Registration and follow-up of homeopathic medicinal products
- Published: November 28, 2019
- Last updated: January 31, 2022
Homeopathic medicinal products must be registered at the Swedish Medical Products Agency before they may be sold on the Swedish market. The agency controls the safety of the products. Efficacy is not assessed and no therapeutic indication may be claimed for a homeopathic medicinal product.
According to Swedish law homeopathic medicinal products must be registered at the Swedish Medical Products Agency (Swedish MPA) before they may be sold on the Swedish market. This applies for both human and veterinary homeopathic medicinal products.
In order to be registered, the homeopathic medicinal product must meet the following requirements:
- the product is for topical or oral use only (applies to products for human use)
- the product is safe
- no efficacy or therapeutic indication is claimed, neither on the product package nor in any product promotion
- the product contains maximum one part in 10 000 of mother tincture (equivalent to D4 in the final product)
- if the active ingredient of a homeopathic medicinal product for human use is also found in a prescription drug, the homeopathic medicinal product must be diluted at least 100-fold compared to the lowest dose for which a prescription is required.
Additionally, the Swedish Medical Products Agency controls that:
- the quality and safety of the final product comply with applicable regulations
- manufacturing has been carried out in a qualitatively acceptable manner following GMP (Good Manufacturing Practice)
- the manufacturing process complies with established homeopathic methods
- the homeopathic stock(s) has a proven homeopathic use
- the labelling of the final product complies with applicable regulations.
The Swedish Medical Products Agency does not assess the efficacy of homeopathic medicinal products, and there are no requirements to show efficacy of the products via clinical study data or supportive scientific literature.
No efficacy or therapeutic indication must be claimed for a homeopathic medicinal product.
Manufacture, import and marketing of homeopathic medicinal products
For manufacture and import of homeopathic medicinal products, the same rules apply as for medicinal products in general. As for other medicinal products, a license is thus required in order to carry out wholesale trade with homeopathic medicinal products. Registered homeopathic medicinal products for human use may be sold in retail without any license, while the Swedish Medical Products Agency must be notified regarding retail of homeopathic veterinary medicinal products.
Regulations on manufacture and import of medicinal products
More about wholesale trade
Applications for registration of homeopathic medicinal products
There is a certain application form in EudraLex volume 2B (Notice to applicants), which should be used for applications for registration of homeopathic medicinal products.
The application form and appurtenant documentation should be organised in accordance with Common Technical Document, CTD, with adequate adjustments for homeopathic medicinal products. Applicable parts of the CTD format should be indicated in the application form.
In addition to application form and appurtenant documentation according to EudraLex, the registration application should comply with the national provision HSLF-FS 2022:10 (Swedish Medical Products Agency's provisions on registration of homeopathic veterinary medicinal products) or HSLF-FS 2022:11 (Swedish Medical Products Agency's provisions on registration of homeopathic medicinal products for human use) as relevant.
The guidance documents of the provisions are being updated. Meanwhile, information may still be used from the previous guidance documents (in Swedish):
An abridgment of the package labelling requirements in English can be found further down.
Regulations and guidelines can also be found at the web page of the EU working group on Homeopathic medicinal products.
Registration application with reduced documentation
Exemptions from the requirements above can be acceptable if the product is based on raw material included in one of the following lists:
- List of stocks with justified homeopathic use (HU)
This is a list of stocks where the homeopathic use is considered justified. For a homeopathic medicinal product based on a stock included in this list, a reference to the list can be made in the application for registration. No additional documentation is required for justification of homeopathic use. - List of first safe dilutions (FSD)
This is a list of raw material where the first safe dilution has been assessed by the HMPWG. For products where the raw material is more diluted than the first safe dilution, a reference to the list can be made. No additional safety documentation is required. Please observe that the list includes oral preparations only; for other routes of administration a product specific safety assessment is necessary.
Lists of assessed homeopathic stocks and dilutions
Variation application
Variations to the information on which the registration of a homeopathic medicinal product is based may only be made with the approval of the Swedish Medical Products Agency. Variations may include e.g. change of manufacturer or supplier, new composition of excipients, changed manufacturing method, revised quality standards and changes in packaging design or size.
Renewal application (renewal of registration)
A marketing registration for a homeopathic medicinal product for human use is valid for five years. In order to renew the registration, a renewal application must be submitted.
A marketing registration for a homeopathic veterinary medicinal product is not limited. Application for renewal is not required.
Fees for homeopathic medicinal products
Application and annual fees for homeopathic medicinal products have to be paid following the ordinance (SFS 2010:1167) concerning fees for the governmental control of medicinal products.
Illegal sales
Sale of homeopathic products not registered by the Swedish Medical Products Agency is illegal.
Illegal sales may be reported to the Swedish Medical Products Agency via email.
Email: registrator@lakemedelsverket.se
Labelling of Homeopathic Medicinal Products
The formal requirements applicable for the labelling of homeopathic veterinary medicinal products can be found in the Swedish Medical Products Agency's provisions (HSLF-FS 2022:10) on registration of homeopathic veterinary medicinal products, and for homeopathic medicinal products for human use requirements can be found in Article 69 of Directive 2001/83/EC and in the national provision HSLF-FS 2022:11, Swedish Medical Products Agency's provisions on registration of homeopathic medicinal products (with further details and explanations in two guidelines, in Swedish only).
The following is an abridgment of the package labelling requirements.
The labelling of homeopathic medicinal products should include:
- Product name. For single-component products (containing a single homeopathic stock) this is generally equal to the name of the corresponding monograph in the European Pharmacopoeia or in another homeopathic pharmacopoeia used officially within the EEA. For combined products (containing two or more stock preparations) an invented product name may be used as a complement to the names of the homeopathic stocks.
- Degree of dilution. Should be stated right after the homeopathic stock and is indicated with symbols in accordance with the European Pharmacopoeia or other official homeopathic pharmacopoeia.
- Dosage form and package size, printed as follows:
- 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
- “Homeopatiskt läkemedel” (homeopathic medicinal product) and “Homeopatiskt läkemedel utan godkända terapeutiska indikationer” (homeopathic medicinal product without approved therapeutic indications), preferably printed on the front side of the package.
- “Förvaras utom syn- och räckhåll för barn” (Keep out of the sight and reach of children).
- For homeopathic medicinal products for human use: “Kontakta läkare om symtom kvarstår” (Consult a physician if symptoms persist).
- For homeopathic veterinary medicinal products: a recommendation to consult a veterinarian before use.
- “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 (e.g. “Innehåller bi” (Contains bee))
- The manufacturer's batch number, preceded by “Sats:”, “Batch:” or “Lot:”.
- Registration number, preceded by “Reg.nr.”
- Expiry date of the product, printed as “Utg. dat.: mm.yyyy”.
- Shelf life of opened package, if applicable.
- Special storage precautions, if any.
- Name and address of the registration holder and possibly its local representative, if applicable.
- Name and address of the product manufacturer, unless this is the same company as the registration holder.
- For homeopathic veterinary medicinal products: the animal species for whom the product is intended and, if applicable, posology for each of those species.
- For homeopathic veterinary medicinal products: the withdrawal period, if applicable.
Ingredients of the product
All ingredients of the product must be declared on the labelling, i.e. both the homeopathic dilution(s) and all excipients.
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. It is sufficient to define the generic name in full text only once, e.g. “Crataegus D6 (Crataegus laevigata, C. monogyna)” or “Crataegus D6 (Crataegus laevigata / monogyna)”.
Homeopathic stock preparation – chemicals
If the homeopathic stock is based on a chemical substance, the Swedish name of the chemical (according to the Swedish Medical Products Standard, SLS) should be specified within brackets after the homeopathic name. If the chemical is a salt, it should be clear how many of each ion that 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. If the homeopathic stock contains a stock made from a specific animal part, the specified part and animal species should be stated.
There are also a few homeopathic stock preparations (e.g. Hepar sulfuris) after which an established description in Swedish should be added within brackets.
Excipients
All excipients should be listed in Swedish (according to the Swedish Medical Products Standard, SLS) in descending order with regards to quantity. Notice that the total amount of each excipient - including possible amount included in each dilution/trituration – should always be declared.
If the excipient has an E-number, it should be used in the labelling.
If the product contains ethanol the content must be specified in percentage either by volume (V/V) or weight (m/m).
Ingredients that may require specific labelling
Some homeopathic medicinal products must be labelled with a warning due to safety concerns, e.g. if any of the excipients could cause allergic reactions. Some warnings must always be included, while others are considered relevant only at lower dilutions.
It is determined on a case-by-case-basis whether safety warnings, that are used for certain excipients in conventional medicine, should also be stated on the homeopathic medicinal product. For sugars (such as lactose, sucrose, etc.) that are clearly specified in the labelling, safety warnings are not required.
Small primary packages
If the primary packaging is very small (for instance a blister, ampoule or tube) the information may be reduced to a minimum, provided that full information is presented on the secondary packaging.
The following information is required even on small primary packages:
- Product name (i.e. active substance or invented name plus three or less active substances), degree of dilution and dosage form.
- Name of the registration holder.
- Expiry date.
- Batch number.
- Method of administration and route of administration, if relevant.
- Package size (number, weight, volume) or amount per unit, if relevant.
For blisters, the last two bullets may usually be disregarded.
Laws and statues
Swedish Medical Products Agency's provisions on manufacture and import of medicinal products LVFS 2004:7 (in Swedish):
Swedish Medical Products Agency's provisions on wholesale trade with medicinal products LVFS 2014:8 (in Swedish):
Swedish Medical Products Agency's provisions on registration of
homeopathic medicinal products for human use HSLF-FS 2022:11 and on registration of homeopathic veterinary products HSLF-FS 2022:10 (in Swedish):
The guidance documents of the provisions are being updated. Meanwhile, information may still be used from the previous guidance documents (in Swedish):