{"id":14930,"date":"2021-05-29T16:58:27","date_gmt":"2021-05-29T16:58:27","guid":{"rendered":"https:\/\/laweuro.com\/?p=14930"},"modified":"2021-05-29T19:32:28","modified_gmt":"2021-05-29T19:32:28","slug":"medicinal-products-act-arzneimittelgesetz-amg","status":"publish","type":"post","link":"https:\/\/laweuro.com\/?p=14930","title":{"rendered":"Medicinal Products Act (Arzneimittelgesetz \u2013 AMG)"},"content":{"rendered":"

Full citation: Medicinal Products Act in the version published on 12 December 2005 (Federal Law Gazette [BGBl.]) Part I p. 3394, last amended by Article 11 of the Act of 6 May 2019 (Federal Law Gazette I p. 646)<\/p>\n

CHAPTER ONE
\nPurpose of the Act, definition of terms, scope<\/p>\n

Section 1 Purpose of the Act<\/a>
\nSection 2 The term \u2018medicinal product\u2019<\/a>
\nSection 3 The term \u2018substance\u2019<\/a>
\nSection 4 Definition of additional terms<\/a>
\nSection 4a Exceptions to the scope of this Act<\/a>
\nSection 4b Special provisions governing advanced therapy medicinal products<\/a><\/p>\n

CHAPTER TWO
\nRequirements on medicinal products<\/p>\n

Section 5 Prohibition of unsafe medicinal products<\/a>
\nSection 6 Empowerment in respect of health protection<\/a>
\nSection 6a (repealed)<\/a>
\nSection 7 Radiopharmaceuticals and medicinal products treated with ionizing radiation<\/a>
\nSection 8 Prohibitions to prevent deception<\/a>
\nSection 9 The party responsible for placing on the market<\/a>
\nSection 10 Labelling<\/a>
\nSection 11 Package leaflet<\/a>
\nSection 11a Expert information<\/a>
\nSection 12 Empowerment in respect of labelling, package leaflet and package sizes<\/a><\/p>\n

CHAPTER THREE
\nManufacture of medicinal products<\/p>\n

Section 13 Manufacturing authorisation<\/a>
\nSection 14 Decision on the manufacturing authorisation<\/a>
\nSection 15 Expert knowledge<\/a>
\nSection 16 Limitation of the manufacturing authorisation<\/a>
\nSection 17 Deadlines for the granting of marketing authorisations<\/a>
\nSection 18 Withdrawal, revocation, suspension<\/a>
\nSection 19 Areas of responsibility<\/a>
\nSection 20 Obligations to notify<\/a>
\nSection 20a Applicability to active substances and other substances<\/a>
\nSection 20b Authorisation for the procurement of tissues and the pertinent laboratory testing<\/a>
\nSection 20c Authorisation for the processing, preservation, testing and storage or the placing on the market of tissues or tissue preparations<\/a>
\nSection 20d Exception from the obligation to obtain an authorisation for tissues and tissue preparations<\/a><\/p>\n

CHAPTER FOUR
\nMarketing authorisation of medicinal products<\/p>\n

Section 21 Obligation to obtain a marketing authorisation<\/a>
\nSection 21a Approval of tissue preparations<\/a>
\nSection 22 Marketing authorisation documents<\/a>
\nSection 23 Particular documents required for medicinal products intended for administration to animals<\/a>
\nSection 24 Expert opinions<\/a>
\nSection 24a Use of a previous applicant’s documents<\/a>
\nSection 24b Authorisation of a generic medicinal product, document protection<\/a>
\nSection 24c Additional requests<\/a>
\nSection 24d General right of use<\/a>
\nSection 25 Decision on marketing authorisation<\/a>
\nSection 25a Prior examination<\/a>
\nSection 25b Mutual-recognition procedure and decentralised procedure<\/a>
\nSection 25c Measures taken by the competent higher federal authority on decisions or resolutions of the European Community or the European Union<\/a>
\nSection 26 Guidelines for the testing of medicinal products<\/a>
\nSection 27 Deadlines for the granting of marketing authorisations<\/a>
\nSection 28 Power to impose conditions<\/a>
\nSection 29 Obligation to notify, renewal of the marketing authorisation<\/a>
\nSection 30 Withdrawal, revocation, suspension<\/a>
\nSection 31 Expiry, prolongation<\/a>
\nSection 32 Official batch testing<\/a>
\nSection 33 Fees and expenses<\/a>
\nSection 34 Informing the public<\/a>
\nSection 35 Empowerments in respect of marketing authorisation and exemptions<\/a>
\nSection 36 Empowerment in respect of standard marketing authorisations<\/a>
\nSection 37 Authorisation by the European Community or the European Union for placing on the market, marketing authorisation of medicinal products from other states<\/a><\/p>\n

CHAPTER FIVE
\nRegistration of medicinal products<\/p>\n

Section 38 Registration of homeopathic medicinal products<\/a>
\nSection 39 Decision on the registration of homeopathic medicinal products, procedural provisions<\/a>
\nSection 39a Registration of traditional herbal medicinal products<\/a>
\nSection 39b Registration documents for traditional herbal medicinal products<\/a>
\nSection 39c Decision on the registration of traditional herbal medicinal products<\/a>
\nSection 39d Other procedural provisions for traditional herbal medicinal products<\/a><\/p>\n

CHAPTER SIX
\nProtection of human subjects in clinical trials<\/p>\n

Section 40 General conditions for clinical trials<\/a>
\nSection 41 Special conditions for clinical trials<\/a>
\nSection 41a Registration process for ethics committees<\/a>
\nSection 41b Rules of procedure and schedule of responsibilities<\/a>
\nSection 41c Power to issue ordinances<\/a>
\nSection 42 Ethics committee procedure, procedure for authorisation by the higher federal authority<\/a>
\nSection 42a Withdrawal, revocation and suspension of the authorisation or of the favourable opinion<\/a>
\nSection 42b Publication of the results of clinical trials<\/a><\/p>\n

CHAPTER SEVEN
\nSale of medicinal products<\/p>\n

Section 43 Pharmacy-only requirement, placing on the market by veterinarians<\/a>
\nSection 44 Exceptions to the pharmacy-only requirement<\/a>
\nSection 45 Authority to allow further exceptions to the pharmacy-only requirement<\/a>
\nSection 46 Authority to extend the pharmacy-only requirement<\/a>
\nSection 47 Distribution channel<\/a>
\nSection 47a Special distribution channels, obligation to keep records<\/a>
\nSection 47b Special distribution channels, diamorphine<\/a>
\nSection 48 Prescription requirement<\/a>
\nSection 49 (no longer applicable)<\/a>
\nSection 50 Retail trading of over-the-counter medicinal products<\/a>
\nSection 51 Sale by itinerant traders<\/a>
\nSection 52 Prohibition of self-service<\/a>
\nSection 52a Wholesale trading of medicinal products<\/a>
\nSection 52 bSupply of medicinal products<\/a>
\nSection 52c Brokering of medicinal products<\/a>
\nSection 53 Expert consultation<\/a><\/p>\n

CHAPTER EIGHT
\nSafety and quality control<\/p>\n

Section 54 Internal regulations<\/a>
\nSection 55 Pharmacopoeia<\/a>
\nSection 55a Official compilation of test procedures<\/a><\/p>\n

CHAPTER NINE
\nSPECIAL PROVISIONS FOR MEDICINAL PRODUCTS INTENDED FOR USE IN ANIMALS<\/p>\n

Section 56 Medicated feeding stuffs<\/a>
\nSection 56a Prescription, dispensing and use of medicinal products by veterinarians<\/a>
\nSection 56b Exceptions<\/a>
\nSection 57 Acquisition and possession by keepers of animals, records<\/a>
\nSection 57a Use by animal keepers<\/a>
\nSection 58 Use in food-producing animals<\/a>
\nSection 58a Notifications about animal keeping<\/a>
\nSection 58b Notifications about the use of medicinal products<\/a>
\nSection 58c Determining the treatment frequency<\/a>
\nSection 58d Reduction in treatment with antibacterially active substances<\/a>
\nSection 58e Authority to issue ordinances<\/a>
\nSection 58f Use of data<\/a>
\nSection 58g Evaluation<\/a>
\nSection 59 Clinical trial and residue testing in food-producing animals<\/a>
\nSection 59a Trade in substances and preparations from substances<\/a>
\nSection 59b Substances for conducting residue tests<\/a>
\nSection 59c Obligations to keep records of substances that can be used as veterinary medicinal products<\/a>
\nSection 59d Administration of pharmacologically active substances to food-producing animals<\/a>
\nSection 60 Pet animals<\/a>
\nSection 61 Powers of veterinary schools<\/a><\/p>\n

CHAPTER TEN
\nPHARMACOVIGILANCE<\/p>\n

Section 62 Organisation of the pharmacovigilance system of the competent higher federal authority<\/a>
\nSection 63 Graduated plan<\/a>
\nSection 63a Graduated plan officer<\/a>
\nSection 63b General pharmacovigilance obligations of the marketing authorisation holder<\/a>
\nSection 63c Documentation and reporting obligations of the holder of a marketing authorisation for medicinal products for human use in the case of suspected adverse reactions<\/a>
\nSection 63d Periodic safety update reports<\/a>
\nSection 63e European procedure<\/a>
\nSection 63f General prerequisites for non-interventional post-authorisation safety studies<\/a>
\nSection 63g Special prerequisites for imposed non-interventional post-authorisation safety studies<\/a>
\nSection 63h Documentation and notification obligations for medicinal products for animal use<\/a>
\nSection 63i Documentation and notification obligations in respect of blood and tissue preparations and tissues<\/a>
\nSection 63j Exceptions<\/a><\/p>\n

CHAPTER ELEVEN
\nSurveillance<\/p>\n

Section 64 Conducting supervision<\/a>
\nSection 65 Sampling<\/a>
\nSection 66 Obligation to tolerate and collaborate<\/a>
\nSection 67 General notification requirement<\/a>
\nSection 67a Database-supported information system<\/a>
\nSection 67b EU Compendium of Tissue Establishments, EU Compendium of Tissue and Cell Products, obligations to inform<\/a>
\nSection 68Ob ligations to notify and to inform<\/a>
\nSection 69 Measures by the competent authorities<\/a>
\nSection 69a The supervision of substances which can be used as medicinal products for animals<\/a>
\nSection 69b Use of specific data<\/a><\/p>\n

CHAPTER TWELVE
\nSpecial provisions for the Federal Armed Forces, Federal Police, Public Order Police, Civil Protection<\/p>\n

Section 70 Application and enforcement of the Act<\/a>
\nSection 71 Exceptions<\/a><\/p>\n

CHAPTER THIRTEEN
\nImport and export<\/p>\n

Section 72 Import authorisation<\/a>
\nSection 72a Certificates<\/a>
\nSection 72b Import authorisations and certificates for tissues and specific tissue preparations<\/a>
\nSection 72c One-off import of tissues and tissue preparations<\/a>
\nSection 73 Prohibition of introduction<\/a>
\nSection 73a Export<\/a>
\nSection 74 Participation of customs offices<\/a><\/p>\n

CHAPTER FOURTEEN
\nInformation officer, pharmaceutical consultant<\/p>\n

Section 74a Information Officer<\/a>
\nSection 75 Expert knowledge<\/a>
\nSection 76 Duties<\/a><\/p>\n

CHAPTER FIFTEEN
\nDesignation of the competent higher federal authorities and other provisions<\/p>\n

Section 77 Competent higher federal authority<\/a>
\nSection 77a Independence and transparency<\/a>
\nSection 78 Prices<\/a>
\nSection 79 Authority to permit exceptions in times of crisis<\/a>
\nSection 80 Authority to issue procedural and compassionate use regulations<\/a>
\nSection 81 Relation to other laws<\/a>
\nSection 82 General administrative regulations<\/a>
\nSection 83 Approximation to European Union legislation<\/a>
\nSection 83a Ordinances for specific cases<\/a>
\nSection 83b Publication of ordinances<\/a><\/p>\n

CHAPTER SIXTEEN
\nLiability for damages caused by medicinal products<\/p>\n

Section 84 Absolute liability<\/a>
\nSection 84a Right to disclosure<\/a>
\nSection 85 Contributory negligence<\/a>
\nSection 86 Extent of liability for damages in the case of death<\/a>
\nSection 87 Extent of liability for damages in the case of bodily injury<\/a>
\nSection 88 Maximum amounts<\/a>
\nSection 89 Compensation in the form of annuities<\/a>
\nSection 90 Statute of limitations (repealed)<\/a>
\nSection 91 Extended liability<\/a>
\nSection 92 Mandatory provision<\/a>
\nSection 93 Several parties liable for damages<\/a>
\nSection 94 Coverage provision<\/a>
\nSection 94a Local jurisdiction<\/a><\/p>\n

CHAPTER SEVENTEEN
\nPenal provisions and provisions on administrative fines<\/p>\n

Section 95Penal provisions<\/a>
\nSection 96Penal provisions<\/a>
\nSection 97Provisions on administrative fines<\/a>
\nSection 98Confiscation<\/a>
\nSection 98a(no longer applicable)<\/a><\/p>\n

CHAPTER EIGHTEEN
\nTransitional and interim provisions
\nFirst sub-chapter
\nTransitional provisions arising out of the Law on the Reform of Drug Legislation<\/p>\n

Section 99 1961 Drug Law<\/a>
\nSection 100<\/a>
\nSection 101 (no longer applicable)<\/a>
\nSection 102<\/a>
\nSection 102a (no longer applicable)<\/a>
\nSection 103<\/a>
\nSection 104 (no longer applicable)<\/a>
\nSection 105<\/a>
\nSection 105a<\/a>
\nSection 105b<\/a>
\nSection 106 (no longer applicable)<\/a>
\nSection 107 (no longer applicable)<\/a>
\nSection 108 (no longer applicable)<\/a>
\nSection 108a<\/a>
\nSection 108b (no longer applicable)<\/a>
\nSection 109<\/a>
\nSection 109a<\/a>
\nSection 110<\/a>
\nSection 111 (no longer applicable)<\/a>
\nSection 112<\/a>
\nSection 113<\/a>
\nSection 114 (no longer applicable)<\/a>
\nSection 115<\/a>
\nSection 116<\/a>
\nSection 117 (no longer applicable)<\/a>
\nSection 118<\/a>
\nSection 119<\/a>
\nSection 120<\/a>
\nSection 121 (no longer applicable)<\/a>
\nSection 122<\/a>
\nSection 123<\/a>
\nSection 124<\/a>
\nSecond sub-chapter<\/a>
\nSection 125 Transitional provisions arising out of the First Act Amending the Drug Law<\/a>
\nSection 126<\/a><\/p>\n

Third sub-chapter
\nTransitional provisions arising out of the Second Act Amending the Drug Law<\/p>\n

Section 127<\/a>
\nSection 128<\/a>
\nSection 129<\/a>
\nSection 130<\/a>
\nSection 131<\/a><\/p>\n

Fourth sub-chapter
\nTransitional provisions arising out of the Fifth Act Amending the Drug Law<\/p>\n

Section 132<\/a><\/p>\n

Fifth sub-chapter
\nTransitional provisions arising of the Seventh Act Amending the Drug Law<\/p>\n

Section 133<\/a><\/p>\n

Sixth sub-chapter
\nTransitional provisions arising out of the Transfusion Act<\/p>\n

Section 134<\/a><\/p>\n

Seventh sub-chapter<\/p>\n

Transitional provisions arising out of the Eighth Act Amending the Drug Law<\/p>\n

Section 135<\/a><\/p>\n

Eighth sub-chapter
\nTransitional provisions arising out of the Tenth Act Amending the Drug Law<\/p>\n

Section 136<\/a><\/p>\n

Ninth sub-chapter
\nTransitional provisions arising out of the Eleventh Act Amending the Drug Law<\/p>\n

Section 137<\/a><\/p>\n

Tenth sub-chapter
\nTransitional provisions arising out of the Twelfth Act Amending the Drug Law<\/p>\n

Section 138<\/a><\/p>\n

Eleventh sub-chapter
\nTransitional provisions arising out of the First Act Amending the Transfusion Act and the Regulations on Medicinal Products<\/p>\n

Section 139<\/a><\/p>\n

Twelfth sub-chapter
\nTransitional provisions arising out of the Thirteenth Act Amending the Drug Law<\/p>\n

Section 140<\/a><\/p>\n

Thirteenth sub-chapter
\nTransitional provisions arising out of the Fourteenth Act Amending the Drug Law<\/p>\n

Section 141<\/a><\/p>\n

Fourteenth sub-chapter<\/p>\n

Section 142 Transitional provisions arising out of the Tissues Act<\/a>
\nSection 142a Transitional provision and grandfathering provision arising out of the Act Implementing Commission Directive (EU) 2015\/566 and (EU) 2015\/565 on the import and coding of human tissue and tissue products<\/a>
\nSection 142b Transitional provisions arising out of the Act Updating the Regulations governing Blood and Tissue Preparations and Amending Additional Provisions<\/a>
\nFifteenth sub-chapter<\/a>
\nSection 143 Transitional provisions arising out of the Act on improving measures against doping in sport (repealed)<\/a>
\nSixteenth sub-chapter<\/a>
\nSection 144 Transitional provisions arising out of the Act amending the regulations on medicinal products and other regulations<\/a>
\nSeventeenth sub-chapter<\/a>
\nSection 145 Transitional provisions arising out of the Act on the Reform of the Market for Medicinal Products<\/a><\/p>\n

Eighteenth sub-chapter
\nTransitional provision<\/p>\n

Section 146 Transitional provisions arising out of the Second Act amending regulations on medicinal products and other regulations<\/a><\/p>\n

Nineteenth sub-chapter
\nTransitional provision<\/p>\n

Section 147 Transitional provisions arising out of the Third Act amending the regulations pertaining to medicinal products and other regulations<\/a><\/p>\n

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Full citation: Medicinal Products Act in the version published on 12 December 2005 (Federal Law Gazette [BGBl.]) Part I p. 3394, last amended by Article 11 of the Act of 6 May 2019 (Federal Law Gazette I p. 646) CHAPTER…<\/p>\n

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