Last Updated on May 29, 2021 by LawEuro
Medicinal Products Act (Laws / Regulations of Germany)
CHAPTER ONE
Purpose of the Act, definition of terms, scope
Section 1
Purpose of the Act
It is the purpose of the present Act to guarantee safety in respect of the trade in medicinal products, ensuring in particular the quality, efficacy and safety of medicinal products in accordance with the following provisions, in the interest of furnishing both human beings and animals with a proper supply of medicinal products.
Section 2
The term ‘medicinal product’
(1) Medicinal products are substances or preparations made from substances that:
1. are intended for use in or on the human or animal body and are intended for use as remedies with properties for the curing, alleviating or preventing of human or animal diseases or disease symptoms or
2. can be used in or on the human or animal body or can be administered to a human being or an animal, either:
a) to restore, correct or influence the physiological functions through a pharmacological, immunological or metabolic effect, or
b) to make a medical diagnosis.
(2) The following shall be considered as medicinal products:
1. objects that contain a medicinal product pursuant to sub-section 1 or to the surface of which a medicinal product specified in sub-section 1 is applied and that are intended to come into either temporary or permanent contact with the human or animal body,
1a. veterinary instruments in so far as they are intended for single use and the labelling of which indicates that they have been subjected to a procedure for microbe reduction,
2. objects that, without being objects pursuant to number 1 or 1a, are intended for the purposes indicated in sub-section 1, to be introduced either temporarily or permanently into the animal body, with the exception of veterinary instruments,
3. wound dressings and surgical sutures in so far as they are intended for use on or the animal body and are not covered by numbers 1, 1a or 2,
4. substances and preparations made from substances that, also in combination with other substances or preparations made from substances, without being applied on or in the animal body, are intended to diagnose the nature, state or functions of the animal body or to identify pathogens in animals.
(3) The term ‘medicinal product’ shall not apply to:
1. foodstuffs within the meaning of Section 2 sub-section 2 of the Food and Feed Code,
2. cosmetic products within the meaning of Section 2 sub-section 5 of the Food and Feed Code,
3. products as defined in Section 2 sub-section 1 of the Tobacco Products Act (Tabakerzeugnisgesetz),
4. substances or preparations made from substances that are exclusively intended for external use in the cleaning or care of animals or to influence their appearance or body odour, provided that no substances or preparations made from substances are added that are excluded from trade outside of pharmacies,
5. biocidal products pursuant to Article 3 (1) letter a of Regulation (EU) No. 528/2012 of 22 May 2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1),
6. feeding stuffs within the meaning of Section 3 numbers 12 to 16 of the Food and Feed Code,
7. medical devices and accessories for medical devices within the meaning of Section 3 of the Medical Devices Act unless they are medicinal products within the meaning of Section 2 sub-section 1 number 2 letter b,
8. organs within the meaning of Section 1a number 1 of the Transplantation Act if they are intended for transplanting to human beings.
(3a) Medicinal products are also products that are, or contain, substances or preparations made from substances that, when all of the product’s properties are taken into account, fall under the definition contained in sub-section 1 and, at the same time, can fall under the definition of a ‘product’ pursuant to sub-section 3.
(4) As long as a product is authorised or registered as a medicinal product pursuant to this Act, or is exempted from the need for authorisation or registration by ordinance, such product shall be considered to be a medicinal product. A product shall not be considered a medicinal product if its authorisation or registration has been rejected by the competent higher federal authority, on the grounds that it is not a medicinal product.
Section 3
The term ‘substance’
For the purpose of this Act, substances are:
1. chemical elements and chemical compounds as well as their naturally occurring mixtures and solutions,
2. plants, parts of plants and plant constituents, algae, fungi and lichen, whether in their processed or crude state,
3. the bodies of animals, including those of living animals, as well as body parts, body constituents and metabolic products of human beings or animals, whether in their processed or crude state,
4. micro-organisms, including viruses, as well as their constituents or metabolic products.
Section 4
Definition of additional terms
(1) Finished medicinal products are medicinal products that are manufactured beforehand and placed on the market in packaging intended for distribution to the consumer, or other medicinal products intended for distribution to the consumer in the preparation of which any form of industrial process is used, or medicinal products that are produced commercially, except in pharmacies. Finished medicinal products are not intermediate products intended for further processing by a manufacturer.
(2) Blood preparations are medicinal products that are, or contain as active substances, stored blood, plasma or serum obtained from blood, blood components or preparations made from blood components.
(3) Sera are medicinal products within the meaning of Section 2 sub-section 1 that contain antibodies, fragments of antibodies or fusion proteins with a functional antibody component as their active substance and are used because of this active substance. Sera shall not be considered as blood preparations as defined in sub-section 2 or as tissue preparations as defined in sub-section 30.
(4) Vaccines are medicinal products within the meaning of Section 2 sub-section 1 that contain antigens or recombinant nucleic acids and are intended for use in human beings or animals for the production of specific antitoxins and protective agents and, in so far as they contain recombinant nucleic acids, are intended exclusively for the prevention or treatment of infectious diseases.
(5) Allergens are medicinal products within the meaning of Section 2 sub-section 1 that contain antigens or haptens and are intended for use in human beings or animals for the diagnosis of specific antitoxins or protective agents (test allergens), or contain substances that are used to achieve an antigen-specific reduction of a specific immunological over-sensitivity (therapeutic allergens).
(6) Test sera are medicinal products within the meaning of Section 2 sub-section 2 number 4 that are obtained from blood, organs, parts of organs or secretions from organs of the healthy or the sick, or from beings who have been sick or previously immunized, which contain specific antibodies and are intended to be used on account of these antibodies, as well as the control sera appertaining to these medicinal products.
(7) Test antigens are medicinal products within the meaning of Section 2 sub-section 2 number 4 that contain antigens or haptens and are intended to be used as such.
(8) Radiopharmaceuticals are medicinal products that are or contain radioactive substances and spontaneously emit ionizing radiation and are intended to be used on account of these properties; radionuclides (precursors) that are manufactured for the radio labelling of other substances prior to administration, as well as systems incorporating a fixed mother radionuclide that produces a daughter radionuclide (generator) intended for use in the manufacture of radiopharmaceuticals, shall also be regarded as radiopharmaceuticals.
(9) Advanced therapy medicinal products are gene therapy medicinal products, somatic cell therapy medicinal products or tissue engineered products pursuant to Article 2, paragraph 1, letter a of Regulation (EC) No. 1394/2007 of the European Parliament and the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No. 726/2004 (OJ L 324 of 10 December 2007, p. 121).
(10) Medicated feeding stuffs are medicinal products in the form of ready feeding stuffs, manufactured from medicated pre-mixes and mixed feed and intended to be placed on the market for administration to animals.
(11) Medicated pre-mixes are medicinal products intended exclusively for use in the manufacture of medicated feeding stuffs. They are regarded as finished medicinal products.
(12) The withdrawal period is the period that needs to elapse between the last administration of the veterinary medicinal product to an animal, in keeping with its intended purpose, and the production of foodstuffs from this animal, so as to protect public health and ensure that such foodstuffs do not contain residues in quantities in excess of the maximum limits for pharmacologically active substances laid down in the latest applicable version of the Annex to Commission Regulation (EU) No. 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15 of 20.1.2010, p. 1).
(13) In the case of medicinal products intended for use in human beings, adverse reactions are noxious and unintended reactions to the medicinal product. In the case of medicinal products intended for use in animals, adverse reactions are noxious and unintended reactions that occur when a medicinal product is administered in keeping with its intended purpose. Serious adverse reactions are adverse reactions that are fatal or life-threatening, require hospitalisation or the prolongation of existing hospitalisation, or lead to persistent or significant disability, incapacity, congenital anomalies or birth defects. In the case of medicinal products intended for administration to animals, adverse reactions are also serious if they cause recurring or persistent symptoms. Unexpected adverse reactions are adverse reactions the nature, extent or consequences of which differ from the medicinal product’s expert information.
(14) Manufacturing is the producing, preparing, formulating, treating or processing, filling as well as decanting, packaging, labelling and release of medicinal products; manufacturing is not the mixing of finished medicinal products with feeding stuffs by the animal keeper for immediate feeding to the animals kept by him/her.
(15) Quality is the nature of a medicinal product, determined by identity, content, purity and other chemical, physical and biological properties or by the manufacturing procedure.
(16) A batch is the quantity of a medicinal product produced from the same amount of starting material in a standard manufacturing process or, in the case of a continuous manufacturing procedure, within a specific period of time.
(17) Placing on the market is the keeping in stock for sale or for other forms of supply, the exhibiting and offering for sale and the distribution to others.
(18) In the case of medicinal products requiring a marketing authorisation or registration, the pharmaceutical entrepreneur shall be the holder of the marketing authorisation or registration. The pharmaceutical entrepreneur is also any person who places medicinal products by parallel distribution or otherwise on the market under his/her own name, with the exception of the cases provided for in Section 9 sub-section 1, sentence 2.
(19) Active substances are substances that are intended for use as medically active constituents in the manufacture of medicinal products or which, through their use in the manufacture of medicinal products, are intended to become medically active constituents.
(20) (repealed).
(21) Xenogeneic medicinal products are medicinal products that are or contain living animal tissues or cells and are intended for use in or on human beings.
(22) Wholesale trade in medicinal products is any professional or commercial activity for the purpose of doing business that consists of the procuring, storing, supplying or exporting of medicinal products, with the exception of the dispensing of medicinal products to consumers other than physicians, dentists, veterinarians or hospitals.
(22a) Brokering of medicinal products is any professional or commercial activity by persons who, without conducting wholesale distribution, independently and on behalf of another, trade in medicinal products within the meaning of Section 2 sub-section 1 or sub-section 2 number 1, which are intended for use in human beings, without having actual power of disposal over said medicinal products.
(23) A clinical trial on human beings is any investigation on human subjects intended to investigate or verify the clinical or pharmacological effects of medicinal products, or to identify adverse reactions or to study the absorption, distribution, metabolisation or excretion, with the aim of ascertaining the safety or efficacy of the medicinal product. Sentence 1 shall not apply to an investigation that is a non-interventional trial. A non-interventional trial is a study, in the context of which findings resulting from persons’ treatment with medicinal products are analysed using epidemiological methods; the treatment, including the diagnosis and monitoring, shall not follow a predetermined trial protocol but shall result exclusively from current medical practice; in so far as a medicinal product requiring a marketing authorisation or a medicinal product requiring approval pursuant to Section 21a sub-section 1 is concerned, this shall be conducted, moreover, according to the specifications regarding its use contained in the marketing authorisation or approval.
(24) The sponsor is a natural or legal person who assumes responsibility for the commissioning, organisation and financing of a clinical trial on human beings.
(25) The investigator is generally a physician responsible for the conduct of the clinical trial on human beings at a site or, in justified exceptional cases, another person whose profession, owing to the scientific requirements and the experience in the care of patients that it calls for, qualifies him/her to conduct research on human beings. If a clinical trial is being conducted at one site by a team of persons, the investigator shall be the person in charge of the team and responsible for conducting the trial. If a clinical trial is being conducted at various trial sites, the sponsor shall name one investigator as the chief investigator.
(26) A homeopathic medicinal product is any medicinal product prepared in accordance with a homeopathic manufacturing procedure described in the European Pharmacopoeia or, in absence thereof, in the pharmacopoeias currently used officially in the EU Member States. A homeopathic medicinal product can also contain a number of active substances.
(27) A risk linked to the use of a medicinal product is:
a) any risk to patients’ health or public health linked to the quality, safety or efficacy of the medicinal product and, in the case of medicinal products intended for use in animals, any risk to human or animal health,
b) any risk of adverse effects on the environment.
(28) The risk-benefit balance is an assessment of the positive therapeutic effects of the medicinal product in relationship to the risk referred to in sub-section 27 letter a, and in the case of medicinal products intended for use in animals, also referred to in sub-section 27 letter b.
(29) Herbal medicinal products are medicinal products that exclusively contain, as active substances, either one or more herbal substances, one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations.
(30) Tissue preparations are medicinal products that are tissues within the meaning of Section 1a number 4 of the Transplantation Act or are manufactured from such tissues. Human sperm and egg cells (germ cells), as well as impregnated egg cells and embryos are neither medicinal products nor tissue preparations.
(30a) The ‘Single European Code’ or ‘SEC’ is the unique identifier for all tissues and tissue preparations that are distributed within the European Union, as specified in Annex VII of Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (OJ L 294 of 25.10.2006, p. 32) last amended by (EU) Directive 2015/565 (OJ L 93 of 9.4.2015, p. 43).
(30b) The EU tissue establishment code is the unique identifier for tissue establishments in the European Union. Within the purview of this Act, it applies to all facilities that conduct activities that require a permit, involving tissues, tissue preparations, haematopoietic stem cells, or stem cell preparations derived from peripheral blood or from umbilical cord blood. Pursuant to Annex VII of Directive 2006/86/EC, the EU tissue establishment code consists of an ISO country code and the tissue establishment number set out in the EU Tissue Establishment Compendium.
(30c) The EU Compendium of Tissue Establishments is the register of all tissue establishments that are approved, licensed, designated or authorised by the Member States’ competent authorities and which contains the information on these tissue establishments pursuant to Annex VIII of Directive 2006/86/EC in the latest applicable version. Within the purview of this Act, it applies to all facilities that conduct activities that require a permit, involving tissues, tissue preparations or haematopoietic stem cells, or stem cell preparations derived from peripheral blood or from umbilical cord blood.
(30d) The EU Tissue and Cell Product Compendium is the register of all the types of tissue, tissue preparations or haematopoietic stem cells, or stem cell preparations derived from peripheral blood or umbilical cord blood, circulating in the European Union, with the corresponding product code.
(31) Reconstitution of a finished medicinal product for human use is the conversion of the medicinal product into its usable form immediately prior to its use according to the specifications contained in the package leaflet or, within the framework of the clinical trial, in accordance with the trial protocol.
(32) Introduction is any type of shipment into, through or from the purview of this Act. Import is the conveyance of products that fall under the Medicinal Products Act from third countries, which are not States Parties to the Agreement on the European Economic Area for free circulation. Products pursuant to sentence 2 shall be considered to be imported if they have been brought into the economic system in contravention of customs regulations. Export is any type of introduction into third countries that are not States Parties to the Agreement on the European Economic Area.
(33) An anthroposophic medicinal product is a medicinal product which has been developed according to the anthroposophic understanding of human beings and nature, according to a European Pharmacopoeia or, in the absence thereof, in accordance with a homeopathic manufacturing practice described in the pharmacopoeias currently used officially in the EU Member States, or according to a special anthroposophic manufacturing procedure, and which is intended for use according to the principles of the anthroposophic understanding of human beings and nature.
(34) A post-authorisation safety study in the case of a medicinal product intended for use in human beings is any assessment of an authorised medicinal product that is conducted to identify, characterise or quantify a safety risk, to confirm a medicinal product’s safety profile or to measure the effectiveness of risk-management measures.
(35) A post-authorisation safety study in the case of a medicinal product intended for use in animals is a pharmaco-epidemiological study or clinical trial according to the conditions contained in the marketing authorisation with the aim of detecting and characterising any health risk in connection with an authorised veterinary medicinal product.
(36) The risk-management system comprises activities in the field of pharmacovigilance and measures that are intended to identify, characterise, avoid or minimise risks associated with a medicinal product; this includes the assessment of the effectiveness of such activities and measures.
(37) The risk-management plan is a detailed description of the risk-management system.
(38)The pharmacovigilance system is a system used by the marketing authorisation holder and the competent higher federal authority to fulfil especially the tasks and obligations listed in the Chapter Ten and which serves the purpose of post-marketing surveillance and the detection of any changes in the risk-benefit profile.
(39) The pharmacovigilance master file is a detailed description of the pharmacovigilance system used by the marketing authorisation holder with respect to one or more authorised medicinal products.
(40) A falsified medicinal product is any medicinal product with a false representation of:
1. its identity, including its packaging and labelling, its name or its composition as regards one or several of its constituents including excipients and the strength of those ingredients;
2. its source, including its manufacturer, its country of manufacture, its country of origin or its marketing authorisation holder; or
3. distribution channels described in the related records and documents.
(41) A falsified active substance is an active substance for which the labelling on the container does not correspond to the actual content or the accompanying documents fail to reflect all of the manufacturers involved or the real channels of distribution.
Section 4a
Exceptions to the scope of this Act
This Act shall not apply to:
1. medicinal products that are manufactured using pathogens or biotechnology and are intended for use in the prevention, diagnosis or cure of epizootics,
2. the procurement and marketing of germ cells for the artificial insemination of animals,
3. tissues that are removed from a person in order to reinsert them without changing their material structure into the same person in one and the same surgical procedure.
Sentence 1 number 1 shall not apply to Section 55.
Section 4b
Special provisions governing advanced therapy medicinal products
(1) In the case of advanced therapy medicinal products which, within the purview of this Act, are:
1. prescribed by a physician as an individual preparation for an individual patient,
2. prepared on a non-routine basis according to specific quality standards, and
3. used in a specialised facility for health care under the professional responsibility of a physician,
within the purview of this Act, Chapter Four with the exception of Section 33 and Chapter Seven of the present Act shall not apply. The remaining provisions of the Act, as well as Article 14 (1) and Article 15 (1-6) of the Regulation (EC) No. 1394/2007 shall apply mutatis mutandis with the proviso that the official tasks and powers laid down therein are assumed by the competent authority or the competent higher federal authority in keeping with the tasks entrusted to them by the present Act and the holder of the authorisation pursuant to sub-section 3 sentence 1, takes the place of the marketing authorisation holder pursuant to the present Act or the marketing authorisation holder pursuant to Regulation (EC) No. 1394/2007.
(2) Prepared on a non-routine basis pursuant to sub-section 1 sentence 1 number 2 are, in particular, medicinal products:
1. that are manufactured and used in such small quantities that it is not to be expected that sufficient clinical experience can be collected for a comprehensive evaluation of the medicinal product, or
2. that have not yet been manufactured and used in sufficient quantities so that it has not yet been possible to obtain the necessary data to enable a comprehensive assessment.
(3) Medicinal products pursuant to sub-section 1 sentence 1 may only be supplied to others if they have been approved by the competent higher federal authority. Section 21a sub-section 2 sentence 1, sub-sections 3 to 6 and 8 shall apply mutatis mutandis. In addition to the information and documents pursuant to Section 21a sub-section 2 sentence 1, the application for approval shall be accompanied by the following information and documents:
1. information on the specialised healthcare facility in which the medicinal product is to be used,
2. the number of planned administrations or patients per year,
3. information on dosage,
4. information on the risk management plan containing a description of the risk management system, which the applicant will introduce for the medicinal product in question, together with a summary of the risk management plan and the risk management system, and
5. in the case of advanced therapy medicinal products consisting of a genetically modified organism or a combination of genetically modified organisms or containing such organisms, also the technical documents pursuant to Annexes III A, III B and IV of Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106 of 17.4.2001, p. 1) last amended by Directive (EU) 2015/412 (OJ L 68 of 13.3.2015, p. 1), as well as information obtained from an environmental impact assessment conducted according to Annex II of Directive 2001/18/EC, pursuant to Annex II letter D of Directive 2001/18/EC.
Section 22 sub-section 2 sentence 1 number 5, sub-sections 4 and 7 sentence 1 shall apply mutatis mutandis.
(4) In the case of advanced therapy medicinal products consisting of a genetically modified organism or a combination of genetically modified organisms or containing such organisms, the competent higher federal authority shall decide on the application for approval, in consultation with the Federal Agency for Consumer Protection and Food Safety. The approval by the competent higher federal authority for the dispensing of medicinal products to other persons pursuant to sentence 1, also includes the authorisation for placing on the market the genetically modified organisms from which the medicinal product pursuant to sentence 1 is manufactured, or which contains. Approval may only be granted if:
1. an environmental impact assessment was conducted according to the basic principles contained in Annex II of Directive 2001/18/EC and based on the information according to Annexes III and IV of Directive 2001/18/EC, and
2. according to the state of the art in science, unjustifiable harmful effects on the health of third parties and the environment are not to be expected.
(5) If the necessary information and documents pursuant to Section 21a sub-section 2 sentence 1 number 8 cannot be submitted, the applicant can submit information and documents regarding the mode of action, the anticipated effect and possible risks.
(6) Approval can be issued for a limited period of time.
(7) The holder of the approval shall inform the competent higher federal authority, at specific intervals stipulated by the latter by means of an ordinance, about the scale of manufacture and about the data for the comprehensive assessment of the medicinal product. The approval shall be withdrawn if it subsequently becomes known that one of the prerequisites, pursuant to sub-section 1 sentence 1 had not existed. The approval shall be revoked if one of the prerequisites, pursuant to sub-section 1 sentence 1 no longer exists.
(8) The applicant shall notify the competent higher federal authority forthwith, enclosing the corresponding documents, in the event of any changes in the information or documents that were enclosed with the application for approval. Subsequent to the approval, sentence 1 shall apply mutatis mutandis to the holder of the approval. The latter is required to inform the competent higher federal authority of new or changed risks or of changes in the medicinal product’s risk-benefit balance. In the case of advanced therapy medicinal products consisting of a genetically modified organism or a combination of genetically modified organisms or containing such organisms, the applicant shall notify the competent higher federal authority forthwith, enclosing the corresponding documents, if he/she becomes aware of new information on risks to the health of non-affected persons or the environment. Subsequent to the approval, sentence 4 shall apply mutatis mutandis to the holder of the approval. Section 29 sub-sections 1a, 1d and 2 shall apply mutatis mutandis.
(9) The following changes may be made only if the competent higher federal authority has granted its approval:
1. change in the information on the dosage, the nature or the duration of the administration, or on the therapeutic indications in so far as it does not concern an addition or modification of an indication that is to be classified under another area of therapy,
2. a limitation of the contra-indications, adverse reactions or interactions with other medicinal products or other substances,
3. a change in either the type or quantity of the excipients, or in the quantity of active substances,
4. a change in the pharmaceutical form into a pharmaceutical form that is compatible with the approved pharmaceutical form,
5. a change in the manufacturing or test procedures, including the information pursuant to Section 21a sub-section 2 sentence 1 number 5,
6. a change in the conditions for storage and the shelf life, or
7. in the case of advanced therapy medicinal products consisting of a genetically modified organism or a combination of genetically modified organisms or containing such organisms, a change that is capable of modifying the risk assessment for the health of non-affected persons or the environment.
The decision on the application for approval must be taken within three months. Sub-section 4 and Section 27 sub-section 2 shall apply mutatis mutandis.
(10) By way of derogation from sub-section 9, a new approval pursuant to sub-section 3 must be applied for in the following cases:
1. in the case of a broadening of the therapeutic indications, in so far as a change pursuant to sub-section 9 sentence 1 number 1 is not concerned,
2. in the case of a change in the composition of the active substances either in type,
3. in the case of a change in the pharmaceutical form, in so far as a change pursuant to sub-section 9 sentence 1 number 4 is not concerned,
The competent higher federal authority shall decide on the obligation to obtain an approval pursuant to sentence 1.
(11) Enquiries about the obligation to obtain an approval for an advanced therapy medicinal product shall be decided by the competent authority in consultation with the competent higher federal authority. Section 21 sub-section 4 shall apply mutatis mutandis.
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