Guideline

• Information in the package leaflet shall be consistent with the content of the SPC and be otherwise beneficial for the user.
• The information should be concise.
• It is preferable to use the active form, e.g. “Ta tabletten med mat” [Take the tablets with food] instead of “Tabletterna tas med mat” [The tablets are taken with food].
• The medicinal product's positive properties should be presented in a balanced way, but may not contain advertising messages or emotive language.
• Particularly important information is given the appropriate prominence in each section. Prominent placement can be done with the help of bulleted lists, boxes or starting each section with particularly important information. Additional subheadings, aside from those already stipulated, may be used.
• For non-prescription medicinal products, the package leaflet and labelling shall contain sufficient information and be designed to allow the animal owner/customer to use the medicinal product without contacting a veterinary surgeon.
• A combined package leaflet may be used if the package leaflets are identical for more than one strength. In these cases, only the strength-specific information may differ. The aim of the combined package leaflet will be to clarify dosage instructions for the user, e.g. when a patient changes from one strength to another during their treatment. However, non-prescription medicinal products should have separate package leaflets for different strengths in order to avoid the risk of incorrect dosage.
• It is sufficient to provide one package leaflet in multipacks. Multipacks of medicinal products subject to parallel trade should contain the same number of package leaflets as the multipack of the medicinal product already approved in Sweden.
• The printed package leaflet shall be easily legible, even for those with impaired vision. The use of uppercase letters must be avoided. Good legibility may also be achieved by splitting the text up into short paragraphs with spaces between them. Use a clear and easily legible font. Avoid paper of a quality that allows text from one side to be visible on the other. Text divided up into a larger number of narrow columns is more easily legible than a small number of wide columns.
• Only information relating to the Swedish market may be stated in the Swedish package leaflet authorised by the Swedish Medical Products Agency. 

Guideline

• Is stated under the heading ”Kontaktuppgifter” [Contact details]
• If the contact point for the reporting of adverse reactions is not the same as the marketing authorisation holder, the subheading <och tillverkare ansvarig för frisläppande av tillverkningssats> [and the manufacturer responsible for the release of the batch] and <och kontaktuppgifter för att rapportera misstänkta biverkningar> [contact details for reporting suspected adverse reactions] should be deleted in the subheading of the QRD template.
• If the manufacturer is in the same group of companies as the MAH, the manufacturer does not need to be stated separately under the heading <Tillverkare ansvarig för frisläppande av tillverkningssats:> [Manufacturer(s) responsible for batch release:]. In such cases the heading can be excluded.
• The local representative must be registered at the Swedish Medical Products Agency.
• If the stated company is not registered as a local representative at the Swedish Medical Products Agency, but only provides information about the medicinal product, the heading <Information lämnas av:> [Provider of information:] may be used instead.
• Name and telephone number are the minimum requirements. When a local representative is not registered in Sweden and the address is specified, the country shall also be included in the address. Complete address (preferably postal address) and/or email address may also be provided.
• A reference to a web-address is not acceptable.
• 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. 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 10 of HSLF-FS 2022:9.

In the package leaflet for veterinary medicinal products subject to parallell trade, use the heading:

NAME AND ADDRESS OF THE WHOLESALE DISTRIBUTOR LICENCED TO SELL THE VETERINARY MEDICINAL PRODUCT SUBJECT TO THE PARALLEL TRADE, RE-PACKAGER(S) AND MANUFACTURER(S)

Names and address details are preceded by the subheadings <Partihandlare> [Wholesale distributor], <Ompackare> [Re-packager] and <Tillverkare> [Manufacturer].

Guideline

• State the name of the active substance(s) in lowercase letters, including the first letter.
• The information, possibly including target species, is stated as in the first section of the summary of product characteristics. The target species can be specified after the pharmaceutical form.
• State the active substance(s) so that it reflects the strength stated directly after the name of the medicinal product. 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.
  • 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 20 mg omeprazole hydrochloride equivalent to 19.52 mg omeprazole, then omeprazole hydrochloride shall be stated in connection to the name of the medicinal product.
• State at least the excipients listed quantitatively in section 2 of the summary of product characteristics.
• A description of the medicinal product's appearance should be included.

Guideline

Target species

• Target species are listed in accordance with the target species in the SPC.
  If there is a risk of confusion, the target species must be listed following Name, strength, pharmaceutical form in the introduction of the package leaflet, e.g. if the same product name is approved for different target species.

Dosage

• Based on the information in the dosage section in the SPC.
• State the dosage for each target species.
• Preferably, only state the most common dosage and, if applicable, the maximum dose.
• Include relevant instructions, e.g. <omskakas> [shake before use], <löses i vätska> [dissolve in liquid].
• State the route of administration in a user-friendly way. 

Administration

• Provide more practical instructions for use that are directed at animal healthcare professionals, farmers or animal owners. If necessary, this can be more detailed than in the SPC.
• For example: Låt vaccinet anta rumstemperatur före användning, Ges tillsammans med foder. [Allow the vaccine to warm to room temperature before use; Is given together with food.].
• If possible, include advice on what to do if a dose is missed. For example, this may be relevant in the case of treatment with antibiotics, contraceptive pills for cats or other continuous treatments.
• Describe non-user-friendly methods of administration with a more user-friendly translation. For example according to the table below:

Guideline

• Is stated under the heading ”Användningsområden” [Indications for use].
• Based on the information in the indication section and relevant information in the pharmacodynamic section of the SPC.
• A short explanatory text may also be included in this section in order to describe the medicinal product's positive effect(s); this information shall be presented in an objective and balanced way.

Guideline

Contraindications

• Based on the information in the section concerning contraindications in the SPC.
• All contraindications shall be listed.

Adverse events

• Based on the information in the section adverse events in the SPC.
• All adverse events listed in the SPC shall be included in the package leaflet.
• Adverse events should be listed based on how often they occur, most frequent reactions first.
• The information can be presented per target species and preferably in tabular form. Information related to several animal species can be presented in a common table if the information is almost identical for the animal species concerned. Deviating information between animal species shall be clearly stated.
• The package leaflet shall be easily understood by animal healthcare professionals, farmers and animal owners. It is appropriate to describe symptoms rather than the exact medical term for a certain side effect. It is recommended that the medical terminology be provided in parentheses.
• The following text is recommended for the reporting of adverse events via the national reporting system:

Läkemedelsverket
Box 26
751 03 Uppsala
www.lakemedelsverket.se

Guideline

• Based on the information in the withdrawal period section in the SPC.
• The withdrawal period is only stated for food-producing animals.
• When appropriate, this section also includes separate text; general information that is not connected to specific types of withdrawal or the withdrawal period for a certain target species according to the SPC.
  For example:

<Mjölk från ston får ej användas för human konsumtion.> [Milk from mares may not be used for human consumption]

<Ej till fjäderfä som producerar ägg för human konsumtion.> [Not for poultry producing eggs for human consumption]

(additional examples may be found in the list ”Karenstider för alla i Sverige godkända läkemedel avsedda för livsmedelsproducerande djur”.

Guideline

• Based on the information in the section on storage in the SPC.
• The following text is used to inform the user of the expiry date:

Använd inte detta läkemedel efter utgångsdatumet på <etiketten> <kartongen> <flaskan> <…><efter EXP. <Utgångsdatumet är den sista dagen i angiven månad.>

[Do not use this medicinal product after the expiry date indicated on the <label><box><bottle><…> <after {< EXP> }. <The expiry date is the last day of the month specified.>]

• Where applicable, shelf life of opened packaging and/or shelf life following preparation must also be stated.
• The storage precautions shall be the same as those in the SPC and should be expressed in standard terms according to the package leaflet in the QRD template.

Guideline

• Subheadings in accordance with the QRD template should be used in this section in order to make the information clear.
• The information is based on the warning section in the SPC.
• The following information should be included in this section:
  • Information about pregnancy, lactation and lay, based on the corresponding section in the SPC.
  • Information about interactions, based on the corresponding section in the SPC.
  • Information about overdosing, symptoms and any practical advice for the animal owner in the event of an overdose, based on the corresponding section in the SPC.
• Information about special warnings or other information that is strictly directed at veterinarians may well be included in the section “Other information” at the end of the package leaflet.
• Standard wordings for warnings for animals and for people who administer the medicinal product, respectively, and that are stated in the QRD template for the SPC should also be listed on the package leaflet.

Guideline

• Based on the information in section 5.5 and section 10 of the SPC.
• Standard wordings in accordance with the QRD template for medicinal products for veterinary use should be used.

Guideline

See guidance to article 14, section 1 a) above.

Guideline

• ”Prescription-only medicinal product”
• ”Non-prescription medicinal product”
• ”Prescription-only medicinal product except for certain package sizes”

Guideline

The implementation period regarding changes in the labelling or package leaflet may be longer or shorter than six months, based on the Swedish Medical Products Agency's assessment in each individual case. Below are some examples of how different types of changes in the labelling or package leaflet may be assessed.

• The Swedish Medical Products Agency may decide that packages with previously approved and new labelling/package leaflet may be sold in parallel only for a limited transitional period.
• When it comes to certain changes (such as name, strength or pharmaceutical form, serious safety updates, certain contraindications and quality changes, etc.), the Swedish Medical Products Agency may decide to prohibit parallel sales, or alternatively to limit the time of parallel sales.
• After name changes, parallel sales of packaging with previously approved and new labelling/package leaflet are usually allowed for one month. The implementation date for the new name to be visible in the systems can be adjusted according to the applicant's wishes.
• After MAH changes, parallel sales of packaging with previously approved and new labelling/package leaflet are usually allowed for six months. The implementation date for when the MAH change will be visible in the systems can be adjusted according to the applicant's wishes.

For certain non-urgent changes, or purely administrative changes, to the package leaflet and labelling, for example a QRD template change according to classification VRA G.I.18, a longer implementation period of the new labelling can be decided. In such cases, the Swedish Medical Products Agency can decide on an implementation period of up to twelve months. Non-urgent changes are primarily changes that do not affect safety, handling or administration of the medicinal product.