Last Updated on May 29, 2021 by LawEuro
Medicinal Products Act (Laws / Regulations of Germany)
CHAPTER FIFTEEN
Designation of the competent higher federal authorities and other provisions
Section 77
Competent higher federal authority
(1) The competent higher federal authority shall be the Federal Institute for Drugs and Medical Devices unless either the Paul Ehrlich Institute (the Federal Agency for Sera and Vaccines) or the Federal Office of Consumer Protection and Food Safety is competent.
(2) The Paul Ehrlich Institute shall be competent for sera, vaccines, blood preparations, tissue preparations, tissues, allergens, advanced therapy medicinal products, xenogeneic medicinal products and blood components manufactured using genetic engineering.
(3) The Federal Office of Consumer Protection and Food Safety shall be responsible for medicinal products which are intended for administration to animals. For the purpose of monitoring the efficacy of antibiotics, the Federal Agency for Consumer Protection and Food Safety conducts repeated observations, tests and evaluations of the resistance developed by disease pathogens of animal origin to substances with an anti-microbial effect which are present as active substances in veterinary medicines (resistance monitoring). Resistance monitoring also includes the drawing up of reports.
(4) The Federal Ministry is hereby empowered, by means of ordinance not subject to the approval of the Bundesrat, to modify the competences of the Federal Institute for Drugs and Medical Devices and the Paul Ehrlich Institute, in so far as this is necessary to take account of new scientific developments or if such a change is required for reasons of a more uniform distribution of the workload.
Section 77a
Independence and transparency
(1) As regards the guarantee of independence and transparency, the competent higher federal authorities and the competent authorities shall ensure that staff employed by the authorising authorities or other competent authorities, who are involved with marketing authorisations and supervision, or experts appointed by them, have no financial or other interests in the pharmaceutical industry that could influence their neutrality. These persons shall make an annual declaration in this regard.
(2) Within the framework of performing the tasks referred to in this Act, the competent higher federal authorities and the competent authorities shall make the procedural rules of their committees, the agendas and minutes of their meetings accessible to the public; manufacturing and business secrets shall be protected in the process.
Section 78
Prices
(1) The Federal Ministry for Economic Affairs and Energy is hereby empowered to fix, in agreement with the Federal Ministry and, as far as medicinal products intended for administration to animals are concerned, in agreement with the Federal Ministry of Food and Agriculture, by ordinance subject to the approval of the Bundesrat:
1. price margins for medicinal products which are distributed in wholesale commerce or in pharmacies or which are re-sold by veterinarians,
2. prices for medicinal products which are manufactured and distributed in pharmacies or by veterinarians, as well as for the containers in which they are supplied,
3. prices for particular services rendered by pharmacies in connection with the dispensing of medicinal products.
By way of derogation from sentence 1, the Federal Ministry for Economic Affairs and Energy is hereby empowered to adjust that portion of the fixed mark-up that does not serve to promote the provision of emergency pharmacy services according to how pharmacy costs develop given cost-effective management, in agreement with the Federal Ministry, by ordinance not subject to the approval of the Bundesrat. The price regulations for wholesale commerce based on sentence 1 number 1, shall also apply to pharmaceutical entrepreneurs or other natural or legal persons who pursue an activity pursuant to Section 4 sub-section 22 in supplying pharmacies that purchase the medicinal products for the purpose of supplying consumers. The Medicinal Product Pricing Ordinance, issued on the basis of sentence 1 also applies to medicinal products that are introduced into the purview of this Act pursuant to Section 73 sub-section 1 sentence 1 number 1a.
(2) The prices and price margins shall take into account the legitimate interests of the medicinal product consumers, the veterinarians, the pharmacies and the wholesale trade; the legitimate interests of medicinal product consumers includes ensuring access to and supply of medicinal products pursuant to Section 52b. The prices and price margins shall take into account the legitimate interests of the medicinal product consumers, the veterinarians, the pharmacies and the wholesale trade; the legitimate interests of consumers of medicinal products includes ensuring supply. A uniform pharmacy retail price shall be guaranteed for medicinal products which are to be dispensed exclusively in pharmacies. Sentence 2 shall not apply to prescription-only medicinal products that are not subject to reimbursement by the statutory health insurance.
(3) In the case of medicinal products pursuant to sub-section 2 sentence 2 for which prices and price ranges have been specified by an ordinance pursuant to sub-section 1, the pharmaceutical entrepreneurs shall guarantee a uniform sales price; in the case of non-prescription medicinal products which are to be reimbursed by the statutory health insurance, the pharmaceutical entrepreneurs shall specify their uniform sales price from which exceptions may be made in individual cases, for the purpose of the settlement of accounts between the pharmacy and the statutory health insurance. Social insurance carriers, private health insurances, as well as their individual associations, can come to an agreement with the pharmaceutical entrepreneur on discounts off the uniform sales price for the prescription of medicinal products which they have to reimburse. When dispensing medicinal products for which the prices and price margins according to the ordinance pursuant to sub-section 1 are excluded from the price-fixing process, the uniform sales price pursuant to sentence 1 may not be exceeded.
(3a) If a reimbursement value applies to a medicinal product pursuant to Section 130b of the Fifth Book of the Social Code, the pharmaceutical entrepreneur shall sell the medicinal product at a price that amounts to the reimbursement value. By way of derogation from sentence 1, the pharmaceutical entrepreneur can sell the medicinal product for an amount that is lower than the specific refund amount; this shall be without prejudice to the obligation contained in sub-section 3 sentence 1 first half sentence. The sale price pursuant to sentence 1 or sentence 2 shall also apply for persons who do not obtain the medicinal product as members of a statutory health insurance in the form of a benefit in kind.
(4) In the case of medicinal products which, in the case of a threatening infectious disease, the spread of which requires an immediate supply of specific medicinal products which goes beyond the normal amount, are dispensed by pharmacies and which have been stored for this purpose, the prices and price ranges to be specified pursuant to sub-section 2 shall be based on the sales price for the specific Land. The same shall apply to medicinal products manufactured in pharmacies from active substances stored for this purpose and dispensed in such cases. In these cases, sub-section 2 sentence 2 shall apply at Land level.
Section 79
Authority to permit exceptions in times of crisis
(1) The Federal Ministry is hereby empowered to permit exceptions to the regulations laid down by this Act and by the ordinances issued by virtue of this Act, in agreement with the Federal Ministry for Economic Affairs and Energy, by ordinance subject to the approval of the Bundesrat, if the necessary supply of medicinal products to the population would otherwise be seriously jeopardized and if a direct or indirect hazard by medicinal products to human health is not to be feared; in particular, regulations can be adopted to counter the spread of risks that might occur in reaction to the presumed or confirmed spread of pathogenic substances, toxins, chemicals or exposure to ionising radiation.
(2) The Federal Ministry of Food and Agriculture is hereby empowered to permit exceptions to the provisions contained in this Act and the ordinances issued on the basis of this Act, in agreement with the Federal Ministry and the Federal Ministry for Economic Affairs and Energy, by ordinance not subject to the approval of the Bundesrat, if the necessary supply of medicinal products to livestock would otherwise be seriously jeopardised and if a direct or indirect hazard by medicinal products to human or animal health is not to be feared.
(3) The ordinances pursuant to sub-section 1 or 2 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 ionising radiation is used or regulations to protect against the risks of ionising radiation are concerned.
(4) The term of validity of the ordinance pursuant to sub-section 1 or 2 shall be limited to six months.
(5) In the event of a shortage of medicinal products necessary for the prevention or treatment of life-threatening diseases in the population or in the event of a dangerous communicable disease the spread of which calls for the provision of specific medicinal products immediately and in a quantity that considerably exceeds the norm, the competent authorities may permit, on a case-by-case basis, that medicinal products which are not authorised or registered for placing on the market within the purview of this Act:
1. may be placed on the market temporarily, and
2. may be introduced into the purview of this Act by way of derogation from Section 73 sub-section 1.
Sentence 1 shall apply if the medicinal products may be legally placed on the market in the State from which they are being introduced into the purview of this Act. The granting of permission by the competent authority also counts as an attestation pursuant to Section 72a sub-section 1 sentence 1 number 3 or pursuant to Section 72b sub-section 2 sentence 1 number 3, that the import is in the public interest. In the event of a shortage or a dangerous communicable disease within the meaning of sentence 1, the competent authorities can, on a case-by-case basis, also permit a temporary deviation from the authorisation requirements or from other prohibitions contained in this Act. The Federal Ministry shall be responsible for assessing whether a shortage or a dangerous communicable disease within the meaning of sentence 1 exists or no longer exists. The assessment shall be made known by way of a notification published in the Federal Gazette. The notification shall be issued in agreement with the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, in so far as radiopharmaceuticals and medicinal products in the manufacture of which ionising radiation is used are concerned.
(6) Measures by the competent authorities pursuant to sub-section 5 are to be restricted to the minimum necessary and must be appropriate to counter the health threats that could be created by the shortage or by the dangerous communicable disease. The lodging of an objection or action to rescind taken in respect of measures pursuant to sub-section 5, shall have no suspensive effect.
Section 80
Authority to issue procedural and compassionate use regulations
The Federal Ministry is hereby empowered to regulate, by ordinance not subject to the approval of the Bundesrat, further details regarding the procedure in respect of:
1. the marketing authorisation including the prolongation of the manufacturing authorisation,
1a. the approval pursuant to Section 21a sub-section 1 or the attestation pursuant to Section 21a sub-section 9,
1b. approval pursuant to Section 4b sub-section 3,
2. the official batch testing and batch release,
3. the notifications in respect of changes in the marketing authorisation documents,
3a. the notifications of changes in the information and documentation submitted for the authorisation pursuant to Section 21a sub-section 1 or changes in the requirements for the attestation pursuant to Section 21a sub-section 9,
3b. the notifications of changes in the information and documentation submitted for the authorisation pursuant to Section 4b sub-section 3,
3c. the competent higher federal authority and the persons involved in the placing on the market in cases of compassionate use pursuant to Section 21 sub-section 2 sentence 1 number 6 in conjunction with Article 83 of Regulation (EC) No. 726/2004,
4. the registration, including the prolongation of the registration,
4a. the notifications in respect of changes in the registration documents,
4b. the publication of the results of clinical trials pursuant to Section 42b,
5. the reporting of medicinal product risks, and
6. the electronic submission of documents pursuant to numbers 1 to 5 including the formats to be used,
in the process, it may require the forwarding of duplicates to the competent authorities and stipulate that the documents are to be submitted in multiple copies as well as on electronic or optical storage media. The Federal Ministry can transfer this authority to the competent higher federal authority without the approval of the Bundesrat. In the ordinance pursuant to sentence 1 number 3a, in particular, the tasks of the competent higher federal authority with regard to the participation of the European Medicines Agency and the Committee for Medicinal Products for Human Use, pursuant to Article 83 of Regulation (EC) No. 726/2004, and the areas of responsibility of the treating physicians and pharmaceutical entrepreneurs or sponsors can be regulated, including notification, documentation and reporting requirements for adverse reactions in particular, pursuant to Article 24 paragraph and Article 25 of Regulation (EC) No. 726/2004. In this regard, regulations can also be laid down for medicinal products which, under the conditions laid down in Article 83 of Regulation (EC) No. 726/2004, relate to medicinal products that are not among those referred to in Article 3 (1) or (2) of this Regulation. The ordinance pursuant to sentences 1 and 2 shall be issued in agreement with the Federal Ministry of Food and Agriculture, in so far as medicinal products intended for administration to animals is concerned.
Section 81
Relation to other laws
The regulations contained in the legislation on narcotic medicinal products and on nuclear energy, the Anti-Doping Act and those contained in the Law on the Protection of Animals shall not be affected.
Section 82
General administrative regulations
The Federal Government shall issue, with the approval of the Bundesrat, the general administrative regulations required for the implementation of this Act. In so far as these apply to the competent higher federal authority, the general administrative regulations shall be issued by the Federal Ministry. The general administrative regulations pursuant to sentence 2 shall be issued in agreement with the Federal Ministry of Food and Agriculture, in so far as medicinal products intended for administration to animals are concerned.
Section 83
Approximation to European Union legislation
Ordinances or general administrative regulations issued in compliance with this Act may also be issued for the purpose of approximation to the legal and administrative regulations of the Member States of the European Union, in so far as this is necessary for the implementation of regulations, directives, decisions or resolutions adopted by European Community or the European Union, which affect fields covered by this Act.
Section 83a
Ordinances for specific cases
The Federal Ministry is hereby empowered to amend, by ordinance not subject to the approval of the Bundesrat, references to regulations contained in legal instruments of the European Community or the European Union in this Act, or in ordinances issued on the basis of this Act, in so far as necessary to adapt to changes in these regulations. In the case of regulations governing medicinal products or substances which are intended for administration to animals, the Federal Ministry of Food and Agriculture shall supersede the Federal Ministry and shall issue the ordinance in agreement with the Federal Ministry.
Section 83b
Publication of ordinances
Ordinances pursuant to this Act can, in derogation of Section 2 sub-section 1 of the Promulgation and Notification Act, be published in the Federal Gazette.
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