Labelling of Homeopathic Medicinal Products

The principle for the labelling of homeopathic medicinal products is that the information should be clear and easy to understand for those who want to use the product. As a practitioner/user, one should be able to quickly grasp what kind of preparation it is, what it contains and if there are any warnings related to the contents.

The formal requirements applicable for the labelling of homeopathic medicinal products for human use can be found in Article 69 of Directive 2001/83/EC and in the Swedish Medical Products Agency's provision, LVFS 2006:12 Föreskrifter om ändring i Läkemedelsverkets föreskrifter och allmänna råd (LVFS 1997:9) om registrering av vissa homeopatika [in Swedish only; approximate English title: ”Instructions regarding amendments to the Swedish Medical Products Agency’s provisions and guidelines (LVFS 1997:9) on the registration of certain homeopathic products”]. Links to the mentioned documents can be found under Regulations.

When assessing applications for registration of homeopathic medicinal products, the MPA frequently receives questions regarding labelling. Below is a summary of the interpretations and clarifications made by the MPA in connection with such questions. This information could be valuable to companies that want to submit new applications or update existing labelling for already registered products. A company is obliged to continuously update their labelling in accordance with current rules and regulations. Such updates should be submitted to the MPA as a variation application.

What information must be included in the labelling?
How should the list of ingredients be optimised?
Are there ingredients that require specific labelling?
How should small packages with limited space be labelled?

What information must be included in the labelling?

Please also refer to the Swedish web page for translated standard terms.

• Product name, dosage form and package size is printed at the top of the label. Dosage form and package size is printed as shown below (see also Example 1-4):
- Number of tablets and tablet weight (mg)
- Number of capsules and capsule weight (mg)
- Granules, x grams
- Oral drops, solution, x mL
- Oral solution, x ampoules x mL
- Ointment, x grams
• Degree of dilution should be indicated with symbols in accordance with the European Pharmacopoeia or other official homeopathic pharmacopoeia.
• “Homeopatikum registrerat utan indikation” [“homeopathic medicinal product registered without therapeutic indications”]
• This text should be clearly visible on the label: “Förvaras utom syn- och räckhåll för barn” (“Keep out of the sight and reach of children")
• “Kontakta läkare om symtom kvarstår” ("Consult a physician if symptoms persist")
• Method of administration and, if necessary, route of administration
• If necessary, other specific warnings (eg. “Innehåller bi” (“Contains bee”))
• The manufacturer's batch number (“Sats:”)
• Registration number (“Reg.nr.”)
• The expiry date (“Utg. dat., mm.yyyy”)
• Shelf life of opened package, if applicable
• Special storage precautions, if any
• Name and address of the registration holder or its local representative and, where appropriate the manufacturer.

How should the list of ingredients be optimised?

All the ingredients of the product must be listed, i.e. both the homeopathic dilution(s) and all excipients.

Homeopathic stock preparation

For special homeopathic stock preparations (eg Hepar sulfuris), a description in Swedish should be written, within brackets, after the homeopathic stock (see Table 1 and Example 3).

Quantity of the dilutions/triturations may, if necessary, be specified in the list. Note that excipients included in the dilutions/triturations must also be listed (see under "Excipients” below).

Homeopathic stock preparation - plants

If the homeopathic stock is based on a plant, the scientific binomial name of the species should be specified within brackets after the homeopathic name. This is not required if the homeopathic name is identical to the plant's scientific name. If three or fewer species are included in the product, the names of all the species should be listed (see Example 1). It is sufficient to define the generic name in full text once. E.g., Crataegus D6 (Crataegus laevigata, C. monogyna) or (Crataegus laevigata / monogyna).

Homeopathic stock preparation - chemicals

If the homeopathic stock is based on a chemical, the Swedish name of the chemical (according to Swedish Medical Products Standard, SLS) should be specified within brackets after the homeopathic name (see Example 2). If the chemical is a salt, it should be clear how many of each ion is contained in the salt. The same applies if the chemical is a hydrate. E.g., NaH2PO4:2H2O should be defined as sodium dihydrogen phosphate dihydrate (in Swedish: natriumdivätefosfatdihydrat).

Homeopathic stock preparation - animals/animal parts

If the homeopathic stock is made from whole animals, the Swedish name of the animal should be specified within brackets after the homeopathic name (see Example 3). If the homeopathic stock contains a product of an animal or animal part, the specified part and animal species should be written according to Example 3.

Table 1: Description of the homeopathic stock preparation in Swedish. – Please refer to the Swedish page for examples and tables.

Excipients

Excipients should be listed in Swedish (according to Swedish Medical Products Standard, SLS) in descending order with regards to quantity. If the excipient has an E-number it may be used in the labelling. Whether the safety warnings, used for certain excipients in conventional medicine, should be included is determined from case to case. For sugars (such as lactose, sucrose, etc.) that are clearly specified in the labelling, safety warnings or E-numbers are not required for homeopathic medicinal products.
If the product contains ethanol the content must be specified in percentage either by volume (V/V) or weight (m/m).

Excipients in the dilutions/triturations

As stated above, the added amount of the respective dilutions/triturations can, if necessary, be listed amongst the contents. Declaration of the total amount of excipients (including the amount included in each dilution/trituration) is nevertheless always obligatory (see Example 3 below).

Table 2: Recommended way of writing of the excipients. – Please refer to the Swedish page for examples and tables.


 

Are there ingredients that require specific labelling?

Yes, there are some products that contain substances that for safety reasons (e.g. allergies) must be labelled with a warning. Some warnings must always be included, while others are considered relevant only at lower dilutions (see Table 3). The list in Table 3 contains examples of warnings. Other warnings not listed here may also be relevant.

Table 3. Substances requiring special labelling – Please refer to the Swedish page for examples and tables.

How should small primary packages with limited space be labelled?

If the primary packaging is very small the information may be reduced down to a minimum as described below. The prerequisite is that full information is included in the secondary packaging.

Blisters

Blisters should be labelled with the product name, strength, active substances (if the product contains three or fewer active ingredients), dosage form, batch number, expiry date, and registration holder. Active substances are written in the same way as on the secondary packaging, with the monograph names and Latin names/translations/explanations within brackets. The expiry date on the blister should be stated as "Utg.dat.", "EXP" or the date only. See Example 4 on the Swedish page.

Ampoules and tubes

Each primary package must be labelled with the product name, strength, active substances (if the product contains three or fewer active ingredients), dosage form, route of administration, pack size, batch number, expiry date and registration holder. Active substances are written in the same way as on the secondary packaging, with the monograph names and Latin names/translations/explanations within brackets. The expiry date should be stated as "Utg.dat.", "EXP" or the date only. See Example 4 on the Swedish page.

 
 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information