Guideline

• The name of the medicinal product and strength are stated clearly on the packaging and in an easily legible font.
• Use of uppercase letters in the full name (as well as in other text) should be avoided to improve legibility. If the product name has been approved in uppercase letters, it can be written in uppercase letters in the first section of the labelling text, and then in lowercase letters in the following text.
• The medicinal product's name and strength are stated in the same font and size and, if possible, on the same line.
• Nothing may come in between the name of the medicinal product and its strength.
• The medicinal product's full name is stated in the same colour.
• The strength is only stated once on each side of the packaging and in connection to the name of the medicinal product.
• Different strengths of a single medicinal product must be clearly differentiated, for example by using different colours for the strengths.
  If the same strength of a medicinal product administered by injection or infusion is available in different total quantities (X ml=Y mg), the total quantity is also differentiated by colours. For parallel imported medicinal products, the colour of the strength is stated in accordance with the directly imported medicinal products colouration.
• The pharmaceutical form is an important part of the identification of a medicinal product and shall always be stated in connection to the name and strength of the medicinal product. For further information, see Section 3:3.
• Active substance is stated in lowercase letters (including the first letter) below the name of the medicinal product and strength, even if this is included in the name of the medicinal product. If the medicinal product contains three or fewer active substances, these shall be stated (in the same order as stated under strength). If the medicinal product contains four or more active substances, these do not need to be stated in connection to the name of the medicinal product.
• The active substance(s) is/are stated on the packaging in a font half the size of that of the name of the medicinal product.
• The active substance is stated in the form that corresponds to the strength.
  • Example 1. If the medicinal product has a strength of 8 mg and contains buprenorphine hydrochloride 8.64 mg equivalent to buprenorphine 8 mg, then buprenorphine shall be stated in connection to the name of the medicinal product.
  • Example 2. If the medicinal product has a strength of 20 mg and contains omeprazole hydrochloride 20 mg equivalent to omeprazole 19.52 mg, then omeprazole hydrochloride shall be stated in connection to the name of the medicinal product.

Please note that, even though the active substance(s) is/are stated in connection with the name of the medicinal product, it/they shall also always be specified in the declaration (see Section 3:2).

Guideline

• The declaration contains a list of the quantity of the form of active substance(s) that correspond to the strength, e.g. buprenorphine hydrochloride equivalent to buprenorphine
  8 mg.
• The declaration begins with <1 tablett innehåller…> [1 tablet contains…], <1 ml innehåller…> [1 ml contains…] <1 tablett:…> [1 tablet:…], <1 ml:…> [1 ml:…] or similar. For vaccines write <1 dos innehåller…> [1 dose contains…].
• In those cases where excipients shall be declared, these are stated together with active substance(s) in the declaration on the outer packaging and/or immediate packaging. Further information in Section 3:4.
• For multilingual packaging, the declaration may be given in Latin
  • In centralised procedure: Latin is used in labelling text in cases where Latin is used on the packaging.
  • In decentralised, mutual and national procedures: Swedish is always used in the labelling text, even if Latin is used on the packaging.
  • For (traditional) herbal medicinal products: name of the plant is usually written in Latin and Swedish, both in the Swedish labelling text and on the packaging.
     

Guideline

• The pharmaceutical form is stated in accordance with the applicable EDQM Standard Terms.
• The complete pharmaceutical form is stated on the front of the packaging. The short term in accordance with the applicable EDQM Standard Terms may be used on the other sides, if there is a lack of space. If the short term for the medicinal product is used in labelling (e.g. “tablet” instead of “film-coated tablet”, this shall also be stated in the package leaflet in Section 6 (and in SmPC Section 3).
• The pharmaceutical form may, when appropriate, be given as the pack size (= quantitative indication), e.g. <30 tabletter> [30 tablets]. If the outer packaging contains several immediate packages, this is stated in conjunction with the pack size, e.g. if there are two containers with 30 tablets in each, this is stated as <60 (2x30) tabletter> [60 (2x30) tablets].
• Packaging size for injection products is stated as “X x Y ml” or X vials of Y ml, or for powder “x vial(s)”.
• The quantity for medicinal products administered by injection is indicated in the Swedish labelling as “5 ml = 50 mg” rather than “50 mg/5 ml”.
• Pack size is stated together with the name of the medicinal product, strength and pharmaceutical form on all sides of the packaging, if space permits.
• The pack size is placed in the top left corner on the front of the packaging.
• Different pharmaceutical forms of the same medicinal product are differentiated clearly in order to avoid mix up.
• If the pack contains cannulas, swabs or similar, this shall be stated on the outer packaging.
• Medicinal product packaging that contains pressurised contents shall state both the net and gross volume.

Guideline

• Topical medicinal products include those that are applied locally, e.g. skin preparations and medicinal products that are administered to the lungs via inhalation. Topical medicinal products also include those that are administered locally on the oral, nasal, rectal or vaginal mucosae.
• For vaccines, the adjuvant/adsorbant is stated both qualitatively and quantitatively.
• In those cases where excipients must be declared, these are stated together with the active substance(s) in the declaration on the outer packaging and/or immediate packaging.

Guideline

• The method of administration is, e.g., <sväljes hela> [to be swallowed whole], <införes i ändtarmen> [for rectal insertion].
• The route of administration is, e.g. <intravenös användning> [intravenous use], <för användning på huden> [for application onto the skin], <för användning i munhålan> [for use in the oral cavity], etc.
• For medicinal products administered by injection or infusion, the route of administration is stated on both the outer packaging and immediate packaging.

Describe non-patient-friendly methods of administration with a more patient-friendly translation.

For example according to the table below:

Guideline

The text <Förvaras utom syn- och räckhåll för barn> [Keep this medicine out of the sight and reach of children.] is used.

Guideline

The text <Läs bipacksedeln före användning> [Read the package leaflet before use] shall appear on the outer packaging and/or immediate packaging of all medicinal products that have an approved package leaflet. In exceptional cases, where SmPC is included, instead use the text <Läs produktresumén före användning> [Read the Summary of Product Characteristics before use].

Guideline

• Medicinal products in aerosol form shall be labelled in accordance with the Swedish Civil Contingencies Agency's statutes.
• Necessary instructions for use, e.g. <tuggas> [to be chewed], <omskakas> [shake before use] <ska spädas> [to be diluted], <löses i ett glas <vatten>> [to be dissolved in a glass [of water]], are stated on the outer packaging and/or immediate packaging.
• Other information that is valuable to the user, e.g. <munnen bör sköljas efter varje inhalation> [rinse mouth after inhalation], <kan färga hud, hår och kläder> [may cause discolouring of skin, hair and clothes], <kan färga urinen/avföringen> [may colour urine/faeces], <kan missfärga mjuka kontaktlinser> [may discolour soft contact lenses], is stated on the outer packaging and/or immediate packaging.
• Provided below are examples of standard wording to use for certain substances or groups of medicinal products. Note that this is not an exhaustive list of warnings:
  
  Cytostatics: <Cytostatikum> [Cytostatics]
  
  Paracetamol: <VARNING! Högre doser än de rekommenderade medför risk för mycket allvarlig leverskada.> [WARNING! Doses higher than recommended lead to risk of very severe liver damage.]
  
  <Använd inte X utan läkares ordination om du har alkoholproblem eller leverskada eller om du samtidigt använder andra smärtstillande läkemedel som innehåller paracetamol.> [Do not use X without doctor’s prescription if you have alcohol problems or if you are using other painkillers containing paracetamol at the same time.]
  
  <Förvaras utom syn- och räckhåll för barn och ungdomar.> [Keep out of the sight and reach of children and adolescents.]
  
  The last sentence replaces the standard wording <Förvaras utom syn- och räckhåll för barn> [Keep out of the sight and reach of children].
  
  Benzoyl peroxide products and tretinoin: <Undvik solning, även i solarier vid behandling med detta läkemedel.> [Avoid sunbathing, including using sunbeds, in connection with treatment with this medicine.]
  
  Steroids for topical use: <Undvik att få <läkemedlet> i ögonen.> [Avoid getting the <medicine><ointment><X> in your eyes.]
  
  For non-prescription medicinal products see Section 3:17.

Guideline

• The expiry date is preceded by the approved abbreviation <Utg.dat.> [Expiry date] or <EXP> [Expiry date] and is stated in the same way as in the package leaflet.
• If <Utg.dat.> or <EXP> are added during printing, it shall be stated which of the abbreviations will be used and where this will be placed on the outer packaging and/or immediate packaging.
• The month is stated with two numerals or with letters and the year with four numerals.
• The expiry date is the last day of the indicated month stated after <Utg.dat.> or <EXP>.
• If information about shelf-life of opened packaging or shelf-life following preparation is stated in the SmPC, these are to be stated on the outer packaging and/or immediate packaging.

Guideline

The storage condition(s) shall be consistent with those stated in the SmPC and are presented in accordance with Appendix III of the QRD template.

Guideline

• State any precautions to take when disposing of unused medicinal products or waste materials from the medicinal product.
• For patches, the following text is used: <Använda plåster viks ihop med den klibbiga sidan inåt och kasseras enligt information i bipacksedeln.> [Used patches shall be folded with the adhesive side inwards and disposed of according to the information in the package leaflet.]

Guideline

• The name and address of the MAH shall be stated.
• The local representative’s name and address are stated on the outer packaging (or the immediate packaging if there is no outer packaging) but is not stated in the labelling text. The local representative shall be registered with the Swedish Medical Products Agency. Information about the local representative is preceded by the heading <Lokal företrädare> [Local representative]. If the stated company only provides information about the medicinal product, the name and address are preceded by the heading <Information lämnas av> [Provider of information].
• In those cases where another product stakeholder, in addition to the MAH, is also stated on the outer packaging and/or immediate packaging, one of the following headings is used in order to enable those involved in the product to be differentiated:
  
  <Innehavare av godkännande för försäljning> [Marketing Authorisation Holder]
  
  <Importör> [Importer] (Only for parallel imported medicinal products.)
  <Innehavare av registrering för försäljning> [Registration Holder] (Only for traditional herbal medicinal products.)
  
  <Lokal företrädare> [Local representative]
  
  <Information lämnas av> [Provider of information]
  
  If space permits, add a heading for both product stakeholders. In case of space restrictions, add a heading for at least one of the product stakeholders (for parallel imported medicinal products, also see below).

• The name, city and country (when the city is not in Sweden) are the minimum requirements for the address information for all product stakeholders. City and country are written in Swedish.
• A reference to a web address is not acceptable.
• Email address is acceptable.
• For parallel imported medicinal products, the re-packager and manufacturer's names and addresses shall also be stated. A relevant company group term may be stated instead of the manufacturer's name and address (see Section 12 of the Swedish Medical Products Agency's Provisions (HSLF-FS 2022:8) on parallel imported human medicinal products). The information is preceded by <Ompackare> [Re-packager] and <Tillverkare> [Manufacturer].
• If a logotype for a local representative is included, the name and address of the local representative must also be written on the outer packaging.

Guideline

The marketing authorisation number is preceded by the term <MTnr:> [Marketing Authorisation number:] and is placed on the packaging together with the name and address of the MAH.

Guideline

• The batch number is preceded by the approved abbreviation <Sats> [Batch], <Batch> or <Lot> [Batch].
• The batch number is placed together with the expiry date on the packaging.
• If <Sats>, <Batch> or <Lot> are added during printing, the labelling text should indicate which of the abbreviations will be used and the mock-up should show where this will be placed on the outer packaging and/or immediate packaging.

Guideline

• The Nordic Article Number is stated in the top right corner on the front of the outer packaging.
• The Nordic Article Number is stated at least once in connection with the name of the medicinal product on the outer packaging or, if there is no outer packaging, on the immediate packaging.
• The Nordic Article Number is stated in numerals in groups of two and is preceded by <Vnr> [Nordic Article Number] (Vnr XX XX XX).
• For medicinal products that will be prepared prior to use, e.g. cytostatics, the Product Number is also stated on the immediate packaging.
• Multipacks: It is sufficient that the Nordic Article Number appears on the outer packaging. If the Nordic Article Number also appears on each subsidiary pack, this number shall not be the same as that on the outer packaging, i.e. each subsidiary pack shall not have the multipack's Nordic Article Number.

Guideline

Consideration shall be given to allowing the pharmacy label to be placed on the outer packaging without hiding any information. For example, an empty space can be left for the pharmacy label.

Guideline

• The packaging of non-prescription medicinal products shall also include information about the product's approved non-prescription indication(s) and normal dosage for this/these indication(s).
• The indication is stated in the labelling text as it is stated in the package leaflet. In some cases, an abbreviated form may also be acceptable. If needed, use clarifying headings, e.g. <Framsida> [Front] and <Baksida> [Back] in the labelling text.
• The indication is placed on the front of the packaging. If the medicinal product has an acceptable short form for the indication in the labelling text, e.g. “mot halsbränna” [treatment of heartburn], this is placed on the front of the packaging. The complete indication is then placed on another side of the packaging, preferably together with the dosage instructions.
• The packaging of non-prescription medicinal products shall be provided with information about dosage according to the dosage instructions in the package leaflet. The following is stated:
  • Dosage (as well as age intervals, when applicable)
  • Maximum treatment time without consulting a doctor
  • Maximum dose: include what is relevant to the product: maximum daily dosage, maximum dosage when used when needed and dose interval
• Special warnings and instructions shall be stated on the outer packaging as the medicinal product is often purchased without a doctor's prescription. Such a warning may be, e.g., that pregnant women and/or nursing mothers should not use the medicinal product.
• For non-prescription medicinal products, the labelling text and the packages must contain the words “Receptfritt läkemedel” [Non-prescription medicinal product].
• For non-prescription medicinal products, there are OTC substance reports for certain substances published on the Swedish Medical Products Agency's website. An OTC substance report is the result of an overview for a substance regarding non-prescription information (including pack sizes approved for non-prescription), which should be stated in the package leaflet/labelling for a medicinal product approved as non-prescription.
• For those substances that do not have published OTC substance reports, additional warnings may be required in accordance with the package leaflet. The following text is an example of the standard wording that is used for a group of medicinal products:
  
  NSAID: <Ska inte användas om du har eller har haft magsår eller om du är överkänslig mot acetylsalicylsyra. Har du astma bör du rådfråga läkare innan du använder X.> [Avoid use if you have or have had stomach ulcers or if you are sensitive to acetylsalicylic acid. If you suffer from asthma you should consult with a doctor before using X.]

• The following shall be stated for traditional herbal medicinal products:
  <Traditionellt växtbaserat läkemedel använt {indication}.
  
  Indikationerna för ett traditionellt växtbaserat läkemedel grundar sig uteslutande på erfarenhet av långvarig användning.> [Traditional herbal medicinal product used {indication}. The product is a traditional herbal medicinal product for use in <the specified indication> <specified indications> exclusively based upon long-standing use.]
  
  <Rådgör med läkare om symtomen kvarstår under användningen av läkemedlet eller om biverkningar som inte nämns i bipacksedeln uppträder. > [Consult a doctor if the symptoms persist during the use of the medicinal product or if adverse effects not mentioned in the package leaflet occur.]
  
  
• Therapeutic indications for non-prescription herbal medicinal products are stated as follows:
  <Växtbaserat läkemedel använt {indication}.> [Herbal medicinal product used {indication}.]

Guideline

Products that have been approved as natural remedies shall be labelled <Naturläkemedel> [Natural remedy] on the front side of the packaging.

Guideline

• Labelling on gas containers can contain both drug-related information and information specific to gas containers and gas under pressure. Non-drug related information based on another authority's requirements is not specifically reviewed by the Swedish Medical Products Agency.
• Also refer to current regulation regarding labelling and associated information texts for gas containers and gas under pressure when designing the labelling, see e.g., regulations issued by the Swedish Work Environment Authority and the Swedish Civil Contingencies Agency.

Guideline

• The name of the medicinal product in accordance with Section 3:1 includes the name of the medicinal product followed by its strength, pharmaceutical form and active substance(s). Active substances do not need to be stated if the medicinal product contains four or more active substances. Active substance can be left out of the generic name in case of space limitation.
• In the mock-up, the design of the blister should be presented, i.e., the number of tablets and how they are placed in the blister. This makes it possible to check that the name of the medicinal product, strength and (if relevant) pharmaceutical form are also legible when only one tablet (regardless of which) remains in the blister.
• For medicinal products that are approved with single-dose blister packs, the blister shall be labelled with the name of the medicinal product, strength, pharmaceutical form, active substance(s), expiry date and batch number on each detachable unit in order to ensure traceability. The name of the MAH shall appear on the blister at least once, but does not need to be stated on each detachable unit. For parallel imported medicinal products, the name of the importer shall be stated on each detachable unit in order to ensure traceability (see Section 12 of HSLF-FS 2022:8).
• Perforated blisters are designed like normal blisters, but may well be designed as single-dose blister.
• The name of the marketing authorisation holder can be replaced with a logotype on the packaging, if the name of the MAH is clear from the logotype.

Guideline

• This paragraph is applicable for immediate packaging that is too small to accommodate all the information stated in Section 3, provided there is a completely labelled outer packaging.
• The name of the medicinal product in accordance with Section 3:1 includes the name of the medicinal product followed by its strength, pharmaceutical form and active substance(s). Active substances do not need to be stated if the medicinal product contains four or more active substances.
• For parallel imported medicinal products, the name of the importer shall be stated in order to ensure traceability (see Section 12 of HSLF-FS 2022:8).
• For medicinal products that will be prepared prior to use, e.g. cytostatics, the Nordic Article Number is also stated on the immediate packaging.

Guideline

Non-prescription medicinal products which have been subject to counterfeiting shall have safety features (anti-tampering device and unique identifier). In order to limit the risk of counterfeit medicinal products entering the legal supply chain, such medicinal products shall not be sold outside of pharmacies.

Guideline

Examples of other information can be things that are now accessed via a separate QR code on the packaging, e.g. instructions for use, package leaflet, etc.

Guideline

• The name of the medicinal product (and, if there are more than one strength, its strength) shall appear in Braille on the outer packaging or, if there is no outer packaging, on the immediate packaging.
• Adhere to the Swedish Braille Authority’s recommendations for labelling of medicinal products.
• If the strength is indicated, it is preferable, if space permits, to also indicate the unit in Braille. Use Euro-Braille for punctuation (for example in mg/ml).
• If the medicinal product has the same name, but is available in different pharmaceutical forms, it is desirable that the pharmaceutical form also appears in Braille. Generic abbreviation of the pharmaceutical form is acceptable.
• The mock-up indicates the placement of the Braille and a translation of the Braille.
• It is the company's responsibility to ensure that the Braille is correct.
• The Braille is placed so that the legibility of other text is not impaired.
• No Braille is required on medicinal product packaging that is not handled by patients.

Guideline

• Symbols and images that aim to clarify information may be allowed on the packaging, especially if there is a risk of incorrect use. In this case, the information shall also be included in the package leaflet, labelling text, and SmPC/SPC.
• Symbols, information and/or images may not constitute advertising.
• Symbols, colours and/or images may not be dominant in relation to the textual information on the packaging and may not disrupt the text printed on the packaging either.
• No images of different organs to clarify their area of use may appear on the packaging of prescription-only medicinal products.
• If the pharmaceutical form is pictured, the image shall be actual size.
• The logo of the MAH and the local representative may appear on the packaging and on the printed package leaflet.
• The logo may not dominate the packaging.
• One condition of the logo being accepted is, however, that the company (name and address) also is stated in clear text.
• For parallel imported medicinal products, the manufacturer's logo may be accepted.

Guideline

• Name, strength, pharmaceutical form and active substance(s) are given a prominent position on the packaging.
• Name, strength, pharmaceutical form, active substance(s), pack size and Nordic Article Number are placed within the same field of view on the front of the packaging.
• The pack size is placed in the top left corner on the front of the packaging.
• The Nordic Article Number is placed in the top right corner on the front of the packaging.
• The packaging is designed in a way that minimises the risk of mix ups.
• If there is more than one medicinal product with the same name, e.g. different pharmaceutical forms or parallel imports, these are differentiated with the help of different colours and/or packaging design.
• Different strengths of a single medicinal product are to be clearly differentiated, for example by using different colours for the strengths on the packaging. If the same strength of a medicinal product administered by injection/infusion is available in different total quantities (X ml=Y mg), the total quantity is also differentiated by colours. For parallel imported medicinal products, any colour differentiation is stated in accordance with the colour differentiation for the directly imported medicinal product.
• The text shall be easily legible, even for those who have impaired vision, and in a clear and easily legible font.
• Avoid using upper case letters for better legibility. Lower case letters are recommended.
• There shall be a clear contrast between the text and the background.
• Text/information that belongs together on the packaging is stated together and against a uniform background.
• All text in the same panel is given the same orientation (horizontally or vertically) on the outer packaging and/or immediate packaging. (Not applicable to Braille).
• Figures stated on the outer packaging and/or immediate packaging are listed together with units, e.g. 1 vial, 1 ml, 1 dose.
• If the label can be folded out, e.g. a package leaflet that can be folded out, the label that is placed directly on the packaging (under the part of the label that folds out) shall be identical to the front of the fold out label.
• The use of more than one language on the packaging may be acceptable if there is space and its legibility is not impaired.
• On multilingual packaging, it is the company's responsibility to ensure that the information in each language used is identical.
• In the case of parallel imported medicinal products, the use of the same packaging material as in the source country may sometimes be allowed, provided that the packaging material is relabelled to comply with the requirements in HSLF-FS 2022:8. Foreign text may, in this case, be acceptable if it does not conflict with that part of the text that is in Swedish, see Section 12 of HSLF-FS 2022:8.
• For vaccines, the indication should be stated on the packaging as follows: <Vaccin mot…> [Vaccine against…].

Guideline

For radioactive medicinal products, the injection vial/ampoule shall be labelled with the name and the code for the medicinal product, including the name or chemical symbol for the radionuclide in question, the batch identification, expiry date, the international symbol for radioactivity, the name and address of the manufacturer, and the amount of radioactivity.

Guideline

• Packaging only intended to be used for dose dispensing does not need to be supplied with information targeted directly at the patient. These packagings are labelled with <Endast för dosdispensering> [For dose dispensing only]. This is stated even if this text is not included in the approved labelling text document.
• The following information can be excluded:
  • Method and route of administration
  • ”Läs bipacksedeln före användning” [Read the package leaflet before use]
  • ”Se bipacksedeln för ytterligare information” [See package leaflet for further information]
  • ”Förvaras utom syn- och räckhåll för barn” [Keep out of the sight and reach of children]
  • Information in Braille
• Instructions for storage and declaration of active substances and excipients are stated in the same way as on packaging that is not intended for dose dispensing.
• In cases where packaging sizes intended for dose dispensing only are included in the labelling text, no separate labelling text is needed. Instead “Endast för dosdispensering” [For dose dispensing only] can be included after the packaging size in Section 4 of the labelling text.
• Packaging for dose dispensing is not exempt from the requirements for safety features.