The topic is short and compact
Section 3(2) MBO-Ä prohibits the sale of goods in connection with medical treatment, unless it is a necessary part of the therapy.
Healing claims and disease references fall under the HWG; a practice line may only claim cosmetic purposes such as cleansing, caring for and protecting the skin.
Products for comedone reduction can be cosmetics; classification in the individual case by the competent authority remains decisive.
Sales and advertising of the practice line must be separated from medical treatment in terms of premises, personnel and economics; formulation rights must be secured contractually.
Scientifically substantiated test claims for cosmetic products such as "dermatologically tested" or "clinically tested" require testing on humans under medical supervision.
So läuft die Entwicklung bei Labtree
1
Konzeptionierung
2
Bemusterung – Standardmuster in 24 h
3
Individualisierung
4
Prototyping
5
Produktion
White Label 2–3 Monate · Private Label 3–6 Monate · Produktion ab 1.000 Stück
May a medical practice sell its own cosmetics?
In connection with medical treatment, as a rule no. Section 3(2) of the (Model) Professional Code of Conduct for Physicians prohibits, in connection with the practice of the medical profession, the sale of goods or the sale of goods with the involvement of practice staff, as well as the provision of commercial services; the only exception is the sale of goods which, because of their special nature, are a necessary part of the medical therapy. For the practice, this means: a care cream or a skin tint is not part of the therapy but a commercial product, which is why a dermocosmetics line sold permanently in the consultation room is not covered by this exception.
What is decisive is the binding effect: the (Model) Professional Code of Conduct for Physicians is a reference text of the German Medical Association, which is revised by the German Medical Assembly. It only takes legal effect once the assembly of the respective regional chamber of physicians adopts it as a statute and the supervisory authority approves it. The wording and interpretation of the prohibition on selling goods can differ between chambers. For planning purposes, this means: before any line concept, the statute of the relevant regional chamber of physicians should be reviewed, not only the model text.
Prohibition: the sale of goods and commercial services in connection with the practice of medicine is prohibited (Section 3(2) MBO-Ä).
Exception: only what, because of its special nature, is a necessary part of the medical therapy.
Verification step: the statute of the relevant regional chamber of physicians is binding; the (Model) Professional Code serves as a reference but does not replace it.
The consequence for planning: it is not the formulation that is the problem, but the place and context of the sale. Those who know the limits of professional law can design the line from the outset for a separate sales channel, instead of having to detach it from the practice afterwards.
Where does dermocosmetics end and the medicinal product begin?
The boundary runs along the product, not the seller. A cosmetic product within the meaning of Article 2(1)(a) of Regulation (EC) No 1223/2009 is intended to clean, perfume, change the appearance of, protect, keep in good condition or correct body odours of external parts of the body. Cleansing, care and protection are therefore cosmetic purposes. A product intended to heal or alleviate diseases, or to alter physiological functions through a pharmacological, immunological or metabolic action, by contrast, moves towards the medicinal product, as the EU Borderline Manual of the Working Group on Borderline Products, version 5.5 of 2025, illustrates with numerous case examples.
As a rule remains a cosmetic | Moves towards a medicinal product |
|---|---|
Cleansing, caring for and protecting the skin as the declared purpose | Healing or alleviating a disease as the declared purpose |
Changing the appearance, e.g. complexion, coverage, texture | Altering physiological functions through pharmacological action |
Products against blackheads (comedones) with a consistently care-focused presentation | A presentation that conveys a therapeutic goal |
How closely presentation and purpose are linked is shown by the EU Borderline Manual of the Working Group on Borderline Products, version 5.5 of 2025: products against blackheads can remain cosmetics if composition, presentation and communication remain consistently care-focused; statements that aim to treat a skin disease, by contrast, make the same product a medicinal product. The Manual is expressly not a binding Commission document. Classification is carried out in the individual case by the competent national authority, i.e. in the DACH region by the respective supervisory authorities.
For the practice line, this means: every product is examined individually before it is developed. Intended purpose, INCI composition, packaging statement and website copy must all convey the same cosmetic picture. The obligations under the EU Cosmetics Regulation, from the responsible person via the product information file to the CPNP notification, apply regardless of who distributes the line and must be completed before production.
Which claims may a practice line not make?
Two sets of prohibitions apply simultaneously to the communication of a practice line: the Heilmittelwerbegesetz (German Act on the Advertising of Medicinal Products) and professional law. Under § 1 (2) HWG, cosmetic products within the meaning of Art. 2 (1)(a) of Regulation (EC) No 1223/2009 are expressly "other products" within the meaning of the Act if the advertising claim relates to the detection, elimination or alleviation of diseases, ailments, bodily harm or pathological complaints. For a practice line this means: any wording that promises a cure or alleviation falls under the obligations of the HWG, regardless of whether the product itself remains a cosmetic.
Professional law comes on top: § 27 (3) MBO-Ä prohibits advertising for one's own or third-party commercial activities or products in connection with medical practice, as well as promotional, misleading or comparative advertising; physicians may neither instigate nor tolerate such advertising by third parties. For the practice line this means: a practice website that links the treatment service to product sales touches both sets of prohibitions at once and should therefore be avoided.
Permitted as cosmetics: claims on cleansing, care, protection, texture and sensorics, for example for creams, serums, cleansers or masks.
Not permitted without HWG consequences: claims that promise the detection, elimination or alleviation of diseases or pathological complaints (§ 1 (1) no. 2, (2) HWG).
Not permitted in the practice context: promotional advertising for one's own line, linking treatment and product recommendation (§ 27 (3) MBO-Ä).
Test claims such as "dermatologically tested" only with a matching study, see the next paragraph.
Test claims face their own hurdle. Under the EU working group's technical document on cosmetic claims, the test design must always match the specific claim. Additional requirements apply to certain claims: "dermatologically tested" requires testing on humans under the supervision of a dermatologist, "clinically tested" requires testing under the supervision of a medically or scientifically qualified professional. Self-assessments by users are not sufficient for such claims. Anyone advertising with test results therefore needs a study whose design supports the specific claim and should be able to keep the evidence on file in the product information file. The general rules for claims on the label are summarised in a separate article on advertising claims in the EU.
How do you separate product sales from medical treatment?
The separation starts with the sales channel. The line is sold outside the consulting room: through its own online shop, through pharmacies, through mail order or through a dedicated sales company. What may not be handed over in the treatment context can be traded normally via a channel-separated distribution, as long as no link to medical practice is established.
Spatial: no product handover in practice premises, no sales shelf in the waiting area.
Personnel: sales tasks are handled by staff who are not involved in the treatment.
Economic: a separate legal entity or at least fully separated accounting for product sales.
Communicative: no product advertising on the practice website, in practice emails or on prescriptions, no recommendation link between treatment and purchase.
The economic separation has a tax dimension. Under § 15 (3) no. 1 EStG, an activity undertaken with the intention of generating income by a partnership is deemed in full to be a commercial business if the partnership also derives commercial income. A group practice that sells cosmetics can therefore trigger commercial income alongside its freelance activity, with consequences for the entire partnership. These consequences should therefore be assessed from a tax perspective before the line is launched.
Separation is thus not an optional extra but a precondition for the line to remain sellable at all. It should be built into the legal structure, contracts and communication channels from the outset, not constructed retrospectively.
How does the practice concept become a line of its own?
The starting point is not an active ingredient but the care goal from the practice: which skin conditions the line should support through care, which textures and formats fit that purpose, whether creams, serums, cleansers or masks. From this, a technical briefing emerges with product type, an active ingredient concept formulated in care terms, texture specifications, packaging and target markets. Anyone building a brand from the ground up will find the framework in the article on founding a cosmetics brand.
With a manufacturer that runs its own laboratory, the path to a production-ready line runs through concept development, sampling, customisation, prototyping and production. In the White Label model, the practice line starts from a proven, tested formulation that is adapted to the care concept and reaches market readiness quickly; in the Private Label model, the formulation is developed from scratch according to the practice's requirements. In both cases, development and production remain under one roof, so quality and batch consistency are secured even in repeat production. Exclusivity and formulation rights are governed contractually. How long it takes to reach market readiness depends primarily on stability and compatibility testing, the alignment loops for formulation and packaging, and regulatory deadlines; the minimum order quantity is usually 1,000 units per product, depending on product type, fill size and packaging.
Labtree is a B2B cosmetics developer and cosmetics manufacturer with its own laboratory work: formulation development, sampling, manufacturability testing and cosmetics production run in a single workflow, and approved formulations go into production with batch release. Before launch, the stability and safety testing that every brand needs in the EU is complete; the labelling obligations on the packaging are summarised in the article on INCI and mandatory labelling information.
For distribution, the same pattern applies as in the sections above: cosmetic-compliant claims, a separate sales channel, separate legal entity. Anyone who wants a practice line developed as Private Label will find on labtree.de the process from concept development through sampling to production and can start an enquiry there directly with their own care concept.
More useful links
FAQ
Can a physician sell their own cosmetic products in their practice?
In the context of medical treatment in the practice, this is generally not permitted. Section 3 (2) MBO-Ä prohibits the sale of goods, except where the sale, owing to its particular characteristics, is a necessary component of the medical therapy. A dermocosmetics line that is not medically essential does not fall under this exception.
When is a skincare product a cosmetic and when is it a medicinal product?
A cosmetic serves to clean, care for, protect or change the appearance of the external parts of the body; a medicinal product, under Section 2 of the AMG or Article 1 No. 2 of Directive 2001/83/EC, is a substance or preparation intended to cure, alleviate or prevent disease, or to restore, correct or influence physiological functions through a pharmacological, immunological or metabolic effect. Classification is decided case by case by the competent authority; a reduction of comedones can remain cosmetic depending on presentation, while references to disease shift a product into medicinal product law.
Why do healing claims trigger the Act on Advertising for Medicinal Products?
Section 1 (2) HWG expressly covers cosmetic products within the meaning of Article 2 (1) (a) of Regulation (EC) No 1223/2009 as soon as the advertising refers to the detection, elimination or alleviation of diseases or pathological complaints. For a practice line, only cosmetic purposes are therefore permissible; effects against diseases must not be advertised.
May a practice have its products scientifically tested?
Yes, and it is in fact the right route for substantiated claims. For this, a test on humans must be carried out under medical supervision with a credible assessment or measurement of efficacy; a mere self-assessment by the test subjects is not sufficient. Such tests are additionally subject to the professional-law rules on cooperation with third parties under Sections 30 to 33 MBO-Ä.
How can a practice distribute its cosmetics line without violating professional law?
Via a separate sales channel outside the consultation room: an own online shop, sale through specialist retailers or pharmacies, or the brand as an independent company. What matters is spatial, personnel and organisational separation from the treatment; in group practices, it should be clarified with the tax advisor whether product sales could take on the character of commercial income.
Who is actually the responsible person for the practice line?
Under Article 4 (1) of Regulation (EC) No 1223/2009, a person in the EU market must be named as responsible person for every cosmetic product placed on the market; when distribution takes place under the brand's own name, this is the brand owner, not the contract manufacturer. The role can be transferred by written mandate to a person established in the EU who accepts the mandate in writing.
Who owns the formulation of the practice line?
When the formulation is newly developed according to the brand's requirements (Private Label), formulation rights and exclusivity are contractually agreed with the manufacturer and can be transferred to the brand. With a ready-made manufacturer formulation (White Label), the formulation remains with the manufacturer; the brand receives an adapted, tested product.
