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Medicinal Products Act
(The Drug Law)

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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 2a des Gesetzes vom 27.3.2014 (BGBl. I S. 261)
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 2a of the Act of 27.3.2014 (Federal Law Gazette I p. 261)
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.

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FIRST CHAPTER
Purpose of the Act, definition of terms, SCOPE
Section 1Purpose of the Act
Section 2The term ‘medicinal product’
Section 3The term ‘substance’
Section 4Definitions of additional terms
Section 4aExceptions to the scope of the present Act
Section 4bSpecial provisions governing advanced therapy medicinal products
SECOND CHAPTER
Requirements on medicinal products
Section 5Prohibition in respect of unsafe medicinal products
Section 6Empowerment in respect of health protection
Section 6aProhibitions regarding medicinal products for doping purposes in sport, information obligations
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 11Package leaflet
Section 11aExpert information*
Section 12Empowerment in respect of labelling, package leaflet and package sizes
THIRD CHAPTER
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 an authorisation
Section 18Withdrawal, revocation, suspension
Section 19Areas of responsibility
Section 20Obligations to notify
Section 20aApplicability to active substances and other substances
Section 20bAuthorisation for the procurement of tissues and the pertinent laboratory testing
Section 20cAuthorisation for the processing, preservation, testing and storage or the placing on the market of tissues or preparations made from tissues
Section 20dException from the obligation to obtain an authorisation for tissues and tissue preparations
FOURTH CHAPTER
MARKETING AUTHORISATION FOR MEDICINAL PRODUCTS
Section 21Obligation to obtain a marketing authorisation
Section 21aAuthorisation of tissue preparations
Section 22Marketing authorisation documents
Section 23Particular documents required for medicinal products intended for administration to animals
Section 24Expertises
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 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, prolongation
Section 32Official batch testing
Section 33Fees and expenses
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
FIFTH CHAPTER
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
SIXTH CHAPTER
PROTECTION OF HUMAN SUBJECTS IN CLINICAL TRIALS
Section 40General conditions for the clinical trial
Section 41Special conditions for the clinical trial
Section 42Ethics committee procedure, procedure for authorisation by the higher federal authority
Section 42aWithdrawal, revocation and suspension of the authorisation or of the favourable opinion
Section 42bPublication of the results of clinical trials
SEVENTH CHAPTER
SALE OF MEDICINAL PRODUCTS
Section 43Pharmacy-only requirement, placing on the market by veterinarians
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
EIGHTH CHAPTER
SAFETY AND QUALITY CONTROL
Section 54Internal regulations
Section 55Pharmacopoeia
Section 55aOfficial compilation of test procedures
NINTH CHAPTER
SPECIAL PROVISIONS FOR MEDICINAL PRODUCTS INTENDED FOR USE IN ANIMALS
Section 56Medicated feeding stuffs
Section 56aPrescription, dispensing and use of medicinal products by veterinarians
Section 56bExceptions
Section 57Acquisition and possession by keepers of animals, records
Section 57aUse by animal keepers
Section 58Use in food-producing animals
Section 58a*Notifications about animal keeping
Section 58bNotifications about the use of medicinal products
Section 58cDetermining the treatment frequency
Section 58dReduction in treatment with antibacterially active substances
Section 58eAuthority to issue ordinances
Section 58fUse of data
Section 58gEvaluation
Section 59Clinical trial and residue testing in food-producing animals
Section 59aTrade in substances and preparations from substances
Section 59bSubstances for conducting residue tests
Section 59cObligations to keep records of substances which can be used as veterinary medicinal products
Section 59dAdministration of pharmacologically active substances to food-producing animals
Section 60Pet animals
Section 61Powers of veterinary schools
TENTH CHAPTER
PHARMACOVIGILANCE
Section 62Organisation of the pharmacovigilance system of the competent higher federal authority
Section 63Graduated plan
Section 63aGraduated plan officer
Section 63bGeneral pharmacovigilance obligations of the marketing authorisation holder
Section 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
Section 63d*Periodic 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 63hDocumentation and notification obligations for medicinal products for animal use
Section 63iDocumentation and notification obligations in respect of blood and tissue preparations and tissues
Section 63jExceptions
ELEVENTH CHAPTER
SUPERVISION
Section 64Conducting supervision
Section 65Sampling
Section 66Obligation to tolerate and collaborate
Section 67*General notification requirement
Section 67aDatabase-supported information system
Section 68Obligation to inform and to report
Section 69Measures by the competent authorities
Section 69aThe supervision of substances which can be used as medicinal products for animals
Section 69bUse of specific data
TWELFTH CHAPTER
SPECIAL PROVISIONS FOR THE FEDERAL ARMED FORCES, FEDERAL POLICE, PUBLIC ORDER POLICE AND CIVIL PROTECTION
Section 70Application and enforcement of the Act
Section 71Exceptions
THIRTEENTH CHAPTER
IMPORT AND EXPORT
Section 72Import authorisation
Section 72aCertificates
Section 72bImport authorisations and certificates for tissues and specific tissue preparations
Section 73Prohibition of introduction
Section 73aExport
Section 74Participation of customs offices
FOURTEENTH CHAPTER
INFORMATION OFFICER, PHARMACEUTICAL CONSULTANT
Section 74aInformation Officer
Section 75Expert knowledge
Section 76Duties
FIFTEENTH CHAPTER
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
Section 83bPublication of ordinances
SIXTEENTH CHAPTER
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(deleted)
Section 91Extended liability
Section 92Mandatory provision
Section 93Several parties liable for damages
Section 94Coverage provision
Section 94aLocal jurisdiction
SEVENTEENTH CHAPTER
PENAL PROVISIONS AND PROVISIONS ON ADMINISTRATIVE FINES
Section 95Penal provisions
Section 96Penal provisions
Section 97Provisions on administrative fines
Section 98Confiscation
Section 98aExtended forfeiture
EIGHTEENTH CHAPTER
TRANSITIONAL AND INTERIM PROVISIONS
First sub-chapter
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
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
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
Second sub-chapter
Section 125Transitional provisions arising out of the First Act Amending the Drug Law
Section 126
Third sub-chapter
Transitional provisions arising out of the Second Act Amending the Drug Law
Section 127
Section 128
Section 129
Section 130
Section 131
Fourth sub-chapter
Transitional provisions arising out of the Fifth Act Amending the Drug Law
Section 132
Fifth sub-chapter
Transitional provisions arising of the Seventh Act Amending the Drug Law
Section 133
Sixth sub-chapter
Transitional provisions arising out of the Transfusion Act
Section 134
Seventh sub-chapter
Transitional provisions arising out of the Eighth Act Amending the Drug Law
Section 135
Eighth sub-chapter
Transitional provisions arising out of the Tenth Act Amending the Drug Law
Section 136
Ninth sub-chapter
Transitional provisions arising out of the Eleventh Act Amending the Drug Law
Section 137
Tenth sub-chapter
Transitional provisions arising out of the Twelfth Act Amending the Drug Law
Section 138
Eleventh sub-chapter
Transitional provisions arising out of the First Act Amending the Transfusion Act and the Regulations on Medicinal Products
Section 139
Twelfth sub-chapter
Transitional provisions arising out of the Thirteenth Act Amending the Drug Law
Section 140
Thirteenth sub-chapter
Transitional provisions arising out of the Fourteenth Act Amending the Drug Law
Section 141
Fourteenth sub-chapter
Section 142Transitional provisions arising out of the Tissues Act
Fifteenth sub-chapter
Section 143Transitional provisions arising out of the Act on improving measures against doping in sport
Sixteenth sub-chapter
Section 144Transitional provisions arising out of the Act amending the regulations on   medicinal products and other regulationsSection 144
Transitional provisions arising out of the Act amending the regulations onmedicinal products and other regulations
Seventeenth sub-chapter
Section 145Transitional provisions arising out of the Act on the    Reform of the Market for Medicinal ProductsSection 145
Transitional provisions arising out of the Act on the Reform of the Market for Medicinal Products
Eighteenth sub-chapter
Transitional provision
Section 146Transitional provisions arising out of the Second Act amending regulations on medicinal products and other regulations
Nineteeth sub-chapter
Transitional provision
Section 147Transitional provisions arising out of the Third Act amending regulations on medicinal products and other regulations
Annex