German Medicinal Products Act: Authorization, Trials, and Safety

The German Medicinal Products Act, known in German as the Arzneimittelgesetz or AMG, is the central law that governs how medicines are developed, tested, made, imported, authorized, priced, labeled, and monitored for safety in Germany.¹ Its stated purpose is to guarantee the quality, efficacy, and safety of medicinal products while ensuring the public has access to a proper supply of medicines.² Almost every entity in the pharmaceutical supply chain has obligations under the Act, and violations can end in fines, criminal prosecution, or the loss of a manufacturing license or marketing authorization.

What the Act Covers

Section 2 defines medicinal products in two ways. A product qualifies as a “presentation” medicine if it is marketed as having properties that treat or prevent disease. It qualifies as a “functional” medicine if it actually achieves its effect through pharmacological or metabolic action in the body. Both categories fall under the AMG’s full regulatory regime.²

Several product categories are carved out. Section 2(3) excludes food, cosmetics, tobacco, medical devices, biocides, and veterinary medicinal products, which are regulated under separate EU and German veterinary law.² The boundary matters. A substance sitting between a medicinal product and a medical device faces entirely different legal requirements depending on which category applies.

How Medicines Are Classified for Sale

The AMG sorts medicines into three dispensing tiers. Section 43 makes pharmacy-only sale the default: any product not specifically exempted must be dispensed by a licensed pharmacist.² Within pharmacies, products split further into prescription-only medicines, marked “Verschreibungspflichtig” on the packaging, and non-prescription pharmacy-only medicines that can be bought without a prescription but still only from a pharmacy.

A narrow set of products can be sold outside pharmacies. Section 44 lists these, including natural and synthetic curative waters, therapeutic clays, certain herbal preparations, plasters, and disinfectants intended mainly for external use.² Retailers selling these products still need the expertise to store and label them properly. Section 52 prohibits vending machine sales of any medicinal product, and self-service is only allowed for non-pharmacy products when a knowledgeable staff member is available.

Licenses for Manufacturing, Wholesale, and Import

Commercial production or processing of medicinal products requires a manufacturing license under Section 13. Wholesale distributors need a parallel license under Section 52a to keep drug integrity intact through the logistics chain.² Applicants must show that they meet quality management standards, operate suitable facilities, and employ qualified personnel. Inspectors from the competent authorities carry out regular site visits, and any lapse can jeopardize the license and the marketing authorizations attached to it.

Every licensed manufacturer must employ at least one Qualified Person (sachkundige Person), as required by Section 14. Section 15 defines the qualifications: either a license to practice as a pharmacist, or a university degree of at least four years in pharmacy, chemistry, pharmaceutical chemistry and technology, biology, or human or veterinary medicine, combined with at least two years of practical experience in the qualitative and quantitative analysis and quality testing of medicinal products.² The practical experience can be shortened to one year for a five-year program or six months for a six-year program. For companies making blood preparations, vaccines, or allergens, the requirement instead is at least three years in medical serology or microbiology.

Importing medicines from outside the European Economic Area triggers an additional license. Section 72 requires an import permit for anyone bringing in medicinal products, certain active substances, or other substances of human origin on a commercial basis, and the same personnel and facility standards apply. Section 72a adds a certificate from the country of origin confirming that manufacturing complied with EU-equivalent Good Manufacturing Practice standards and that the site is under regular monitoring.² For finished medicines, German customs clearance under Section 73(6) also requires a certificate from the competent local authority confirming the type and quantity of the products, that all marketability requirements have been met, and that the importer holds the required permit.³ Tissue preparations need a separate import permit under Section 72b with its own GMP equivalency certification.

Conditions for Clinical Trials

Under Section 40, a clinical trial on humans can only start after two clearances: a favorable opinion from the competent ethics committee under Section 42(1) and approval from the competent higher federal authority under Section 42(2).² Neither ethical review nor scientific assessment on its own is enough.

Substantive conditions must also hold throughout the trial:

The foreseeable risks and inconveniences must be medically justifiable against the expected benefit for the participant and the anticipated significance of the medicine.
Each participant must be of legal age, capable of understanding the trial’s nature and implications, and must give written informed consent that specifically covers the collection and processing of health-related data.
The trial must be conducted in an appropriate facility by a qualified investigator with at least two years of experience in clinical trials of medicinal products.
A pharmacological-toxicological test of the medicine must have been completed in line with current scientific knowledge before any human testing begins.
The sponsor must maintain insurance covering participants for injury or death resulting from the trial.

A sponsor or sponsor representative with a registered office in the EU or European Economic Area must be reachable for the duration of the trial. These conditions apply regardless of whether marketing authorization will later be sought through the national or the EU centralized procedure.

Marketing Authorization

No finished medicinal product may be placed on the German market without a marketing authorization from the competent higher federal authority.² Sections 21 and 22 set out what the application dossier must contain:

Applicant and manufacturer names, company details, and addresses.
The product name, active ingredients by type and quantity, and all other constituents.
The manufacturing method, quality control test methods, and chemical and pharmaceutical testing demonstrating stability and quality.
Pharmacological-toxicological test results and full reports from clinical trials on human subjects.
The intended dosage, method of administration, and therapeutic indication.

Samples of the proposed packaging and a draft patient information leaflet must accompany the dossier. Which authority reviews the application depends on the product: most medicines go to the Federal Institute for Drugs and Medical Devices (BfArM), while vaccines, blood products, and similar biologicals go to the Paul-Ehrlich-Institut (PEI).⁴ Every application must also include an environmental risk assessment covering each pharmacologically active substance.⁵

Formal review begins once the dossier is submitted through the PharmNet.Bund electronic portal, which handles secure document transfer between companies and federal authorities.⁶ Under Section 25, the authority evaluates whether the medicine’s benefits outweigh its risks in intended use. For applications going through the EU centralized procedure at the European Medicines Agency, the standard evaluation period is 210 active days.⁷ National procedure timelines may differ. If safety or efficacy concerns arise, the applicant may be invited to a hearing.

The Sunset Clause

A marketing authorization does not last indefinitely without use. Under Section 31(1), the authorization expires if the product is not placed on the market within three years of being granted, or if the product is withdrawn from the market for three consecutive years.⁸ The competent authority can grant exceptions when health protection considerations justify keeping an unused authorization in force, and the three-year clock can be suspended if legal obstacles prevent marketing.

Benefit Assessment and Pricing

Winning a marketing authorization does not settle what statutory health insurance funds will pay. Under the AMNOG reform codified in Section 35a of the Social Code, Book Five, every new medicine goes through an early benefit assessment run by the Federal Joint Committee (G-BA).⁹ The sequence:

The pharmaceutical company must submit a dossier proving the new medicine’s additional benefit over the appropriate comparator therapy, and it must reach the G-BA no later than the day the product first enters circulation in Germany.
Within six months of market authorization, the G-BA evaluates the claimed additional benefit.
Results are published within three months. After a further three months of hearings, the G-BA issues a formal resolution specifying the extent of additional benefit, eligible patient groups, and treatment cost parameters.
The Central Federal Association of Health Insurance Funds and the company then have six months to negotiate the reimbursement price.

If the G-BA finds no additional benefit over existing treatments, the product is folded into the reference price system within six months of launch, and reimbursement cannot exceed the cost of the comparator therapy.⁹

Packaging and Leaflet Rules

Sections 10 and 11 dictate what must appear on every finished medicinal product sold in Germany.² The outer packaging must carry all required information in legible, permanent, readily comprehensible German, including:

The product name, pharmaceutical form, strength, and the international nonproprietary name of the active substance if the product contains up to three active substances.
The marketing authorization number (abbreviated “Zul.-Nr.”), batch identification (“Ch.-B.”), and the pharmaceutical entrepreneur’s name and address.
The method of administration, expiry date, content by weight, volume, or count, and the instruction to keep the product out of reach of children.
The dispensing marking: “Verschreibungspflichtig” for prescription-only products or “Apothekenpflichtig” for pharmacy-only products.

A patient information leaflet headed “Gebrauchsinformation” must accompany every package, written in German and covering instructions for use and potential side effects.² On top of the national rules, the EU Falsified Medicines Directive requires anti-tampering devices and a unique identifier encoded in a two-dimensional barcode on the outer packaging of most prescription medicines.¹⁰

Ongoing Safety Monitoring

Safety obligations continue after a drug reaches the pharmacy shelf. Section 63a requires every pharmaceutical entrepreneur placing finished medicinal products on the market to appoint a Graduated Plan Officer (Stufenplanbeauftragter).² The officer must be a resident of an EU member state and must have both the relevant expertise and the personal reliability the role demands. The Graduated Plan Officer is legally responsible for setting up and managing the pharmacovigilance system, collecting and evaluating reports on drug risks, and coordinating response measures.¹¹ The company must notify the competent local and higher federal authorities of the officer’s identity and report any change in advance, or immediately if the change was unforeseen. Where multiple officers are appointed, each officer’s area of responsibility must be clearly defined.

Companies must also submit Periodic Safety Update Reports (PSURs) at intervals set by the EU reference dates (EURD) list, a legally binding schedule that overrides any submission frequency written into an individual marketing authorization.¹² For active substances not yet on the EURD list, the default cadence is every six months, then annually, then every three years. The EURD list is updated monthly, and changes take effect six months after publication. Competent authorities can also request a PSUR outside the regular schedule. Failing to maintain an effective pharmacovigilance system, or to submit required safety data, can lead to suspension or revocation of the marketing authorization.

Penalties for Violations

The AMG backs its requirements with both criminal and administrative sanctions. Sections 95 and 96 establish criminal offenses for serious violations, such as placing unauthorized medicinal products on the market or conducting clinical trials without the required approvals. Section 97 covers administrative offenses for less severe breaches, with fines of up to 25,000 euros per violation.² The competent higher federal authority acts as the administrative authority for certain categories of violations, while others fall to regional enforcement bodies. Beyond direct financial penalties, violations can trigger the revocation of manufacturing licenses and marketing authorizations, which often carries a heavier commercial consequence than the fine itself.

1
Federal Institute for Drugs and Medical Devices. Medicinal Products
2
Federal Ministry of Health. Medicinal Products Act (Arzneimittelgesetz – AMG)
3
Customs Online. Imports of Medicinal Products
4
Paul-Ehrlich-Institut. Marketing Authorisation of Medicinal Products for Human Use
5
European Medicines Agency. Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use
6
Federal Institute for Drugs and Medical Devices. PharmNet.Bund
7
European Medicines Agency. The Evaluation of Medicines, Step-by-Step
8
PharmNet.Bund. Sunset Clause
9
The Federal Joint Committee. Early Benefit Assessment of New Medicinal Products
10
European Commission. Falsified Medicines
11
Federal Institute for Drugs and Medical Devices. Graduated Plan Officer (Stufenplanbeauftragter)
12
European Medicines Agency. Periodic Safety Update Reports (PSURs)