Drucksachen,20/14514: Gesetzentwurf Entwurf eines Gesetzes zur Änderung des Tierarzneimittelgesetzes und des Apothekengesetzes (PDF)

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German Bundestag

20/14514

Draft Law

Draft of a Law to Amend the Animal Medicinal Products Act and the Pharmacy Act

Berlin, 2023-01-15

Submitted by the Federal Government

Draft of a Law

to amend the Animal Medicinal Products Act and the Pharmacy Act

The Bundestag has adopted the following law:

Article 1 Amendment to the Animal Medicinal Products Act

The Animal Medicinal Products Act of 29 November 2012 (Federal Law Gazette I p. 2425), as last amended by Article 1 of the Law of 23 June 2021 (Federal Law Gazette I p. 1880), shall be amended as follows:

  1. Section 14 paragraph 1 sentence 2 shall be amended to read as follows:

“In the case of medicinal products that are manufactured industrially on a large scale and are intended for use in food-producing animals, this may also be certified by a qualified person responsible for the quality assurance of the medicinal product on the basis of regular checks.”

  1. Section 28 paragraph 3 shall be amended to read as follows:

“(3) The Federal Ministry of Health may, by ordinance with the consent of the Bundesrat, regulate the details of the distribution of medicinal products intended for animals in accordance with Section 27 (1) and (2) and of the sale of such medicinal products to natural persons who are not veterinarians in accordance with Section 27 (3), including

  • the conditions under which such distribution and sale may take place,
  • the persons who may carry out such distribution and sale,
  • the form in which such distribution and sale may take place,
  • the requirements for the labelling of medicinal products intended for animals in accordance with Section 27 (1) and (2) and for the information to be provided to natural persons who are not veterinarians in accordance with Section 27 (3),
  • the monitoring of compliance with the provisions on the distribution and sale of medicinal products intended for animals.”

Article 2 Amendment to the Pharmacy Act

The Pharmacy Act of 25 September 1960 (Federal Law Gazette I p. 731), as last amended by Article 13 of the Law of 16 December 2022 (Federal Law Gazette I p. 2668), shall be amended as follows:

  1. Section 47 paragraph 1 sentence 1 shall be amended to read as follows:

“Pharmacies may only be operated by persons who are authorized to do so in accordance with Section 2 and who have their place of business in the Federal Republic of Germany.”

  1. Section 47a paragraph 1 shall be amended to read as follows:

“(1) Distance sales of medicinal products by pharmacies are permitted. The sale of medicinal products intended exclusively for human use pursuant to Section 43 (1) of the Medicinal Products Act shall be excluded.”

  1. Section 48 paragraph 7 sentence 1 shall be amended to read as follows:

“The Federal Ministry of Health may, by ordinance with the consent of the Bundesrat, regulate the details of distance sales of medicinal products in accordance with Section 47a, including

  • the conditions under which distance sales may take place,
  • the persons who may carry out distance sales,
  • the form in which distance sales may take place,
  • the requirements for the labelling of medicinal products sold at a distance in accordance with Section 47a,
  • the monitoring of compliance with the provisions on distance sales of medicinal products.”

Article 3 Amendment to the Medicinal Products Act

The Medicinal Products Act of 26 August 1976 (Federal Law Gazette I p. 2445), as last amended by Article 2 of the Law of 23 June 2021 (Federal Law Gazette I p. 1880), shall be amended as follows:

  1. Section 43 paragraph 1 shall be amended to read as follows:

“(1) Medicinal products intended exclusively for human use may only be sold to end users by pharmacies. This shall not apply to

  • medicinal products which, pursuant to Section 49a (1) of the Animal Medicinal Products Act, may be sold to natural persons who are not veterinarians, and
  • medicinal products which, pursuant to Section 47a (1) of the Pharmacy Act, may be sold at a distance.”

Article 4 Entry into Force

This law shall enter into force on the day after its promulgation.

20/14514: Gesetzentwurf Entwurf eines Gesetzes zur Änderung des Tierarzneimittelgesetzes und des Apothekengesetzes (PDF)

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