Slide 174-196

Prices The Federal Ministry of Economics and Technology 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 Agriculture, Food and Consumer Protection, 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 sold 3. prices for particular services rendered by pharmacies in connection with the dispensing of medicinal products.

Authority to permit exceptions in times of crisis

The Federal Ministry is hereby empowered to permit exceptions to the regulations laid down by the present Act and by the ordinances issued by virtue of the present Act, in agreement with the Federal Ministry of Economics and Technology, by ordinance not 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. The Federal Ministry of Agriculture, Food and Consumer Protection is hereby empowered to permit exceptions to the provisions contained in the present Act and the ordinances issued on the basis of the present Act, in agreement with the Federal Ministry and the Federal Ministry of Economics and Technology, by ordinance not subject to the approval of the Bundesrat, if the necessary supply of medicinal products to livestock

the general administrative regulations required for the implementation of the present Act. General administrative regulations € The Federal Government shall issue. The ordinances pursuant to sub -section 1 or 2 shall be issued in agreement with the Federal Ministry for the Environment. 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. The term of validity of the ordinance pursuant to sub -section 1 or 2 shall be limited to six months. Authority to issue procedural and compassionate use regulations The Federal Ministry is hereby empowered to regulate. with the approval of the Bundesrat.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. the marketing authorisation including the prolongation of the manufacturing authorisation 2. the official batch testing and batch release 3. . the reporting of medicinal product risks. further details regarding the procedure in respect of: 1. the registration 5. by ordinance not subject to the approval of the Bundesrat. Nature Conservation and Nuclear Safety. of changes in the marketing Relation to other laws € The regulations contained in the legislation on narcotic medicinal products and on nuclear energy and those contained in the Law on the Protection of Animals shall not be affected. the notifications in respect authorisation documents 4.

expert information or instructions for use which do not comply with current medical knowledge. the medicinal product has harmful effects which exceed the limits considered tolerable in the light of current medical knowledge. the injured party can request information from the pharmaceutical entrepreneur unless such information is not necessary to verify a right to compensation pursuan t. the damage will be presumed to have been caused by the medicinal product in question. . or the body or the health of a person is substantially damaged. the pharmaceutical entrepreneur who placed the medicinal product on the market within the purview of the present Act shall be obliged to compensate the injured party for the damage caused. the damage has occurred as a result of labelling. in the circumstances pertaining to the individual case. The liability to compensate shall only exist if 1. which was distributed to the consumer within the purview of the present Act and which is subject to compulsory marketing authorisation or is exempted by ordin ance from the need for a marketing authorisation. as a result of the administration of a medicinal product intended for human use.LIABILITY FOR DAMAGES CAUSED BY MEDICINAL PRODUCTS Absolute liability If. € If the medicinal product administered is capable of causing the damage. a person is killed. The authority is not obliged to disclose the information where provisions require that the data remain secret or when non -disclosure is justified by an overriding interest of the pharmaceutical entrepreneur or a third party.or 2. when used in accordance with its intended purpose. The pharmaceutical entrepreneur shall be exempted from liability to pay damages pursuant € Right to disclosure Where facts exist to justify the assumption that a medicinal product has caused the damage.

the party liable for damages shall indemnify the third party. only up to a capital amount of 600. compensation shall be given by reimbursing the costs of the treatment as well as the costs incurred by the pecuniary prejudice sustained by the injured party as a result of the temporary or permanent suspension or reduction of his earning capacity or the resultant increase in his needs. at the time of injury.000euros or an annuit y of up to 36.Extent of liability for damages in the case of death (1) In the case of death. Liability for damages shall also be enforced if. compensation shall be made by reimbursing the costs of an attempted cure as well as the costs incurred by the pecuniary prejudice sustained by the deceased party as a result of the suspension or reduction of his earning capacity or the resultant increase in his needs during his disease. The party liable for damages shall furthermore reimburse the funeral costs to the party who is responsible for defraying these expenses. guaranteeing maintenance to the extent to which the deceased party would have been liable for the length of lifespan he would probably have had. (2) If at the time of injury. in the case of the death of or injury to a person. Extent of liability for damages in the case of bodily injury In the case of injury to a person's body or damage to his health.000 euros per year. Maximum amounts The party liable for damages shall be liable 1. the dece ased party maintained a relationship with a third party by virtue of which he was or was liable to come under the legal obligation to support this third party and if the third party was deprived of the right to maintenance as a result of the death. In this case. .reasonable financial compensation can also be claimed when the damage is not of a pecuniary nature. the third party had been conceived but not yet born.

an exemption or warranty obligation issued by a domestic credit institution. the combined indemnification to be paid to several injured parties exceed the maximum amounts specified therein. 2.a third party insurance taken out with an insurance company authorised to conduct business within the purview of the present Act. in the case of the death of or injury to several persons by the same medicinal product. (2) No account shall be taken of sub -section 1 when determining the international jurisdiction of the courts of a foreign nation pursuant to Section 328 sub-section 1 no. has his usual place of abode at the time of filing the action shall have jurisdiction. Local jurisdiction (1) In the case of legal actions initiated on the basis of section 84. up to a capital amount of 120 million euros or an annuity of up to 7.2 million euros per year. 1 of the Code of Civil Procedure. failing this. 2. then the individual compensation shall be reduced pro -rata to the maximum total given. placed by him on the market. in the case of sentence 1 no. notwithstanding the limits stipulated in no. 1. It can only be made available by means of: 1. . Coverage provision (1) The pharmaceutical entrepreneur shall ensure that he is able to meet his legal commitments in respect of compensation for the damage incurred as a result of the administration of a medicinal product intended for human use.2.Should. the court in whose district the plaintiff has his domicile or. or a credit institution of one of the other Member States of the European Union or another State Party to the Agreement on the European Economic Area. The provision for coverage must be made available in the amounts specified in section 88 sentence 1. and subject to a compulsory marketing authorisation or exempted by ordinance from a marketing authorisation (provision for coverage).

Anabolic androgenic steroids a) Exogenous anabolic androgenic steroids          1-Androstendiol 1-Androstendion Bolandiol Bolasterone Boldenone Boldione Calusterone Clostebol Danazol  Dehydrochlormethyltestost erone Desoxymethyltestosterone Drostanolone Ethylestrenol Fluoxymesterone Formebolone Furazabol Gestrinone 4-Hydroxytestosteron         . Section 73d of the Penal Code shall apply if the perpetrator acts commercially or as a member of a gang which has come together for the recurrent commission of such acts. 2a.Confiscation Materials connected with an offence as defined in Section 95 or Section 96 or an administrative offence as defined in Section 97 may be confiscated. 1a. 3a in conjunction with Section 8 sub-section 1 no. as well as the manufacture and placing on the market of counterfeit medicinal p roducts pursuant to Section 95 sub-section 1 no. Section 74a of the Penal Code and Section 23 of the Law on Administrative Offences shall apply. Annex I. Anabolic active substances 1. Extended forfeiture In the cases mentioned in Section 95 sub -section 1 no.

synonym Dihydrotestosterone Prasterone.              Mestanolone Mesterolone Methandienone Metenolone Methandriol Methasterone Methyldienolone Methyl-1-testosteron Methylnortestosterone Methyltrienolone Methyltestosterone Mibolerone Nandrolone 19-Norandrostendion               Norboletone Norclostebol Norethandrolone Oxabolone Oxandrolone Oxymesterone Oxymetholone Prostanozol Quinbolone Stanozolol Stenbolone 1-Testosteron Tetrahydrogestrinone Trenbolone b) Endogenous anabolic androgenic steroids      Androstenediol Androstenedione Androstanolone. Other anabolic active substances   Clenbuterol Tibolone . synonym Dehydroepiandrosterone. DHEA Testosterone 2.

Erythropoietin and analogues 2. Hormones and related substances 1. IGF-1 3.  Zeranol Zilpaterol II. Growth Hormone and Insulin -like Growth Factors. Corticotrophins III. Selective estrogen receptor modulators (SERMs)    Raloxifene Tamoxifen Toremifene . Insulin 5. Aromatase inhibitors       Anastrozole Letrozole Aminoglutethimide Exemestane Formestane Testolactone 2. Anti-estrogenic substances 1. Gonadotrophins  Chorionic Gonadotrophin und Luteinising Hormone 4.

3. esters. The list includes the different salts. ethers. isomers. . mixtures of isomers. complexes or derivates. Other anti-estrogenic substances     Clomiphene Cyclofenil Fulvestrant.

as the Food and Drug Administration (FDA) to enforce legislation relating to food and drugs. * In 1927 a separate law enforcement agency was formed. and then. the revised Food. Drug and Insecticide Administration. As a result. a batch of sulfanilamide was dissolved in the industrial solvent.GOOD MANUFACTURING PRACTICE (GMP) INTRODUCTION The production of pharmaceutical and other medical products is stringently regulated by the federal government and these regulations also have a profound effect many biotechnology companies. The 1906 FDCA authorized regulations to ensure that pharmaceutical manufacturers did not adulterate or mislabel their products but did not deal with the safety or effectiveness of drugs. M uch of this history involves tragedies and abuses that led to increasingly stringent regulation of drug and food production. While we take for granted that the government regulates the production of drugs.S. in 1930. There were 358 poisonings and 107 deaths. Drug and . A few important incidents and historical of GMP are: * Upton Sinclair recorded filthy conditions and unacceptable practices in the food industry in his novel The Jungle. The regulated characteristics of such products relate to safety. * In 1937. first known as the Food. diethylene glycol. as is illustrated dramatically in the history of drug and food regulation in the U. mostly children. honesty (as in labeling). effectiveness and reliability. this was not always the case. As a result of this incident. the original Food Drug and Cosmetic Act (FDCA) was passed in 1906 to prevent the commerce of unacceptable food and drugs.

GMP. * In 1963 the first set of Good Manufacturing Practices. These regulations guide companies in the production of safe and effective drugs. * A number of injuries and deaths in the 1960s and 1970s caused by contaminated products led to the revised GMPs in the late 1970s. Unfortunately. Thalidomide was not used commercially in the U.S. Fifty one people were paralyzed and ten died . These inadequacies led to the promulgation of the Good Laborat ory Practices Regulations in 1976. validated systems. . this drug led to the birth of thousands of childr en without arms or legs. * In 1955 some children vaccinated with polio vaccine contracted paralytic polio. These regulations included requirements for standard operating procedures. * Inspections of pharmaceutical animal testing laboratories revealed that toxicology studies supporting new drug applications were poorly conceived and improperly conducted. At that time the drug thalidomide was commonly prescribed for insomnia and nausea in pregnant women in Europe. regulations were published. congress in 1962 to pass the Kefauver-Harris Amendments which required that drugs be proven to be both safe and effective before release. * One of the great successes of the FDA occurred in the early 1960s. News of the thalidomide tragedy influenced the U. Frances Kelsy of the FDA refused to accept it in the U. whose goal is to assure the quality of data submitted to FDA in support of the safety of new products.Cosmetic Act was passed in 1938 which required drugs to be tested for safety before release.S.S. until it was proven safe. because Dr. This incident and others like it led to increased factory inspections and testing of the safety of products before their release to the public. and exten sive documentation. The problem was traced to one manufacturer who apparently did not properly inactivate the virus used to make the vaccine.

Chemical preservatives and toxic colors were virtually uncontrolled 3. Medicines containing opium. there was a cavalier attitude regarding drugs and medicines 2. This brief historical summary illustrates that the regulation of food and medical products is generally driven by a tragedy. when followed by man ufacturers for therapeutic goods. Some cause the formation GMPs initiated: 1. Despite these laws. GMP is that part of Quality assurance which ensures that the products are consistently manufactured and controlled to the Quality standards appropriate to their intended use "GMP". Pioneers of bacteriology were just starting their string of victories over infectious diseases 7.* In 1982 insulin produced by recombinant DNA methods became the first such "modern biotechnology" product to be appr oved for market and sale. A set of principles and procedures which. Sanitation was primitive 4. or an advance in science and technology. a problem. heroin. morphine. The public and their elected officials respond by enacting a law(s) that is intended to reduce risks while maximizing benefits. and cocaine were sold without restriction and their labels gave no hint of their presence . helps ensure that the products manufactured will have the required quality. A governmental regulatory agency is empowered to interpret and enforce the law through a system of regulations . Milk was unpasteurized and cows were not tested for tuberculosis 6. Today GMPs mean a process must be performed according to industry standards. Ice was principal means of refrigeration 5.

Records and Reports j. Integrity ‡ ‡ ‡ . Organization b. Equipment d. Buildings and Facilities c. Returned and Salvaged Goods The real mean of GMP : 1. Control of Components e. Facilities ‡ ‡ Design them properly Keep them neat and clean Make people well Keep the products safe (chemically and microbiologically) Speak up if there is a mistake 3. Holding and Distribution h. Packaging and Labeling g. Laboratory Controls i. People ‡ ‡ ‡ Hire the right people Train them extensively Support them fully 2.Current GMPs contains : a. Production and Process Controls f.

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