Last Updated on May 29, 2021 by LawEuro
Medicinal Products Act (Laws / Regulations of Germany)
CHAPTER SEVEN
Sale of medicinal products
Section 43
Pharmacy-only requirement, placing on the market by veterinarians
(1) Medicinal products as defined in Section 2 sub-section 1 or sub-section 2 number 1, which are not released for trade outside of pharmacies by the provisions either of Section 44 or of the ordinance issued in compliance with Section 45 sub-section 1 may, except for the cases provided for in Section 47, be placed on the market professionally or commercially to the consumer exclusively in pharmacies and not by sale at a distance without official authorisation; further details are regulated by the Act on Pharmaceutical Services (Apothekengesetz). With the exception of the cases provided for in sub-section 4 and Section 47 sub-section 1, no trade may be conducted outside of pharmacies with those medicinal products reserved exclusively for sale in pharmacies pursuant to sentence 1. The information about the issuing or modification of an authorisation for the sale at a distance of medicinal products pursuant to sentence 1 shall be entered into the database referred to in Section 67a.
(2) Medicinal products reserved, in compliance with sub-section 1 sentence 1, for trade in pharmacies, may not be dispensed by legal persons, non-incorporated associations and companies established under civil law and under commercial law to their members, unless these members are either pharmacies themselves or are persons and establishments as defined in Section 47 sub-section 1 and the dispensing of medicinal products is carried out under the conditions specified therein.
(3) Medicinal products as defined in Section 2 sub-section 1 or sub-section 2 number 1 may only be dispensed by pharmacies upon prescription. This shall be without prejudice to Section 56 sub-section 1.
(4) Medicinal products within the meaning of Section 2 sub-section 1 or sub-section 2 number 1 may furthermore be dispensed by veterinarians, within the framework of the operation of a veterinary in-house dispensary, to the owners of animals undergoing treatment and may be held in stock for this purpose. This shall also apply to the dispensing of medicinal products, deemed advisable by veterinarians and supervised by them, for the purpose of implementing measures to prevent illness in animals whereby the amount dispensed may not exceed the amount needed according to veterinarian indication. Furthermore, medicinal products within the meaning of Section 2 sub-section 1 or sub-section 2 number 1, which are intended for the conduct of animal health measures and are not subject to prescription, may continue to be dispensed to animal keepers by the veterinary authorities, in the amounts necessary in each case. At the time of dispensing, the animal keeper shall be given written instructions about the manner, timing and duration of use.
(5) Medicinal products intended for administration to animals and which are not released for trade outside of pharmacies, may only be dispensed to the animal keeper or to other persons not specified in Section 47 sub-section 1 in pharmacies or in the veterinarian’s in-house dispensary or by the veterinarian. This shall apply neither to medicated feeding stuffs nor to medicinal products within the meaning of sub-section 4 sentence 3. By way of derogation from sentence 1, medicinal products which are authorised for administration exclusively to non-food-producing animals may be dispensed through sale at a distance by pharmacies which are officially authorised to do so pursuant to sub-section 1. Furthermore, medicinal products specified in sentence 3 may be dispensed through sale at a distance within the framework of the operation of a veterinary in-house dispensary in an amount required for the short-term further treatment of individual animals treated by the veterinarian. This shall be without prejudice to other provisions governing the dispensing of medicinal products by veterinarians pursuant to this Act and the Veterinary In-House Dispensaries Ordinance (Verordnung über tierärztliche Hausapotheken).
(6) In the context of the transfer of a veterinary praxis to the successor operating the veterinary in-house dispensary, medicinal products may be handed over.
Section 44
Exceptions to the pharmacy-only requirement
(1) Medicinal products which are intended by the pharmaceutical entrepreneur solely to serve purposes other than the curing or alleviation of disease, suffering, bodily injuries or symptoms of illness shall be released for trade outside of pharmacies.
(2) Furthermore, the following shall be released for trade outside of pharmacies:
1.
a) natural curative waters as well as their salts, also in the form of tablets or pastilles,
b) synthetic curative waters as well as their salts, also in the form of tablets or pastilles, but only if they are equivalent in their composition to natural curative waters,
2. therapeutic clays, moor muds for baths and other peloids, preparations for the manufacturing of baths, soaps for external use,
3. designated by their customary German names,
a) plants and parts of plants, also chopped,
b) mixtures of whole or cut plants or parts of plants as finished medicinal products,
c) distillates made from plants and parts of plants,
d) juices pressed from fresh plants and parts of plants in so far as they are prepared without the use of any solvents other than water,
4. plasters,
5. disinfectants intended exclusively or mainly for external use as well as disinfectants for the mouth and the throat.
(3) Sub-sections 1 and 2 shall not apply to medicinal products which:
1. may only be dispensed upon a medical, dental or veterinarian prescription or
2. are excluded by ordinance pursuant to Section 46 from trade outside of pharmacies.
Section 45
Authority to allow further exceptions to the pharmacy-only requirement
(1) The Federal Ministry is hereby empowered to release, in agreement with the Federal Ministry for Economic Affairs and Energy and upon consultation with experts, by ordinance, subject to the approval of the Bundesrat, substances, preparations made from substances or objects which are intended to be used either in part or exclusively in curing or alleviating diseases, suffering, bodily injuries or symptoms of diseases, for trade outside of pharmacies:
1. in so far as they may not only be dispensed upon a medical, dental or veterinarian prescription,
2. in so far as they do not require testing, storage and dispensing to be carried out in a pharmacy, as a result of their composition or effect,
3. in so far as a direct or indirect hazard to human or animal health need not be feared as a result of their release or in particular as a result of inappropriate handling or
4. in so far as the proper supply of medicinal products is not jeopardized by their release.
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.
(2) The release may be limited to finished medicinal products, certain dosages, therapeutic indications or pharmaceutical forms.
(3) The ordinance shall be issued in agreement with the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety, in so far as radiopharmaceuticals and medicinal products in the manufacture of which ionizing radiation is used are concerned.
Section 46
Authority to extend the pharmacy-only requirement
(1) The Federal Ministry is hereby empowered to exclude, in agreement with the Federal Ministry for Economics and Energy and upon consultation with experts, by ordinance subject to the approval of the Bundesrat, medicinal products as defined in Section 44 from trade outside of pharmacies, if a direct or indirect hazard to human or animal health is to be feared even when such medicinal products are used in keeping with their designated purpose or in the customary manner. 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.
(2) The ordinance in compliance with sub-section 1 may be limited to certain dosages, therapeutic indications or pharmaceutical forms.
(3) The ordinance shall be issued in agreement with the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety, in so far as radiopharmaceuticals and medicinal products in the manufacture of which ionizing radiation is used are concerned.
Section 47
Distribution channel
(1) Pharmaceutical entrepreneurs and wholesalers may only supply medicinal products reserved for pharmacies to the following parties other than pharmacies:
1. other pharmaceutical entrepreneurs and wholesalers,
2. hospitals and physicians as far as the following items are concerned:
a) blood preparations obtained from human blood or blood components manufactured using genetic engineering which, in so far as clotting factor preparations are concerned, are authorised for dispensing by the haemostaseologically qualified physician to his/her patients within the framework of the medically supervised self-treatment of haemophiliacs,
b) tissue preparations or animal tissue,
c) infusion solutions in containers of at least 500 ml intended for the replacement or the correction of body fluid, as well as solutions for haemodialysis and transperitoneal dialysis which, in so far as solutions for transperitoneal dialysis are concerned, may be dispensed on prescription by the physician qualified in nephrology, in the context of a physician-supervised self-treatment, to his/her dialysis patients,
d) preparations which are exclusively intended for the diagnosis of the nature, state or functions of the body or mental health conditions,
e) medicinal gases which are authorised also for distribution to alternative practitioners,
f) radiopharmaceutical or,
g) medicinal products which are labelled ‘Zur klinischen Prüfung bestimmt’ (for clinical trial), in so far as they are furnished free of charge,
h) leeches and fly larvae (maggots) which are also authorised for dispensing to alternative practitioners, or
i) medicinal products which are made available in the case specified under Section 21 sub-section 2 number 6,
3. hospitals, public health offices and physicians, in the case of vaccines intended for use in a vaccination programme conducted free of charge, on the basis of Section 20 sub-sections 5, 6 or 7 of the Federal Protection against Infection Act of 20 July 2000 (Federal Law Gazette I, p.1045), or supplies of vaccines required to avoid the risk of an epidemic or threat to life,
3a. special yellow fever vaccination centres pursuant to Section 7 of the Act Implementing the International Health Regulations (2005), in so far as yellow fever vaccines are concerned,
3b. hospitals and public health offices, in the case of medicinal products with an antibacterial or antiviral action intended for use on the basis of Section 20 sub-sections 5, 6 or 7 of the Protection against Infection Act for specific prophylaxis against communicable diseases,
3c. federal health authorities or health authorities of the Laender or agencies designated by them in individual cases, in the case of medicinal products which are being stockpiled in case of a dangerous, communicable disease, the spread of which renders necessary an immediate supply of specific medicinal products in excess of normal requirements,
4. veterinary authorities, as far as medicinal products intended for use in the execution of public health measures are concerned,
5. central medicinal product purchasing agencies, established on a statutory basis or approved by the competent authority in consultation with the Federal Ministry,
6. veterinarians, within the framework of the operation of a veterinary in-house dispensary, in so far as finished medicinal products are concerned, for administration to animals undergoing treatment by them and for dispensing to the owners of those animals,
7. persons entitled to practise dentistry, as far as finished products are concerned, which are used exclusively in the field of dentistry and in the treatment of a patient,
8. research and scientific institutions which have been granted an authorisation pursuant to Section 3 of the Narcotic Drugs Act (Betäubungsmittelgesetz) entitling them to purchase the medicinal product in question,
9. universities, as far as medicinal products needed for the education of students of pharmacy and veterinary medicine are concerned.
The recognition of the central purchasing agency pursuant to sentence 1 number 5 shall be granted, in so far as medicinal products intended for administration to animals are concerned, in consultation with the Federal Ministry of Food and Agriculture.
(1a) Pharmaceutical entrepreneurs and wholesalers may only supply medicinal products intended for administration to animals to the recipients specified in sub-section 1 number 1 or 6 if the latter have submitted an attestation from the competent authority stating that they have fulfilled their obligation to notify according to Section 67.
(1b) Pharmaceutical entrepreneurs and wholesalers shall keep records on the purchase and distribution of prescription-only medicinal products intended for administration to animals and which are not exclusively intended for administration to animals other than those whose products and meat are intended for human consumption, from which the amount of the purchase with indication of the supplier(s) and the amounts supplied with indication of the recipient(s) can be proven for each of these medicinal products separately and in chronological order, and shall submit these records to the competent authority upon request.
(1c) Pharmaceutical entrepreneurs and wholesalers shall, by the 31 March of each calendar year, electronically notify the central medicinal product information system, pursuant to Section 67a sub-section 1, as prescribed in an ordinance pursuant to sentence 2, about the type and quantity of medicinal products supplied to veterinarians in the previous calendar year which contained:
1. substances with an anti-microbial effect,
2. substances listed in Table 2 of the Annex to Regulation (EU) No. 37/2010, or
3. substances listed in one of the annexes of the Ordinance on Substances with Pharmacological Effects.
The Federal Ministry of Food and Agriculture shall be empowered, in agreement with the Federal Ministry, by ordinance subject to the approval of the Bundesrat:
1. to specify details concerning the content and the form of the notification pursuant to sentence 1, and
2. to stipulate that:
a) the notifications contain the marketing authorisation number of the medicinal product supplied in each case,
b) the notification about the quantity of medicinal product supplied be itemised using the first two digits of the veterinarian’s postal area code.
Furthermore, ordinances pursuant to sentence 2 can contain regulations governing the corresponding application of Section 67a sub-section 3 and 3a.
(2) The recipients specified in sub-section 1 numbers 5 to 9 may only obtain medicinal products for their own use within the framework of the fulfilment of their duties. The central purchasing agencies specified in sub-section 1 number 5 shall only be officially recognized if evidence is produced that they are run under the professional supervision of a pharmacist or, in so far as medicinal products intended for administration to animals are concerned, under the professional supervision of a veterinarian, and provided that suitable premises and equipment are available for the testing, control and storing of the medicinal products.
(3) Pharmaceutical entrepreneurs may supply samples of finished medicinal products or have samples of finished medicinal products supplied to:
1. physicians, dentists or veterinarians or
2. other persons practising medicine or dentistry as a profession, provided no prescription-only medicinal products are involved,
3. training centres for health professions.
Pharmaceutical entrepreneurs may supply samples of a finished medicinal product or have samples of a finished medicinal product supplied to training centres for health professions only in the amounts required for the purpose of training. Samples may not contain any of the substances or preparations:
1. referred to in Section 2 of the Narcotic Drugs Act or listed as such in Annexes II or III of the Narcotic Drugs Act, or
2. which, pursuant to Section 48 sub-section 2 sentence 3, may only be prescribed by special prescription.
(4) Pharmaceutical entrepreneurs may supply samples of a finished medicinal product or have samples of a finished medicinal product supplied to persons pursuant to sub-section 3 sentence 1 only upon written request in the smallest package size and, in the course of one year, not more than two samples of one finished medicinal product. Samples shall be accompanied by the relevant expert information in so far as such information is provided for in Section 11a. The sample shall particularly serve the purpose of informing the physician about the medicinal product itself. Records shall be kept on the recipients of samples, the kind and extent as well as the date on which the samples were supplied, under separate cover for each recipient, and they shall be submitted to the competent authority upon request.
Section 47a
Special distribution channels, obligation to keep records
(1) Pharmaceutical entrepreneurs may supply a medicinal product that is authorised for the conduct of abortions only to facilities within the meaning of Section 13 of the Pregnancy Conflicts Act of 27 July 1992 (Federal Law Gazette I, p. 1398) amended by Article 1 of the Act of 21 August 1995 (Federal Law Gazette I, p. 1050) and only on the prescription of one of the physicians administering treatment in said facility. Other persons are not authorised to place the medicinal products specified in sentence 1 on the market.
(2) Pharmaceutical entrepreneurs shall give serial numbers to the packages of the medicinal products specified in sub-section 1 sentence 1 which are intended for delivery; the medicinal products may not be delivered without this labelling. The pharmaceutical entrepreneur shall keep records of the delivery and both the facility and the attending physician shall keep records of the receipt and use of said medicinal products and shall submit them for inspection to the competent authority upon request.
(2a) Both the pharmaceutical entrepreneur and the facility shall store the medicinal products specified in sub-section 1 sentence 1 which are in their possession in a separate place and secure them against unauthorised removal.
(3) Sections 43 and 47 shall not apply to the medicinal products specified in sub-section 1 sentence 1.
Section 47b
Special distribution channels, diamorphine
(1) Pharmaceutical entrepreneurs may supply a finished medicinal product containing diamorphine which is authorised for opioid substitution treatment, only to a recognised facility pursuant to Section 13 sub-section 3 sentence 2 number 2a of the Narcotic Drugs Act and only on prescription by a physician treating at that facility. Other persons may not place the medicinal products specified in sentence 1 on the market.
(2) Sections 43 and 47 shall not apply to the medicinal products specified in sub-section 1 sentence 1.
Section 48
Prescription requirement
(1) Medicinal products:
1. that, pursuant to the ordinance issued in sub-section 2, also in conjunction with sub-sections 4 and 5, are certain substances, preparations from substances or objects or which have such substances or preparations from substances added to them, or
2. that are not included under number 1 and are intended for use in food-producing animals, or
3. are medicinal products pursuant to Section 2 sub-section 1 or sub-section 2 number 1, which contain substances that have effects which are not generally known in medical science, or contain preparations of such substances, shall be dispensed to consumers only on prescription by a physician, dentist or veterinarian. Medicinal products for human use may not be dispensed if it is obvious that no direct contact took place between the physician or dentist and the person for whom the medicinal product was prescribed, before the medical or dental prescription was issued. Only in justified exceptional cases is deviation from this practice allowed, particularly when the physician or dentist knows the person sufficiently well from prior direct contact and the treatment is merely being repeated or continued. Sentence 1 number 1 and sentence 2 shall not apply to dispensing by pharmacies for the equipping of merchant ships with the medicinal products necessary, according to maritime labour regulations, to protect the health of persons on board and enable their immediate, appropriate medical treatment on board. Sentence 1 number 3 shall also apply to medicinal products which are preparations derived from substances whose effects are generally known even if the effects of these preparations are not generally known to medical science, unless the effects can be determined on the basis of the preparation’s composition, dosage, pharmaceutical form or therapeutic indication. Sentence 1 number 3 shall apply not only to medicinal products which are preparations made from substances whose effects are known if these are available outside of pharmacies. With the inclusion of the substance or preparation in question in the ordinance pursuant to sub-section 2 number 1, the obligation to obtain a prescription pursuant to the ordinance shall supersede the obligation to obtain a prescription pursuant to sentence 1 number 3.
(2) The Federal Ministry is hereby empowered, in agreement with the Federal Ministry for Economic Affairs and Energy by ordinance subject to the approval of the Bundesrat:
1. to specify substances or preparations made of substances, for which the prerequisites pursuant to sub-section 1 sentence 1 number 3, also in conjunction with sub-section 1 sentence 5, are fulfilled,
2. to specify substances, preparations thereof or objects:
a) that can either directly or indirectly endanger human health or, if they are intended for use in animals, the health of the animal, the user or the environment, even under normal conditions of use, if used without medical, dental or veterinary supervision,
b) that are frequently used in considerable quantity, in a manner which is not in keeping with their designated purpose, if this might represent a direct or indirect risk to human or animal health; or
c) if they are intended for use in animals, if their use requires a prior veterinary diagnosis or can have effects that render subsequent diagnostic or therapeutic procedures more difficult or interfere with them,
3. to repeal the prescription-only status of medicinal products if experience gained from using them shows that the conditions referred to in number 2 do not or no longer exist; in the case of medicinal products referred to in number 1, the prescription-only status cannot be repealed until at least three years have elapsed since entry into force of the ordinance on which it is based,
4. for substances or preparations thereof, to stipulate that they may be supplied only if certain maximum quantities for single and daily use are not exceeded in the prescription or if, when they are exceeded, the prescriber has expressly made this clear,
5. to specify that a medicinal product cannot be repeatedly dispensed on the same prescription,
6. to stipulate that a medicinal product can be supplied only on prescription by a physician with a specific specialty or for use in facilities authorised to carry out treatment with the medicinal product or that records must be kept of the prescription, dispensing and use of the medicinal product,
7. to issue provisions on the form and content of the prescription, including prescriptions in electronic form.
8. to determine the cases in which exceptions exist to the requirements stipulated in sub-section 1 sentence 2.
The ordinance pursuant to sentence 1 numbers 2 to 7 shall be issued after hearing experts unless medicinal products are concerned that are authorised pursuant to Article 3 (1) or (2) of Regulation (EC) No. 726/2004 or that correspond to such medicinal products with respect to their active substances, indications, strength and pharmaceutical form. In the case of medicinal products the prescription of which requires compliance with special safety requirements, it may be stipulated in the ordinance pursuant to sentence 1 number 7, that:
1. the prescription may only be written on an official form (special prescription) which is issued by the competent higher federal authority at the request of a physician,
2. the form must contain information on the use as well as confirmations, especially regarding obligations to inform patients about the use and risks of the medicinal product, and
3. a copy of the prescription is to be returned to the competent higher federal authority by the pharmacy.
(3) The ordinance referred to in sub-section 2, also in conjunction with sub-sections 4 and 5, can be restricted to specific dosages, strengths, pharmaceutical forms, finished medicinal products or therapeutic indications. Similarly, an exception to the prescription-only requirement may be envisaged for dispensing to midwives and obstetric nurses where this is deemed necessary for the proper exercise of their profession. The restriction to specific finished medicinal products for use in human beings pursuant to sentence one shall apply if, pursuant to Article 74a of Directive 2001/83/EC, the prescription-only requirement is repealed on the basis of significant preclinical tests or clinical trials; in this regard, the period of one year referred to in Article 74a shall be observed.
(4) 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.
(5) The ordinance shall be issued in agreement with the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety, in so far as radiopharmaceuticals and medicinal products in the manufacture of which ionizing radiation is used are concerned.
(6) In the case referred to in sub-section 1 sentence 1 number 2, the Federal Ministry of Food and Agriculture shall be empowered, in agreement with the Federal Ministry, by ordinance subject to the approval of the Bundesrat, to grant exemptions from the prescription requirement subject to compliance with the requirements laid down in Articles 67 (aa) of Directive 2001/82/EC.
Section 49
(no longer applicable)
Section 50
Retail trading of over-the-counter medicinal products
(1) The retailing, outside of pharmacies, of medicinal products as defined in Section 2 sub-section 1 or sub-section 2 number 1 which are released for trade outside of pharmacies, may only be carried out if the entrepreneur, the legally appointed representative of the enterprise or a person commissioned by the entrepreneur either to head the enterprise or to head its sales section, is in possession of the necessary expert knowledge. Enterprises with several branch premises shall require a person having the necessary expert knowledge for each of the branch premises.
(2) To be considered as possessing the necessary expert knowledge, the person in question shall furnish proof of experience and skill in respect of the proper filling, packaging, labelling, storing and marketing of medicinal products which are released for trade outside of pharmacies as well as knowledge of the existing regulations applicable to these medicinal products. The Federal Ministry is hereby empowered to issue, in agreement with the Federal Ministry for Economic Affairs and Energy and the Federal Ministry for Education and Research, by ordinance subject to the approval of the Bundesrat, regulations as to how proof of the necessary expert knowledge is to be furnished in order to guarantee a proper trade in medicinal products. It may hereby recognize certificates of professional training or of attendance at further education courses. Furthermore, it may stipulate that proof of the expert knowledge shall be furnished by means of an examination set by the competent authority or by an office accordingly designated by that same authority and may regulate the particulars of the examination requirements and procedure. The ordinance shall be issued by the Federal Ministry of Food and Agriculture in agreement with the Federal Ministry, the Federal Ministry for Economic Affairs and Energy and the Federal Ministry for Education and Research in so far as medicinal products intended for administration to animals are concerned.
(3) Expert knowledge pursuant to sub-section 1 shall not be required by a person retailing finished medicinal products which:
1. may be distributed in itinerant trading,
2. are intended for use as a contraceptive or for the prevention of venereal diseases in human beings,
3. (no longer applicable)
4. are disinfectants intended exclusively for external use, or
5. are oxygen.
Section 51
Sale by itinerant traders
(1) Itinerant traders shall be prohibited from offering medicinal products for sale or seeking to procure orders for medicinal products; exempted from the prohibition shall be finished medicinal products released for trade outside of pharmacies which:
1. are plants, parts of plants or juices pressed from fresh plants or parts of plants, the effects of which are generally known and which are designated by their customary German names, provided they are manufactured without the use of any solvent other than water, or
2. are curative waters and their salts in their natural mixing proportions or imitations thereof.
(2) The prohibition contained in the first half-sentence of sub-section 1 shall not apply if the trader visits other persons within the framework of their business activities, unless the trader offers for sale medicinal products which are intended for administration to animals in agricultural and forestry undertakings, commercial livestock enterprises as well as for use in vegetable, fruit growing and horticultural enterprises, or in wine-growing, bee-keeping and fishery, or seeks to procure, in such undertakings, orders for medicinal products, the dispensing of which is reserved solely for pharmacies. The same shall also apply to commercial travellers and other persons active on behalf of and in the name of a trader.
Section 52
Prohibition of self-service
(1) Medicinal products as defined in Section 2 sub-section 1 or sub-section 2 number 1 may:
1. not be placed on the market by means of vending machines,
2. nor be placed on the market using other forms of self-service.
(2) Sub-section 1 shall not apply to finished medicinal products which:
1. may be distributed in itinerant trading,
2. are intended for use as contraceptives or for the prevention of venereal disease in human beings and which have been released for trade outside of pharmacies,
3. (no longer applicable)
4. are disinfectants intended exclusively for external use, or
5. are oxygen.
(3) Furthermore, sub-section 1 number 2 shall not be applicable to medicinal products released for marketing outside of pharmacies in cases where a person in possession of the expert knowledge required under Section 50 is available.
Section 52a
Wholesale trading of medicinal products
(1) Any person who engages in the wholesale trading of medicinal products within the meaning of Section 2 sub-section 1 or sub-section 2 number 1, test sera or test antigens, requires an authorisation to do so. Excepted from this obligation to obtain an authorisation are the finished medicinal products specified in Section 51 sub-section 1 number 2 and released for trade outside of pharmacies.
(2) In submitting the application, the applicant shall:
1. name the specific sites, as well as he activities and the medicinal products for which the authorisation is to be issued,
2. submit evidence that he/she is in possession of suitable and adequate premises, installations and facilities in order to ensure the proper storage and distribution and, where envisaged, proper decanting, packaging and labelling of medicinal products,
3. appoint a responsible person who possesses the required expert knowledge to perform the activity and
4. enclose a statement in which he/she commits himself in writing to observe the regulations governing the proper operation of a wholesale enterprise.
(3) The decision on the granting of the authorisation shall be reached by the competent authority of the federal Land where the factory site is situated or is to be situated. The competent authority shall reach a decision on the application for an authorisation within a period of three months. Should the competent authority require additional information from the applicant on the prerequisites pursuant to sub-section 2, the deadline specified in sentence 2 shall be interrupted until such time as the competent authority has received the necessary additional information.
(4) The authorisation may only be refused if:
1. the prerequisites pursuant to sub-section 2 are not fulfilled,
2. facts justify the assumption that the applicant or the person responsible pursuant to sub-section 2 number 3 does not possess the necessary reliability to perform the activity, or
3. the wholesaler is unable to guarantee that the regulations governing proper operations are being observed.
(5) The authorisation shall be withdrawn if it becomes known subsequently that one of the grounds for refusal, pursuant to sub-section 4 existed at the time the authorisation was granted. The authorisation is to be revoked if the prerequisites for the granting of an authorisation no longer exist; instead of the revocation, the suspension of the authorisation may also be ordered.
(6) An authorisation pursuant to Section 13 or Section 72 shall also include authorisation for the wholesale trading of the medicinal products covered by the authorisation referred to in Section 13 or Section 72.
(7) Sub-sections 1 to 5 shall not apply to the activities conducted by pharmacies within the framework of normal pharmacy operations.
(8) The authorisation holder shall notify the competent authority in advance of any changes in the information specified in sub-section 2 as well as any fundamental change in the wholesale trading activity, submitting evidence to that effect. In the case of an unforeseen change with respect to the person responsible pursuant to sub-section 2 number 3, the notification shall be immediate.
Section 52b
Supply of medicinal products
(1) Pharmaceutical entrepreneurs and operators of wholesale businesses for medicinal products who, within the purview of this Act, distribute a medicinal product which has actually been placed on the market and is intended for use in or on human beings, which has been authorised for marketing by the competent higher federal authority or for which a marketing authorisation pursuant to Article 3 (1) or (2) of Regulation (EC) No. 726/2004 has been granted by the European Community or the European Union, shall ensure an adequate and continuous supply of the medicinal product so that the demand from patients within the purview of this Act is met.
(2) Pharmaceutical entrepreneurs must guarantee, within the framework of their responsibility, a demand-oriented and continuous supply to the full-range wholesalers of medicinal products. Full-range wholesalers of medicinal products are wholesale businesses which maintain a complete, manufacturer-independent assortment of pharmacy-only medicinal products which, in terms of depth and scope, is constituted in such a way that the demand from patients from the pharmacies with which the wholesaler does business can be met within an appropriate space of time on weekdays; the medicinal products to be kept in stock must correspond, in such a case, to at least the average demand for a period of two weeks. Sentence 1 shall not apply to medicinal products which are subject to the distribution channels specified in Section 47 sub-section 1 sentence 1 numbers 3 to 9 or Section 47a or which, for other legal or practical reasons, cannot be supplied through the wholesale business.
(3) Full-range wholesalers of medicinal products must, within the framework of their responsibility, guarantee a demand-oriented and continuous supply to the pharmacies with which they do business. Sentence 1 shall apply mutatis mutandis to other medicinal product wholesale businesses for the totality of the medicinal products they hold in stock in each case.
(3a) Pharmaceutical entrepreneurs must, within the framework of their responsibility, inform hospitals without delay, once they become aware of delivery bottlenecks for prescription-only medicinal products used in inpatient care.
(4) This shall be without prejudice to the provisions contained in the Act against Restraints of Competition (Gesetz gegen Wettbewerbsbeschränkungen).
Section 52c
Brokering of medicinal products
(1) A medicinal product broker may conduct activities within the purview of this Act only if he/she is domiciled within the purview of this Act, in another Member State of the European Union or in another State Party to the Agreement on the European Economic Area.
(2) The medicinal product broker may begin his/her activities only after notifying the competent authority pursuant to Section 67 sub-section 1 sentence 1 and being registered by the authority in a public database pursuant to Section 67a or a database of another Member State of the European Union or in that of another State Party to the Agreement on the European Economic Area. The notification shall state the type of activity, the name and the address of the medicinal product broker. The competent authority pursuant to sentence 1 is the authority in whose remit the medicinal product broker has his/her domicile.
(3) If the medicinal product broker fails to meet the requirements stipulated in this Act or in an ordinance issued based on this Act, the competent authority can refuse to register him/her in the database or erase him/her from it.
Section 53
Expert consultation
(1) In so far as expert opinions need to be heard pursuant to Section 36 sub-section 1, Section 45 sub-section 1 and Section 46 sub-section 1 prior to the issue of ordinances, the Federal Ministry shall establish an expert committee by ordinance not subject to the approval of the Bundesrat. The committee shall comprise experts from the field of medical and pharmaceutical science, from hospitals, from the health professions, from the business circles involved and from the social security institutions. In the ordinance, the exact details of the composition, appointment of the members and the procedure of the committee may be determined. The ordinance shall be issued by the Federal Ministry of Food and Agriculture in agreement with the Federal Ministry, in so far as medicinal products intended for administration to animals are concerned.
(2) In so far as the opinion of experts needs to be heard pursuant to Section 48 sub-section 2, prior to the issue of an ordinance, sub-section 1 shall apply mutatis mutandis, subject to the provision that the committee shall comprise experts from the fields of medical and pharmaceutical science, as well as experts from the drug commissions of the physicians, veterinarians and pharmacists. The representatives of medical and pharmaceutical practice as well as representatives from the pharmaceutical industry shall participate in the meeting without the right to vote.
Leave a Reply