(Translator's note: The Danish guideline no. 31 of 13 May 2005 on labelling of and package leaflets for medicinal products refers to executive order no. 7 of 8 January 2002, as amended, which is repealed due to a new executive order implementing amendments to Directives 2001/83EC and 2001/82EC (the so-called Review 2001). However, much of this guidance still applies to provisions of the new executive order. A new guideline is expected issued in 2006.
To facilitate the use of the English version of this guideline some text in Danish that shall appear in the labelling or the package leaflet has been translated and put into parentheses. End of note)
The guideline comprises in-depth comments and supplementary guidelines on the provisions on package size, packaging, labels and package leaflets for medicinal products as laid down in executive order no. 7 of 8 January 2002 of the Danish Medicines Agency concerning labelling etc. of medicinal products (as amended) that entered into force 19 January 2002.
The guideline replaces guideline no. 91 of 7 June 1993 of the Danish Medicines Agency.
The executive order applies to all medicinal products to be approved by a marketing authorisation granted by the Danish Medicines Agency. However, medicinal products comprised by the executive order on homoeopathic medicinal products, cf. section 1(2) of the executive order, are exempt from the this executive order.
The executive order implements provisions of Directive 2001/82/EC and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products and medicinal products for human use.
The provisions of the directives relating to labelling and package leaflets for veterinary medicinal products and medicinal products for human use are only partly harmonised. This entails that there is a number of special provisions relating to certain types of medicinal products. Despite this it is considered relevant to include all provisions on labelling and package leaflets in one executive order.
The two EU guidelines on readability and legibility "A Guideline on the readability of the label and package leaflet of medicinal products for human use" and excipients "Excipients in the label and package leaflet for human use" are thus introduced in the Danish guideline.
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Re Part 2
General provisions
Comments to individual sections concerning general provisions
Re section 1(2)
The labelling of the dose dispensed medicinal products does not fall within the scope of this executive order but within the executive order on dose dispensing of medicinal products.
Re section 4(2)
On multilingual packages the label information should be arranged by language.
If the wording by and large is identical on pan-Scandinavian packages, the information may be stated in just one language. If this is the case, single difficult words should be written in two or more languages.
On multilingual packages both the active agent and the excipients may be stated in Latin, possibly in a short version.
Re section 4(3)
If, exceptionally, the labelling of the immediate package is in other languages than Danish, the following languages are recommended: Norwegian, Swedish and English allowing for the protection of users. This is for instance the case with medicinal products, which are administered exclusively by health care professionals or veterinarians.
Re section 4(4)
If the labelling of radioactive medicinal products is in other languages than Danish, the following languages are recommended: Norwegian, Swedish and English.
Re section 5(2)
The information shall be in Danish and be comprehensible to the users.
If the package leaflet is stated in several languages, all information shall be arranged by language.
Re section 6(2)
Symbols and pictograms shall be stylized and objective without promotional elements.
The provision also warrants the use of Braille (embossed writing). The information in Braille shall be in accordance with the labelling and package leaflet.
Re section 7
A distinction should be made between packages which may cause confusion due to similarity of names, similarity of pharmaceutical form (e.g. ointment, cream), similarity of design or several different strengths by using e.g. different font sizes, colours, different package designs etc. to make plain the difference. Furthermore, the companies should aim at package designs that are not easily confused with packages from other companies in order to reduce the risk of medication errors.
By approval of the packaging material design the Danish Medicines Agency does not address trademark related issues, and an approval of a certain package design is not an order to use that specific design as other designs may also be approved depending on the circumstances. Whether an approved package design infringes the trademarks of other companies is a matter of private law.
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Re section 10
The provision does not apply to e.g. package leaflet changes that are not or shall not be part of the summary of product characteristics, including layout, language corrections, changes in the user instruction, addition of Braille and pictograms.
The provision does not apply to labelling changes not comprised by the executive order, e.g. language corrections, changes in the user instruction, if any, addition of Braille and layout changes.
Re section 11
Health care professionals may e.g. be physicians, dentists, nurses and other persons qualified to administer medicinal products to the users.
The provision is primarily directed to parenteral medicinal products; however, parenteral slow-release medicinal products should have a package leaflet that may be given to the patient if the effect is continuously exerted when the patient is no longer under the direct monitoring of the professional.
Vaccines should also include a package leaflet to the patient.
In all cases, if the professional hands out a medicinal product to the patient for self-administration outside the hospital, a package leaflet (or a copy) should be available to the patient. This also applies if it is only a question of single doses.
Regarding radioactive medicinal products including diagnostics it is recommended to include a package leaflet to the patient. The aim is to demystify the use of radioactive medicinal products and it is important for the security of the patients.
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Re Parts 3 and 4
Labelling
Primary objectives of the labelling
The labelling of medicinal products serves three primary objectives:
- Identification;
- Correct use;
- General information to the users.
When designing the labelling it is important that the primary objectives are observed and that the information included is clearly stated on the packaging material. It is appropriate to arrange the information necessary to fulfil these objectives separately on both the immediate and outer packaging.
Identification
A medicinal product is identified by:
- The name of the medicinal product;
- The strength of the medicinal product;
- Pharmaceutical form;
- Package size;
- Product code "Vnr", cf. section 22a of the Danish Medicinal Products Act. However, this does not apply to a number of medicinal products, e.g. radioactive medicinal products, herbal medicinal products and homeopathic medicinal products, cf. the executive order on product codes for medicinal products.
Such elements should be arranged horizontally in the same field of vision.
Correct use
In order to ensure that medicinal products are used correctly the packages must comprise relevant user information on:
- Use and, if necessary, route of administration, cf. section 27;
- Technical information if not stated in the package leaflet;
- Indication for over-the-counter medicinal products, herbal medicinal products and "strong" vitamin and mineral preparations, cf. section 28;
- Warnings, cf. section 30;
- Storage conditions, cf. section 31 (e.g. time of use after opening);
- Expiry date.
This information shall be easily legible and clearly formulated. In certain cases it may be necessary to emphasise certain information by means of layout or by stating less important information in smaller print. The information should be arranged in a separate field, preferably horizontally. On multilingual packages the information must be arranged by language.
If relevant for technical reasons the expiry date may be stated elsewhere on the package.
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Other information
Other necessary information on the package may be stated in smaller print or given a less prominent place. This concerns:
- Declaration of contents, cf. sections 25 and 26;
- Technical information if not stated in the package leaflet;
- Name and address of the marketing authorisation holder, logo and other symbols, cf. section 32 and section 6(2-3);
- Illustrations of use;
- Marketing authorisation number "MT nr.";
- Batch number.
Legibility
The font is important for the legibility. Simple fonts are preferred. Very small or very wide fonts should be avoided. Empty spaces around the text are encouraged to ease the legibility. If coloured text or background is used attempts should be made to achieve the best possible contrast.
The labelling shall be printed in at least 7 points (Didot) (the height of a lower-case "x" shall be at least 1.4 mm) and the space between the lines shall be at least 3 mm.
It should be avoided to use upper-case letters only.
In general, the name and strength shall be stated in identical fonts and font sizes. For instance as to the strength 10 mg both 10 and mg shall be stated in identical fonts and font sizes. The strength may be stated before or after the pharmaceutical form.
The labelling may comprise text in Braille. The information in Braille shall be in accordance with the remaining text.
Dosage label
When designing the packaging material the requirement that the immediate package when dispensed from a pharmacy shall be provided with a special label, cf. the executive order on prescriptions, should be taken into consideration. An empty space of at least 14 x 34 mm should be allocated for this purpose.
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Comments on individual sections regarding labelling
Re section 13
If possible, the package should be designed so that it may be opened by impaired and elderly patients but not by small children.
Medicinal products primarily to be used for children should be in a childproof package.
Re section 17(1)(10)
The expiry date is to be stated as: "Udløbsdato", "Exp", "Anvendes senest" or "Anvendes inden / Anvendes før".
"Anvendes" may be abbreviated "Anv."
The expiry date is to be stated as the month with 2 digits or at least 3 letters and the year with 4 digits.
Example: februar 2005, feb. 2005 or 02-2005. Roman numerals should not be used.
The month stated indicates that the expiry date is the last day of this month, however, in "Anvendes inden /Anvendes før" it means that the expiry date is the last day of the previous month.
When using the statement "Exp" the meaning shall be explained in the package leaflet, e.g. "Den anførte måned betyder, at udløbsdatoen er den sidste dag i denne måned." ("The month stated indicates that the expiry date is the last day of this month").
When using "Exp" for the labelling of small immediate packages for medicinal products for human use (section 18), blister packs (section 19) and small immediate packages for multiple dosage of medicinal products for veterinary use (section 20) the explanation of the meaning of "Exp" may be omitted if the expiry date on the outer package is stated using one of the other designations.
If dilution, reconstitution or opening entails reduced shelf life this shall be stated on the label. This information shall be in accordance with the approved summary of product characteristics. If this is very comprehensive, the label may refer to the package leaflet, e.g. with "holdbarhed efter færdigtilberedning/åbning se indlægssedlen" ("please refer to the package leaflet regarding shelf life after finished preparation/opening").
For radioactive medicinal products and certain vaccines it may be relevant to state shelf life after dilution, reconstitution or opening with "tidspunkt, dag, måned og år" ("time, day, month and year").
The batch number is stated as "Batchnummer -----", "Batch nr. ----" or "Lot no ----".
In small immediate packages for medicinal products for human use (section18), blister packs (section 19) and small immediate packages for multiple dosages for medicinal products for veterinary use (section 20) it is sufficient to state the batch code and expiry date.
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Re section 18
Small immediate packages are for instance inhalation spray containers, ampoules, small vials, small bottles with ophthalmic preparations and small tubes.
Re section 19
The strength shall be stated if the pharmaceutical form in question is available in several strengths.
The pharmaceutical form shall be stated if the medicinal product is available in several mistakable forms, e.g. tablets and melting tablets.
The weekday may be stated but only if it is in accordance with the dosage in the summary of product characteristics approved by the Danish Medicines Agency. The designation of the weekday shall be unambiguous and comprehensible in Danish.
Re section 22(1)
The medicinal product is stated with the name approved by the Danish Medicines Agency, cf. also section 18 of the Danish Medicinal Products Act.
Re section 22(2)
Regarding medicinal products with one active substance where the name of the medicinal product is not identical to the common name of the medicinal product, the common name shall be printed on the label in at least half the size of the name of the medicinal product, cf. section 6(3), of the Danish Medicinal Products Act, and within the same field of vision, e.g. on the line below name, pharmaceutical form and strength. However, this does not apply to herbal medicinal products and "strong" vitamin and mineral preparations.
The common name shall be stated in a way that does not complicate the unambiguous identification of the medicinal product. Thus, it should not be stated between e.g. the name of the medicinal product and the strength.
The common name may be stated in its Danish form or the Latin form, possibly abbreviated.
The description of the pharmaceutical form must be in accordance with the current edition of the Danish Drug Standards (DLS) "Lægemiddelformer og termer der kan benyttes til mærkning" ("Pharmaceutical forms and terms to be used for labelling").
Short terms may be used according to the provisions of the DLS and the terms shall be written in full on the outer packaging.
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Re section 23(1)(1)
- When preparing fluid medicinal products prior to dispensing the following may be stated "Brugsfærdig injektionsvæske: mængde/ml" ("Ready-to-use injection: quantity/mL") or "Brugsfærdig oralopløsning mængde/ml" ("Ready-to-use oral solvent: quantity/mL").
- For a medicinal product in ampoules or disposable syringes the strength is stated in quantity of the active substance/ml. In such cases the quantity should be supplemented with information on the total quantity per total volume, possibly total quantity in the specific ampoule/disposable syringe. This should not be stated in a way that makes it more prominent than the strength.
- For ready-to-use injection fluids prepared from injection concentrate and -substance marketed in a given quantity of solution the strength may be stated as e.g.: "Brugsfærdig injektionsvæske: mængde/ml" ("Ready-to-use injection: quantity/mL").
- For multidose containers and parenteral products in large volumes (e.g. vials and infusion containers) the strength shall be stated as volume/mL, /100 mL, /1000 mL etc. as relevant.
- The concentrate for injection and infusion fluids: The total content of active substance and the strength stated as volume/mL shall be stated on the label. The package must be labelled "Skal fortyndes" ("To be diluted") (Annexe 2) and e.g. "Fortynding se indlægsseddel" ("For dilution, please see package leaflet") and "Brugsfærdig injektions-infusionsvæske mængde/ml" (Ready-to-use injection/infusion quantity/mL").
Re section 23(1)(3)
The strength is to be stated as quantity of the active substance/dosage unit/unit of time for patches, for implants and intrauterine devices classified as medicinal products. The provision regarding statement of strength for dosed medicinal products also apply to metered dose inhalation products, e.g. aerosol and spray preparations.
Re section 24(1)
The package size designation should appear close to the name of the medicinal product, the pharmaceutical form and the strength.
Re section 24(3)
Excess solution for reconstitution or dilution of concentrate is not to be stated.
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Re section 25 and section 26(1)
Active ingredients are to be described as stated in section 26.
If the common name does not appear from the DLS, Danicized forms prepared according to the principles of DLS for the determination of Danish names may be used.
Qualitative and quantitative declaration of salts, hydrates and esters should be according to the current edition of the "Guideline on Summary of Product Characteristics".
Examples:
1 tablet contains 60 mg toremifene as citrate (the preparation contains toremifene citrate ~ 60 mg of the active toremifene).
1 mL contains 40 mg methyl prednisolone acetate.
1 tablet contains 5 mg protriptyline hydrochloride.
The declaration of contents may begin with e.g. "1 tablet/mg/ml indeholder" or finish with e.g. "pr. tablet/mg/ml". The declaration of contents may be omitted for solid dose forms with one active substance provided that other ingredients are not required according to the executive order as the common name is stated, cf. section 6 of the Danish Medicinal Products Act.
Excipients are stated in accordance with the current edition of DLS.
The excipients are de-clared qualitatively for all parenteral, topical and ophthalmic medicinal products.
Topical use means e.g. medicinal products for use on the skin, inhalation preparations and medicinal products for use on the oral and nasal mucous membrane, the rectal and vaginal mucous membrane, i.e. with a local or transdermal effect.
Colouring agents should preferably be stated using e.g. the designation "Color / farvestoffer" followed by the name and E number if possible. For excipients to be stated according to Annexe 1, e.g. "se information i indlægsseddel"/"se indlægssedlen" ("Please refer to information in the package leaflet"/"Please see package leaflet") may be added in connection with stating the excipient. Other excipients may e.g. be stated using the generic description "Constit / hjælpestoffer".
Water in/for injection and infusion fluids are designated "vand til injektionsvæsker", water in/for other sterile medicinal products are labelled "sterilt vand" and water in non-sterile medicinal products are labelled "renset vand", cf. the DLS.
Infusion fluids are usually de-clared per 1000 mL or litre, while oral solutions and similar products are de-clared per mL.
The declaration for infusion fluids, infusion concentrates and infusion substances should be supplemented with information on the content of electrolytes expressed in mmol.
Vaccines are usually de-clared per dose and otherwise in accordance with the current requirements of the European Pharmacopeia (Ph. Eur.).
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Re section 25(2)
Only excipients that result in information in the package leaflet according to Annexe 1 are to be stated on the label (please also refer to Re Annexe 1).
Re section 27
The route of administration is to be stated according to the current DLS, standard terms.
The following abbreviations for the route of administration may be used for injection infusion fluids:
s.c.
i.m.
i.v.
Instructions on the ready preparation of non-ready-for-use medicinal products, e.g. powder for oral solution, injection and infusion substances, injection and infusion concentrates, should usually appear from the packaging material, cf. the summary of product characteristics, point 6.6.
Re section 28(1)
In terms of language, the statement of the therapeutic indications on the label shall be identical to the statement in the package leaflet.
The dosage should not be stated on the label, however, after the statement of the therapeutic indications "se vedlagte indlægsseddel" (Please see enclosed package leaflet") may be added.
Re section 28(4)
In connection with the area of indication the vitamin or mineral in question may be included in the designation, e.g. "Stærkt C-vitaminpræparat". In case of composite preparations only the designation "Stærkt vitaminmineralpræparat" may be used.
Re section 29(1)
The animal species shall appear on medicinal products for veterinary use. The only exception from this requirement is stated in section 20 of the executive order.
The following wording is preferred: "Til hund", "Til kat", "Til hest" etc. If the animal species is stated prominently e.g. in connection with the drug name or the pharmaceutical form, repetition is not necessary.
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Re section 29(2)
Information on the withdrawal period shall be stated on veterinary medicinal products administered to animals, whose meat or products are intended for human consumption even if the withdrawal period is nil.
When the withdrawal periods differ between countries multilingual packages cannot be approved.
Re section 30(1)
"Opbevares utilgængeligt for børn" ("Keep out of the reach and sight of children") must be stated even if the warning regarding children and adolescents in Annexe 2 is stated on the label.
Re section 30(2)
If there is an approved dosage for children below the age of 15 years, but not for the entire age range of 2-15 years the warning "Bør ikke anvendes til børn under 2 år uden lægens anvisning" shall be changed replacing 2 years with the lower limit of the approved dosage for children. The warning "Bør ikke anvendes til børn under 2 år uden lægens anvisning" shall however be stated even if there is an approved dosage for children below the age of 2 years.
Re section 30(4)
The text box to be stated on certain packages with medicinal products containing paracetamol or salicylates, cf. Annexe 2, should appear on the front of the package. In case of multilingual packages, cf. section 4(4), the text box is to be stated together with the Danish text.
On multidose containers "Indeholder ikke konserveringsmidler" ("Does not contain preservatives") may be stated in accordance with "Note for Guidance, CPMP/QWP/419/03".
If the European Pharmacopeia includes other warnings/information such warnings/information shall be stated as the complete European Pharmacopeia is implemented in the DLS.
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Re section 31
The stated storage instructions shall be in accordance with the current DLS.
The storage conditions stated on the packaging shall be in accordance with the approved summary of product characteristics.
Re section 32(1)
The name and address of the registration holder is the company's full name and address, town and country as a minimum. However, it is not necessary to state the name of the country if this is Denmark.
The address is the address that enables the user to contact the company.
The email address may be stated but references to web pages are not allowed.
Re section 32(2)
The manufacturer is the one responsible for the release of the final product (batch release / final batch release).
In case of manufacture outside the EEA the manufacturer is the one responsible for the batch release in the EEA.
Re section 32(3)
A representative for Denmark shall be able to handle queries in Danish.
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Re Parts 5 and 6
Package leaflets
Primary objectives of package leaflets
Package leaflets are intended for the users and aim at ensuring a high level of information for and protection of users regarding medicinal products for both human and veterinary use.
They should contribute to improving the possibilities of using medicinal products correctly based on adequate and comprehensible information.
Package leaflet design
Legibility
Font size:
The package leaflet shall be printed using at least 8 points (Didot), however to be legible for elderly patients 12 points (Didot) should be used, and the space between the lines shall be at least 3 mm.
A package leaflet with text in Braille may be added. The information in Braille shall be in accordance with the printed package leaflet.
Font:
Simple fonts are preferred. Very small or very wide fonts should be avoided. If coloured text or background is used attempts should be made to achieve the best possible contrast.
It should be avoided to use upper-case letters only.
Readability
Syntax:
Long sentences should be avoided (e.g. more than 20 words).
The length of the lines should not exceed 70 characters.
Different fonts, upper and lower-case letters, word length, the number of sentences between full stops and the length of the sentences may influence the readability. Reeling off sentences without connecting link/punctuation and subordinate clauses should be avoided. The punctuation should be simple with commas, full stops, dashes and bullets.
A bulleted list should start with the unusual and specific example and finish with the more usual or general example.
Example:
Contact your physician:
- If you have tuberculosis;
- If you have an allergy affecting your lungs and making breathing difficult for you;
- If you have a chronic lung disease.
In a bulleted list a minimum of words per bullet should be used and never more than one sentence.
A bulleted list should not comprise more than 9 bullets if the bullets are simple and no more than 5 bullets if the bullets are complex.
Abbreviations should be avoided.
Instead of repeating the name of the medicinal product a pronoun (e.g. "it") should be used when it is clear what "it" refers to.
Normal word order should be used. Inverted word order and the use of passive should be avoided.
Paper:
Long package leaflets should be in the format A4/A5.
The paper quality of the package leaflet should be at least 40 g/m². It may be difficult to read package leaflets on thinner paper, as this may be too transparent.
The package leaflets should not be so creased that it is difficult to unfold them properly and the many creases make it difficult to read the package leaflets.
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Comments on individual sections regarding package leaflets
Re section 33
The user information may be stated in full on either the outer or immediate package or in a package leaflet. If the user information is stated in a package leaflet, part of the user information may also appear on the package.
A prerequisite for stating the information on the actual package is that it does not interfere with the readability of the information to appear on the package, cf. the executive order on labelling.
Furthermore, it is allowed to use the so-called fold-out labels, provided the provisions of the above executive order are met, also after any tearing off.
Re section 34
The package leaflets shall be prepared in accordance with the executive order on labelling and the current edition of the "Guideline on drawing up the Danish package leaflet of pharmaceutical specialities for human use".
The headings and standard texts of the guidelines shall be followed. In individual, special cases it is allowed to deviate from the standard texts.
This also applies to medicinal products for which the package leaflet may be omitted in accordance with section 11. If the package contains a package leaflet, it must be drawn up in accordance with the above guideline.
Medicinal products for which the package leaflet may be omitted in accordance with section 11 may comprise a technical user instruction containing only technical information for health care professionals on the preparation and route of administration. This also applies to radioactive medicinal products and preparation kits.
A package should contain one package leaflet only. If relevant (e.g. for parenteral slow-release medicinal products), the package leaflet may include a tear-off technical instruction for health care professionals.
Usually, information shall be given on all main sections, however, for individual medicinal products or groups of medicinal products this will not be relevant. In such cases individual main sections may be omitted.
Re section 34 (1)
The designation of the pharmaceutical form shall be the complete designation of the pharmaceutical form in accordance with the current summary of product characteristics, which must be in accordance with the DLS. Short terms are not to be used in the package leaflet.
Re section 34 (7)(d)
The warnings in Annexe 2 shall be stated in the section "Særlige forholdsregler" (special precautions) in the package leaflet if it is not obvious to include them in other sections.
The stated warnings may be reformulated provided the meaning remains unchanged. However, this does not apply when the wording is stated in quotation marks.
The text box warning shall be stated precisely in the layout shown (colours, size, wording, etc.) also in the package leaflet.
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Re sections 35 and 36
Most comments to the guideline on medicinal products for human use, cf. sections 33 and 34, also apply to veterinary medicinal products. The order in section 36(1)(1-12) should be followed. Only the comments to section 34 relevant to section 36(1)(1-5) apply.
As an introduction in the user instruction or in the individual sections it should be stated that the veterinarian might indicate another use or dose than stated, and in such cases the veterinarian's directions must be followed.
All package leaflets shall be drawn up in accordance with this executive order. This also applies to medicinal products for which the package leaflet may be omitted in accordance with section 11 if the package comprises a package leaflet.
A package should contain one package leaflet only. If relevant, the package leaflet may include a tear-off technical instruction for the veterinarian.
If a technical instruction is included, this should appear from the outer package.
A user instruction to be used by the farmer/owner of the animal shall be part of the package leaflet.
The following special information is required:
- The animal species for which the medicinal product is approved as well as the dosage for each species;
- The withdrawal period for the treatment of animals whose meat or products are intended for human consumption even if the withdrawal period is nil;
- Precautions for the disposal of unused medicinal products or waste.
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Re Annexe 1
The summary of product characteristics must include information in accordance with the information required in the package leaflet/label according to Annexe 1.
Annexe 1 does not apply to veterinary medicinal products.
The provisions of Annexe 1 do not apply if the substance is the active substance in a medicinal product.
Definition:
With the exception of the active substance, excipients are all the substances included in a pharmaceutical form administered to the patient.
Excipients may include:
- Colouring agents, preservatives, additives, stabilisers, thickeners, emulsifiers, flavour and aromatic additives, etc.;
- Excipients in e.g. capsules, gelatine capsules, rectal capsules, etc. to be swallowed or in other ways administered to the patient together with the medicinal product;
- Mixtures of excipients included e.g. in connection with the extrusion of tablets or film coating in pharmaceutical forms administered;
- pH adjusting agents;
- The ingredients in ink for the labelling of e.g. tablets/capsules;
- Solution/dilution products in herbal extracts and vitamin concentrates;
- Ingredients in mixtures of chemically related substances (e.g. preservatives).
Usually, residues from the manufacture, impurities, solution residues, decomposition products, etc. are not excipients. However, the Danish Medicines Agency may determine that residue, impurities or similar substances may appear in an amount that should be de-clared.
Excipients are usually inactive without any pharmacological effect. In certain circumstances some excipients do have an own effect.
The marketing authorisation holder should ensure that the use of excipients in the individual pharmaceutical forms is relevant in accordance with Annexe 1.
Nomenclature:
The following apply to the designation of all excipients in labelling, package leaflet and summary of product characteristics:
- Excipients shall be designated according to the current DLS, INN name, Ph.Eur, Ban, USAN or if this does not exist, the trade name.
- Any E number shall be added to the name of the excipients in Annexe 1. However, on labelling (small packages) it is only allowed to state the E number provided that both name and E number appear from the package leaflet.
- Flavouring agents may be designated by trade name. If these products contain substances included in Annexe 1, such products shall be de-clared separately.
- Chemically modified excipients shall be de-clared to avoid confusion with non-modified substances (e.g. pregelatinized starch and starch).
- Agents for adjusting pH shall be named (DLS) and the function stated, e.g. hydrochloric acid, pH adjustment/adjustment of acidity.
- All standard product ingredients containing mixtures, solution, etc. of excipients shall be de-clared in the package leaflet, e.g. labelling inks containing x, y and z. Instead the labelling may state: Labelling ink, refer to the package leaflet. If such standard products contain an excipient mentioned in Annexe 1 under the relevant route of administration, this excipient shall be stated in the labelling; reference to the package leaflet does not suffice.
Excipients in labelling:
When a pharmaceutical form contains an excipient included in Annexe 1 in the relevant route of administration and relevant quantity the excipient shall be stated by name according to Annexe 1 in the labelling and "se indlægssedlen"/"se information i indlægssedlen" ("Please see package leaflet"/"Please see information in package leaflet"). Thus, only excipients that result in information in the package leaflet according to Annexe 1 shall be stated in the labelling.
Excipients in package leaflet:
If a pharmaceutical form contains an excipient included in Annexe 1, the package leaflet shall contain relevant information corresponding to column 4 of Annexe 1 in a language comprehensible to the user. This information might be relevant in several sections of the package leaflet. To simplify the package leaflet the information should only be included in one section; however, it may be relevant to make cross-references in other sections.
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