The import of Food, pharmaceuticals and machinery to Germany is subject to strict legal regulations and controls. Here are the most important regulations, permits and competent authorities for each category:

1. import of foodstuffs

Food imports to Germany must comply with the EU regulations for food safety, hygiene and labeling fulfill.

1.1 Important regulations

–Food Hygiene Regulation (Regulation (EC) No. 852/2004)
-EU Regulation on residues of pesticides & harmful substances (Regulation (EC) No 396/2005)
-Labeling obligations according to LMIV (EU Regulation 1169/2011)
–Organic products require EU organic certification
–Genetically modified foods (GMOs) are subject to strict approval rules

1.2 Special requirements for animal products

• Meat, fish, dairy products and eggs are subject to the strict rules of the Regulation (EC) No 853/2004.
• Veterinary inspections are required (import only via authorized border inspection posts).
• Import from non-EU countries: Health certificate & customs inspection required.

1.3 Import procedure & registration

Customs declaration via the ATLAS system
Veterinary inspections for animal products via the TRACES system
Food monitoring by the Federal Office of Consumer Protection & Food Safety (BVL)

Important authority:
Federal Office of Consumer Protection and Food Safety (BVL)
www.bvl.bund.de

2. import of pharmaceuticals & medical devices
Pharmaceutical products and medical devices are subject to very strict regulations to ensure quality and safety for consumers.

2.1 Important regulations

–German Medicinal Products Act (AMG) & EU Regulation (Regulation (EU) 2019/6)
–Medical Devices Act (MPG) & Medical Devices Regulation (MDR, Regulation (EU) 2017/745)
–GMP guidelines (Good Manufacturing Practice) for pharmaceutical products
–GDP guidelines (Good Distribution Practice) for transportation & storage
–Import only with the approval of the Federal Institute for Drugs and Medical Devices (BfArM)

2.2 Special requirements for pharmaceutical importers

• Import license required in accordance with Section 72 of the German Medicinal Products Act (AMG)
• Medicinal products must be EU or approved by the BfArM be
• GMP certificate necessary for manufacturers outside the EU
• Storage according to GDP standards (Good Distribution Practice)
• Batch release by a certified laboratory before sale in Germany

2.3 Import procedure & registration

Customs declaration via the ATLAS system
Registration & approval at the Federal Institute for Drugs and Medical Devices (BfArM)
Pharmaceutical companies must register in the European medicines directory EudraGMDP

Important authorities:
Federal Institute for Drugs and Medical Devices (BfArM)
www.bfarm.de

Paul-Ehrlich-Institut (PEI) - Responsible for vaccines & biopharmaceuticals
www.pei.de

European Medicines Agency (EMA) - EU regulatory authority
www.ema.europa.eu

3. import of machinery & industrial equipment

Machines and industrial plants must meet the EU directives for product safety in order to be sold and used on the German market.

3.1 Important regulations

-Machinery Directive 2006/42/EC - Safety requirements for machines
-Low Voltage Directive 2014/35/EU - Electrical safety
-EMC Directive 2014/30/EU - Electromagnetic compatibility
-Pressure Equipment Directive 2014/68/EU - for machines with high pressure
-CE labeling requirement - All machines must bear a CE mark
-Technical documentation & declaration of conformity required

3.2 Special requirements for the import of machinery

• Risk analysis & safety assessment according to EU standards
• Technical documentation must be available in German
• Operating instructions in German is obligatory
• Machines must have a CE declaration of conformity
• If there is no CE marking, the importer himself must Carry out CE certification

3.3 Import procedure & registration

- Customs declaration via the ATLAS system
- Technical acceptance by the market surveillance authorities possible
- CE marking must be carried out before sale

Important authorities:
German market surveillance authorities - checking the safety of machinery
www.baua.de (Federal Institute for Occupational Safety and Health)

TÜV & DEKRA - Certification bodies for machines
www.tuv.com
www.dekra.de

What do importers need to consider?

-food: Strict hygiene, labeling and residue controls.
-Pharmaceuticals: Mandatory approval, import authorization & quality controls (GMP/GDP).
-machines: CE marking, safety test & declaration of conformity required.
-Observe customs regulations: Registration via ATLAS system & TRACES for animal products.
-Obtain official approvals: Registration with BfArM, BVL or market surveillance bodies.

 Tip: Anyone who imports regularly should have a Tax consultants & import experts to avoid legal risks.