{"id":12174,"date":"2025-03-06T10:39:31","date_gmt":"2025-03-06T10:39:31","guid":{"rendered":"https:\/\/bosporus24.de\/?p=12174"},"modified":"2025-03-11T10:35:02","modified_gmt":"2025-03-11T10:35:02","slug":"import-von-lebensmitteln-pharmazeutika-und-maschinen-welche-vorschriften-gelten","status":"publish","type":"post","link":"https:\/\/bosporus24.de\/en\/import-von-lebensmitteln-pharmazeutika-und-maschinen-welche-vorschriften-gelten\/","title":{"rendered":"Import of food, pharmaceuticals and machinery: What regulations apply?"},"content":{"rendered":"<p data-start=\"94\" data-end=\"335\">The import of <strong data-start=\"109\" data-end=\"155\">Food, pharmaceuticals and machinery<\/strong> to Germany is subject to strict <strong data-start=\"193\" data-end=\"237\">legal regulations and controls<\/strong>. Here are the most important regulations, permits and competent authorities for each category:<\/p>\n<h1 data-start=\"342\" data-end=\"375\"><strong data-start=\"344\" data-end=\"375\">1. import of foodstuffs<\/strong><\/h1>\n<p data-start=\"376\" data-end=\"509\">Food imports to Germany must comply with the <strong data-start=\"424\" data-end=\"497\">EU regulations for food safety, hygiene and labeling<\/strong> fulfill.<\/p>\n<h3 data-start=\"511\" data-end=\"544\"><strong data-start=\"515\" data-end=\"544\">1.1 Important regulations<\/strong><\/h3>\n<p data-start=\"545\" data-end=\"911\"><span data-start=\"547\" data-end=\"604\">&#8211;<\/span><strong data-start=\"547\" data-end=\"604\">Food Hygiene Regulation (Regulation (EC) No. 852\/2004)<\/strong><br data-start=\"604\" data-end=\"607\" \/><strong data-start=\"609\" data-end=\"694\">-EU Regulation on residues of pesticides &amp; harmful substances (Regulation (EC) No 396\/2005)<\/strong><br data-start=\"694\" data-end=\"697\" \/><strong data-start=\"699\" data-end=\"762\">-Labeling obligations according to LMIV (EU Regulation 1169\/2011)<\/strong><br data-start=\"762\" data-end=\"765\" \/><span data-start=\"767\" data-end=\"820\">&#8211;<\/span><strong data-start=\"767\" data-end=\"820\">Organic products require EU organic certification<\/strong><br data-start=\"820\" data-end=\"823\" \/><span data-start=\"825\" data-end=\"909\">&#8211;<\/span><strong data-start=\"825\" data-end=\"909\">Genetically modified foods (GMOs) are subject to strict approval rules<\/strong><\/p>\n<h3 data-start=\"913\" data-end=\"971\"><strong data-start=\"917\" data-end=\"971\">1.2 Special requirements for animal products<\/strong><\/h3>\n<ul data-start=\"972\" data-end=\"1272\">\n<li data-start=\"972\" data-end=\"1084\">Meat, fish, dairy products and eggs are subject to the strict rules of the <strong data-start=\"1049\" data-end=\"1081\">Regulation (EC) No 853\/2004<\/strong>.<\/li>\n<li data-start=\"1085\" data-end=\"1183\"><strong data-start=\"1087\" data-end=\"1110\">Veterinary inspections<\/strong> are required (import only via authorized border inspection posts).<\/li>\n<li data-start=\"1184\" data-end=\"1272\">Import from non-EU countries: <strong data-start=\"1215\" data-end=\"1269\">Health certificate &amp; customs inspection required<\/strong>.<\/li>\n<\/ul>\n<h3 data-start=\"1274\" data-end=\"1313\"><strong data-start=\"1278\" data-end=\"1313\">1.3 Import procedure &amp; registration<\/strong><\/h3>\n<p data-start=\"1314\" data-end=\"1539\"><strong data-start=\"1317\" data-end=\"1356\">Customs declaration via the ATLAS system<\/strong><br data-start=\"1356\" data-end=\"1359\" \/><strong data-start=\"1362\" data-end=\"1431\">Veterinary inspections for animal products via the TRACES system<\/strong><br data-start=\"1431\" data-end=\"1434\" \/><strong data-start=\"1437\" data-end=\"1537\">Food monitoring by the Federal Office of Consumer Protection &amp; Food Safety (BVL)<\/strong><\/p>\n<p data-start=\"1541\" data-end=\"1686\"><strong data-start=\"1541\" data-end=\"1562\">Important authority:<\/strong><br data-start=\"1562\" data-end=\"1565\" \/><strong data-start=\"1568\" data-end=\"1636\">Federal Office of Consumer Protection and Food Safety (BVL)<\/strong><br data-start=\"1636\" data-end=\"1639\" \/><a target=\"_new\" rel=\"noopener\" data-start=\"1642\" data-end=\"1684\">www.bvl.bund.de<\/a><\/p>\n<p><strong data-start=\"1695\" data-end=\"1745\">2. import of pharmaceuticals &amp; medical devices<br \/>\n<\/strong>Pharmaceutical products and medical devices are subject to very strict regulations to ensure quality and safety for consumers.<\/p>\n<h3 data-start=\"1901\" data-end=\"1934\"><strong data-start=\"1905\" data-end=\"1934\">2.1 Important regulations<\/strong><\/h3>\n<p data-start=\"1935\" data-end=\"2355\"><span data-start=\"1937\" data-end=\"1998\">&#8211;<\/span><strong data-start=\"1937\" data-end=\"1998\">German Medicinal Products Act (AMG) &amp; EU Regulation (Regulation (EU) 2019\/6)<\/strong><br data-start=\"1998\" data-end=\"2001\" \/><span data-start=\"2003\" data-end=\"2087\">&#8211;<\/span><strong data-start=\"2003\" data-end=\"2087\">Medical Devices Act (MPG) &amp; Medical Devices Regulation (MDR, Regulation (EU) 2017\/745)<\/strong><br data-start=\"2087\" data-end=\"2090\" \/><span data-start=\"2092\" data-end=\"2170\">&#8211;<\/span><strong data-start=\"2092\" data-end=\"2170\">GMP guidelines (Good Manufacturing Practice) for pharmaceutical products<\/strong><br data-start=\"2170\" data-end=\"2173\" \/><span data-start=\"2175\" data-end=\"2252\">&#8211;<\/span><strong data-start=\"2175\" data-end=\"2252\">GDP guidelines (Good Distribution Practice) for transportation &amp; storage<\/strong><br data-start=\"2252\" data-end=\"2255\" \/><span data-start=\"2257\" data-end=\"2353\">&#8211;<\/span><strong data-start=\"2257\" data-end=\"2353\">Import only with the approval of the Federal Institute for Drugs and Medical Devices (BfArM)<\/strong><\/p>\n<h3 data-start=\"2357\" data-end=\"2414\"><strong data-start=\"2361\" data-end=\"2414\">2.2 Special requirements for pharmaceutical importers<\/strong><\/h3>\n<ul data-start=\"2415\" data-end=\"2776\">\n<li data-start=\"2415\" data-end=\"2485\"><strong data-start=\"2417\" data-end=\"2483\">Import license required in accordance with Section 72 of the German Medicinal Products Act (AMG)<\/strong><\/li>\n<li data-start=\"2486\" data-end=\"2560\">Medicinal products must be <strong data-start=\"2515\" data-end=\"2553\">EU or approved by the BfArM<\/strong> be<\/li>\n<li data-start=\"2561\" data-end=\"2625\"><strong data-start=\"2563\" data-end=\"2581\">GMP certificate<\/strong> necessary for manufacturers outside the EU<\/li>\n<li data-start=\"2626\" data-end=\"2690\"><strong data-start=\"2628\" data-end=\"2659\">Storage according to GDP standards<\/strong> (Good Distribution Practice)<\/li>\n<li data-start=\"2691\" data-end=\"2776\"><strong data-start=\"2693\" data-end=\"2743\">Batch release by a certified laboratory<\/strong> before sale in Germany<\/li>\n<\/ul>\n<h3 data-start=\"2778\" data-end=\"2817\"><strong data-start=\"2782\" data-end=\"2817\">2.3 Import procedure &amp; registration<\/strong><\/h3>\n<p data-start=\"2818\" data-end=\"3066\"><strong data-start=\"2821\" data-end=\"2860\">Customs declaration via the ATLAS system<\/strong><br data-start=\"2860\" data-end=\"2863\" \/><strong data-start=\"2866\" data-end=\"2962\">Registration &amp; approval at the Federal Institute for Drugs and Medical Devices (BfArM)<\/strong><br data-start=\"2962\" data-end=\"2965\" \/><strong data-start=\"2968\" data-end=\"3064\">Pharmaceutical companies must register in the European medicines directory EudraGMDP<\/strong><\/p>\n<p data-start=\"3068\" data-end=\"3203\"><strong data-start=\"3068\" data-end=\"3090\">Important authorities:<\/strong><br data-start=\"3090\" data-end=\"3093\" \/><strong data-start=\"3096\" data-end=\"3159\">Federal Institute for Drugs and Medical Devices (BfArM)<\/strong><br data-start=\"3159\" data-end=\"3162\" \/><a href=\"https:\/\/www.bfarm.de\" target=\"_new\" rel=\"noopener\" data-start=\"3165\" data-end=\"3201\">www.bfarm.de<\/a><\/p>\n<p data-start=\"3205\" data-end=\"3325\"><strong data-start=\"3208\" data-end=\"3285\">Paul-Ehrlich-Institut (PEI) - Responsible for vaccines &amp; biopharmaceuticals<\/strong><br data-start=\"3285\" data-end=\"3288\" \/><a href=\"https:\/\/www.pei.de\" target=\"_new\" rel=\"noopener\" data-start=\"3291\" data-end=\"3323\">www.pei.de<\/a><\/p>\n<p data-start=\"3327\" data-end=\"3442\"><strong data-start=\"3330\" data-end=\"3388\">European Medicines Agency (EMA) - EU regulatory authority<\/strong><br data-start=\"3388\" data-end=\"3391\" \/><a href=\"https:\/\/www.ema.europa.eu\" target=\"_new\" rel=\"noopener\" data-start=\"3394\" data-end=\"3440\">www.ema.europa.eu<\/a><\/p>\n<h1 data-start=\"3449\" data-end=\"3497\"><strong data-start=\"3451\" data-end=\"3497\">3. import of machinery &amp; industrial equipment<\/strong><\/h1>\n<p data-start=\"3498\" data-end=\"3657\">Machines and industrial plants must meet the <strong data-start=\"3540\" data-end=\"3580\">EU directives for product safety<\/strong> in order to be sold and used on the German market.<\/p>\n<h3 data-start=\"3659\" data-end=\"3692\"><strong data-start=\"3663\" data-end=\"3692\">3.1 Important regulations<\/strong><\/h3>\n<p data-start=\"3693\" data-end=\"4142\"><strong data-start=\"3695\" data-end=\"3729\">-Machinery Directive 2006\/42\/EC<\/strong> - Safety requirements for machines<br data-start=\"3770\" data-end=\"3773\" \/><strong data-start=\"3775\" data-end=\"3815\">-Low Voltage Directive 2014\/35\/EU<\/strong> - Electrical safety<br data-start=\"3840\" data-end=\"3843\" \/><strong data-start=\"3845\" data-end=\"3874\">-EMC Directive 2014\/30\/EU<\/strong> - Electromagnetic compatibility<br data-start=\"3911\" data-end=\"3914\" \/><strong data-start=\"3916\" data-end=\"3952\">-Pressure Equipment Directive 2014\/68\/EU<\/strong> - for machines with high pressure<br data-start=\"3984\" data-end=\"3987\" \/><strong data-start=\"3989\" data-end=\"4017\">-CE labeling requirement<\/strong> - All machines must bear a CE mark<br data-start=\"4070\" data-end=\"4073\" \/><strong data-start=\"4075\" data-end=\"4140\">-Technical documentation &amp; declaration of conformity required<\/strong><\/p>\n<h3 data-start=\"4144\" data-end=\"4204\"><strong data-start=\"4148\" data-end=\"4204\">3.2 Special requirements for the import of machinery<\/strong><\/h3>\n<ul data-start=\"4205\" data-end=\"4565\">\n<li data-start=\"4205\" data-end=\"4265\"><strong data-start=\"4207\" data-end=\"4247\">Risk analysis &amp; safety assessment<\/strong> according to EU standards<\/li>\n<li data-start=\"4266\" data-end=\"4333\"><strong data-start=\"4268\" data-end=\"4331\">Technical documentation must be available in German<\/strong><\/li>\n<li data-start=\"4334\" data-end=\"4389\"><strong data-start=\"4336\" data-end=\"4369\">Operating instructions in German<\/strong> is obligatory<\/li>\n<li data-start=\"4390\" data-end=\"4453\"><strong data-start=\"4392\" data-end=\"4451\">Machines must have a CE declaration of conformity<\/strong><\/li>\n<li data-start=\"4454\" data-end=\"4565\">If there is no CE marking, the importer himself must <strong data-start=\"4530\" data-end=\"4563\">Carry out CE certification<\/strong><\/li>\n<\/ul>\n<h3 data-start=\"4567\" data-end=\"4606\"><strong data-start=\"4571\" data-end=\"4606\">3.3 Import procedure &amp; registration<\/strong><\/h3>\n<p data-start=\"4607\" data-end=\"4779\"><strong data-start=\"4610\" data-end=\"4649\">- Customs declaration via the ATLAS system<\/strong><br data-start=\"4649\" data-end=\"4652\" \/><strong data-start=\"4655\" data-end=\"4721\">- Technical acceptance by the market surveillance authorities possible<\/strong><br data-start=\"4721\" data-end=\"4724\" \/><strong data-start=\"4727\" data-end=\"4777\">- CE marking must be carried out before sale<\/strong><\/p>\n<p data-start=\"4781\" data-end=\"4979\"><strong data-start=\"4781\" data-end=\"4803\">Important authorities:<\/strong><br data-start=\"4803\" data-end=\"4806\" \/><strong data-start=\"4809\" data-end=\"4884\">German market surveillance authorities - checking the safety of machinery<\/strong><br data-start=\"4884\" data-end=\"4887\" \/><a href=\"https:\/\/www.baua.de\" target=\"_new\" rel=\"noopener\" data-start=\"4890\" data-end=\"4924\">www.baua.de<\/a> (Federal Institute for Occupational Safety and Health)<\/p>\n<p data-start=\"4981\" data-end=\"5122\"><strong data-start=\"4984\" data-end=\"5038\">T\u00dcV &amp; DEKRA - Certification bodies for machines<\/strong><br data-start=\"5038\" data-end=\"5041\" \/><a href=\"https:\/\/www.tuv.com\" target=\"_new\" rel=\"noopener\" data-start=\"5044\" data-end=\"5078\">www.tuv.com<\/a><br data-start=\"5078\" data-end=\"5081\" \/><a href=\"https:\/\/www.dekra.de\" target=\"_new\" rel=\"noopener\" data-start=\"5084\" data-end=\"5120\">www.dekra.de<\/a><\/p>\n<h1 data-start=\"5605\" data-end=\"5651\"><strong data-start=\"5607\" data-end=\"5649\">What do importers need to consider?<\/strong><\/h1>\n<p data-start=\"5652\" data-end=\"6125\"><strong data-start=\"5654\" data-end=\"5671\">-food:<\/strong> Strict hygiene, labeling and residue controls.<br data-start=\"5731\" data-end=\"5734\" \/><strong data-start=\"5736\" data-end=\"5754\">-Pharmaceuticals:<\/strong> Mandatory approval, import authorization &amp; quality controls (GMP\/GDP).<br data-start=\"5825\" data-end=\"5828\" \/><strong data-start=\"5830\" data-end=\"5844\">-machines:<\/strong> CE marking, safety test &amp; declaration of conformity required.<br data-start=\"5919\" data-end=\"5922\" \/><strong data-start=\"5924\" data-end=\"5954\">-Observe customs regulations:<\/strong> Registration via <strong data-start=\"5970\" data-end=\"5995\">ATLAS system &amp; TRACES<\/strong> for animal products.<br data-start=\"6019\" data-end=\"6022\" \/><strong data-start=\"6024\" data-end=\"6063\">-Obtain official approvals:<\/strong> Registration with BfArM, BVL or market surveillance bodies.<\/p>\n<p data-start=\"6127\" data-end=\"6266\"><span data-start=\"6130\" data-end=\"6139\">\u00a0<\/span><strong data-start=\"6130\" data-end=\"6139\">Tip:<\/strong> Anyone who imports regularly should have a <strong data-start=\"6185\" data-end=\"6220\">Tax consultants &amp; import experts<\/strong> to avoid legal risks.<\/p>","protected":false},"excerpt":{"rendered":"<p>Der Import von Lebensmitteln, Pharmazeutika und Maschinen nach Deutschland unterliegt strengen gesetzlichen Vorschriften und Kontrollen. Hier sind die wichtigsten Regelungen, Genehmigungen und zust\u00e4ndigen Beh\u00f6rden f\u00fcr jede Kategorie: 1. Import von [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[22,184,185],"tags":[],"class_list":["post-12174","post","type-post","status-publish","format-standard","hentry","category-buerokratie-und-behoerdenwege-fuer-unternehmen","category-import-von-lebensmitteln","category-pharmazeutika-und-maschinen-welche-vorschriften-gelten"],"_links":{"self":[{"href":"https:\/\/bosporus24.de\/en\/wp-json\/wp\/v2\/posts\/12174","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bosporus24.de\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/bosporus24.de\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/bosporus24.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/bosporus24.de\/en\/wp-json\/wp\/v2\/comments?post=12174"}],"version-history":[{"count":1,"href":"https:\/\/bosporus24.de\/en\/wp-json\/wp\/v2\/posts\/12174\/revisions"}],"predecessor-version":[{"id":12175,"href":"https:\/\/bosporus24.de\/en\/wp-json\/wp\/v2\/posts\/12174\/revisions\/12175"}],"wp:attachment":[{"href":"https:\/\/bosporus24.de\/en\/wp-json\/wp\/v2\/media?parent=12174"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bosporus24.de\/en\/wp-json\/wp\/v2\/categories?post=12174"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bosporus24.de\/en\/wp-json\/wp\/v2\/tags?post=12174"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}