Updated – January 20, 2023
regulation Medical Needs Supply Guarantee Ordinance (MedBVSV) from May 26, 2020
Last amended by Art. 1 V v. March 9, 2022 BAnz AT March 10, 2022 V1
The following laws and regulations were adopted §3 paragraph 1 of the MedBVSV for corona vaccines overridden:
§ 8 paragraph 3, §§ 10, 11, 11a and 21 paragraph 1, § 21a paragraph 1 and 9, § 32 paragraph 1, §§ 43, 47 and 72 paragraph 1 and 4, § 72a paragraph 1, § 72b Paragraphs 1 and 2, § 72c paragraph 1, §§ 73a, 78 and 94 of the Medicines Act (AMG) as well as § 4a paragraph 1 and § 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.
Medicines Act (AMG)
§8 para. 3 AMG (prohibition of placing expired medicinal products on the market)
Expired corona vaccines may be placed on the market and vaccinated.
§10 AMG (labeling requirement for medicinal products)
Corona vaccines do not require labeling
§11 AMG (package insert)
Corona vaccines do not require a package leaflet
§11a AMG (technical information)
Corona vaccines do not require any specialist information
§21 AMG (registration requirement)
Corona vaccines may also be marketed without approval.
§32 AMG (state batch testing)
Corona vaccines may also be placed on the market without government batch testing.
§43 AMG (pharmacy requirement)
Corona vaccines may be marketed bypassing pharmacies.
§47 AMG (distribution channels)
Corona vaccines may be placed on the market bypassing the distribution channels (wholesale - pharmacy - doctor - patient).
§72 paragraph 1 and 4 AMG (import permit)
Corona vaccines can be imported into Germany without an import permit.
§72a Paragraph 1 AMG (certificates for import)
Corona vaccines can be imported into Germany without certificates.
§72b paragraphs 1 and 2 AMG (import permit for fabrics)
Tissues that are used to treat or prevent COVID-19 may be imported into Germany without permission.
§72c para. 1 AMG (single import of tissue)
The one-time import of tissue that is used to treat or prevent COVID-19 may be imported into Germany without permission.
§73a AMG (export)
The export of corona vaccines from Germany does not require approval.
§78 AMG (prices)
Prices for corona vaccines can be set freely.
§84 AMG (strict liability)
Doctors and pharmacists are not liable for the administration of corona vaccines.
§94 AMG (coverage provision)
Manufacturers are not liable for the marketing of their corona vaccines.
Medicines Trade Ordinance (AM-HandelsV)
§ 4a Paragraph 1 AM-HandelsV (supply only by authorized companies)
Corona vaccines can be delivered to anyone.
§ 6 paragraph 1 AM-HandelsV (delivery only to companies with permission)
Corona vaccines can be delivered to anyone.
The following laws and regulations were adopted §4 of the MedBVSV for corona vaccines overridden:
Medicines Act (AMG)
§13 AMG (manufacturing permit)
With the approval of the authorities, corona vaccines can also be produced without a manufacturing permit.
§15 AMG (expertise)
With the approval of the authorities, corona vaccines can also be produced without expertise.
§19 AMG (areas of responsibility)
With the approval of the authorities, corona vaccines can also be produced without a competent person.
Medicines and Active Ingredients Manufacturing Ordinance (AMWHV)
§3 AMWHV (quality management system, good manufacturing practice and good technical practice)
Corona vaccines can also be produced contrary to QMS, GMP and GfP with the approval of the authorities.
§4 AMWHV (personnel)
With the approval of the authorities, corona vaccines can also be produced without sufficient knowledgeable and qualified personnel.
§11 AMWHV (self-inspection and supplier qualification)
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.
§15 AMWHV (labeling)
Corona vaccines can also be produced without labeling with the approval of the authorities.
§16 AMWHV (release)
With the approval of the authorities, corona vaccines can also be placed on the market without a qualitative review and approval.
§17 AMWHV (placing on the market and import)
With the approval of the authorities, corona vaccines can be placed on the market and imported from abroad without approval.
§22 – 26 AMWHV (manufacture, testing, labeling, release and placing on the market, placing on the market and import)
With the approval of the authorities, all of the above regulations no longer apply to corona vaccines.
The following laws and regulations have been repealed for corona vaccines according to Section 5 of the MedBVSV:
Transfusion Act (TFG)
§4 & §7 TFG (requirements for the donation institution / requirements for withdrawing the donation)
People who have been vaccinated with a corona vaccine are allowed to donate blood.
§ 5 Paragraph 1 Sentence 2 TFG (Selection of Donating Persons)
People who have been vaccinated with a corona vaccine are allowed to donate blood.
Here you can go directly to the aforementioned laws and regulations:
Medicines and Active Ingredients Manufacturing Ordinance (AMWHV)
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