Pharmacy guide

Law: what pharmacies must consider for genetic tests, supplements and cosmetics

Reviewed by Dr. Daniel Wallerstorfer, molecular biologist and founder of Novogenia · Updated: 13 October 2026 · Reading time: 11 min

In short

An offer that combines genetic analysis, counseling, food supplements and skincare needs three legal keys. Pharmacy law: in Germany, advice on health and nutrition questions and personal care products are part of the customary pharmacy range (Section 1a ApBetrO); in Austria, Section 1 ABO 2005 lists advice on health and nutrition questions. Genetic testing law: lifestyle analyses are possible, while in Germany medical analyses are reserved for physicians (Section 7 GenDG). In Switzerland, pharmacists may initiate analyses on nutrition, sport and well-being themselves, and the sample is taken in their presence (Art. 34 GUMG, Art. 40 GUMV). Food and cosmetics law: you are responsible for the information on your own brand; in Germany, every food supplement is notified to the BVL (Section 5 NemV).

Three keys for a new offer

One sentence in Germany’s Pharmacy Operations Ordinance reads as if written for this topic. It lists “advice on health and nutrition questions” among the customary pharmacy services. That is the core of a personalized offer: the genetic analysis lays the foundation, your team turns it into counseling, and a matching product can follow.

To put this offer on a solid legal footing, you need three keys:

Pharmacy law: What may your pharmacy offer besides medicines?
Genetic testing law: Who may initiate which genetic analysis – and how does the saliva sample get to the lab?
Food and cosmetics law: Who answers for the formula, the label and the claims when the product carries your brand?

Germany, Austria and Switzerland cut these keys differently. This article gives you orientation, not individual legal advice. What you may say about the services: Advertising health services.

Germany: Pharmacy Operations Ordinance, GenDG and NemV

What the pharmacy may offer. Section 1a of the Pharmacy Operations Ordinance (Apothekenbetriebsordnung, ApBetrO) defines two terms:

Customary pharmacy goods (subsection 10): among others, products that directly serve or promote human health (No. 2) and personal care products (No. 3). Serums and body lotion are personal care products. Food supplements are not named; what matters is whether a product directly serves or promotes health.
Customary pharmacy services (subsection 11): services that serve or promote health – “in particular” advice on health and nutrition questions and on preventive measures, and providing health-related information. Genetic analyses are not listed, but the list is not exhaustive.

The limit is set by Section 2(4) ApBetrO: you may offer customary pharmacy goods and services only to an extent that does not impair the proper operation of the pharmacy and the priority of its mandate to supply medicines. If in doubt about how your specific offer is classified, check with your state chamber of pharmacists.

Which genetic analyses. The Gene Diagnostics Act (Gendiagnostikgesetz, GenDG) applies to genetic testing for medical purposes, for establishing parentage, and in insurance and employment (Section 2(1)). Diagnostic tests may only be performed by physicians, predictive tests only by specialists in human genetics or correspondingly qualified physicians (Section 7(1) GenDG). The law explicitly classifies as diagnostic the question of whether genes can influence the effect of a medicine (Section 3 No. 7(c)). Close as it is to pharmacy, pharmacogenetics is a physician’s task in Germany.

Lifestyle analyses without a medical purpose, such as nutrition, sport or skin, are not named in the GenDG’s scope. Watch the boundary: if an analysis is meant to clarify whether genes, together with external factors, can trigger a disease or health disorder, it is diagnostic (Section 3 No. 7(b)). Such questions belong with a physician (see Genetic tests for medical practices).

Food supplements under your brand. A manufacturer or importer placing a food supplement on the market must notify the Federal Office of Consumer Protection and Food Safety (BVL) no later than at first placing on the market, with a sample of the label (Section 5(1) NemV). This is a notification, not an approval – more in How to register a food supplement.

Austria: ABO 2005, Gene Technology Act and NEMV

What the pharmacy may offer. Under Section 1(4) of the Pharmacy Operations Ordinance 2005 (Apothekenbetriebsordnung, ABO 2005), pharmacists may provide services, in particular advice on health and nutrition questions, health education, preventive measures and arranging health services – provided this does not encroach on the reserved areas of regulated health professions. Section 1(5) also allows customary pharmacy goods.

Which genetic analyses. The Gene Technology Act (Gentechnikgesetz, GTG) divides genetic analyses for medical purposes into four types (Section 65(1)). For types 3 and 4 – determining a predisposition to a disease – Section 68(1) GTG requires an approved facility and a referral by a medical specialist. Under the Act, a genetic analysis allows statements about carrier status, disease risk, an existing disease, or the course of a disease or therapy (Section 4 No. 23); lifestyle analyses without such statements fall outside this definition.

Pharmacogenetics: Section 65 GTG does not mention purely pharmacogenetic analyses, and the specialist referral applies only to types 3 and 4. In Austria, partners such as pharmacies may therefore offer pharmacogenetic analyses. If a result also says something about a predisposition to a disease, the rules for types 3 and 4 apply. Decisions about medications are always made by the treating physician. More in the Pharmacogenetics guide.

Food supplements. The Food Supplements Ordinance (Nahrungsergänzungsmittelverordnung, NEMV) governs composition and labeling; supplements may only be sold to consumers prepackaged (Section 1(1)). It does not provide for a notification like Germany’s. Selling to Germany, for example online, requires the BVL notification there.

Switzerland: the pharmacy initiates the analysis itself

In Switzerland, the path for pharmacies is shorter than for most partners – and more tightly regulated. Unlike the GenDG and the GTG, the Federal Act on Human Genetic Testing (GUMG) and its Ordinance (GUMV) explicitly regulate genetic analyses outside medicine as well:

Pharmacists initiate: Analyses on dietary behavior, physical activity and general well-being count as particularly sensitive (Art. 31(1) GUMG, Art. 37(1) GUMV). They may only be initiated by health professionals authorized to practice under their own professional responsibility (Art. 34 GUMG) – and pharmacists are explicitly on the list (Art. 40(b) GUMV).
Sample in their presence: The sample is taken in the presence of the person initiating the test (Art. 34(3) GUMG). Self-tests are not permitted for these analyses (Art. 13 GUMG) – a kit to take home is ruled out.
Some topics are always medical: Analyses on food intolerances, metabolic disorders, an increased risk of sports injuries, or on diseases, allergies and inflammation count as medical (Art. 37(2) GUMV). They are initiated by physicians (Art. 20 GUMG).
Pharmacogenetics: Pharmacists may initiate pharmacogenetic tests if a defined selection of variants is examined, results of known clinical significance are expected, and preventive or therapeutic measures exist (Art. 7(1) with Art. 5(2) GUMV). For prescription medicines, you first consult the prescriber; information and results are discussed in a separate consultation area (Art. 7(2), (3) GUMV).
Information and lab: Written information names the lab, companies involved abroad and contacts for questions and data processing (Art. 32 GUMG). A lab abroad requires, among other things, the customer’s written consent (Art. 36 with Art. 29 GUMG).

Food supplements. Swiss law applies here, not EU law: the Foodstuffs Act (LMG) and the FDHA Ordinance on Food Supplements (VNem). Three differences matter:

Fixed maximum amounts: Annex 1 of the VNem sets maximum amounts per recommended daily dose (Art. 2(5) VNem). A personalized formula for Switzerland must stay within them, too.
No product notification, but the business reports: The VNem does not provide for notifying each product. Anyone handling food must, however, report their activity to the cantonal enforcement authority (Art. 20 LGV).
Responsible person in Switzerland: Every food and consumer-goods business designates a responsible person with a business address in Switzerland (Art. 73 LGV); cosmetics count as consumer goods (Art. 5(b) LMG).

And pharmacy law? Anyone dispensing medicines needs a cantonal license, and the cantons may set further requirements (Art. 30 Therapeutic Products Act, HMG). Ask your cantonal authority whether its own rules apply to new services.

Three countries at a glance

Question	Germany	Austria	Switzerland
Lifestyle analyses	not named in the GenDG’s scope; observe the boundary in Section 3 No. 7	no genetic analysis under Section 4 No. 23 GTG without statements on disease	pharmacists initiate them themselves (Art. 34 GUMG, Art. 40 GUMV)
Medical analyses	physicians (Section 7 GenDG)	types 3 and 4: specialist referral (Section 68 GTG)	physicians (Art. 20 GUMG)
Pharmacogenetics	reserved for physicians (Section 3 No. 7(c), Section 7 GenDG)	not named in Section 65 GTG; partners may offer it	pharmacy under conditions (Art. 7 GUMV)
Saliva sample	in the pharmacy or at home	in the pharmacy or at home	only in the presence of the initiating person (Art. 13, 34 GUMG)
Supplement notification	required with the BVL (Section 5 NemV)	not provided for in the NEMV	no product notification; the business reports its activity (Art. 20 LGV)
Responsibility for information	whoever markets it under their name (Art. 8(1) Reg. (EU) 1169/2011)	the same	responsible person in Switzerland (Art. 73 LGV)

Own brand: who answers for what

Once a product carries your name, your name stands behind its information – whoever handles formulation and production:

Food supplements: The business responsible for the food information is the one under whose name the food is marketed (Art. 8(1) Regulation (EU) No 1169/2011). With your own brand, that is you. The mandatory information is explained in Food supplement labeling requirements.
Cosmetics: A cosmetic product may only be placed on the market if a responsible person within the EU has been designated (Art. 4(1) Regulation (EC) No 1223/2009). Novogenia takes on this role; you remain jointly responsible for your own advertising and for supplying the products (Cosmetics responsible person, safety report, CPNP).
Partner shop: If your customer orders through a Novogenia partner shop, Novogenia is her contracting party for products and non-medical analyses, according to the terms and conditions.

Which model suits your pharmacy: Own brand: supplements and cosmetics.

Consent and data protection: genes are specially protected

Genetic data belong to the special categories of personal data (Art. 9(1) GDPR). Processing them is permitted, for example, with explicit consent (Art. 9(2)(a)). In Switzerland, Art. 5 GUMG requires free and explicit consent after adequate information, which can be withdrawn at any time. In practice:

Clarify in advance who sees the report: At Novogenia, you decide whether your pharmacy sees its customers’ reports. This belongs in the consent.
Use the right words: For lifestyle analyses, speak of a “report” or “result,” never of a medical “finding.”
Minors: According to Novogenia’s terms, only non-medical analyses, and only with the written consent of the legal guardians.

More in Genetic data and the GDPR; the process is shown in The consultation process in the pharmacy.

Checklist: before you start

You know the rules in every country where your customers live.
Your offer stays within pharmacy law – in Germany within the scope of Section 2(4) ApBetrO, in Austria without encroaching on the reserved areas of other health professions.
Lifestyle analyses and medical analyses are clearly separated; medical questions go to physicians where the law requires it.
In Switzerland, the initiating pharmacist is present when the sample is taken, and the written information meets Art. 32 GUMG.
Consent is recorded in writing, including who sees the report.
Notification of your food supplements is settled in every country that requires it.
Label and advertising are checked – you answer for them.

How we do it at Novogenia

How we support you at Novogenia:

Clear separation: Sales partners such as pharmacies offer lifestyle analyses. Where national law requires it, we provide medical analyses only through physicians.
Our own lab: We analyze every saliva sample in our lab in Eugendorf near Salzburg, Austria, hold the Austrian license for medical genetic analyses, are CLIA-certified and work according to ISO 15189.
The right kit: a non-medical-device kit for lifestyle analyses, a medical-device kit for medical analyses.
Notification: In most cases, we handle the notification of your food supplements for you or support you with it.
Cosmetics: We take on the role of the responsible person under the EU Cosmetics Regulation.
Safe dosing: For every nutrient with a tolerable upper intake level (UL) set by EFSA, our maximum is at or below that value.

Frequently asked questions

Are genetic analyses a customary pharmacy service in Germany?

Section 1a(11) ApBetrO does not mention genetic analyses explicitly. The list is not exhaustive, though (it says “in particular”), and it includes advice on health and nutrition questions and providing health-related information. Medical genetic testing remains reserved for physicians (Section 7 GenDG). If in doubt about how your specific offer is classified, check with your state chamber of pharmacists.

May my pharmacy offer lifestyle genetic analyses in Switzerland?

Yes. Pharmacists authorized to practice under their own professional responsibility may initiate analyses on nutrition, sport and well-being (Art. 34 GUMG, Art. 40(b) GUMV). The sample is taken in their presence, and home tests are not permitted for these analyses (Art. 13 GUMG). Topics such as food intolerances or metabolic disorders count as medical (Art. 37(2) GUMV).

Do I have to register my own-brand food supplement?

In Germany, yes: the product is notified to the BVL no later than when it is first placed on the market, together with a sample of the label (Section 5 NemV). Austria’s NEMV does not provide for such a notification. Switzerland has no product notification, but the business reports its activity to the cantonal authority (Art. 20 LGV). In most cases, we handle the notification for you or support you with it.

May pharmacies offer pharmacogenetic analyses?

It depends on the country. In Germany, pharmacogenetics is a diagnostic test reserved for physicians (Section 3 No. 7(c) and Section 7 GenDG). In Austria, Section 65 GTG does not mention it, and the specialist referral applies only to types 3 and 4 (Section 68) – partners may offer it. In Switzerland, pharmacists may initiate it under certain conditions (Art. 7 GUMV). Decisions about medications are always made by the treating physician.

Do I need consent for a lifestyle analysis, too?

Yes. Under the GDPR, genetic data belong to the special categories of personal data (Art. 9(1)); processing them is permitted, for example, with explicit consent (Art. 9(2)(a)). In Switzerland, Art. 5 GUMG requires free and explicit consent after adequate information. Record the consent in writing – including whether your pharmacy sees the report.

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Note: This guide is general information for businesses and professionals and does not replace medical or legal advice. The genetic traits determined in a genetic analysis are well documented (each gene included is backed by at least three independent studies); recommendations derived from them are logical conclusions, not scientifically proven. Regulations can change; errors and changes excepted.