Last Updated on May 29, 2021 by LawEuro
Medicinal Products Act (Laws / Regulations of Germany)
CHAPTER EIGHT
Safety and quality control
Section 54
Internal regulations
(1) The Federal Ministry is hereby empowered to issue in agreement with the Federal Ministry for Economic Affairs and Energy, by ordinance subject to the approval of the Bundesrat, internal regulations for enterprises or facilities which introduce medicinal products into the purview of this Act or in which medicinal products are developed, manufactured, tested, stored, packaged or placed on the market or in which medicinal products are otherwise traded, in so far as it is deemed necessary in order to ensure the proper operation of the enterprise or facility and the quality required of the medicinal products and pharmacovigilance; this shall apply mutatis mutandis to active substances and other substances as well as tissues intended for the manufacture of medicinal products. The ordinance shall be issued by the Federal Ministry of Food and Agriculture in agreement with the Federal Ministry and the Federal Ministry for Economic Affairs and Energy, in so far as medicinal products intended for administration to animals are concerned. The ordinance shall be issued in agreement with the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety if radiopharmaceuticals or medicinal products in the manufacture of which ionizing radiation is used are concerned.
(2) In the ordinance pursuant to sub-section 1, regulations may be laid down in particular concerning:
1. the development, manufacture, testing, storage, packaging, quality assurance, acquisition, supply, stockpiling and marketing,
2. the maintaining and keeping of records on the operational processes specified in number 1,
3. the keeping and monitoring of the animals used in the manufacture and testing of medicinal products and the records kept on them,
4. staffing requirements,
5. the nature, size and equipment of the premises,
6. sanitation requirements,
7. the nature of the containers,
8. the labelling of the containers in which medicinal products and their starting materials are stored,
9. the stand-by obligation for medicinal product wholesalers,
10. the retention of batch samples including quantities and duration of storage,
11. the labelling, separation or destruction of medicinal products which are unfit for marketing,
12. the prerequisites and requirements regarding the veterinarian’s activities pursuant to number 1 (operation of a veterinary in-house dispensary), as well as the requirements regarding the administration of medicinal products by the veterinarian to the animals he/she treats.
(2a) (repealed)
(3) The regulations under sub-sections 1 and 2 shall also apply to persons practising the activities indicated in sub-section 1 professionally.
(4) Sub-sections 1 and 2 shall apply to pharmacies as defined in the Pharmacies Act, in so far as these require an authorisation pursuant to Section 13 Section 52a or Section 72.
Section 55
Pharmacopoeia
(1) The Pharmacopoeia is a collection of recognized pharmaceutical rules regarding the quality, testing, storage, dispensing and designation of medicinal products and the substances used in their manufacture, published by the Federal Institute for Drugs and Medical Devices in agreement with the Paul Ehrlich Institute and the Federal Agency for Consumer Protection and Food Safety. The Pharmacopoeia also contains requirements regarding the nature of containers and outer packaging.
(2) The rules contained in the Pharmacopoeia are laid down by the German Pharmacopoeia Commission or by the European Pharmacopoeia Commission. Publication of the rules can be refused or annulled for legal or technical reasons.
(3) It is incumbent upon the German Pharmacopoeia Commission to stipulate the rules contained in the Pharmacopoeia and to assist the competent higher federal authority with its work within the framework of the Convention on the Elaboration of a European Pharmacopoeia.
(4) The German Pharmacopoeia Commission shall be set up at the Federal Institute for Drugs and Medical Devices. In consultation with the Paul Ehrlich Institute and the Federal Agency for Consumer Protection and Food Safety, the Federal Institute for Drugs and Medical Devices shall appoint the members of the German Pharmacopoeia Commission, proportionally, from among experts in the fields of medical and pharmaceutical science, the health professions, the affected business circles and the field of pharmacovigilance, provide the chairperson and issue by-laws. The by-laws shall require the agreement of the Federal Ministry in agreement with the Federal Ministry of Food and Agriculture. The members of the Commission are bound to maintain confidentiality.
(5) In principle, the German Pharmacopoeia Commission shall take decisions regarding the rules contained in the Pharmacopoeia unanimously. Decisions taken by three-quarters of the members of the Commission or less shall not be valid. The detailed provisions shall be laid down in the by-laws.
(6) Sub-sections 2 to 5 shall apply mutatis mutandis to the work of the German Homeopathic Pharmacopoeia Commission.
(7) Promulgation shall take place in the Federal Gazette. It can be limited to indicating the source of the version of the Pharmacopoeia in question and the date on which the revised version becomes valid.
(8) Only substances and the containers and outer packaging, in so far as they come into contact with the medicinal products, and only pharmaceutical forms which are in compliance with recognised pharmaceutical rules, may be used in the manufacture of medicinal products. Sentence 1 shall apply to medicinal products which are manufactured exclusively for export with the proviso that the regulations in force in the receiving country can be taken into consideration.
(9) By way of derogation from sub-section 1 sentence 1, the promulgation shall be conducted by the Federal Agency for Consumer Protection and Food Safety in agreement with the Federal Institute for Drugs and Medical Devices and the Paul Ehrlich Institute, in so far as medicinal products for use in animals are concerned.
Section 55a
Official compilation of test procedures
The competent higher federal authority shall publish an official compilation of test procedures for the sampling and testing of medicinal products and their starting materials. The procedures shall be established in consultation with experts from the field of pharmacovigilance, scientists and pharmaceutical entrepreneurs. The compilation of procedures shall be kept up to date.
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