Pharmaceutical products, medical device and pharmacy Law (German AMG) - horak Attorneys at Law, Germany

What is the subject of the German Medicine Act (AMG)?

The German Medicinal Products Act (AMG) addresses the quality, efficacy and safety of medicines for human use. Veterinary medicines are governed principally by Regulation (EU) 2019/6 and the German Veterinary Medicinal Products Act (TAMG).

Whether a product is a medicinal product depends on the statutory definition, including presentation and pharmacological, immunological or metabolic action or diagnostic purpose. Human and veterinary medicines have different regulatory frameworks. Classification against food and medical-device rules must be assessed for the particular product.

Medical devices are subject to a separate framework; borderline and combination products require assessment. Section 5 AMG prohibits placing unsafe medicines on the market or administering them to another person. The test concerns a justified suspicion of harmful effects exceeding what medical science considers acceptable when the medicine is used as intended; it does not prohibit every medicine with any potential side effect.

Thus, the German Medicine Act regulated traffic requirements of medical products (f.i. labeling obligations of active pharmaceutical products, package inserts, obligations to provisions of particular technical information), manufacture of medicines (f.i. requirements of manufacturing authorizations) and obviously, the related permissions, and the medical products dispensing (f.i. pharmacy obligations, self-serve prohibition, mail-order business, drug prescription, over the counter drugs).

Medical devices are principally governed by the MDR, IVDR and supplementary MPDG rules. Product-specific transitional provisions require separate assessment.

Which rules govern medical devices?

Medical devices are governed principally by Regulation (EU) 2017/745 (MDR), Regulation (EU) 2017/746 (IVDR) and supplementary German MPDG provisions. The former MPG has largely been replaced.

Classification depends on the manufacturer’s intended purpose and the definitions in the MDR or IVDR. Software may also qualify. The distinction from medicines and the applicable risk class affect the regulatory route.

Requirements for conformity assessment, CE marking, clinical or performance evaluation, surveillance and economic operators must be assessed for the particular product. Specific transitional rules may apply to legacy devices; the process is not generally equivalent to marketing authorisation for medicines.

What does pharmacy law mean?

Pharmacies law is actually fluctuating between standardized European guidelines and national traditions. Central aspects of Pharmacy Law are regulated by the Pharmacy Act, the Pharmacy Operating Regulations as well as the legal regulation. In addition, there are numerous ordinances, e.g. the pharmaceutical Price Regulation.

As far as concerned the Section 1 of the Pharmacy regulations (ApoG), pharmacies are obliged to ensure a proper supply of medicines for the public benefit of the citizens. Anyone who wants to open a pharmacy requires specific permissions of the competent authority. The authorization is valid only for the pharmacist who requested the permission, only for the premises designated in the license certificate.

Pharmacy law includes permits for a main pharmacy and up to three branch pharmacies under section 1 ApoG, mail-order requirements under section 11a ApoG, advertising, pricing and product classification. There is no blanket prohibition on every pharmacy branch or every supply of medicines by mail; product-specific restrictions remain relevant.

Why is the Food Act or the Medicines Act a matter of importance?

Food and food supplements may be advertised with claims that affect their classification or breach health-claim and medicinal-advertising rules. Such claims can affect whether a product may lawfully be marketed; this is a question of marketability, not merely transport.

Food is defined by Article 2 of Regulation (EC) No 178/2002 and section 2 LFGB; medicinal products are excluded. Under section 1 NemV, food supplements supplement the normal diet with concentrated nutrients or other substances with nutritional or physiological effects in dose form. A proven dietary deficiency is not a universal condition. Classification, composition, labelling and claims must satisfy the applicable AMG, LFGB, NemV and EU rules.

What do we need to work on your pharmaceutical legal issues?

As the respective problems in the individual legal areas are already really complex, it is opportune to discuss with us all the information and documents that are necessary to handle and solve your pharmaceutical legal questions.