Übersetzung durch den Sprachendienst des Bundesministeriums für Gesundheit.
Translation provided by the Language Service of the Federal Ministry of Health.
Stand: Die Übersetzung berücksichtigt die Änderung(en) des Gesetzes durch Artikel 8c des Gesetzes vom 20. Dezember 2022 (BGBl. I S. 2793)
Der Stand der deutschsprachigen Dokumentation kann aktueller sein. Vergleichen Sie dazu bitte http://www.gesetze-im-internet.de/amg_1976/BJNR024480976.html.
Version information: The translation includes the amendment(s) to the Act by Article 8c of the Act of 20 December 2022 (Federal Law Gazette I p. 2793)
Translations may not be updated at the same time as the German legal provisions displayed on this website. To compare with the current status of the German version, see http://www.gesetze-im-internet.de/amg_1976/BJNR024480976.html.
Translations of any materials into languages other than German are intended solely as a convenience to the non-German-reading public. If any questions arise related to the accuracy of the information contained in the translation, please refer to the German version of the document which is the official version of the document. Any discrepancies or differences created in the translation are not binding and have no legal effect for compliance or enforcement purposes.
Zur Nutzung dieser Übersetzung lesen Sie bitte den Hinweis unter "Translations".
For conditions governing use of this translation, please see the information provided under "Translations".
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Division 1
Purpose of the Act and definition of terms, scope |
| Section 1Purpose of the Act |
| Section 2The term ‘medicinal product’ |
| Section 3The term ‘substance’ |
| Section 4Definition of additional terms |
| Section 4aExceptions to the scope of this Act |
| Section 4bSpecial provisions governing advanced therapy medicinal products |
Division 2
Requirements on medicinal products |
| Section 5Prohibition of unsafe medicinal products |
| Section 6Prohibitions to protect health, power to issue ordinances |
| Section 6a(repealed) |
| Section 7Radiopharmaceuticals and medicinal products treated with ionizing radiation |
| Section 8Prohibitions to prevent deception |
| Section 9The party responsible for placing on the market |
| Section 10Labelling |
| Section 10aLabelling of investigational and auxiliary medicinal products for clinical trials |
| Section 11Package leaflet |
| Section 11aExpert information |
| Section 12Empowerment in respect of labelling, package leaflet and package sizes |
Division 3
Manufacture of medicinal products |
| Section 13Manufacturing authorisation |
| Section 14Decision on the manufacturing authorisation |
| Section 15Expert knowledge |
| Section 16Limitation of the manufacturing authorisation |
| Section 17Deadlines for the granting of marketing authorisations |
| Section 18Withdrawal, revocation, suspension |
| Section 19Areas of responsibility |
| Section 20Obligations to notify |
| Section 20aApplicability to active substances and other substances |
| Section 20bAuthorisation for the collection of tissues and the pertinent laboratory tests |
| Section 20cAuthorisation for the processing, preservation, testing and storage or the placing on the market of tissues or tissue preparations |
| Section 20dException from the obligation to obtain an authorisation for tissues and tissue preparations |
Division 4
Marketing authorisation of medicinal products |
| Section 21Obligation to obtain a marketing authorisation |
| Section 21aApproval of tissue preparations |
| Section 22Marketing authorisation documents |
| Section 23(no longer applicable) |
| Section 24Expert reports |
| Section 24aUse of a previous applicant’s documents |
| Section 24bAuthorisation of a generic medicinal product, document protection |
| Section 24cAdditional requests |
| Section 24dGeneral right of use |
| Section 25Decision on the marketing authorisation |
| Section 25aPrior examination |
| Section 25bMutual-recognition procedure and decentralised procedure |
| Section 25cMeasures taken by the competent higher federal authority on decisions or resolutions of the European Community or the European Union |
| Section 26Guidelines for the testing of medicinal products |
| Section 27Deadlines for the granting of marketing authorisations |
| Section 28 Power to impose conditions |
| Section 29Obligation to notify, renewal of the marketing authorisation |
| Section 30Withdrawal, revocation, suspension |
| Section 31Expiry, extension |
| Section 32Official batch testing |
| Section 33Reimbursement of expenses and fees |
| Section 34Informing the public |
| Section 35Empowerments in respect of marketing authorisation and exemptions |
| Section 36Empowerment in respect of standard marketing authorisations |
| Section 37Authorisation by the European Community or the European Union for placing on the market, marketing authorisation of medicinal products from other states |
Division 5
Registration of medicinal products |
| Section 38Registration of homeopathic medicinal products |
| Section 39Decision on the registration of homeopathic medicinal products, procedural provisions |
| Section 39aRegistration of traditional herbal medicinal products |
| Section 39bRegistration documents for traditional herbal medicinal products |
| Section 39cDecision on the registration of traditional herbal medicinal products |
| Section 39dOther procedural provisions for traditional herbal medicinal products |
Division 6
Protection of human subjects in clinical trials |
| Section 40Procedure for authorising clinical trials |
| Section 40aGeneral prerequisites for clinical trials |
| Section 40bSpecial prerequisites for clinical trials |
| Section 40cProcedure to extend an authorised clinical trial to another Member State, procedure with regard to modifications as well as assessment procedures |
| Section 40dSpecial obligations of the investigator, the sponsor and the competent higher federal authority |
| Section 41Ethics committee opinion |
| Section 41aRegistration process for ethics committees |
| Section 41bRules of procedure and schedule of responsibilities |
| Section 41cPower to issue ordinances |
| Section 42Corrective measures |
| Section 42aData protection |
| Section 42bPublication of the results of clinical trials |
| Section 42cInspections |
Division 7
Sale of medicinal products |
| Section 43Pharmacy-only requirement |
| Section 44Exceptions to the pharmacy-only requirement |
| Section 45Authority to allow further exceptions to the pharmacy-only requirement |
| Section 46Authority to extend the pharmacy-only requirement |
| Section 47Distribution channel |
| Section 47aSpecial distribution channels, obligation to keep records |
| Section 47bSpecial distribution channels, diamorphine |
| Section 48Prescription requirement |
| Section 49(no longer applicable) |
| Section 50Retail trading of over-the-counter medicinal products |
| Section 51Sale by itinerant traders |
| Section 52Prohibition of self-service |
| Section 52aWholesale trading of medicinal products |
| Section 52bSupply of medicinal products |
| Section 52cBrokering of medicinal products |
| Section 53Expert consultation |
Division 8
Safety and quality control |
| Section 54Internal regulations |
| Section 55Pharmacopoeia |
| Section 55aOfficial compilation of test procedures |
Division 9
(repealed) |
Division 10
Monitoring, compiling and evaluating the risks of medicinal products |
| Section 62Organisation |
| Section 63Graduated plan |
| Section 63aGraduated plan officer |
| Section 63bGeneral pharmacovigilance obligations of the marketing authorisation holder |
| Section 63cDocumentation and reporting obligations of the holder of a marketing authorisation in the case of suspected adverse reactions |
| Section 63dPeriodic safety update reports |
| Section 63eEuropean procedure |
| Section 63fGeneral prerequisites for non-interventional post-authorisation safety studies |
| Section 63gSpecial prerequisites for imposed non-interventional post-authorisation safety studies |
| Section 63h(repealed) |
| Section 63iDocumentation and notification obligations in respect of blood and tissue preparations and tissues |
| Section 63jDocumentation and notification obligations on the part of the person conducting treatment, in respect of advanced therapy medicinal products that require neither a marketing authorisation nor approval |
| Section 63kExceptions |
Division 11
Surveillance |
| Section 64Conducting supervision |
| Section 65Sampling |
| Section 66Obligation to tolerate and collaborate |
| Section 67General notification requirement |
| Section 67aDatabase-supported information system |
| Section 67bEU Compendium of Tissue Establishments, EU Compendium of Tissue and Cell Products, obligations to inform |
| Section 68Obligations to notify and to inform |
| Section 69Measures by the competent authorities |
| Section 69a(no longer applicable) |
| Section 69b(no longer applicable) |
Division 12
Special provisions for the Federal Armed Forces, Federal Police, Public Order Police, Civil Protection |
| Section 70Application and enforcement of the Act |
| Section 71Exceptions |
Division 13
Import and export |
| Section 72Import authorisation |
| Section 72aCertificates |
| Section 72bImport authorisations and certificates for tissues and specific tissue preparations |
| Section 72cOne-off import of tissues and tissue preparations |
| Section 73Prohibition of introduction |
| Section 73aExport |
| Section 74Participation of customs offices |
Division 14
Information officer, pharmaceutical consultant |
| Section 74aInformation officer |
| Section 75Expert knowledge |
| Section 76Duties |
Division 15
Designation of the competent higher federal authorities and other provisions |
| Section 77Competent higher federal authority |
| Section 77aIndependence and transparency |
| Section 78Prices |
| Section 79Authority to permit exceptions in times of crisis |
| Section 80Authority to issue procedural and compassionate use regulations |
| Section 81Relation to other laws |
| Section 82General administrative regulations |
| Section 83Approximation to European Union legislation |
| Section 83aOrdinances for specific cases |
Division 16
Liability for damages caused by medicinal products |
| Section 84Absolute liability |
| Section 84aRight to disclosure |
| Section 85Contributory negligence |
| Section 86Extent of liability for damages in the case of death |
| Section 87Extent of liability for damages in the case of bodily injury |
| Section 88Maximum amounts |
| Section 89Compensation in the form of annuities |
| Section 90(no longer applicable) |
| Section 91Extended liability |
| Section 92Mandatory provision |
| Section 93Several parties liable for damages |
| Section 94Coverage provision |
| Section 94aLocal jurisdiction |
Division 17
Penal provisions and provisions on administrative fines |
| Section 95Penal Provisions |
| Section 96Penal Provisions |
| Section 97Provisions on administrative fines |
| Section 98Confiscation |
| Section 98a(no longer applicable) |
Division 18
Transitional provisions |
Subdivision 1
Transitional provisions arising out of the Law on the Reform of Drug Legislation |
| Section 991961 Drug Law |
| Section 100 |
| Section 101(no longer applicable) |
| Section 102 |
| Section 102a(no longer applicable) |
| Section 103 |
| Section 104(no longer applicable) |
| Section 105 |
| Section 105a |
| Section 105b(no longer applicable) |
| Section 106(no longer applicable) |
| Section 107(no longer applicable) |
| Section 108(no longer applicable) |
| Section 108a |
| Section 108b(no longer applicable) |
| Section 109 |
| Section 109a |
| Section 110 |
| Section 111(no longer applicable) |
| Section 112 |
| Section 113(repealed) |
| Section 114(no longer applicable) |
| Section 115 |
| Section 116 |
| Section 117(no longer applicable) |
| Section 118 |
| Section 119 |
| Section 120 |
| Section 121(no longer applicable) |
| Section 122 |
| Section 123 |
| Section 124 |
| Subdivision 2 |
| Section 125(repealed) |
| Section 126 |
Subdivision 3
Transitional provisions arising out of the Second Act Amending the Drug Law (Act on Medicinal Products) |
| Section 127 |
| Section 128 |
| Section 129 |
| Section 130 |
| Section 131 |
Subdivision 4
Transitional provisions arising out of the Fifth Act Amending the Drug Law (Act on Medicinal Products) |
| Section 132 |
Subdivision 5
Transitional provision arising of the Seventh Act Amending the Drug Law |
| Section 133(repealed) |
Subdivision 6
Transitional provisions arising out of the Transfusion Act |
| Section 134 |
Subdivision 7
Transitional provisions arising out of the Eighth Act Amending the Drug Law (Act on Medicinal Products) |
| Section 135 |
Subdivision 8
Transitional provisions arising out of the Tenth Act Amending the Drug Law (Act on Medicinal Products) |
| Section 136 |
Subdivision 9
Transitional provisions arising out of the Eleventh Act Amending the Drug Law (Act on Medicinal Products) |
| Section 137(repealed) |
Subdivision 10
Transitional provisions arising out of the Twelfth Act Amending the Act on Medicinal Products |
| Section 138 |
Subdivision 11
Transitional provisions arising out of the First Act Amending the Transfusion Act and the Regulations on Medicinal Products |
| Section 139 |
Subdivision 12
Transitional provisions arising out of the Thirteenth Act Amending the Act on Medicinal Products |
| Section 140(repealed) |
Subdivision 13
Transitional provisions arising out of the Fourteenth Act Amending the Act on Medicinal Products |
| Section 141 |
| Subdivision 14 |
| Section 142Transitional provisions arising out of the Tissues Act |
| Section 142aTransitional 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 |
| Section 142bTransitional provisions arising out of the Act Updating the Regulations governing Blood and Tissue Preparations and Amending Additional Provisions |
| Subdivision 15 |
| Section 143Transitional provisions arising out of the Act on improving measures against doping in sport (repealed) |
| Subdivision 16 |
| Section 144Transitional provisions arising out of the Act amending the regulations on medicinal products and other regulations |
| Subdivision 17 |
| Section 145Transitional provisions arising out of the Act on the Reform of the Market for Medicinal Products |
Subdivision 18
Transitional provision |
| Section 146Transitional provisions arising out of the Second Act amending regulations on medicinal products and other regulations |
Subdivision 19
Transitional provision |
| Section 147Transitional provision arising out of the Third Act amending the regulations pertaining to medicinal products and other regulations |
Subdivision 20
Transitional provision |
| Section 148Transitional provision arising out of the Fourth Act amending regulations pertaining to medicinal products and other regulations, as well as the Act enacting a Veterinary Medicinal Products Act and adapting regulations pertaining to medicinal products and other regulations |
Annex:
(to section 6) |
