Guideline

• Name, strength, pharmaceutical form and active substance(s) are given a prominent position on the packaging.
• Name, strength, pharmaceutical form, target species, active substance(s), pack size and Nordic Article Number are placed within the same field of view 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 products subject to parallel trade, 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 products subject to parallel trade, any colour differentiation is stated in accordance with the colour differentiation used for the veterinary medicinal product already approved in Sweden.
• The text shall be easily legible, even for those who have impaired vision, and in a clear and easily legible font.
• Avoid writing words with only capital letters as the use of lowercase letters gives a better readability.
• 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 is given the same orientation (horizontally or vertically) on the outer packaging and/or immediate packaging.
• 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.
• For medicinal products subject to parallel trade, the use of the same packaging material as in the source Member State is allowed, provided that the packaging material is relabelled to comply with the requirements in HSLF-FS 2021:97. 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 9 of HSLF-FS 2022:9.
• If the medicinal product subject to parallel trade in any way differs from the medicinal product already approved in Sweden, the outer packaging shall be labelled with a text stating this difference, se section 9 of HSLF-FS 2022:9.
• 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.
• Medicinal products in aerosol form shall be labelled in accordance with the Swedish Civil Contingencies Agency's statutes.

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.

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 Nordic Article 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.
• In addition to the labelling with Vnr XX XX XX, a bar code or a 2D code may be placed on the outer packaging, or if there is no outer packaging, on the immediate packaging, so that information on the Nordic Article Number can be obtained by machine reading.

Guideline

• 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.

Guideline

• The name of the veterinary medicinal product and strength are stated clearly and in an easily legible font.
• The name of the veterinary medicinal product 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 veterinary medicinal product and its strength
• The veterinary medicinal product's full name is stated in the same colour.
• Different strengths of a single veterinary 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 products subject to parallel trade, any colour differentiation is stated in accordance with the colour differentiation used for the veterinary medicinal product already approved in Sweden.
• If the veterinary medicinal product has an invented name and contains only one active substance, this shall be stated in lower case letters (including the first letter), below the name of the medicinal product and strength. If the veterinary medicinal product contains several 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 veterinary medicinal product.
• The active substance is stated in the form that corresponds to the strength. For example, if the medicinal product has a strength of 2 mg/ml and contains dexamethasone disodiumphosphate 2.77 mg/ml equivalent to dexamethasone 2 mg/ml, then dexamethasone shall be stated in connection to the name of the medicinal product. Please note that, even though the active substance is stated in connection with the name of the medicinal product, it shall also always be specified in the declaration.
• 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. If target species are included in the name in SPC section 1, it shall be stated in the same way (as in the SPC).
• The pharmaceutical form is stated in accordance with the applicable EDQM Standard Terms.
• Different pharmaceutical forms of the same medicinal product are differentiated clearly in order to avoid mix up.
• The pharmaceutical form may, when appropriate, be given as the pack size (= quantitative indication), e.g. <30 tabletter> [30 tablets].
• 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.
• Veterinary medicinal product packaging that contains pressurised contents shall state both the net and gross volume.

Guideline

• The declaration contains a list of the quantity of the form of the active substance(s) that correspond to the strength, e.g. buprenorphine hydrochloride equivalent to buprenorphine
  8 mg, or 20 mg omeprazole hydrochloride equivalent to omeprazole 19.52 mg.
• The declaration begins with <1 tablett innehåller…> [1 tablet contains…], <1 ml innehåller…> [1 ml contains…] or similar. For vaccines write <1 dos innehåller…> [1 dose contains…].
• In those cases where excipients are stated quantitatively in SPC section 2, these are stated in the declaration on the outer packaging and/or immediate packaging.
• Active substance and excipients are stated together on the outer packaging and/or immediate packaging.
• For vaccines, the adjuvant/adsorbant is stated both qualitatively and quantitatively.

Guideline

The batch number is placed together with the expiry date on the packaging.

Guideline

• When using a logo name, the company name should be readable in the logo.
• The logo may not be dominant in relation to the information text on the packaging.
• For medicinal products subject to parallel trade, the name and address of the wholesale distributor licenced to sell the veterinary medicinal product subject to the parallel trade shall be stated, instead of the marketing authorisation holder. For medicinal products subject to parallel trade the re-packager's and the 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 also section 9 of HSLF-FS 2022:9.
• The information is preceded by <Partihandlare> [Wholesale distributor], <Ompackare> [Re-packager] and <Tillverkare> [Manufacturer].
• For medicinal products subject to parallel trade, the manufacturer's logo may be accepted.
• Logotype is not applicable for the labelling text

Guideline

• The labelling shall contain information about the target species, in singular form.
• A picture of the target species (the type(s) of animals to receive the treatment) may be accepted as a complement or clarification. The picture may not be dominant in relation to the information text on the packaging

Guideline

• If <Exp.> is added during printing, it shall be stated where it will be placed on the outer packaging and/or immediate packaging.
• The date stated after <Exp.> means that the shelf life of the medicinal product is the last date of the indicated month.
• Where applicable, shelf life of opened packaging or shelf life following preparation must also be stated.

Guideline

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

Guideline

The route of administration is, e.g. <intravenös användning> [intravenous use]

Guideline

• Preceded by: <Karenstid:> [Withdrawal period]
• Withdrawal period shall be stated in <dygn> [days]

Guideline

The information referred to is the name of the veterinary medicinal product followed by its strength and pharmaceutical form, declaration of active substance, batch number, name of the marketing authorisation holder, target species, expiry date, storage instructions, route of administration, if applicable, withdrawal period. For guidance see above.

Guideline

• The strength is only stated once on each side of the packaging and in connection to the name of the medicinal product.
• 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 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)”.
• 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.
• If the pack contains cannulas, swabs or similar, this shall be stated on the outer packaging.

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 <För djur> [For animals] is used.

Guideline

The text <Läs bipacksedeln före användning> [Read the package leaflet before use] shall appear on the outer packaging.

Guideline

• Section f) refers to homeopathic veterinary medicinal products subject to Article 85(2) and thus covered by Article 5 on marketing authorisation.
• For labelling of homeopathic veterinary medicinal products registered in accordance with Article 86, refer to the Swedish Medical Products Agency’s provisions (HSLF-FS 2022:10) on registration of homeopathic veterinary medicinal products.

Guideline

The indication is placed on the front of the packaging. If the medicinal product has an acceptable short form for the indication, e.g. “Mot fästingar och loppor” [Treatment of ticks and fleas], this is placed on the front of the packaging. The complete indication according to the package leaflet/labelling text is then placed on another side of the packaging, preferably together with the dosage instructions.

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

• Small containers can e.g. be ampoules, pipettes, small single-dose syringes with paste for oral use and blisters including single-dose blisters. For single-dose blisters, all information should be found on each separable device to ensure traceability.
• The design of the blister is marked on the mock-up (number of tablets and how they are placed on the blister). This is to ensure that the product name and strength are legible when only one tablet (regardless of which one) remains in the blister.
• For medicinal products subject to parallel trade, ampoules, blisters and small single-dose containers must also be labelled with the name of the wholesale distributor licenced to sell the veterinary medicinal product subject to the parallel trade. This is to ensure traceability, see section 9 of HSLF-FS 2022:9.

Guideline

• The name of veterinary medicinal product.
• Pictogram can be used for differentiation.

Guideline

Amount of active substance/substances.

Guideline

The batch number is placed together with the expiry date on the packaging.

Guideline

The applicant may require additional information to be included on the labelling, if relevant. For example, the following additional information is acceptable:

• Warnings and information about safe and correct use.
• Necessary instructions for use, e.g. <omskakas> [shake before use] <ska spädas> [to be diluted].
• QR code in accordance with the EMA guideline document.