be avoided; - The planned use of a promotional type of trademark affixed to the INN must be thoroughly explained during the procedure; - Prefixes and abbreviations in INN names are not acceptable. Exception is the HCT (hydrochlorothiazid) and ASA (acetyl salicylic acid). The prefix Co- can be used for fix combinations; - For medicines containing different active substances only a / sign should separate the active substances (pl.: Metformine/Glibenclamide MAH); - If various salts of an active substance are used and the MAH wants to authorize several of them, the salt should be shown in the name clearly and well separable from one another (e.g.: Amlodipin maleate MAH 5 mg tablet and Amlodipin bezilate MAH 5 mg tablet). 12/18 12 August 2015

13 3.4.8 Names of generic medicinal products referring to a centrally authorized medicinal product Article 3 (3) c) of Regulation No 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency says that a generic medicinal product of a reference medicinal product authorised by the Community should be authorized under the same name in all the Member States where the application has been made. For the purposes of this provision, all the linguistic versions of the INN (international nonproprietary name) shall be considered to be the same name. Accordingly, a generic medicinal product of a centrally authorized reference medicinal product should be authorized under the same name in all the member states regardless of which procedure (central, mutual recognition or decentralized) the generic medicine is to be authorized for marketing. There are two cases when departure form the aforesaid main rule is allowed: Use of the first name may be allowed in a Member State where the trade mark law of that member state does not allow use of the suggested invented name, in this case a detailed explanation must be provided in substantiation of the use; or Use of a different name may be allowed if the MAH is not identical in all the member states AND the MAH in one or more member states is not eligible for the use of the trademark. In this case satisfactory evidence must be provided to prove that the MAH is not eligible to the trademark in the problematic Member State. Of course with INN-MAH structured names, if the marketing authorization is transferred to another MAH after authorization, the marketing authorization of the generic medicinal product should be modified in accordance with Commission Regulation No. 1234/2008/EC concerning the examination of variations to the terms of marketing authorizations for medicinal products for human and veterinary use. Prior to submission of the marketing authorization application Applicants are advised to check member state markets for similar names and provide several alternative medicine names. 3.5 Braille requirement for name on product label Within the meaning of Subsection (7) of Section 2 of MoH decree 30/2005 (VIII. 2.) on the labeling and patient information leaflet of medicinal products for human use the name of a newly authorized medicinal product is to be shown in Braille on the outer packaging, or failing which, on the immediate packaging. If the medicine is available in more than one strengths, the strength should also be shown next to the name of the medicinal product. For medicinal products already authorized at the time when the decree took effect the provisions applying to labeling and patient information leaflet including an obligation to show the medicine name in Braille have to be complied with, with effect of December 31, /18 12 August 2015

14 4. UMBRELLA TRADE NAMES The so-called Umbrella trade names constitute a special group in medicine names and hence is to be discussed separately. Umbrella trade names are understood to mean the extension of an invented name affixed, if need be, with a prefix or suffix on several products ( umbrella trade names or umbrella brands ). The real purpose of the umbrella trade names is to highlight the property that identifies a product of an umbrella brand as one group. The marketing authorization holder is responsible for the use of umbrella trade names. If any probable mix up among the products of an umbrella brand may raise potential medicine safety and/or efficacy concerns the use of the umbrella trade name has better avoided in respect of the problematic medicine. In particular the following cases may constitute public health risk: - The medicinal products contain different active substance(s); - The medicinal products were meant for different patient populations; - The medicinal products safety profile is different in each patient population (e.g. some medicines can be given to pregnant women, others cannot); - If their interactions differ; - If the properties and treatment of overdose is different for each medicinal product; - If the umbrella trade name is used for several product categories (medicinal products, paramedicines, food supplements, cosmetics, etc). During examination of the acceptability of an umbrella trade name the main point is that the suggested name should raise no safety and efficacy concerns and that the name satisfies legislative criteria. In the result thereof and/or in the absence of explicit legal regulation OGYÉI in every case looks upon and assesses separately the acceptability of an umbrella trade name for the medicinal product in question. In general the following can be said: It is not recommended that the suggested name of a medicine be an umbrella brand name used for products of other status (food supplements, food, cosmetics, etc) already launched on the market; If OGYÉI learns that a MAH had extended a medicine name to some other product category that OGYÉI understandably has no legal means to prevent and holds that by the individual circumstances of the case this is misleading for the consumers or implies medicine safety risks, OGYÉI takes the necessary steps to start a consumer protection and/or advertising supervisory proceeding as provided for in law; It is only in exceptional cases that an umbrella brand name can be shared between several marketing authorization holders. Applicant must given an explanation for the shared use; Umbrella trade names can parallel be used for prescription-only and non-prescription medicines. It follows that any change affecting the prescription status of a medicine ( switch ) does not rule out continuing use of the umbrella trade name for the switched preparation. Yet, Applicants are being warned that radically different rules apply for commercial practice with medicinal products included in the scope of the health insurance system than with non-prescription medicines. 14/18 12 August 2015

15 The following situations may be possible with umbrella trade names: 1. An umbrella trade name is to be extended to a medicine that contains the same active substance as the other medicines in the product family and has the same therapeutic area. Acceptable. E.g.: Invented MAH 400 mg film-coated tablet, Invented MAH 20 mg/ml oral suspension, Invented MAH 400 mg suppository 2. An umbrella trade name is to be extended to a medicine that contains the same active substance as the other medicines in the product family but has a different therapeutic area. Acceptable, provided, the therapeutic area is shown in the medicine s name in harmony with the indications in the summary of product characteristics. Applicants must provide evidence to prove that extension of the umbrella trade name to another therapeutic area poses no safety risk. E.g.: Invented 500 mg tablet (indication: fever, pain, inflammation) Invented Protect 100 mg tablet (cardiovascular indication) 3. An umbrella trade name is to be extended to a medicine that contains more active substance(s) than the other medicines in the product family but has the same therapeutic area as theirs. Acceptable, provided, a prefix or suffix is affixed to the name to differentiate the medicine from the other products in the umbrella brand to exclude ambiguity. Pl.: Invented 20 mg hard capsule Invented Plus 20 mg/10 mg hard capsule Co-Invented 20 mg/10 mg hard capsule 4. An umbrella trade name is to be extended to a medicine that contains more active substance(s) than the other medicines in the product family but has a different therapeutic area. Not recommended but is acceptable in exceptional cases if the therapeutic area is shown in the medicine s name in harmony with the indications in the summary of product characteristics. Applicants must provide evidence to prove that extension of the umbrella trade name to another therapeutic area poses no safety risk. 5. An umbrella trade name is to be extended to a medicine that contains different active substance(s) and has the same therapeutic area as the other medicines in the product family. Not recommended but is acceptable in exceptional cases, if Applicant can prove without a shadow of doubt that this does not imply medicine safety and/or efficacy concerns. 15/18 12 August 2015

16 6. An umbrella trade name is to be extended to a medicine that contains different active substance(s) and has a different therapeutic area from that of the other medicines in the product family. Not acceptable. Again, OGYÉI in each case subjects the suggested name to a risk-based examination to make sure that inclusion of the product in the brand has no medicine safety and/or efficacy concerns. Apart from the above general principles OGYÉI also considers the following factors to decide about the acceptability of an umbrella trade name: - Explanation to substantiate the suggested name; - Description of own or other manufacturer s products that belong to the same or similar brand; - Indication field for all relevant medicinal products; - Classification categories for the products concerned; - Differences in interactions with other medicines; - Any medicine safety issue likely to emerge if the product is included in the brand; - Specific patient and consumer groups (children, expecting mothers, elderly, etc.), where there are differences between preparations in the same brand; - Differences in overdose effects and treatment; - Differences in indications, contra-indications, warning, posology (dosing frequency and various strengths) and in information in the summary of product characteristics and patient information leaflets; - Use of various prefixes and suffixes and a study of how they differentiate products from one another; - Differences between the properties of the active ingredients in preparations in the brand and safety risks originating from it; - Packaging characteristics: color, design, size, shape, the look of the inner packaging, its shape, color, useful information, indication of the active ingredient, distinction between products in a brand. If an examination according to the aforesaid points holds that inclusion of a product in the brand has undoubtedly no adverse effect on the safe and efficient use of the products potentially affected by the name OGYÉI agrees to the umbrella trade name being extended to another medicinal product. 16/18 12 August 2015

17 5. REGULATORY ASPECTS RELATED TO PROPOSED MEDICINE NAMES New procedure In the procedure to grant marketing authorization to a medicinal product Applicant proposes one or more names. OGYÉI is being in touch with the Applicant to discuss acceptability of the names. In decentralized or mutual recognition procedures it is important to agree on a name by the start of the national phase. Variation of a marketing authorization MAH is allowed to any time modify the name of an authorized medicine. According to A. 2 of European Commission s Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures (2013/C 223/01) (hereinafter: Guideline) a change in the name of an authorized medicinal product is to be regarded a minor change of I.B type. During a marketing authorization variation procedure Commission regulation No. 1234/2008/EC concerning the examination of variations to the terms of marketing authorizations for medicinal products for human use and veterinary medicinal products has to be followed. Change of status of a medicinal product In the case of switch from prescription to non-prescription status it is up to Applicant to decide to either to request extension or variation to an earlier marketing authorization while keeping the original name or propose a new name for the medicine by starting a new marketing authorization procedure. If the MAH wants to market the medicine in both prescription and non-prescription status, and since a medicinal product cannot be present on the market in both status with the same name, the MAH has to give a new invented name to one of the medicines or affix a suitable qualifier to one of them to differentiate one from the other. 17/18 12 August 2015

18 6. PRIOR OPINION ON MEDICINE NAMES Prior to the start of a marketing authorization procedure or a procedure for the variation of a marketing authorization OGYÉI may be requested to give prior scientific advice on the planned medicine names. The fee for the scientific advice is HUF/hour. The request should be sent by post to our central mailing address (referring to 2801 case identification number) or in exceptional cases to scientific.advice@ogyei.gov.hu. The request must include: - The name planned for the medicine; - Active substance; - Strength; - Pharmaceutical form; - Indications; - Specific target group (children, elderly, expecting mothers, etc.); - Route of administration; - The planned status of the medicinal product (prescription-only, non-prescription, etc.); - Other necessary explanations. OGYÉI drafts the prior opinion in 30 days from date of receipt of the request. The prior opinion on the acceptability of the name reflects the conditions that existed at the time of the making of the opinion, hence content of the opinion on the grounds of other possible new circumstances learned by OGYÉI after issuing this prior opinion (e.g. a name of a medicinal product in a procedure initiated in the meantime) is in no way binding for OGYÉI during later official proceedings. 18/18 12 August 2015