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Medicinal Products Act
(Arzneimittelgesetz – AMG)

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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 1 des Gesetzes vom 19. Juli 2023 (BGBl. 2023 I Nr. 197)
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 1 of the Act of 19 July 2023 (Federal Law Gazette 2023 I no. 197)
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".

           
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Section 6a(repealed)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 ionising 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 28Power 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(no longer applicable)
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(no longer applicable)
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(no longer applicable)
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(no longer applicable)
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 (no longer applicable)
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)