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Medicinal Products Act
(The Drug Law)

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▄bersetzung durch den Sprachendienst des Bundesministeriums fŘr Gesundheit.

Translation provided by the Language Service of the Federal Ministry of Health.

Stand: Die ▄bersetzung berŘcksichtigt die ─nderung(en) des Gesetzes durch Artikel 1 des Gesetzes vom 19.10.2012 (BGBl. I S. 2192)

Version information: The translation includes the amendment(s) to the Act by Article 1 of the Act of 19.10.2012 (Federal Law Gazette I p. 2192)

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.

ę 2013 juris GmbH, SaarbrŘcken

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FIRST CHAPTER
Purpose of the Act, definition of terms, SCOPE
Sectioná1Purpose of the Act
Sectioná2The term ‘medicinal product’
Sectioná3The term ‘substance’
Sectioná4Definitions of additional terms
Sectioná4aExceptions to the scope of the present Act
Sectioná4bSpecial provisions governing advanced therapy medicinal products
SECOND CHAPTER
Requirements on medicinal products
Sectioná5Prohibition in respect of unsafe medicinal products
Sectioná6Empowerment in respect of health protection
Sectioná6aProhibitions regarding medicinal products for doping purposes in sport, information obligations
Sectioná7Radiopharmaceuticals and medicinal products treated with ionizing radiation
Sectioná8Prohibitions to prevent deception
Sectioná9The party responsible for placing on the market
Sectioná10Labelling
Sectioná11Package leaflet
Sectioná11aExpert information1
Section 12Empowerment in respect of labelling, package leaflet and package sizes
THIRD CHAPTER
MANUFACTURE OF MEDICINAL PRODUCTS
Sectioná13Manufacturing authorisation
Sectioná14Decision on the manufacturing authorisation
Sectioná15Expert knowledge
Sectioná16Limitation of the manufacturing authorisation
Sectioná17Deadlines for the granting of an authorisation
Sectioná18Withdrawal, revocation, suspension
Sectioná19Areas of responsibility
Sectioná20Obligations to notify
Sectioná20aApplicability to active substances and other substances
Sectioná20bAuthorisation for the procurement of tissues and the pertinent laboratory testing
Sectioná20cAuthorisation for the processing, preservation, testing and storage or the placing on the market of tissues or preparations made from tissues
Sectioná20dException from the obligation to obtain an authorization for tissues and tissue preparations
FOURTH CHAPTER
MARKETING AUTHORISATION FOR MEDICINAL PRODUCTS
Sectioná21Obligation to obtain a marketing authorisation
Sectioná21aAuthorisation of tissue preparations
Sectioná22Marketing authorisation documents
Sectioná23Particular documents required for medicinal products intended for administration to animals
Sectioná24Expertises
Sectioná24aUse of a previous applicant's documents
Sectioná24bAuthorisation of a generic medicinal product, document protection
Sectioná24cAdditional requests
Sectioná24dGeneral right of use
Sectioná25Decision on marketing authorisation
Sectioná25aPrior examination
Sectioná25bMutual-recognition procedure and decentralised procedure
Sectioná25cMeasures taken by the competent higher federal authority on decisions or resolutions of the European Community or the European Union
Sectioná26Guidelines for the testing of medicinal products
Sectioná27Deadlines for the granting of marketing authorisations
Sectioná28Power to impose conditions
Sectioná29Obligation to notify, renewal of the marketing authorisation
Sectioná30Withdrawal, revocation, suspension
Sectioná31Expiry, prolongation
Sectioná32Official batch testing
Sectioná33Costs
Sectioná34Informing the public
Sectioná35Empowerments in respect of marketing authorisation and exemptions
Sectioná36Empowerment in respect of standard marketing authorisations
Sectioná37Authorisation 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
Sectioná38Registration of homeopathic medicinal products
Sectioná39Decision on the registration of homeopathic medicinal products, procedural provisions
Sectioná39aRegistration of traditional herbal medicinal products
Sectioná39bRegistration documents for traditional herbal medicinal products
Sectioná39cDecision on the registration of traditional herbal medicinal products
Sectioná39dOther procedural provisions for traditional herbal medicinal products
SIXTH CHAPTER
PROTECTION OF HUMAN SUBJECTS IN CLINICAL TRIALS
Sectioná40General conditions for the clinical trial
Sectioná41Special conditions for the clinical trial
Sectioná42Ethics committee procedure, procedure for authorisation by the higher federal authority
Sectioná42aWithdrawal, revocation and suspension of the authorisation or of the favourable opinion
Sectioná42bPublication of the results of clinical trials
SEVENTH CHAPTER
SALE OF MEDICINAL PRODUCTS
Sectioná43Pharmacy-only requirement, placing on the market by veterinarians
Sectioná44Exceptions to the pharmacy-only requirement
Sectioná45Authority to allow further exceptions to the pharmacy-only requirement
Sectioná46Authority to extend the pharmacy-only requirement
Sectioná47Distribution channel
Sectioná47aSpecial distribution channels, obligation to keep records
Sectioná47bSpecial distribution channels, diamorphine
Sectioná48Prescription requirement
Sectioná49(no longer applicable)
Sectioná50Retail trading of over-the-counter medicinal products
Sectioná51Sale by itinerant traders
Sectioná52Prohibition of self-service
Sectioná52aWholesale trading of medicinal products
Sectioná52bSupply of medicinal products
Sectioná52cBrokering of medicinal products
Sectioná53Expert consultation
EIGHTH CHAPTER
SAFETY AND QUALITY CONTROL
Sectioná54Internal regulations
Sectioná55Pharmacopoeia
Sectioná55aOfficial compilation of test procedures
NINTH CHAPTER
SPECIAL PROVISIONS FOR MEDICINAL PRODUCTS INTENDED FOR USE IN ANIMALS
Sectioná56Medicated feedingstuffs
Sectioná56aPrescription, dispensing and use of medicinal products by veterinarians
Sectioná56bExceptions
Sectioná57Acquisition and possession by keepers of animals, records
Sectioná57aUse by animal keepers
Sectioná58Use in food-producing animals
Sectioná59Clinical trial and residue testing in food-producing animals
Sectioná59aTrade in substances and preparations from substances
Sectioná59bSubstances for conducting residue tests
Sectioná59cObligations to keep records of substances which can be used as veterinary medicinal products
Sectioná59dAdministration of pharmacologically active substances to food-producing animals
Sectioná60Pet animals
Sectioná61Powers of veterinary schools
TENTH CHAPTER
PHARMACOVIGILANCE
Sectioná62Organisation of the pharmacovigilance system of the competent higher federal authority
Sectioná63Graduated plan
Sectioná63aGraduated plan officer
Sectioná63bGeneral pharmacovigilance obligations of the marketing authorisation holder
Sectioná63c*Documentation and reporting obligations of the holder of a marketing authorization for medicinal products for human use in the case of suspected adverse reactions
Sectioná63d*Periodic safety update reports
Sectioná63eEuropean procedure
Sectioná63fGeneral prerequisites for non-interventional post-authorisation safety studies
Sectioná63gSpecial prerequisites for imposed non-interventional post-authorisation safety studies
Sectioná63hDocumentation and notification obligations for medicinal products for animal use
Sectioná63iDocumentation and notification obligations in respect of blood and tissue preparations and tissues
Sectioná63jExceptions
ELEVENTH CHAPTER
SUPERVISION
Sectioná64Conducting supervision
Sectioná65Sampling
Sectioná66Obligation to tolerate and collaborate
Sectioná67General notification requirement
Sectioná67aDatabase-supported information system
Sectioná68Obligation to inform and to report
Sectioná69Measures by the competent authorities
Sectioná69aThe supervision of substances which can be used as medicinal products for animals
Sectioná69bUse of specific data
TWELFTH CHAPTER
SPECIAL PROVISIONS FOR THE FEDERAL ARMED FORCES, FEDERAL POLICE, PUBLIC ORDER POLICE AND CIVIL PROTECTION
Sectioná70Application and enforcement of the Act
Sectioná71Exceptions
THIRTEENTH CHAPTER
IMPORT AND EXPORT
Sectioná72Import authorisation
Sectioná72a*Certificates
Sectioná72bImport authorisations and certificates for tissues and specific tissue preparations
Sectioná73Prohibition of introduction
Sectioná73aExport
Sectioná74Participation of customs offices
FOURTEENTH CHAPTER
INFORMATION OFFICER, PHARMACEUTICAL CONSULTANT
Sectioná74aInformation Officer
Sectioná75Expert knowledge
Sectioná76Duties
FIFTEENTH CHAPTER
DESIGNATION OF THE COMPETENT HIGHER FEDERAL AUTHORITIES AND OTHER PROVISIONS
Sectioná77Competent higher federal authority
Sectioná77aIndependence and transparency
Sectioná78Prices
Sectioná79Authority to permit exceptions in times of crisis
Sectioná80Authority to issue procedural and compassionate use regulations
Sectioná81Relation to other laws
Sectioná82General administrative regulations
Sectioná83Approximation to European Union legislation
Sectioná83aOrdinances for specific cases
SIXTEENTH CHAPTER
LIABILITY FOR DAMAGES CAUSED BY MEDICINAL PRODUCTS
Sectioná84Absolute liability
Sectioná84aRight to disclosure
Sectioná85Contributory negligence
Sectioná86Extent of liability for damages in the case of death
Sectioná87Extent of liability for damages in the case of bodily injury
Sectioná88Maximum amounts
Sectioná89Compensation in the form of annuities
Sectioná90(deleted)
Sectioná91Extended liability
Sectioná92Mandatory provision
Sectioná93 Several parties liable for damages
Sectioná94aLocal jurisdiction
SEVENTEENTH CHAPTER
PENAL PROVISIONS AND PROVISIONS ON ADMINISTRATIVE FINES
Sectioná95Penal provisions
Sectioná96Penal provisions
Sectioná97Administrative fines
Sectioná98Confiscation
Sectioná98aExtended forfeiture
EIGHTEENTH CHAPTER
TRANSITIONAL AND INTERIM PROVISIONS
First sub-chapter
Transitional provisions arising out of the Law on the Reform of Drug Legislation
Sectioná991961 Drug Law
Sectioná100
Sectioná101(no longer applicable)
Sectioná102
Sectioná102a(no longer applicable)
Sectioná103
Sectioná104(no longer applicable)
Sectioná105
Sectioná105a
Sectioná105b
Sectioná106(no longer applicable)
Sectioná107(no longer applicable)
Sectioná108(no longer applicable)
Sectioná108a
Sectioná108b(no longer applicable)
Sectioná109
Sectioná109a
Sectioná110
Sectioná111(no longer applicable)
Sectioná112
Sectioná113
Sectioná114(no longer applicable)
Sectioná115
Sectioná116
Sectioná117(no longer applicable)
Sectioná118
Sectioná119
Sectioná120
Sectioná121(no longer applicable)
Sectioná122
Sectioná123
Sectioná124
Second sub-chapter
Sectioná125Transitional provisions arising out of the First Act Amending the Drug Law
Sectioná126
Third sub-chapter
Transitional provisions arising out of the Second Act Amending the Drug Law
Sectioná127
Sectioná128
Sectioná129
Sectioná130
Sectioná131
Fourth sub-chapter
Transitional provisions arising out of the Fifth Act Amending the Drug Law
Sectioná132
Fifth sub-chapter
Transitional provisions arising of the Seventh Act Amending the Drug Law
Sectioná133
Sixth sub-chapter
Transitional provisions arising out of the Transfusion Act
Sectioná134
Seventh sub-chapter
Transitional provisions arising out of the Eighth Act Amending the Drug Law
Sectioná135
Eighth sub-chapter
Transitional provisions arising out of the Tenth Act Amending the Drug Law
Sectioná136
Ninth sub-chapter
Transitional provisions arising out of the Eleventh Act Amending the Drug Law
Sectioná137
Tenth sub-chapter
Transitional provisions arising out of the Twelfth Act Amending the Drug Law
Sectioná138
Eleventh sub-chapter
Transitional provisions arising out of the First Act Amending the Transfusion Act and the Regulations on Medicinal Products
Sectioná139
Twelfth sub-chapter
Transitional provisions arising out of the Thirteenth Act Amending the Drug Law
Sectioná140
Thirteenth sub-chapter
Transitional provisions arising out of the Fourteenth Act Amending the Drug Law
Sectioná141
Fourteenth sub-chapter
Sectioná142Transitional provisions arising out of the Tissues Act
Fifteenth sub-chapter
Sectioná143Transitional provisions arising out of the Act on improving measures against doping in sport
Sixteenth sub-chapter
Sectioná144Transitional provisions arising out of the Act amending the regulations on medicinal products and other regulations
Seventeenth sub-chapter
Sectioná145Transitional provisions arising out of the Act on the Reform of the Market for Medicinal Products
Eighteenth sub-chapter
Transitional provision
Sectioná146Transitional provisions arising out of the Second Act amending regulations on medicinal products and other regulations
Annex