The COACT trial showed that immediate angiography with an intent to revascularize is not superior to delayed angiography among patients presenting with out-of-hospital cardiac arrest secondary to a shockable rhythm and with no ECG evidence of ST-segment elevations post-ROSC.
The goal of the trial was to compare the safety and efficacy of emergent coronary angiography with percutaneous coronary intervention PCI if indicated compared with delayed angiography among patients presenting with out-of-hospital cardiac arrest who did not have ST-segment elevation on electrocardiogram ECG post—return of spontaneous circulation ROSC.
In the delayed arm, coronary angiography was performed after neurological recovery, in general after the patient was moved out of the intensive care unit. Median times to angiography post-arrest were 2. The intent of angiography was to revascularize any possible culprit lesions, either with PCI or coronary artery bypass grafting. Targeted temperate management was initiated as soon as possible. The primary outcome, survival to 90 days for immediate vs.
The intervention group will undergo intense aerobic exercise with prior IL-6R infusion for 1h prior to the exercise bout. Outcome Measures.
Secondary Outcome Measures : Change in NK cell count in adipose tissue [ Time Frame: 3 hours after intervention ] Using a combination of histology, western blot and gene-expression analysis for CD56, CD57 and other NK-cell markers, the principal investigator will identify and count the number of NK cells in adipose tissue.
Using a combination of histology, western blot and gene-expression analysis for CD56, CD57 and other NK-cell markers, the principal investigator will identify the phenotype of NK cells in adipose tissue. Using a combination of histology, western blot and gene-expression analysis for CD56, CD57 and other NK-cell markers, the principal investigator will identify and count the number of NK cells in muscle tissue. Using a combination of histology, western blot and gene-expression analysis for CD56, CD57 and other NK-cell markers, the principal investigator will identify the phenotype of NK cells in muscle tissue.
Using a combination of histology, western blot and gene-expression analysis for CD68, CD, CD, TNF-alpha and other macrophage markers, the principal investigator will identify and count the number of macrophages in muscle tissue.
Using a combination of histology, western blot and gene-expression analysis for CD68, CD, CD, TNF-alpha and other macrophage markers, the principal investigator will identify and count the number of macrophages in adipose tissue. Using a combination of histology, western blot and gene-expression analysis for CD3, CD8, and other T-cell markers, the principal investigator will count the number of T-cells in adipose tissue.
Using a combination of histology, western blot and gene-expression analysis for CD3, CD8, and other T-cell markers, the principal investigator will count the number of T-cells in muscle tissue. Using flow cytometry we will identify and count monocytes in circulation. Using flow cytometry the investigators will count T-cells in circulation.
Using flow cytometry the investigators will count B-cells in circulation. The change in IL-6 receptor surface expression on circulating NK-cells using flow cytometry.
As an explorative outcome the investigators will investigate possible novel signal molecules released during exercise with immunological importance, either in circulation or in tissue i. VO2max using bicycle ergometer and Oxicon Online system. Lean body mass using dual-energy x-ray absorptiometry DXA. Fat mass using dual-energy x-ray absorptiometry DXA. Hunger, satiety, fullness, and prospective food consumption will be rated using a visual analog scales VAS.
A line of 20 cm is drawn from left to right on A4 paper starting at 0 cm with " not hungry at all" ending at 20 cm with "never been more hungry in my life". The subject mark somewhere in between according to his subjective feeling, The length is reported and indicates the degree of hunger, eg.
In general the longer to right the person marks the line, the stronger is the subjective felling within the given question. Caloric intake will be determined by providing meal consisting of a hot pot of homogeneous pasta Bolognese 1, g, 1, kcal, 55 E percent carbohydrate, 30 E percent fat, 15 E percent protein; homogeneous composition served with a glass of water of ml 1 h after exercise.
The duration of the meal is sat to 30 minutes. Gastric emptying will be assessed by the participants drinking ml in which 1,5 g paracetamol is dissolved. Eligibility Criteria. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. Christensen regionh.
More Information. Publications: Amar, D. Bergstrom J. Percutaneous needle biopsy of skeletal muscle in physiological and clinical research. Scand J Clin Lab Invest. Acute exercise preferentially redeploys NK-cells with a highly-differentiated phenotype and augments cytotoxicity against lymphoma and multiple myeloma target cells. Brain Behav Immun. Epub Nov 5. Molecular mechanisms of natural killer cell activation in response to cellular stress.
Cell Death Differ. Epub Apr Exercise Training in Cancer Control and Treatment. Compr Physiol. Epub Feb Ghanemi A, St-Amand J. Interleukin-6 as a "metabolic hormone". Epub Jul 6. Curr Cardiovasc Risk Rep.
Autologous serum collected 1 h post-exercise enhances natural killer cell cytotoxicity. Novel insights on human NK cells' immunological modalities revealed by gene expression profiling.
J Immunol. Erratum in: J Immunol. Physical activity and survival after prostate cancer diagnosis in the health professionals follow-up study. J Clin Oncol. Epub Jan 4. Larrabee RC. Leucocytosis after violent Exercise. J Med Res. NK cells in the tumor microenvironment. Crit Rev Oncog. Lukaski HC. Soft tissue composition and bone mineral status: evaluation by dual-energy X-ray absorptiometry.
J Nutr. Med Sci Sports Exerc. Physical activity and male colorectal cancer survival. Arch Intern Med. At the request of the competent higher federal authority, the applicant must submit information on the manufacturing process.
Subsections 6 , 7 and 7a does not apply to these medicinal products. This requires a uniform authorisation number to which further codes must be added to allow differentiation between the different pharmaceutical forms or concentrations. For authorisations pursuant to section 24b 1 , individual authorisations of a reference medicinal product are regarded as a uniform comprehensive authorisation.
Section 25a Prior examination. Section 25 6 sentence 5 applies accordingly. Section 25 4 and 6 does not apply to the prior examination. Section 25b Mutual-recognition procedure and decentralised procedure.
Section 25 5 sentence 5 applies accordingly. Preliminary proceedings pursuant to section 68 of the Rules of the Administrative Courts do not take place in the case of remedies against decisions of the competent higher federal authority referred to in sentence 2. In addition, section 25 6 does not apply. Section 25c Measures taken by the competent higher federal authority on decisions or resolutions of the European Community or the European Union.
Section 26 Guidelines for the testing of medicinal products. The regulations must comply with the prevailing state of scientific knowledge and are to be continually adjusted to it; animal tests, in particular, are to be replaced by other test methods if this is reasonable in the light of the state of scientific knowledge and considering the purpose of the test. The ordinance is issued, insofar as radiopharmaceuticals and medicinal products in the manufacture of which ionizing radiation is used are concerned, and insofar as tests for ecotoxicity are concerned, in agreement with the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety and, insofar as medicinal products intended for administration to animals are concerned, in agreement with the Federal Ministry of Food and Agriculture.
Documents on empirical medical findings prepared in accordance with scientific methods are also deemed to be documents on scientific findings. Section 27 Deadlines for the granting of marketing authorisations. The decision on the recognition of a marketing authorisation is to be taken within a period of three months following receipt of the assessment report.
An assessment report is to be drawn up within a period of three months. Section 28 Power to impose conditions. In the case of conditions imposed pursuant to subsections 2 to 3d for the protection of the environment, the competent higher federal authority decides, in agreement with the Federal Environmental Agency, if the impact on the environment is to be evaluated.
For this purpose, the competent higher federal authority transmits the data and documents, necessary for its evaluation of the environmental impact, to the Federal Environmental Agency. Conditions may also be imposed subsequently.
The competent higher federal authority reviews the findings of these tests and trials on an annual basis. Sentence 1 applies accordingly to documents on the residue test procedure pursuant to section 23 1 no. Should the prerequisites for the imposition of conditions pursuant to sentence 1 no.
The conditions imposed are immediately enforceable. The lodging of an objection and action to rescind have no suspensive effect. The competent higher federal authority checks compliance with any condition imposed pursuant to sentence 1 immediately after the date for the submission of documents has expired. Subsection 1 sentences 2 and 3 apply accordingly. The results are to be documented in such a way as to show the type, scope and date of the studies or tests. The competent higher federal authority informs the European Medicines Agency of the marketing authorisations it has granted subject to conditions pursuant to subsections 3 , 3a and 3b.
Section 29 Obligation to notify, renewal of the marketing authorisation. The marketing authorisation holder must comply with the requirement referred to in sentence 1 once the marketing authorisation has been granted. In the case of medicinal products for human use this information includes both positive and negative results of clinical trials or other studies that may refer to all indications and population groups and not only to those specified in the marketing authorisation, as well as information regarding the use of the medicinal product beyond the terms of the marketing authorisation.
The marketing authorisation holder must also submit to the competent higher federal authority, upon request, all information and documents demonstrating that the risk-benefit balance is still favourable. In the case of medicinal products for human use, the competent higher federal authority can request a copy of the pharmacovigilance system master file at any time. The marketing authorisation holder must submit the pharmacovigilance system master file at the latest seven days after receiving the request.
Sentences 1 to 3 do not apply to the parallel importer. Notification must be submitted at least two months before the suspension of marketing. This does not apply in the event of circumstances over which the marketing authorisation holder has no control. Changes in the dates or frequencies given in the manufacturing authorisation, arising from sentence 1, become effective six months after their publication on the European internet website.
In particular, the marketing authorisation holder must explain whether the measure pursuant to sentence 1 is based on one of the grounds listed in section 25 2 sentence 1 nos. The notification pursuant to sentence 1 is also to be made if the measure is taken in a third country and is based on one of the grounds pursuant to sentence 2. If a measure pursuant to sentence 1 or sentence 3 is based on one of the grounds listed in sentence 2, the marketing authorisation holder must also notify the European Medicines Agency thereof.
A pharmaceutical entrepreneur may place the medicinal product on the market under its current name for a further period of one year, wholesalers and retailers for a further period of two years, beginning on the following 1 January or 1 July after the promulgation of the change in the Federal Gazette. Sentence 1 no. The approval is deemed to be granted if no objection to the change has been filed within a period of three months. The competent higher federal authority decides on the obligation to obtain a marketing authorisation pursuant to sentence 1.
For such medicinal products, the obligations of the pharmaceutical entrepreneur are those stipulated in Regulation EC No. Subsections 2a to 3 apply to:. Section 30 Withdrawal, revocation, suspension. Furthermore, the marketing authorisation is to be withdrawn or revoked, if:. Therapeutic efficacy is lacking if it is clear that no therapeutic results can be achieved with the medicinal product.
In the cases referred to in sentence 1, the suspension of the marketing authorisation may also be ordered for a limited period of time. No preliminary procedure pursuant to section 68 of the Rules of the Administrative Courts is held in the event of an appeal against decisions by the competent higher federal authority pursuant to sentence 1. In these cases, the suspension of the marketing authorisation may also be ordered for a limited period of time.
In the cases referred to in subsection 2 , the marketing authorisation can be amended by imposing a condition if this is sufficient to comply with the requirements of medicinal product safety. A preliminary procedure pursuant to section 68 of the Rules of the Administrative Courts does not take place in the cases referred to in sentence 2. In the cases set forth in section 25 2 no.
It is permitted to return the medicinal product, appropriately marked, to the pharmaceutical entrepreneur. The competent authority may order the return of a medicinal product. Section 31 Expiry, prolongation.
In the cases referred to in the sentence 1 no. To this end, the marketing authorisation holder must submit to the competent higher federal authority a revised version of the quality, safety and efficacy documents including all amendments made since the marketing authorisation was granted; in the case of medicinal products intended for use in animals, a consolidated list of amendments is to be submitted instead of the revised version.
In respect of medicinal products intended for administration to food-producing animals, the competent higher federal authority may furthermore demand that the report comprise details of experience gained in the residue test procedure. Section 25 5 sentence 5 and subsection 5a apply accordingly. In respect of the decision regarding prolongation, it is to be verified whether findings exist that could influence the subordination of the medicinal product to the prescription requirement.
This does not apply if the competent higher federal authority ascertains that a condition for the withdrawal or the revocation of the marketing authorisation as defined in section 30 existed; section 30 4 applies. Section 32 Official batch testing. The batch is to be released if a test official batch test has shown that the batch has been manufactured and tested by methods of manufacture and control, which comply with the prevailing standard of scientific knowledge, and that it possesses the required quality, efficacy and safety.
The batch is also to be released if the competent authority of another Member State of the European Union has decided, on the basis of an experimental investigation, that the prerequisites stated in sentence 2 are met. The regulations must comply with the prevailing standard of scientific knowledge and are to be continually adjusted to it. Sentence 1 applies accordingly if, in the case of a released batch, one of the medicinal products named in subsection 1 sentence1, or in the case of an exempted medicinal product, there is sufficient reason to suspect that the medicinal product is counterfeit.
Section 33 Reimbursement of expenses and fees. In such a case, flat-rate fee agreements can be concluded with the associations to which the users belong. The corresponding regulations on fees apply accordingly in determining fees. Section 34 Informing the public. Sentence 1 nos. In the case of information pursuant to sentence 1 nos. If the pharmacovigilance reservations pursuant to sentence 1 no. In the case of medicinal products for animal use, the competent higher federal authority immediately provides the public with information on the granting of the marketing authorisation together with the expert information, the assessment report pursuant to sentence 1 no.
Sentences 1 and 4 also apply to changes in the aforementioned information. In addition, decisions relating to the withdrawal, revocation or suspension of a marketing authorisation are also to be made publicly available.
The competent higher federal authority is empowered, in the case of medicinal products for human use, to disclose information regarding the submission of a proper application for authorisation, the submission of a proper application for the approval of a confirmatory clinical trial, as well as on the approval or refusal of a confirmatory clinical trial.
After taking the decision, the competent higher federal authority makes available the information pursuant to subsections 1 and 1b , referring to the lack of enforceability. It makes available a version of the educational material that is suitable for reproduction in electronic programmes in keeping with section 73 9 of the Fifth Book of the Social Code.
Information on the size of the released batches may be published, if necessary to protect the health of the public. If necessary, the competent higher federal authority provides the public with with its own version of necessary information for health professionals on the risks associated with medicinal products to enable their safe use.
It makes available a version of the information according to sentences 1 and 2 that is suitable for rendering in electronic programmes according to section 73 9 of the Fifth Book of the Social Code. Two weeks after publication of the administrative act in the Federal Gazette, the Act is considered to be promulgated.
Other notifications by the competent higher federal authority, including the letters giving the parties affected the opportunity to submit comments pursuant to section 28 1 of the Administrative Procedures Act, may also be published in the Federal Gazette if more than 50 addressees are affected.
Sentence 2 applies accordingly. Section 35 Empowerments in respect of marketing authorisation and exemptions. Section 36 Empowerment in respect of standard marketing authorisations. The Federal Ministry can transfer this authority to the competent higher federal authority without the approval of the Bundesrat. For the sake of the protection of human or animal health, the exemption may be made dependent on a particular manufacturing procedure, composition, labelling, package leaflet, expert information or pharmaceutical form and be limited to certain methods of administration, therapeutic indications or fields of application.
It is admissible for the pharmaceutical entrepreneur to provide information regarding additional contra-indications, adverse reactions and interactions. The pharmaceutical entrepreneur is free to choose the name of the medicinal product. In the process, the monographs are to be examined to determine whether the requirements regarding the necessary quality, efficacy and safety, including a positive risk-benefit balance, can continue to be considered fulfilled for medicinal products exempted from the obligation to obtain a marketing authorisation.
Section 37 Authorisation by the European Community or the European Union for placing on the market, marketing authorisation of medicinal products from other states. The marketing authorisation issued for a medicinal product by another state is considered a valid marketing authorisation as defined in section 21, insofar as this is stipulated in an ordinance issued by the Federal Ministry. The ordinance is issued in agreement with the Federal Ministry of Food and Agriculture insofar as medicinal products intended for administration to animals are concerned.
Division 5 Registration of medicinal products. Section 38 Registration of homeopathic medicinal products. A marketing authorisation is not necessary; section 21 1 sentence 2 and subsection 3 apply accordingly.
A registration is not required for medicinal products that are placed on the market by a pharmaceutical entrepreneur in amounts of up to 1, packages per year, unless these are medicinal products:. This does not apply to the information regarding the effects and therapeutic indications, the documents and expert opinions on the clinical trials, nor to information pursuant to section 22 2 nos.
The documents on the pharmaceutical-toxicological test are to be submitted if the safety of the product, especially as results from an adequately high degree of dilution, is not otherwise evident.
Section 22 1a applies accordingly. Section 39 Decision on the registration of homeopathic medicinal products, procedural provisions. Section 25 4 and 5 sentence 5 apply accordingly.
The registration is valid only for the homeopathic medicinal product and its degrees of dilution as specified in the notice of registration. The competent higher federal authority can make the registration notification subject to conditions. Section 28 2 and 4 apply. Section 29 1a , 1e , 1f and 2 to 2b apply accordingly.
The obligation pursuant to sentence 1 is to be fulfilled by the registration holder after the registration has been granted. In the following cases, an application for a new registration is to be required:. For the expiry and prolongation of the registration, section 31 applies accordingly provided that the grounds for refusal pursuant to subsection 2 nos.
Section 39a Registration of traditional herbal medicinal products. Finished medicinal products that are herbal medicinal products and medicinal products within the meaning of section 2 1 , may be placed on the market as traditional herbal medicinal products only if they are registered by the competent higher federal authority.
This also applies to herbal medicinal products containing vitamins or minerals provided that the action of the vitamins or minerals is ancillary to that of the traditional herbal medicinal product regarding the therapeutic indication or indications. Section 39b Registration documents for traditional herbal medicinal products. Evidence of use over a period of 30 years pursuant to sentence 1 no. It can also be provided if the number or quantity of active substances of the medicinal product has been reduced over this period.
A corresponding medicinal product as referred to in sentence 1 no. If the individual active substances are not sufficiently well known, information is to be provided about the individual active substances. Section 39c Decision on the registration of traditional herbal medicinal products. The registration applies only to the herbal medicinal product listed in the notification. Section 28 2 and 4 apply accordingly.
For medicinal products intended for use in animals, the first sentence applies accordingly. For the expiry and prolongation of the registration, section 31 applies accordingly provided that the reasons for rejection referred to in subsection 2 apply. Section 39d Other procedural provisions for traditional herbal medicinal products.
Division 6 Protection of human subjects in clinical trials. Section 40 General conditions for clinical trials. The clinical trial of a medicinal product on human beings may only be commenced by the sponsor if the competent ethics committee has issued a favourable opinion on it pursuant to section 42 1 and the competent higher federal authority has given its approval pursuant to section 42 2.
The clinical trial of a medicinal product may only be conducted on human beings if and as long as:. If the person affected is unable to write, in exceptional cases, instead of the written consent required in sentence 3 no. The witness may not be anyone working at the trial site nor a member of the investigating team. The orally given consent is to be documented in writing, dated and signed by the witness. The investigator must designate at least one deputy with comparable qualifications.
Furthermore, the person concerned is to be given the opportunity to have a counselling session with an investigator or a member of the investigating team who is a physician, or in the case of a dental trial, a dentist about the other conditions surrounding the conduct of the clinical trial. A declaration of consent pursuant to subsection 1 sentence 3 no. The person concerned is to be informed especially of the fact that:. In the case of a revocation of a declaration of consent made pursuant to subsection 1 sentence 3 no.
Data that are no longer needed are to be deleted immediately. Furthermore, the collected personal data are to be deleted after the period specified on the basis of section 42 3 has elapsed as long as no legal statutory or contractual retention periods exist to the contrary. Its scope must be reasonably commensurate with the risks involved in the clinical trial and determined on the basis of the risk assessment in such a way as to ensure that for every case of the death or permanent occupational disability of a person concerned by clinical trial, at least , euros are available.
Insofar as benefits are paid by the insurance, all claims to damages are extinguished. The medicinal product is indicated if its administration to minors is medically indicated. It must correspond to the minor's presumed will where such a will can be ascertained. An opportunity for a counselling session pursuant to subsection 2 sentence 2 is to be offered, not only to the legal representative but also to the minor,. The contact point is to be set up at the higher federal authority competent in the specific case.
Section 41 Special conditions for clinical trials. If, in an emergency situation, consent cannot be obtained, treatment that needs to be given without delay to save the life of the person concerned, restore good health or alleviate suffering can be started immediately.
Consent for continued participation must be obtained as soon as it is possible and reasonable. The clinical trial may only be conducted if there is a justified expectation that the benefits of using the investigational medicinal product for the person concerned outweigh the risks or that the use does not entail any risks,. Section 40 4 no.
Section 41a Registration process for ethics committees. Personal data may be published only with the consent of the specific individual. The list is to be updated regularly. Section 41b Rules of procedure and schedule of responsibilities.
The rules of procedure stipulate in particular the details of the registration procedure, the deadlines for opinions by the registered ethics committees, the fixed fee scales or guideline rates, depending in each case on the number of personnel and amount of material required for the opinions and assessment reports by the registered ethics committees, the criteria for a schedule of responsibilities, including the factors that are decisive for the distribution of the applications to be processed, as well as who bears responsibility for requesting additional information from the sponsor pursuant to Regulation EU No.
This schedule of responsibilities is to be updated annually by 1 January of each year. In special cases, the schedule of responsibilities can be updated and modified by way of derogation from sentence 2.
The Federal Institute for Drugs and Medical Devices publishes each new updated schedule of responsibilities. Section 41c Power to issue ordinances. The Federal Ministry is hereby empowered to set up, by ordinance not subject to the approval of the Bundesrat, a Federal Ethics Committee at the Federal Institute for Drugs and Medical Devices and the Paul Ehrlich Institute, if this is necessary to ensure the conduct of the procedures provided for in Regulation EU No.
The provisions contained in this Division apply accordingly to the Federal Ethics Committee, subject to the proviso that the Federal Ethics Committee is deemed to be registered. Section 42 Ethics committee procedure, procedure for authorisation by the higher federal authority. If the clinical trial is to be conducted by several investigators, the application is to be submitted to the independent ethics committee responsible for the chief investigator. The detailed provisions regarding the setting up, composition and financing of the ethics committee are stipulated by Land law.
The sponsor must submit to the ethics committee all of the information and documents required by the ethics committee for its opinion. In assessing the documents, the ethics committee can use its own scientific findings, consult experts or request expert opinions.
It must call in experts or ask for expert reports in the case of clinical trials conducted on minors if it is not in possession of expert knowledge of its own in the field of paediatrics, including the ethical and psychosocial aspects of paediatrics, or in the case of xenogeneic medicinal products or gene therapy medicinal products.
A favourable opinion may only be refused if:. The detailed provisions are laid down in the ordinance pursuant to subsection 3. The ethics committee must have at the latest 60 days from the date of receipt of the required documents to give its opinion on the application referred to in sentence 1, which period can be extended or shortened in compliance with the ordinance pursuant to subsection 3 ; no time limit with respect to the authorisation period applies in the testing of xenogeneic medicinal products.
In this regard, the sponsor must submit all the information and documents necessary for the assessment especially the results of the analytical and pharmacological-toxicological tests as well as the trial protocol and the clinical data on the medicinal product including the investigator's brochure.
The authorisation is considered granted if the competent higher federal authority does not inform the sponsor of any reasoned objections within a maximum of 30 days after receipt of the application documents. If the sponsor fails to modify the application correspondingly, within a maximum of 90 days following the reasoned objections, the application is deemed to be rejected.
By way of derogation from sentence 4, the clinical trial of medicinal products:. The competent higher federal authority must take a decision on the application for the authorisation of a medicinal product pursuant to sentence 7 nos.
In such instances, no transmission of personal data takes place; furthermore, business and company secrets remain confidential. The ordinance may contain in particular regulations concerning:. Section 42a Withdrawal, revocation and suspension of the authorisation or of the favourable opinion. In the cases referred to in sentence 1, the suspension of the authorisation can also be ordered for a limited period of time.
In such a case, the suspension of the authorisation can also be ordered for a limited period of time. The competent authority immediately informs the other authorities responsible for surveillance and ethics committees, as well as the European Commission and the European Medicines Agency, stating the grounds for its action. Section 28 2 no. In the event that the competent higher federal authority orders the immediate interruption of the clinical trial, it informs the sponsor immediately of this order.
The lodging of an objection and action to rescind the revocation, the withdrawal or the order to suspend the authorisation as well as against orders pursuant to subsection 5 have no suspensive effect.
Subsections 3 and 4 apply accordingly. The competent ethics committee informs the competent higher federal authority and the other authorities responsible for surveillance immediately, stating the grounds.
This is without prejudice to measures taken by the competent supervision authority pursuant to section Section 42b Publication of the results of clinical trials. These reports are to be made available within six months subsequent to the granting or modification of the marketing authorisation or authorisation, if the modification is based on confirmatory clinical trials.
In addition, information regarding subsequent essential modifications to the trial protocol, as well as interruptions and early termination of the clinical trial, are to be included in report. Furthermore, the report of findings is to be drawn up according to the requirements of good clinical practice. With the exception of the name and address of the pharmaceutical entrepreneur or the sponsor, as well as the name and the address of the consenting investigators pursuant to section 4a of the Federal Data Protection Act, the reports pursuant to sentence 1 may not contain personal nor especially patient-related data.
The report may be written in German or English. Section 63b 3 sentence 1 does not apply. This is without prejudice to the provisions protecting intellectual property and those protecting operating and trade secrets, as well as sections 24a and 24b. Division 7 Sale of medicinal products.
Section 43 Pharmacy-only requirement, placing on the market by veterinarians. With the exception of the cases provided for in subsection 4 and section 47 1 , no trade may be conducted outside of pharmacies with those medicinal products reserved exclusively for sale in pharmacies pursuant to sentence 1.
The information on the issuing or modification of an authorisation for the sale at a distance of medicinal products pursuant to sentence 1 is to be entered into the database referred to in section 67a. This is without prejudice to section 56 1. Within the framework of emergency care, a haemostaseologically qualified physician may dispense medicinal products from the emergency stocks pursuant to sentence 1 to patients or healthcare facilities. This also applies to the dispensing of medicinal products deemed advisable by veterinarians and supervised by them for the purpose of implementing measures to prevent illness in animals whereby the amount dispensed may not exceed the amount needed according to veterinarian indication.
Medicinal products within the meaning of section 2 1 or subsection 2 no. At the time of dispensing, the animal keeper is to be given written instructions about the manner, timing and duration of use. This applies neither to medicated feeding stuffs nor to medicinal products within the meaning of subsection 4 sentence 3.
By way of derogation from sentence 1, medicinal products that are authorised for administration exclusively to non-food-producing animals may be dispensed through sale at a distance by pharmacies that are officially authorised to do so pursuant to subsection 1.
Furthermore, medicinal products specified in sentence 3 may be dispensed through sale at a distance within the framework of the operation of a veterinary in-house dispensary in an amount required for the short-term further treatment of individual animals treated by the veterinarian.
Section 44 Exceptions to the pharmacy-only requirement. Section 45 Authority to allow further exceptions to the pharmacy-only requirement. The ordinance is issued by the Federal Ministry of Food and Agriculture in agreement with the Federal Ministry and the Federal Ministry for Economic Affairs and Energy, insofar as medicinal products intended for administration to animals are concerned. Section 46 Authority to extend the pharmacy-only requirement.
Section 47 Distribution channel. State-recognised teaching facilities for pharmaceutical-technical assistants, insofar as medicinal products needed for the education of students are concerned. The recognition of the central purchasing agency pursuant to sentence 1 no. The Federal Ministry of Food and Agriculture is empowered, in agreement with the Federal Ministry, by ordinance subject to the approval of the Bundesrat:. Furthermore, ordinances pursuant to sentence 2 can contain regulations governing the corresponding application of section 67a 3 and 3a.
The central purchasing agencies specified in subsection 1 no. Pharmaceutical entrepreneurs may supply samples of a finished medicinal product or have samples of a finished medicinal product supplied to training centres for health professions only in the amounts required for the purpose of training. Samples may not contain any of the substances or preparations:.
0コメント