{"id":2223,"date":"2022-08-12T08:07:58","date_gmt":"2022-08-12T08:07:58","guid":{"rendered":"https:\/\/csiag.de\/?p=2223"},"modified":"2023-01-20T17:02:42","modified_gmt":"2023-01-20T17:02:42","slug":"regulation-suspends-laws-and-regulations-for-corona-vaccines","status":"publish","type":"post","link":"https:\/\/csiag.de\/en\/blog\/2022\/08\/12\/verordnung-setzt-gesetze-und-verordnungen-fuer-corona-impftstoffe-ausser-kraft\/","title":{"rendered":"Regulation overrides laws and regulations for corona vaccines"},"content":{"rendered":"Reading time<\/span> 3<\/span> minutes<\/span><\/span>\n

regulation Medical Needs Supply Guarantee Ordinance (MedBVSV)<\/strong> from May 26, 2020<\/p>\n\n\n\n

Last amended by Art. 1 V v. March 9, 2022 BAnz AT March 10, 2022 V1

<\/p>\n\n\n\n

The following laws and regulations were adopted<\/strong> \u00a73 paragraph 1 of the MedBVSV<\/u><\/strong><\/a> for corona vaccines overridden:<\/strong><\/p>\n\n\n\n

\u00a7 8 paragraph 3, \u00a7\u00a7 10, 11, 11a and 21 paragraph 1, \u00a7 21a paragraph 1 and 9, \u00a7 32 paragraph 1, \u00a7\u00a7 43, 47 and 72 paragraph 1 and 4, \u00a7 72a paragraph 1, \u00a7 72b Paragraphs 1 and 2, \u00a7 72c paragraph 1, \u00a7\u00a7 73a, 78 and 94 of the Medicines Act (AMG) as well as \u00a7 4a paragraph 1 and \u00a7 6 paragraph 1 of the Medicines Trade Ordinance (AM-HandelsV) do not apply to the Federal Ministry commissioned by it Bodies and for persons from whom the Federal Ministry or a body commissioned by it procures the medicinal products, if the Federal Ministry or a body commissioned by it procures medicinal products or active ingredients, starting materials and auxiliary substances and places them on the market in accordance with Section 2 Paragraph 1.<\/em><\/p>\n\n\n\n

Medicines Act (AMG)<\/strong><\/p>\n\n\n\n

\u00a78 para. 3 AMG (prohibition of placing expired medicinal products on the market)<\/strong><\/p>\n\n\n\n

Expired corona vaccines may be placed on the market and vaccinated.<\/em><\/p>\n\n\n\n

\u00a710 AMG (labeling requirement for medicinal products)<\/strong><\/p>\n\n\n\n

Corona vaccines do not require labeling<\/em><\/p>\n\n\n\n

\u00a711 AMG (package insert)<\/strong><\/p>\n\n\n\n

Corona vaccines do not require a package leaflet<\/em><\/p>\n\n\n\n

\u00a711a AMG (technical information)<\/strong><\/p>\n\n\n\n

Corona vaccines do not require any specialist information<\/em><\/p>\n\n\n\n

\u00a721 AMG (registration requirement)<\/strong><\/p>\n\n\n\n

Corona vaccines may also be marketed without approval.<\/em><\/p>\n\n\n\n

\u00a732 AMG (state batch testing)<\/strong><\/p>\n\n\n\n

Corona vaccines may also be placed on the market without government batch testing.<\/em><\/p>\n\n\n\n

\u00a743 AMG (pharmacy requirement)<\/strong><\/p>\n\n\n\n

Corona vaccines may be marketed bypassing pharmacies.<\/em><\/p>\n\n\n\n

\u00a747 AMG (distribution channels)<\/strong><\/p>\n\n\n\n

Corona vaccines may be placed on the market bypassing the distribution channels (wholesale - pharmacy - doctor - patient).<\/em><\/p>\n\n\n\n

\u00a772 paragraph 1 and 4 AMG (import permit)<\/strong><\/p>\n\n\n\n

Corona vaccines can be imported into Germany without an import permit.<\/em><\/p>\n\n\n\n

\u00a772a Paragraph 1 AMG (certificates for import)<\/strong><\/p>\n\n\n\n

Corona vaccines can be imported into Germany without certificates.<\/em><\/p>\n\n\n\n

\u00a772b paragraphs 1 and 2 AMG (import permit for fabrics)<\/strong><\/p>\n\n\n\n

Tissues that are used to treat or prevent COVID-19 may be imported into Germany without permission.<\/em><\/p>\n\n\n\n

\u00a772c para. 1 AMG (single import of tissue)<\/strong><\/p>\n\n\n\n

The one-time import of tissue that is used to treat or prevent COVID-19 may be imported into Germany without permission.<\/em><\/p>\n\n\n\n

\u00a773a AMG (export)<\/strong><\/p>\n\n\n\n

The export of corona vaccines from Germany does not require approval.<\/em><\/p>\n\n\n\n

\u00a778 AMG (prices)<\/strong><\/p>\n\n\n\n

Prices for corona vaccines can be set freely.<\/em><\/p>\n\n\n\n

\u00a784 AMG (strict liability)<\/strong><\/p>\n\n\n\n

Doctors and pharmacists are not liable for the administration of corona vaccines.<\/em><\/p>\n\n\n\n

\u00a794 AMG (coverage provision)<\/strong><\/p>\n\n\n\n

Manufacturers are not liable for the marketing of their corona vaccines.<\/em><\/p>\n\n\n\n

Medicines Trade Ordinance (AM-HandelsV)<\/strong><\/p>\n\n\n\n

\u00a7 4a Paragraph 1 AM-HandelsV (supply only by authorized companies)<\/strong><\/p>\n\n\n\n

Corona vaccines can be delivered to anyone.<\/em><\/p>\n\n\n\n

\u00a7 6 paragraph 1 AM-HandelsV (delivery only to companies with permission)<\/strong><\/p>\n\n\n\n

Corona vaccines can be delivered to anyone.<\/em><\/p>\n\n\n\n

The following laws and regulations were adopted <\/strong>\u00a74 of the MedBVSV<\/u><\/strong><\/a> for corona vaccines overridden:<\/strong><\/p>\n\n\n\n

Medicines Act (AMG)<\/strong><\/p>\n\n\n\n

\u00a713 AMG (manufacturing permit)<\/strong><\/p>\n\n\n\n

With the approval of the authorities, corona vaccines can also be produced without a manufacturing permit.<\/em><\/p>\n\n\n\n

\u00a715 AMG (expertise)<\/strong><\/p>\n\n\n\n

With the approval of the authorities, corona vaccines can also be produced without expertise.<\/em><\/p>\n\n\n\n

\u00a719 AMG (areas of responsibility)<\/strong><\/p>\n\n\n\n

With the approval of the authorities, corona vaccines can also be produced without a competent person.<\/em><\/p>\n\n\n\n

Medicines and Active Ingredients Manufacturing Ordinance (AMWHV)<\/strong><\/p>\n\n\n\n

\u00a73 AMWHV (quality management system, good manufacturing practice and good technical practice)<\/strong><\/p>\n\n\n\n

Corona vaccines can also be produced contrary to QMS, GMP and GfP with the approval of the authorities.<\/em><\/p>\n\n\n\n

\u00a74 AMWHV (personnel)<\/strong><\/p>\n\n\n\n

With the approval of the authorities, corona vaccines can also be produced without sufficient knowledgeable and qualified personnel.<\/em><\/p>\n\n\n\n

\u00a711 AMWHV (self-inspection and supplier qualification)<\/strong><\/p>\n\n\n\n

With the approval of the authorities, corona vaccines can be produced without regular self-inspections and qualification of suppliers for raw materials, packaging material, etc.<\/em><\/p>\n\n\n\n

\u00a715 AMWHV (labeling)<\/strong><\/p>\n\n\n\n

Corona vaccines can also be produced without labeling with the approval of the authorities.<\/em><\/p>\n\n\n\n

\u00a716 AMWHV (release)<\/strong><\/p>\n\n\n\n

With the approval of the authorities, corona vaccines can also be placed on the market without a qualitative review and approval.<\/em><\/p>\n\n\n\n

\u00a717 AMWHV (placing on the market and import)<\/strong><\/p>\n\n\n\n

With the approval of the authorities, corona vaccines can be placed on the market and imported from abroad without approval.<\/em><\/p>\n\n\n\n

\u00a722 \u2013 26 AMWHV (manufacture, testing, labeling, release and placing on the market, placing on the market and import)<\/strong><\/p>\n\n\n\n

With the approval of the authorities, all of the above regulations no longer apply to corona vaccines.<\/em><\/p>\n\n\n\n

The following laws and regulations have been repealed for corona vaccines according to Section 5 of the MedBVSV:<\/strong><\/p>\n\n\n\n

Transfusion Act (TFG)<\/strong><\/p>\n\n\n\n

\u00a74 & \u00a77 TFG (requirements for the donation institution \/ requirements for withdrawing the donation)<\/strong><\/p>\n\n\n\n

People who have been vaccinated with a corona vaccine are allowed to donate blood.<\/em><\/p>\n\n\n\n

\u00a7 5 Paragraph 1 Sentence 2 TFG (Selection of Donating Persons)<\/strong><\/p>\n\n\n\n

People who have been vaccinated with a corona vaccine are allowed to donate blood.<\/em><\/p>\n\n\n\n

Here you can go directly to the aforementioned laws and regulations:<\/p>\n\n\n\n

Medicines Act<\/u><\/a><\/p>\n\n\n\n

Transfusion law<\/u><\/a><\/p>\n\n\n\n

Medicines and Active Ingredients Manufacturing Ordinance (AMWHV)<\/u><\/a><\/p>\n\n\n\n

Medical Needs Supply Guarantee Ordinance (MedBVSV)<\/u><\/a><\/p>","protected":false},"excerpt":{"rendered":"

Reading time<\/span> 3<\/span> minutes<\/span><\/span>Verordnung Medizinischer Bedarf Versorgungssicherstellungsverordnung (MedBVSV) of 26.05.2020 Last amended by Art. 1 V of 9.3.2022 BAnz AT 10.03.2022 V1 The following laws and ordinances were repealed for corona vaccines in accordance with Section 3 (1) of the MedBVSV: Section 8 (3), Sections 10, 11, 11a and 21 (1), Section 21a (1) and (9), Section... Read More \"Regulation overrides laws and regulations for corona vaccines<\/span><\/a><\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_lmt_disableupdate":"","_lmt_disable":"","neve_meta_sidebar":"","neve_meta_container":"","neve_meta_enable_content_width":"","neve_meta_content_width":0,"neve_meta_title_alignment":"","neve_meta_author_avatar":"","neve_post_elements_order":"","neve_meta_disable_header":"","neve_meta_disable_footer":"","neve_meta_disable_title":"","footnotes":""},"categories":[628],"tags":[],"class_list":["post-2223","post","type-post","status-publish","format-standard","hentry","category-corona"],"acf":[],"modified_by":"Achim Goerner","_links":{"self":[{"href":"https:\/\/csiag.de\/en\/wp-json\/wp\/v2\/posts\/2223","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/csiag.de\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csiag.de\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csiag.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/csiag.de\/en\/wp-json\/wp\/v2\/comments?post=2223"}],"version-history":[{"count":0,"href":"https:\/\/csiag.de\/en\/wp-json\/wp\/v2\/posts\/2223\/revisions"}],"wp:attachment":[{"href":"https:\/\/csiag.de\/en\/wp-json\/wp\/v2\/media?parent=2223"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csiag.de\/en\/wp-json\/wp\/v2\/categories?post=2223"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csiag.de\/en\/wp-json\/wp\/v2\/tags?post=2223"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}