Policy document: Nomenclature of pharmaceutical products

Transcription

1 MEDICINES EVALUATION BOARD Policy document: Nomenclature of pharmaceutical products 15 September 2015

2 Table of contents 1. Introduction and definitions Other policy documents regarding the nomenclature of pharmaceutical products General policy Invented name or generic name Invented names Generic product names Name of the marketing authorisation holder Identical product names Umbrella brands in the name Differences in legal status of supply Strength and pharmaceutical form Additions or characteristics The indication Special age groups Use of prefixes and suffixes Abbreviations and numbers Other additions Special products/situations Combination packages and combination products Line extensions Generics of centrally authorised products Parallel importation Vaccines Biologicals Radiopharmacaceuticals Medicines Evaluation Board 2

3 1. Introduction and definitions Directive 2001/83/EC contains the European guidelines for nomenclature of pharmaceutical products. These requirements have been adopted in the Dutch Medicines Act. This document applies to all product names that are confirmed by the MEB, in other words, the product name for all medicinal products for which the MEB has issued a (parallel) marketing authorisation. The marketing authorisation holder must consult this document when submitting a proposal for a product name. The Medicines Act can be used as a starting point for the definition of the name of a medicinal product: Product name: Name of a medicinal product, consisting of an invented name or a general/scientific name, accompanied by a brand or the name of the marketing authorisation holder. Nomenclature: The name of a medicinal product followed by the strength, pharmaceutical form and - if necessary - the active ingredient. This provides a set of distinguishing characteristics on the packaging. It is important to read and apply this policy document about the nomenclature together with the policy for labelling for the assessment of the nomenclature. The documents by the European working party on Quality Review of Documents (QRD) provide more information about the identification of a product in the summary of product characteristics, in the package leaflet and on the packaging. The nomenclature of products that are/will be authorised via the centralised procedure is coordinated by the EMA s Name Review Group. The guidelines for the nomenclature of Centralised products are described in the document Guideline on the acceptability of invented names for human medicinal products processed through the centralised procedure. 1.1 Other policy documents regarding the nomenclature of pharmaceutical products. Via WHO The use of common stems in the selection of International Non-proprietary Names (INN) for pharmaceutical substances. (WHO/EDM/QSM/99.6) This document provides a set of instructions for the use of INNs of pharmaceutical substances in the nomenclature of medicinal products. Via EMA: Guideline on the acceptability of invented names for human medicinal products processed through the centralised procedure, EMA/CHMP/287710/2014 (Rev 6) Acceptance criteria drafted by the CHMP for nomenclature of pharmaceutical products processed via the Centralised Procedure. Via CMD QRD Recommendations on the expression of strength in the name of centrally authorised human medicinal products (as stated in section 1 of SPC, and in the name section of labeling and PL) (EMA document Doc. Ref. EMA/707229/2009) Via MEB MEB-5 Package leaflet for pharmaceutical products MEB-6 Labelling of pharmaceutical products These are policy documents by the MEB regarding the package leaflet and the labelling of medicinal products. These documents provide an explanation of the stipulations in the Medicines Act. MEB 21 Listing abbreviated indications on packaging of OTC products Via Wetten.Overheid.nl Medicines Act Regulation Medicines Act Medicines Evaluation Board 3

4 2. General policy The product name is the name of a medicinal product, consisting of an invented name or a general/scientific name accompanied by a brand or the name of the marketing authorisation holder. Distinguishing between the product name and the nomenclature of a product might prevent long product names. The product name is always listed before the comma, for example Paracetamol Marketing Authorisation Holder 500 mg, tablets. According to Directive 2001/83/EC, it is not compulsory to state the strength and pharmaceutical form in the product name. The product name must be followed by the strength, pharmaceutical form and active ingredient. In other words, this information must be part of the nomenclature. If the pharmaceutical form and strength already are part of the product name, they do not have to be repeated after the comma. The QRD states that this information can be presented on several lines and in various font sizes if necessary, provided that the reader will view the information as one integrated concept. The omission of the brand or the name of the marketing authorisation holders (i.e. only stating the general or scientific name of the substance) is not permitted. The option to use the preparation names (only listing the active ingredient with strength, without the addition of the marketing authorisation holder and/or umbrella name) has ended. The term register name (product name before the comma; pharmaceutical form and strength after the comma) has been replaced by the term nomenclature. Regarding the order of information in the product name, it should be noted that a generic name should always start with the name of the active ingredient. The reason for this is that it is more difficult for pharmacists and other healthcare professionals to search in registers if all product names start, for example, with the same name of the marketing authorisation holder. However, the abovementioned does not apply to invented names (refer to section 3.1) and umbrella brands (refer to section 4). The MEB has no additional requirements, other than those listed above, for the order in which the marketing authorisation holder, strength and pharmaceutical form are subsequently listed. Basic principles of nomenclature: The product name is part of the assessment of the dossier and is assessed based on the potential risk of medication errors. The following principles should be observed: Product name in Dutch Details for the labelling, including the nomenclature of the medicinal product, must be drafted in the official language of the member state where the product will be marketed. This is evidenced by the reference in article 63, 1 st section of Directive 2001/83/EC to articles 54, 59 and 62 of that same Directive (article 54, section a relates to the name of the medicinal product). If an INN name is being used, the translation of the INN name must be used. All translations of these INN names are considered to be equal to the internationally approved INN name. Name confusion should be avoided. The product name should not cause confusion with the name of another authorised pharmaceutical product or with other active ingredients. This applies to the name when it is printed, handwritten or pronounced. The following aspects should be taken into consideration: 1. The use of an invented name should not cause confusion with the general or scientific name and also should not cause confusion regarding the composition of the product. 2. The name should not result in any misunderstanding with regards to the therapeutic or pharmaceutical characteristics of the product 3. The similarities/differences in the method of administration 4. The similarities/differences in legal status of supply (e.g. prescription only (UR) or nonprescription (UA, UAD or AV)). The MEB requires sufficient differentiation in pronunciation and in writing between various pharmaceutical products. The product names must differ by at least three characters in order to Medicines Evaluation Board 4

5 achieve this. The MEB can always require more pronounced differences between product names, if the MEB is of the opinion that this is necessary. Not for promotional purposes An invented name is not allowed to convey a promotional message. Product names (including any additions) that have a promotional aspect are not acceptable. This also means that it is not acceptable to include any promotional aspect in the name of the marketing authorisation holder in the product name or any promotional aspect in an abbreviation that refers to the name of the marketing authorisation holder. The MEB acknowledges that there is a thin line between promotional and informative and in general the MEB is very reticent about approving any potentially promotional product names. Policy regarding previously approved product names: If a name of a previously authorised product no longer meets the current nomenclature requirements, then the company can be informed about this during a procedure. However, the company is not required to change the name with immediate effect, unless this is in the interest of public health. Medicines Evaluation Board 5

6 3. Invented name or generic name 3.1. Invented names When an invented name is used, the name should not start and/or end with a letter combination that is used by the World Health Organization as INN stem for a certain class of active ingredients. The WHO document the use of common stems in the selection of International Non Proprietary Names (INN) for pharmaceutical substances (WHO/EDM/QSM/99.6) states: in line with the WHO World Health Assembly resolution (WHA 46.19) it would be appreciated if invented names were not derived from international non-proprietary names (INNs) and if INN stems were not used in invented names. This practice endangers the principle that INNs are public property; it can frustrate the rational selection of further INNs for related substances, and it will ultimately compromise the safety of patients by promoting confusion in nomenclature between active substances and medicinal products. The MEB recommends that the WHO should be consulted. The inclusion of the name of the marketing authorisation holder or a brand in the product name is permitted, if this product name is an invented name. The name of the marketing authorisation holder or brand that part of the product name can be considered part of the fantasy -aspect. However, one should be cautious that the combination of the invented name and the name of the marketing authorisation holder (or brand) does not result in a so-called umbrella brand in the name. Additional conditions apply in such cases. Refer to section 4 Umbrella brands Example: Pardolica Marketing Authorisation Holder 500 mg, tablets This name is permitted. The use of the marketing authorisation holder s name can be considered as part of the fantasy in the abovementioned invented name. The use of a capital letter in the middle of a word seems contrived and is not recommended. However, the MEB has no major objections to this. 3.2 Generic product names General or scientific name (INN) The general or scientific name is the general name (INN name) recommended by the World Health Organization. If an INN name exists for a specific substance, it should be used exactly as published, without omissions or abbreviations. All translations of these INN names are considered to be identical to the internationally approved INN name. In the absence of an INN name, the name can be selected in accordance with the European Pharmacopoeia, BAN (British Approved Name) or USAN (United States Adopted Name). An exception are the vitamin analogues, because the general nomenclature for vitamins is more recognisable to the consumer than the INN name. Example: Paracetamol Marketing Authorisation Holder or Brand Name 500 mg, tablets This name is permitted. This is a general/scientific name to which the name of the marketing authorisation holder or a brand has been added. Salt form & combination products For the nomenclature of products with the same composition, the order of the product name of the individual components, the salt form and any strength indication and pharmaceutical form - if relevant - must be used consistently. If the general or scientific name is used, then this name should be presented in such a way that the active ingredient is listed first, followed by the salt, unless the WHO stipulates a different order. The innovator, the reference product, or the first representative always takes precedence in the aspects listed above. This also applies to combination products, such as augmentin (amoxicillin/clavulanic acid) or co-trimoxazole (trimethoprim and sulphamethoxazole). It is important to maintain a consistent policy for this in order to avoid confusion. Medicines Evaluation Board 6

7 Example: Potassium losartan 50 mg, tablets This name is not permitted. The base should be mentioned first, followed by the salt, unless the WHO stipulates a different order. Losartan potassium 50 mg, tablets is permitted. Complete listing of the salt form in the product name is generally correct, but in many cases it is not necessary, because the salt has no influence on the therapeutic effect. In addition, the inclusion of the salt form in the product name makes the product name unnecessarily long, which the MEB does not prefer. A condition is that the salt form must be stated near the product name on the packaging, in accordance with the labelling policy document (also refer to the examples in section 6). This option lapses if other salt or ester forms have also been authorised, as the product name in such cases does not clarify which compound is in use. Different formulations For generic medicinal products where the innovator consists of various formulations, it is important to determine whether the INN name alone is sufficient to distinguish between the various products. In some situations, the INN name alone does not distinguish sufficiently, for example in the case of lipid complexes. In these cases, one of the following options should be selected: Name of the generic medicinal product: The company can opt for either a fantasy name, or an addition to the name (e.g. liposomal). Additional information on the packaging: This must be assessed on a case-by-case basis, but examples include: for once daily dosing or liposomal formulation Example: Amphotericin B lipid complexes These products all have the same ingredient name, but contain different lipid complexes. If various innovator formulations with the same active ingredient are in use, then a description of the formulation must be added to the name of a generic medicinal product to ensure that it is sufficiently distinguishable. Generics Amphotericin B Amphotericin B colloidal Amphotericin B lipid complex Amphotericin B liposomal Innovators Fungizone Amphocil Abelcet Ambisome 3.3 Name of the marketing authorisation holder The name of the marketing authorisation holder should not cause confusion and may not be promotional in nature. Therefore, numbers and abbreviations that could result in confusion are not permitted (also refer to section 7.4). If the name of the marketing authorisation holder is used in the product name, then it must correspond to the full name or a part of the name of the marketing authorisation holder. A marketing authorisation holder is allowed to use several different names, provided that these names are not being used by other marketing authorisation holders or used as brands. If the name of the marketing authorisation holder is not being used and the manufacturer is not acting as the marketing authorisation holder for other products, then the manufacturer s name can be used in the product name. The manufacturer s name is considered as the brand. However, this is not permitted if the manufacturer acts as the marketing authorisation holder for other products. This could result in confusion about who is responsible for marketing the product, due to the manufacturers own other authorisations. The marketing authorisation holder can be a different legal entity to the brand name holder (although they will of course have reached an agreement on the matter). The marketing authorisation holder may differ, but both use the same brand in their product name. A condition here is that the brand name is not the same as the company name of a company acting as marketing authorisation holder for products other than the abovementioned product. Medicines Evaluation Board 7

8 Example: Company (brand)name Paracetamol 500 mg* Marketing authorisation holder tablets This name is not permitted. A combination of a brand and a marketing authorisation holder causes confusion about who is responsible for marketing the product. A choice must be made between a brand or the name of the marketing authorisation holder. Example: Pardolica Manufacturer s name 500 mg, tablets This name is permitted, provided that the manufacturer does not act as marketing authorisation holder for other products in the Netherlands. The manufacturer s name effectively forms a brand. Example: Company (brand) name Paracetamol 500 mg, tablets This name is permitted in specific situations. The company markets a number of non-prescription products that use the name of the company or the name of the chemist chain. In this case, the company s name is a brand that accompanies the general/scientific name (paracetamol). This could result in an umbrella brand (refer to section 4) In the event of a merger between two marketing authorisation holders, the company name of company X that has been taken over may still be used in the product name, whilst company Y that has taken over the other company (and also acting as marketing authorisation holder) will now act as marketing authorisation holder for the products of company X. This is on condition that legal entity X does not still hold authorisations with the name of company X in the product name. This also applies to international mother companies that operate as license holder and have a Dutch subsidiary company that acts as a contact address or distributor. Example: Paracetamol Subsidiary company 500 mg tablets This name is permitted. The subsidiary company acts as distributor of the mother company s products in the Netherlands. The mother company owns the subsidiary company. The subsidiary company does not act as marketing authorisation holder for other products. In fact, the subsidiary company s name can be considered a brand. However, this is not permitted if the subsidiary company acts as the marketing authorisation holder for a number of other products. 3.4 Identical product names Generic product names A marketing authorisation holder can apply for several generic products, in which the product name for these generic products could be identical. In principle, the same generic product name for two different dossiers that are not a copy (but are from the same marketing authorisation holder) is acceptable. It is a condition is that the composition of both products is qualitatively and quantitatively similar (if both products differ in the excipient listed in the guideline of excipients, then the product names cannot be identical) and that both products are bio-equivalent to the same reference product or therapeutically equivalent (this applies to both generic and hybrid products). If these conditions have been met, the style of the mock-ups may also be similar. Invented names In the case of invented names, the general rule is that product names should differ sufficiently to avoid confusion between names. In general, a fantasy name cannot be used multiple times, with the exception of line-extensions (see section 8.2). However, in exceptional cases, it is possible to re-use an invented name in order to make use of the brand familiarity of the product. It is a condition is that the original product is no longer authorised and no longer on the market. Medicines Evaluation Board 8

9 4. Umbrella brands in the name An umbrella brand is a communal brand for a group of over-the-counter medicinal products that serves to increase the consumer s familiarity with the products as a group. These products can differ in composition, active ingredients, pharmaceutical form and therapeutic indications. For umbrella brands, the name of the active ingredient must be included in the product name. The reason for this policy is that - in practice - the product names of a series of products from one umbrella line can be so similar that the use of the active ingredient alone does not distinguish the products sufficiently. The only exception to the requirement of stating the active ingredient is when a unique fantasy name is linked to the umbrella brand, meaning that the entire name is linked exclusively to that single product. The nomenclature of the products should not result in any misunderstanding about the efficacy regarding the listed indications or regarding the composition, as far as the active ingredients are concerned. The use of indications in the name is no longer permitted for names with an umbrella brand either, except for the situation described in section 7.1. If there are several products within one umbrella line that have the same active ingredient, but different indications, then the MEB stipulates that the abbreviated indication should be listed on the primary side of the packaging. This is the side on which the trade name is also presented. A list of abbreviated indications is available (policy document MEB 21 Listing abbreviated indications on packaging of OTC products). Finally, the MEB has a strong preference for maintaining the strength in the name. Umbrella brands should also avoid creating confusion about who is responsible for marketing the product. A company that uses the umbrella brand as company name may not act as marketing authorisation holder for other products. Of course, the name of the umbrella and the marketing authorisation holder may correspond for the product itself. In fact, in the latter is a case of name of the marketing authorisation holder in the product name, which is permitted. Medicines Evaluation Board 9

10 5. Differences in legal status of supply It is not possible to register two products with different legal status of supply (over-the-counter and prescription) under the same product name, because in this situation there will be a substantial difference in both dossiers, for example a difference in therapeutic indications, dosage and/or contraindication. By definition, an over-the-counter product does not have the same indication as a prescription product. For over-the-counter medicinal products, a medicinal product can be assigned a different legal status of supply, for example UA, UAD or AV. The product information might be the same, but a different legal status of supply can be awarded based on the packaging sizes. In these cases, the same product name can be used because there is no substantial difference between the dossiers. If a change in the legal status of supply results in changes to the name, then the name must be sufficiently distinct so that it cannot be confused with the original product. The indication may notbe used in the name for this purpose (see section 7.1). Medicines Evaluation Board 10

11 6. Strength and pharmaceutical form It is not compulsory to state the strength and pharmaceutical form in the product name. If the strength is included in the name, it does not have to be listed again following on from the name on the packaging. This information will have to be stated elsewhere on the most important side of the packaging, for example in the case of tablets: one tablet contains X mg Y, with Y being the active ingredient. Please refer to the labelling policy document for information about stating this information on the packaging. If a strength without a strength-unit has been accepted in the product name, the number will have to be stated in combination with the strength unit in the nomenclature. Please refer to the QRD Recommendations on the expression of strength in the name of centrally authorised human medicinal products on the EMA website for the correct listing of the strength in the name for various pharmaceutical forms. The complete pharmaceutical form should be stated as stipulated by the EDQM. The use of 2 different terms on 1 package should be avoided as it could result in confusion, for example in the case of specific release profiles. Therefore, the use of a patient-friendly term for the pharmaceutical form is not permitted. However, the EDQM does have an option for indexing of several pharmaceutical forms, for example capsules, soft. In these cases, the pharmaceutical form in the product name should be amended to a correct presentation, i.e. soft capsules. Specific conditions for stating the strength The type of compound (salt/ester) in which the active ingredient is present should be taken into consideration. According to the Directive, any reference to the active ingredient on the packaging should always correspond to the strength. Complete listing of the salt form in the product name is often not necessary. However, it is now compulsory to declare the strength according to the base, if the active ingredient is actually the base. However, if the innovator is declared in the salt form, generic products should follow the innovator strength. The strength of the medicinal product is expressed as the quantity of active ingredient per unit of dosage, volume or weight, depending on the pharmaceutical form. The symbol µ, as used to indicate micrograms, should not be used as this sign can cause confusion. In general, it is no longer permitted to state the concentration as a percentage. However, for those products where the concentration has a greater impact on the effect than the total amount and where stating the strength in percentages has been common practice for some time - for example Sodium chloride 0.9 % - it is still acceptable to state percentages in the name. Example Acebutolol Acebutolol Marketing authorisation holder or brand name 200 mg tablets Acebutolol This name is permitted. The number 200 mg in the name corresponds to the actual situation. However, it must be stated elsewhere on the packaging (and also in the summary of product characteristics and in the package leaflet) that the HCl salt has been incorporated ( one tablet contains acebutolol-hcl equivalent to 200 mg acebutolol ). (refer to section 3.2) Example Perindopril (innovator Coversyl 2 mg) Perindopril Marketing authorisation holder or brand name 2 mg tablets perindopril tert-butylamine This name is permitted. The reference to the active ingredient should preferably correspond to the strength as expressed in the name. The product actually contains 2 mg perindopril tert-butylamine and not 2 mg perindopril base. Although the name in the first sentence suggests that 2 mg of base is present, this name is permitted. Complete listing of the salt form in the product name is - in general - correct, but in many cases it is not necessary, because it has no influence on the therapeutic effect. In Medicines Evaluation Board 11

12 addition, the inclusion of the salt form in the product name makes the product name unnecessarily long, which the MEB does not prefer. A condition is that the salt form must be stated near the product name on the packaging, in accordance with the labelling policy document (refer to section 3.2). Perindopril tertbutylamine Marketing authorisation holder or brand name 2 mg tablets perindopril tertbutylamine** This name is permitted. The name is declared in the salt form, because - in this case - the company has registered several different salts of the same base. In order to distinguish between these forms, it is permitted to include the salt in the product name. For completeness, it could be noted that it is not acceptable here to convert to the quantity of base, as this would result in a decimal fraction in the strength indication and the relationship with the innovator strength would also become unclear. Therefore, in situations such as for products containing perindopril tertbutylamine, it is preferable to opt for an invented name. Perindopril Marketing authorisation holder or brand name mg tablets perindopril (as tertbutylamine salt) This name is not permitted. The conversion to the amount of base results in an undesirable decimal fraction in the strength indication. In addition, the relationship to the innovator strength becomes unclear. Example Amlodipine Amlodipine (as maleate) Marketing authorisation holder or brand name 5 mg tablets amlodipine** This name is permitted. A condition is that it must be stated elsewhere on the packaging (and also in the summary of product characteristics and in the package leaflet) that the maleate compound has been incorporated ( one tablet contains amlodipine maleate equivalent to 5 mg amlodipine). Invented name 5 mg tablets amlodipine maleate equivalent to 5 mg amlodipine This name is permitted. If the marketing authorisation holder does not wish to use the abovementioned nomenclature, then an invented name can be used, as for the innovator product. However, this means that the compound used can no longer be deduced directly from the name. In those cases where the same marketing authorisation holder has registered products with different compounds of amlodipine, an additional clarification on the second line is deemed essential. Medicines Evaluation Board 12

13 7. Additions or characteristics Special additions to the invented name or the general or scientific name are limited according to the regulations. However, it can be desirable to provide more information on the packaging, because the patient bases his/her choice of product on the packaging. Therefore, in certain cases, the MEB is prepared to allow additions other than those stipulated by law on the packaging, provided that the conditions in this chapter are met. The MEB will permit additions that are not in the Dutch language, but are considered commonplace, provided that they meet the additional conditions listed below: The foreign term should not serve as a replacement for the information that the Medicines Act stipulates must be included on the packaging (and must therefore be in Dutch). In this case, the foreign term in the product name is merely additional to the abovementioned statutory information that should always appear on the packaging (in Dutch). This will not have any detrimental effect on a reader who does not speak a foreign language. Information in another language can be acceptable on condition that this information is also stated in Dutch on the packaging due to the statutory requirements of the Medicines Act. Finally, in all cases, the foreign term in the product name should not result in any confusion. If higher or lower strengths are released to or removed from the market, this can have consequences for additions or previously approved names for existing products. Depending on the situation, additions may have to be removed or amended. 7.1 The indication For over-the-counter medicinal products, there is the option to include a so-called abbreviated indication (or in some specific cases, additional information about the area of application) elsewhere on the packaging. The document abbreviated indications (MEB 21) has been drafted for this. A request for inclusion of an abbreviated indication on this list can also be submitted to the MEB. Although indications are generally no longer permitted in the product name, it is now permitted to include a part of the indication in the product name with the following conditions: The indication is in accordance with the policy document Abbreviated indications. The pharmaceutical form is part of the name (in other words, stomach tablets,, so including the word tablets ) Although an invented name should generally be a name without general meaning, the MEB does not object if there is a certain correlation between the invented name and the application. Of course, this correlation should not be misleading. A name such as Imigran (for migraines) is acceptable in this context. 7.2 Special age groups If a pharmaceutical product is intended for use by a specific age group, then this age group should be listed additionally on the packaging (see revised Directive 2001/83/EC). However, this information should not be included in the name. The age category should be stated as accurately as possible. A less accurate listing, for example for children or junior is only acceptable to the MEB if the age group is described in more detail elsewhere on the packaging, for example for children aged 1 to 8 years. The MEB is of the opinion that mentioning the age group is only desirable if the product is authorised alongside another product, but intended for a different age group. This policy prevents having to add adults to the packaging of all products that have not been studied, for example, in children. For more information, please refer to the policy document MEB-6 Labelling of pharmaceutical products. Medicines Evaluation Board 13

14 7.3 Use of prefixes and suffixes If the active ingredient is a pro-drug or is derived from a previously authorised active ingredient, the use of an existing name with the addition of a prefix or suffix (for example, the prefix pro ) is not permitted. If a product is considered as a new active ingredient, then a different product name should be selected for this product than the approved product name for the original active ingredient. 7.4 Abbreviations and numbers The MEB recommends not to use abbreviations. The MEB will not allow an abbreviation if it can result in confusion with abbreviations that have a pharmaceutical or scientific meaning (for example, SC, HP, IU, IM, CR). The use of numbers in the name of a product - other than as part of the strength - might result in confusion about the strength and the administration instructions and is therefore not permitted. Numbers are also not permitted as part of the marketing authorisation holder s name. An exception to this is the functional addition of a combination of numbers and letters that have been commonplace for a long time and are therefore indispensable to avoid confusion, such as vitamins (for example Vitamin D3). 7.5 Other additions Permitted additions: Addition hyphen (- or dash) symbol or TM Kit" Combination package Specific details Permitted. Permitted in the name, when stating the name on the packaging and in the package leaflet. The addition of these symbols is not permitted in the Summary of Product Characteristics, refer to the document by the European level working party Quality Review of Documents QRD. Such symbols will therefore not be listed on the marketing authorisation. Permitted Medicines Evaluation Board 14

15 Permitted under specific conditions: sugar-free gluten-free no preservatives CFC-free Forte Mitis Extra Extra strong. "cardio" "retard" "CR IV IM SC "Plus" with citrus flavour", menthol, mint, spearmint etc. Easyhaler, Clickhaler, Turbohaler, Autohaler These terms are permitted for the purposes of health education. Other similar terms for free from certain substances are not permitted. Permitted, provided that the strength is included in the name in quantitative terms. A condition here is that several strengths/pharmaceutical forms of product in question have to be authorised. These additions must not be used as a claim to emphasise certain characteristics. In other words, it is not permissible to indicate the strength only in qualitative terms. cardio has been permitted in the past due to the practical application. This addition is only permitted in combination with acetylsalicylic acid. Permitted, provided that it characterises the pharmaceutical form. Permitted, provided that it characterises the route of administration. Additions to indicate that the product consists of a combination of two or more active ingredients are permitted provided that both ingredients are mentioned in the name. Plus is not permitted as a claim to emphasise certain characteristics (see below). Permitted, provided that it corresponds to the composition of the product and is a neutral taste description. (Taste) Sensations, such as Hot, Cool, Cool Mint, coolmint, Fresh, Fresh Mint, freshmint, etc. are not permitted, because these are deemed promotional. Permitted, provided that they pertain to the inhaler device itself. Additions relating to the pharmacology of the product are not permitted. Medicines Evaluation Board 15

16 Not permitted: Addition Instant, Quick "Combi" Comp Co- - -Plus Pro- Specific details Not permitted, because instant and quick can be interpreted in different ways as fast-acting or for immediate use. This can cause confusion. Not permitted, because this can suggest both a combination product and a combination package. Kit or Combination package is permitted for combination packages. The additions to the name Co- and -plus (for example, Co-X and X plus) are not permitted for combination products if one of the active ingredients of the combination product in question is also available on the market in singular form under the name X. Even if a generic wishes to market the relevant combination product and has not marketed the singular product, then the addition of the name Co- or Plus will not be permitted. Plus is only permitted if both ingredients are mentioned in the name. Not permitted for pro-drugs and/or derivatives of existing products (see chapter 7.3) Medicines Evaluation Board 16

17 8. Special products/situations 8.1 Combination packages and combination products Combination package: a package that contains more than one medicinal product and is marketed under one trade name with a single marketing authorisation. The individual products differ in qualitative or quantitative composition and are administered simultaneously or consecutively. The strengths of the individual products must be included in the name of combination packages. The MEB has a strong preference for listing the pharmaceutical form in the name of combination packages. If both products have the same pharmaceutical form, it is not necessary to repeat the pharmaceutical form. However, if different pharmaceutical forms are used, all pharmaceutical forms should be listed. Only the name of the combination product should be stated on the outer packaging. The name of the combination product is also listed on the individual components, with the substance name contained in the individual component listed below. Example: RiseCaD 35 mg film-coated tablets and 500 mg/880 IU effervescent granulate Full product name on combination package: RiseCaD 35 mg film-coated tablets and 500 mg/880 IU effervescent granulate Primary packaging of the individual components: RiseCaD Sodium risedronate 35 mg, film-coated tablets RiseCaD Calcium/cholecalciferol 500 mg/880 IU effervescent granulate Combination product: product with a combination of active ingredients in one and the same pharmaceutical form. The name of a combination product should differ sufficiently from the names of the individual active ingredients and product names of other combination products. As stated previously, if the product contains one or two active ingredients, then the MEB strongly prefers the inclusion of the strength(s) in the name. The MEB no longer upholds this preference for products that contain three or more active ingredients. For combination products, a completely invented name must be used, or if the name refers to the ingredients, a reference to all the ingredients must be included. The order of the strength should correspond to the active ingredients as referred to in the product name. Example: Calci-kit D3 500 mg/800 IU/70mg This name is not permitted. As evidenced by the strength, this product consists of 3 ingredients, namely alendronic acid with calcium and vitamin D3. The product name does clearly refer to the calcium and vitamin D3, but not to the alendronic acid, which is the main ingredient in the preparation. Example: Alenca D3 70 mg/500 mg/800 IU This name is permitted. This product refers to all three active ingredients, namely alendronic acid, calcium and vitamin D3. The order of the strength listings should correspond to the order of active ingredients as referred to in the product name. 8.2 Line extensions In the case of a line extension, the product name must be the same as the name used for the previously authorised medicinal product. The difference between both products is expressed in the nomenclature (i.e. pharmaceutical form, strength and/or any additions). Medicines Evaluation Board 17

18 8.3 Generics of centrally authorised products A condition for a generic product of an innovator product authorised via a centralised procedure is that the product name must be similar in all member states where the product application has been submitted, regardless of the procedure that has been applied for the authorisation of the product (MRP, DCP, CP). In accordance with Directive 2001/83/EC, the name of a product can be either a fantasy name or a general or scientific name in combination with the name of the marketing authorisation holder or the (umbrella) brand. The general recommendations for product names should be observed in this matter. Exception to the abovementioned condition are: A deviation from the proposed product name in one of the member states is permitted, if the proposed name is rejected or an appeal is lodged against the proposed name based on the trademark law in that member state. This must be demonstrated in sufficient detail. A deviation from the proposed product name in one of the member states is permitted, if the marketing authorisation holder is not the same in each member state and the marketing authorisation holder does not control the (umbrella) brand in one or more countries. Proof must be submitted to show that the marketing authorisation holder does not own the (umbrella) brand. 8.4 Parallel importation The MEB prefers that a parallel marketing authorisation uses the same name as the Dutch reference product in order to limit the risk of confusion. If the Dutch reference product has a name that is not yet in line with the current nomenclature document, this might result in a conflicting situation. In such cases, the MEB will tolerate a name that does not meet the requirements in the current nomenclature document. 8.5 Vaccines If a new serotype is added to vaccines that consist of various serotypes, the original invented name can be maintained. In that case, the name of the vaccine is followed by the number of serotypes present and the pharmaceutical form. The description of the serotypes is presented in the qualitative and quantitative composition, for example: Invented name X serotypes suspension for injection. The abovementioned also applies if different antigens are added to an existing product. This is particularly important if both vaccines are available on the market simultaneously, so that it is possible to distinguish between the two products. 8.6 Biologicals If changes to the production of a biological (for example, in the case of line extensions) result in a new form of the product and the old product is replaced, a decision will be made on a case-by-case basis whether the existing product name can be maintained. If the characteristics of a certain product have changed (for example due to the addition of an adjuvant), a name change may be essential. 8.7 Radiopharmaceuticals Exemption from use of the Dutch language is permitted for the radiopharmaceuticals and for medicinal products for which the MEB (in very exceptional circumstances) has granted an exemption from having to apply a Dutch label. In these cases, the foreign name on the label would differ from the name in Dutch, which could result in confusion and is therefore undesirable. Medicines Evaluation Board 18