Examining the file media/Synopses/75F6206AC1903FE8C7A358428940D702.html:
This file was generated: 2020-01-25 20:52:03
Overall Tag Match Counts:
Searching for tag abuse:
(return to top)
...
p.(None): Protection of clinical trial subjects
p.(None):
p.(None): 1. This Directive shall apply without prejudice to the national provisions on the protection
p.(None): of clinical trial subjects if they are more comprehensive than the provisions of this Directive and consistent
p.(None): with the procedures and time-scales specified therein. Member States shall, insofar as they have not already
p.(None): done so, adopt detailed rules to protect from abuse individuals who are incapable of giving their informed
p.(None): consent.
p.(None): 2. A clinical trial may be undertaken only if, in particular:
p.(None): (a) the foreseeable risks and inconveniences have been weighed against the anticipated benefit for the individual
p.(None): trial subject and other present and future patients. A clinical trial may be initiated only if the Ethics
p.(None): Committee and/or the competent authority comes to the conclusion that the anticipated therapeutic and public health
...
Searching for tag access:
(return to top)
...
p.(None):
p.(None):
p.(None): 2001L0020 — EN — 07.08.2009 — 002.001 — 4
p.(None):
p.(None): ▼B
p.(None): trial takes place and all the other Member States should have access to the same information. A
p.(None): European database bringing together this information should therefore be set up, with due regard for the
p.(None): rules of confidentiality.
p.(None):
p.(None): (10) Clinical trials are a complex operation, generally lasting one or more years, usually involving
p.(None): numerous participants and several trial sites, often in different Member States. Member States'
...
...
p.(None): suspected serious adverse reactions which have occurred over this period and a report of the subjects'
p.(None): safety.
p.(None): 3. (a) Each Member State shall see to it that all suspected unex- pected serious adverse
p.(None): reactions to an investigational medicinal product which are brought to its attention are imme- diately entered
p.(None): in a European database to which, in accordance with Article 11(1), only the competent authorities of
p.(None): the Member States, the Agency and the Commission shall have access.
p.(None): (b) The Agency shall make the information notified by the sponsor available to the
p.(None): competent authorities of the Member States.
p.(None):
p.(None): Article 18
p.(None): Guidance concerning reports
...
Searching for tag age:
(return to top)
...
p.(None):
p.(None): ▼B
p.(None): there are grounds for expecting that the administering of the medicinal product would be of direct
p.(None): benefit to the patient, thereby outweighing the risks. However, there is a need for clinical trials
p.(None): involving children to improve the treatment available to them. Children represent a vulnerable
p.(None): population with developmental, physiological and psychological differences from adults, which make age- and
p.(None): development- related research important for their benefit. Medicinal products, including vaccines,
p.(None): for children need to be tested scientifically before wide- spread use. This can only be achieved by ensuring that
p.(None): medicinal products which are likely to be of significant clinical value for children are fully studied.
p.(None): The clinical trials required for this purpose should be carried out under conditions affording the best
p.(None): possible protection for the subjects. Criteria for the protection of children in clinical trials
...
Searching for tag authority:
(return to top)
...
p.(None): restrictive basis. Medicinal products for trial may be administered to all such individuals only when there are grounds
p.(None): for assuming that the direct benefit to the patient outweighs the risks. Moreover, in such cases
p.(None): the written consent of the patient's legal representative, given in cooperation with the treating
p.(None): doctor, is necessary before participation in any such clinical trial.
p.(None): (5) The notion of legal representative refers back to existing national law and consequently may include
p.(None): natural or legal persons, an authority and/or a body provided for by national law.
p.(None): (6) In order to achieve optimum protection of health, obsolete or repetitive tests will not be
p.(None): carried out, whether within the Community or in third countries. The harmonisation of
p.(None): technical requirements for the development of medicinal products should therefore be pursued
p.(None): through the appropriate fora, in particular the International Conference on Harmonisation.
p.(None): (7) For medicinal products falling within the scope of Part A of the Annex to Council Regulation (EEC)
...
...
p.(None): is therefore necessary to simplify and harmonise the administrative provisions governing such trials by
p.(None): establishing a clear, transparent procedure and creating conditions conducive to effective coordi-
p.(None): nation of such clinical trials in the Community by the authorities concerned.
p.(None):
p.(None): (11) As a rule, authorisation should be implicit, i.e. if there has been a vote in favour by the Ethics
p.(None): Committee and the competent authority has not objected within a given period, it should be possible to
p.(None): begin the clinical trials. In exceptional cases raising especially complex problems, explicit
p.(None): written authorisation should, however, be required.
p.(None):
p.(None): (12) The principles of good manufacturing practice should be applied to investigational medicinal
p.(None): products.
...
...
p.(None):
p.(None):
p.(None): 2001L0020 — EN — 07.08.2009 — 002.001 — 7
p.(None):
p.(None): ▼B
p.(None): (l) ‘inspection’: the act by a competent authority of conducting an official review of documents,
p.(None): facilities, records, quality assurance arrangements, and any other resources that are deemed by the
p.(None): competent authority to be related to the clinical trial and that may be located at the site of the
p.(None): trial, at the sponsor's and/or contract research organisation's facilities, or at other establishments which the
p.(None): competent authority sees fit to inspect;
p.(None): (m) ‘adverse event’: any untoward medical occurrence in a patient or clinical trial subject administered
p.(None): a medicinal product and which does not necessarily have a causal relationship with this treatment;
p.(None): (n) ‘adverse reaction’: all untoward and unintended responses to an investigational medicinal product
p.(None): related to any dose administered;
p.(None):
...
...
p.(None): done so, adopt detailed rules to protect from abuse individuals who are incapable of giving their informed
p.(None): consent.
p.(None): 2. A clinical trial may be undertaken only if, in particular:
p.(None): (a) the foreseeable risks and inconveniences have been weighed against the anticipated benefit for the individual
p.(None): trial subject and other present and future patients. A clinical trial may be initiated only if the Ethics
p.(None): Committee and/or the competent authority comes to the conclusion that the anticipated therapeutic and public health
p.(None): benefits justify the risks and may be continued only if compliance with this requirement is permanently monitored;
p.(None): (b) the trial subject or, when the person is not able to give informed consent, his legal
p.(None): representative has had the opportunity, in a prior interview with the investigator or a member of the
p.(None): investigating team, to understand the objectives, risks and inconveniences of the trial, and the conditions
p.(None): under which it is to be conducted and has also been informed of his right to withdraw from the trial
...
...
p.(None): subjects and the relevant aspects of any agreement between the sponsor and the site;
p.(None):
p.(None): (k) the arrangements for the recruitment of subjects.
p.(None):
p.(None): 4. Notwithstanding the provisions of this Article, a Member State may decide that the competent
p.(None): authority it has designated for the purpose of Article 9 shall be responsible for the consideration
p.(None): of, and the giving of an opinion on, the matters referred to in paragraph 3(h), (i) and (j) of this Article.
p.(None):
p.(None): When a Member State avails itself of this provision, it shall notify the Commission, the other Member
p.(None): States and the Agency.
p.(None):
p.(None): 5. The Ethics Committee shall have a maximum of 60 days from the date of receipt of a valid application to give
p.(None): its reasoned opinion to the applicant and the competent authority in the Member State concerned.
p.(None):
p.(None): 6. Within the period of examination of the application for an opinion, the Ethics Committee may send a single
p.(None): request for information supple- mentary to that already supplied by the applicant. The period laid down in paragraph
p.(None): 5 shall be suspended until receipt of the supplementary information.
p.(None):
...
...
p.(None): Commencement of a clinical trial
p.(None):
p.(None): 1. Member States shall take the measures necessary to ensure that the procedure described in this Article is
p.(None): followed for commencement of a clinical trial.
p.(None): The sponsor may not start a clinical trial until the Ethics Committee has issued a favourable opinion and inasmuch as
p.(None): the competent authority of the Member State concerned has not informed the sponsor of any grounds for
p.(None): non-acceptance. The procedures to reach these decisions can be run in parallel or not, depending on the
p.(None): sponsor.
p.(None): 2. Before commencing any clinical trial, the sponsor shall be required to submit a valid request for authorisation
p.(None): to the competent authority of the Member State in which the sponsor plans to conduct the clinical trial.
p.(None): 3. If the competent authority of the Member State notifies the sponsor of grounds for
p.(None): non-acceptance, the sponsor may, on one occasion only, amend the content of the request
p.(None): referred to in paragraph 2 in order to take due account of the grounds given. If the sponsor fails
p.(None): to amend the request accordingly, the request shall be considered rejected and the clinical trial may
p.(None): not commence.
p.(None): 4. Consideration of a valid request for authorisation by the competent authority as stated in paragraph 2
p.(None): shall be carried out as rapidly as possible and may not exceed 60 days. The Member States may lay down
p.(None): a shorter period than 60 days within their area of responsibility if that is in compliance with
p.(None): current practice. The competent authority can nevertheless notify the sponsor before the end of this period
p.(None): that it has no grounds for non-acceptance.
p.(None): No further extensions to the period referred to in the first subparagraph shall be permissible except in the case of
p.(None): trials involving the medicinal products listed in paragraph 6, for which an extension of a maximum of 30 days shall
p.(None): be permitted. For these products, this 90-day period may be extended by a further 90 days in the event of
p.(None): consultation of a group or a committee in accordance with the regulations and procedures of the Member States
...
...
p.(None): (c) any amendments made to the protocol, as provided for in point a of Article 10;
p.(None): (d) the favourable opinion of the Ethics Committee;
p.(None): (e) the declaration of the end of the clinical trial; and
p.(None): (f) a reference to the inspections carried out on conformity with good clinical practice.
p.(None): 2. At the substantiated request of any Member State, the Agency or the Commission, the competent
p.(None): authority to which the request for authorisation was submitted shall supply all further information
p.(None): concerning the clinical trial in question other than the data already in the European database.
p.(None): 3. In consultation with the Member States, the Commission shall draw up and publish detailed guidance
p.(None): on the relevant data to be included in this European database, which it operates with the assistance of the
p.(None): Agency, as well as the methods for electronic communication of the data. The detailed guidance thus drawn up
p.(None): shall ensure that the confidentiality of the data is strictly observed.
...
...
p.(None): authorisation referred to in Article 9(2) are no longer met or has information raising doubts about the safety or
p.(None): scientific validity of the clinical trial, it may suspend or prohibit the clinical trial and shall
p.(None): notify the sponsor thereof.
p.(None): Before the Member State reaches its decision it shall, except where there is imminent risk, ask the
p.(None): sponsor and/or the investigator for their opinion, to be delivered within one week.
p.(None): In this case, the competent authority concerned shall forthwith inform the other competent authorities,
p.(None): the Ethics Committee concerned, the Agency and the Commission of its decision to suspend or prohibit the
p.(None): trial and of the reasons for the decision.
p.(None):
p.(None): (1) OJ L 378, 27.12.2006, p. 1.
p.(None):
p.(None): 2001L0020
p.(None): — EN — 07.08.2009 — 002.001 — 14
p.(None):
p.(None): ▼B
p.(None): 2. Where a competent authority has objective grounds for considering that the sponsor or
p.(None): the investigator or any other person involved in the conduct of the trial no longer meets the
p.(None): obligations laid down, it shall forthwith inform him thereof, indicating the course of action which he
p.(None): must take to remedy this state of affairs. The competent authority concerned shall forthwith inform
p.(None): the Ethics Committee, the other competent authorities and the Commission of this course of action.
p.(None):
p.(None): Article 13
p.(None): Manufacture and import of investigational medicinal products
p.(None):
...
...
p.(None): release certification signed by the qualified person.
p.(None):
p.(None): 4. In all cases, the qualified person must certify in a register or equivalent document that each
p.(None): production batch satisfies the provisions of this Article. The said register or equivalent document shall be kept
p.(None): up to date as operations are carried out and shall remain at the disposal of the agents of the competent
p.(None): authority for the period specified in the provisions of the Member States concerned. This period shall
p.(None): in any event be not less than five years.
p.(None):
p.(None): 5. Any person engaging in activities as the qualified person referred to in Article 21 of Directive
p.(None): 75/319/EEC as regards investigational medicinal products at the time when this Directive is applied in
p.(None): the Member State where that person is, but without complying with the conditions laid down in Articles
...
...
p.(None):
p.(None): 1. To verify compliance with the provisions on good clinical and manufacturing practice, Member
p.(None): States shall appoint inspectors to inspect the sites concerned by any clinical trial conducted,
p.(None): particularly the trial site or sites, the manufacturing site of the investigational medicinal product,
p.(None): any laboratory used for analyses in the clinical trial and/or the sponsor's premises.
p.(None): The inspections shall be conducted by the competent authority of the Member State concerned, which shall
p.(None): inform the Agency; they shall be carried out on behalf of the Community and the results shall be
p.(None): recognised by all the other Member States. These inspections shall be coordinated by the Agency, within
p.(None): the framework of its powers as provided for in Regulation (EEC) No 2309/93. A Member State may request
p.(None): assistance from another Member State in this matter.
p.(None): 2. Following inspection, an inspection report shall be prepared. It must be made available to the
...
Searching for tag capacity:
(return to top)
...
p.(None): Clinical trials on minors
p.(None):
p.(None): In addition to any other relevant restriction, a clinical trial on minors may be undertaken only if:
p.(None): (a) the informed consent of the parents or legal representative has been obtained; consent must represent the minor's
p.(None): presumed will and may be revoked at any time, without detriment to the minor;
p.(None): (b) the minor has received information according to its capacity of understanding, from staff with
p.(None): experience with minors, regarding the trial, the risks and the benefits;
p.(None): (c) the explicit wish of a minor who is capable of forming an opinion and assessing this information
p.(None): to refuse participation or to be withdrawn from the clinical trial at any time is considered by
p.(None): the investigator or where appropriate the principal investigator;
p.(None): (d) no incentives or financial inducements are given except compen- sation;
...
...
p.(None):
p.(None): ▼B
p.(None): (a) the informed consent of the legal representative has been obtained; consent must represent the
p.(None): subject's presumed will and may be revoked at any time, without detriment to the subject;
p.(None): (b) the person not able to give informed legal consent has received information according to
p.(None): his/her capacity of understanding regarding the trial, the risks and the benefits;
p.(None): (c) the explicit wish of a subject who is capable of forming an opinion and assessing this information to refuse
p.(None): participation in, or to be withdrawn from, the clinical trial at any time is considered by the
p.(None): investigator or where appropriate the principal investigator;
p.(None): (d) no incentives or financial inducements are given except compen- sation;
p.(None): (e) such research is essential to validate data obtained in clinical trials on persons able to give
...
Searching for tag children:
(return to top)
...
p.(None): 2001L0020 — EN — 07.08.2009 — 002.001 — 3
p.(None):
p.(None): ▼B
p.(None): there are grounds for expecting that the administering of the medicinal product would be of direct
p.(None): benefit to the patient, thereby outweighing the risks. However, there is a need for clinical trials
p.(None): involving children to improve the treatment available to them. Children represent a vulnerable
p.(None): population with developmental, physiological and psychological differences from adults, which make age- and
p.(None): development- related research important for their benefit. Medicinal products, including vaccines,
p.(None): for children need to be tested scientifically before wide- spread use. This can only be achieved by ensuring that
p.(None): medicinal products which are likely to be of significant clinical value for children are fully studied.
p.(None): The clinical trials required for this purpose should be carried out under conditions affording the best
p.(None): possible protection for the subjects. Criteria for the protection of children in clinical trials
p.(None): therefore need to be laid down.
p.(None): (4) In the case of other persons incapable of giving their consent, such as persons with dementia,
p.(None): psychiatric patients, etc., inclusion in clinical trials in such cases should be on an even more
p.(None): restrictive basis. Medicinal products for trial may be administered to all such individuals only when there are grounds
p.(None): for assuming that the direct benefit to the patient outweighs the risks. Moreover, in such cases
...
Searching for tag economic:
(return to top)
...
p.(None):
p.(None): Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
p.(None):
p.(None): Having regard to the proposal from the Commission (1),
p.(None):
p.(None): Having regard to the opinion of the Economic and Social Committee (2),
p.(None):
p.(None): Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),
p.(None):
p.(None): Whereas:
p.(None): (1) Council Directive 65/65/EEC of 26 January 1965 on the approx- imation of provisions laid down by law,
...
Searching for tag health:
(return to top)
...
p.(None): for assuming that the direct benefit to the patient outweighs the risks. Moreover, in such cases
p.(None): the written consent of the patient's legal representative, given in cooperation with the treating
p.(None): doctor, is necessary before participation in any such clinical trial.
p.(None): (5) The notion of legal representative refers back to existing national law and consequently may include
p.(None): natural or legal persons, an authority and/or a body provided for by national law.
p.(None): (6) In order to achieve optimum protection of health, obsolete or repetitive tests will not be
p.(None): carried out, whether within the Community or in third countries. The harmonisation of
p.(None): technical requirements for the development of medicinal products should therefore be pursued
p.(None): through the appropriate fora, in particular the International Conference on Harmonisation.
p.(None): (7) For medicinal products falling within the scope of Part A of the Annex to Council Regulation (EEC)
p.(None): No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal
...
...
p.(None): done so, adopt detailed rules to protect from abuse individuals who are incapable of giving their informed
p.(None): consent.
p.(None): 2. A clinical trial may be undertaken only if, in particular:
p.(None): (a) the foreseeable risks and inconveniences have been weighed against the anticipated benefit for the individual
p.(None): trial subject and other present and future patients. A clinical trial may be initiated only if the Ethics
p.(None): Committee and/or the competent authority comes to the conclusion that the anticipated therapeutic and public health
p.(None): benefits justify the risks and may be continued only if compliance with this requirement is permanently monitored;
p.(None): (b) the trial subject or, when the person is not able to give informed consent, his legal
p.(None): representative has had the opportunity, in a prior interview with the investigator or a member of the
p.(None): investigating team, to understand the objectives, risks and inconveniences of the trial, and the conditions
p.(None): under which it is to be conducted and has also been informed of his right to withdraw from the trial
...
Searching for tag incapacitated:
(return to top)
...
p.(None): (h) the Ethics Committee, with paediatric expertise or after taking advice in clinical, ethical
p.(None): and psychosocial problems in the field of paediatrics, has endorsed the protocol; and
p.(None): (i) the interests of the patient always prevail over those of science and society.
p.(None):
p.(None): Article 5
p.(None): Clinical trials on incapacitated adults not able to give informed legal consent
p.(None):
p.(None): In the case of other persons incapable of giving informed legal consent, all relevant requirements listed for
p.(None): persons capable of giving such consent shall apply. In addition to these requirements, inclusion in
p.(None): clinical trials of incapacitated adults who have not given or not refused informed consent
p.(None): before the onset of their incapacity shall be allowed only if:
p.(None):
p.(None):
p.(None): 2001L0020 — EN — 07.08.2009 — 002.001 — 9
p.(None):
...
...
p.(None): participation in, or to be withdrawn from, the clinical trial at any time is considered by the
p.(None): investigator or where appropriate the principal investigator;
p.(None): (d) no incentives or financial inducements are given except compen- sation;
p.(None): (e) such research is essential to validate data obtained in clinical trials on persons able to give
p.(None): informed consent or by other research methods and relates directly to a life-threatening or debilitating
p.(None): clinical condition from which the incapacitated adult concerned suffers;
p.(None): (f) clinical trials have been designed to minimise pain, discomfort, fear and any other foreseeable risk in
p.(None): relation to the disease and devel- opmental stage; both the risk threshold and the degree of distress
p.(None): shall be specially defined and constantly monitored;
p.(None): (g) the Ethics Committee, with expertise in the relevant disease and the patient population concerned or after
p.(None): taking advice in clinical, ethical and psychosocial questions in the field of the relevant
...
Searching for tag language:
(return to top)
...
p.(None):
p.(None):
p.(None): Article 14
p.(None): Labelling
p.(None):
p.(None): The particulars to appear in at least the official language(s) of the Member State on the outer
p.(None): packaging of investigational medicinal products or, where there is no outer packaging, on the immediate
p.(None): packaging, shall be published by the Commission in the good manu- facturing practice guidelines on
p.(None): investigational medicinal products adopted in accordance with Article 19a of Directive 75/319/EEC.
p.(None):
p.(None): In addition, these guidelines shall lay down adapted provisions relating to labelling for investigational
...
Searching for tag minor:
(return to top)
...
p.(None):
p.(None): Article 4
p.(None): Clinical trials on minors
p.(None):
p.(None): In addition to any other relevant restriction, a clinical trial on minors may be undertaken only if:
p.(None): (a) the informed consent of the parents or legal representative has been obtained; consent must represent the minor's
p.(None): presumed will and may be revoked at any time, without detriment to the minor;
p.(None): (b) the minor has received information according to its capacity of understanding, from staff with
p.(None): experience with minors, regarding the trial, the risks and the benefits;
p.(None): (c) the explicit wish of a minor who is capable of forming an opinion and assessing this information
p.(None): to refuse participation or to be withdrawn from the clinical trial at any time is considered by
p.(None): the investigator or where appropriate the principal investigator;
p.(None): (d) no incentives or financial inducements are given except compen- sation;
p.(None): (e) some direct benefit for the group of patients is obtained from the clinical trial and only where
p.(None): such research is essential to validate data obtained in clinical trials on persons able to give informed
p.(None): consent or by other research methods; additionally, such research should either relate directly to a
p.(None): clinical condition from which the minor concerned suffers or be of such a nature that it can only be
p.(None): carried out on minors;
p.(None): (f) the corresponding scientific guidelines of the Agency have been followed;
p.(None): (g) clinical trials have been designed to minimise pain, discomfort, fear and any other foreseeable risk in
p.(None): relation to the disease and devel- opmental stage; both the risk threshold and the degree of distress
p.(None): have to be specially defined and constantly monitored;
...
Searching for tag minors:
(return to top)
...
p.(None): 3. The medical care given to, and medical decisions made on behalf of, subjects shall be the responsibility
p.(None): of an appropriately qualified doctor or, where appropriate, of a qualified dentist.
p.(None): 4. The subject shall be provided with a contact point where he may obtain further information.
p.(None):
p.(None): Article 4
p.(None): Clinical trials on minors
p.(None):
p.(None): In addition to any other relevant restriction, a clinical trial on minors may be undertaken only if:
p.(None): (a) the informed consent of the parents or legal representative has been obtained; consent must represent the minor's
p.(None): presumed will and may be revoked at any time, without detriment to the minor;
p.(None): (b) the minor has received information according to its capacity of understanding, from staff with
p.(None): experience with minors, regarding the trial, the risks and the benefits;
p.(None): (c) the explicit wish of a minor who is capable of forming an opinion and assessing this information
p.(None): to refuse participation or to be withdrawn from the clinical trial at any time is considered by
p.(None): the investigator or where appropriate the principal investigator;
p.(None): (d) no incentives or financial inducements are given except compen- sation;
p.(None): (e) some direct benefit for the group of patients is obtained from the clinical trial and only where
p.(None): such research is essential to validate data obtained in clinical trials on persons able to give informed
p.(None): consent or by other research methods; additionally, such research should either relate directly to a
p.(None): clinical condition from which the minor concerned suffers or be of such a nature that it can only be
p.(None): carried out on minors;
p.(None): (f) the corresponding scientific guidelines of the Agency have been followed;
p.(None): (g) clinical trials have been designed to minimise pain, discomfort, fear and any other foreseeable risk in
p.(None): relation to the disease and devel- opmental stage; both the risk threshold and the degree of distress
p.(None): have to be specially defined and constantly monitored;
p.(None): (h) the Ethics Committee, with paediatric expertise or after taking advice in clinical, ethical
...
Searching for tag risk:
(return to top)
...
p.(None): the testing of medicinal products (5) lays down uniform rules on the compilation of dossiers
p.(None): including their presentation.
p.(None): (2) The accepted basis for the conduct of clinical trials in humans is founded in the protection of human
p.(None): rights and the dignity of the human being with regard to the application of biology and
p.(None): medicine, as for instance reflected in the 1996 version of the Helsinki Declaration. The clinical trial
p.(None): subject's protection is safe- guarded through risk assessment based on the results of toxico- logical
p.(None): experiments prior to any clinical trial, screening by ethics committees and Member States' competent authorities,
p.(None): and rules on the protection of personal data.
p.(None): (3) Persons who are incapable of giving legal consent to clinical trials should be given special
p.(None): protection. It is incumbent on the Member States to lay down rules to this effect. Such persons may not be
p.(None): included in clinical trials if the same results can be obtained using persons capable of giving
...
...
p.(None): ▼B
p.(None):
p.(None):
p.(None): (18) It is also necessary to make provision for the monitoring of adverse reactions occurring in
p.(None): clinical trials using Community surveillance (pharmacovigilance) procedures in order to ensure the immediate
p.(None): cessation of any clinical trial in which there is an unacceptable level of risk.
p.(None): (19) The measures necessary for the implementation of this Directive should be adopted in
p.(None): accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the
p.(None): exercise of implementing powers conferred on the Commission (1),
p.(None):
p.(None): HAVE ADOPTED THIS DIRECTIVE:
...
...
p.(None): such research is essential to validate data obtained in clinical trials on persons able to give informed
p.(None): consent or by other research methods; additionally, such research should either relate directly to a
p.(None): clinical condition from which the minor concerned suffers or be of such a nature that it can only be
p.(None): carried out on minors;
p.(None): (f) the corresponding scientific guidelines of the Agency have been followed;
p.(None): (g) clinical trials have been designed to minimise pain, discomfort, fear and any other foreseeable risk in
p.(None): relation to the disease and devel- opmental stage; both the risk threshold and the degree of distress
p.(None): have to be specially defined and constantly monitored;
p.(None): (h) the Ethics Committee, with paediatric expertise or after taking advice in clinical, ethical
p.(None): and psychosocial problems in the field of paediatrics, has endorsed the protocol; and
p.(None): (i) the interests of the patient always prevail over those of science and society.
p.(None):
...
...
p.(None): investigator or where appropriate the principal investigator;
p.(None): (d) no incentives or financial inducements are given except compen- sation;
p.(None): (e) such research is essential to validate data obtained in clinical trials on persons able to give
p.(None): informed consent or by other research methods and relates directly to a life-threatening or debilitating
p.(None): clinical condition from which the incapacitated adult concerned suffers;
p.(None): (f) clinical trials have been designed to minimise pain, discomfort, fear and any other foreseeable risk in
p.(None): relation to the disease and devel- opmental stage; both the risk threshold and the degree of distress
p.(None): shall be specially defined and constantly monitored;
p.(None): (g) the Ethics Committee, with expertise in the relevant disease and the patient population concerned or after
p.(None): taking advice in clinical, ethical and psychosocial questions in the field of the relevant
p.(None): disease and patient population concerned, has endorsed the protocol;
p.(None): (h) the interests of the patient always prevail over those of science and society; and
p.(None): (i) there are grounds for expecting that administering the medicinal product to be tested will
p.(None): produce a benefit to the patient outweighing the risks or produce no risk at all.
p.(None):
p.(None): Article 6
p.(None): Ethics Committee
p.(None):
p.(None): 1. For the purposes of implementation of the clinical trials, Member States shall take the measures
...
...
p.(None):
p.(None): 1. Where a Member State has objective grounds for considering that the conditions in the request for
p.(None): authorisation referred to in Article 9(2) are no longer met or has information raising doubts about the safety or
p.(None): scientific validity of the clinical trial, it may suspend or prohibit the clinical trial and shall
p.(None): notify the sponsor thereof.
p.(None): Before the Member State reaches its decision it shall, except where there is imminent risk, ask the
p.(None): sponsor and/or the investigator for their opinion, to be delivered within one week.
p.(None): In this case, the competent authority concerned shall forthwith inform the other competent authorities,
p.(None): the Ethics Committee concerned, the Agency and the Commission of its decision to suspend or prohibit the
p.(None): trial and of the reasons for the decision.
p.(None):
...
Searching for tag social:
(return to top)
...
p.(None):
p.(None): Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
p.(None):
p.(None): Having regard to the proposal from the Commission (1),
p.(None):
p.(None): Having regard to the opinion of the Economic and Social Committee (2),
p.(None):
p.(None): Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),
p.(None):
p.(None): Whereas:
p.(None): (1) Council Directive 65/65/EEC of 26 January 1965 on the approx- imation of provisions laid down by law,
...
Searching for tag special:
(return to top)
...
p.(None): rights and the dignity of the human being with regard to the application of biology and
p.(None): medicine, as for instance reflected in the 1996 version of the Helsinki Declaration. The clinical trial
p.(None): subject's protection is safe- guarded through risk assessment based on the results of toxico- logical
p.(None): experiments prior to any clinical trial, screening by ethics committees and Member States' competent authorities,
p.(None): and rules on the protection of personal data.
p.(None): (3) Persons who are incapable of giving legal consent to clinical trials should be given special
p.(None): protection. It is incumbent on the Member States to lay down rules to this effect. Such persons may not be
p.(None): included in clinical trials if the same results can be obtained using persons capable of giving
p.(None): consent. Normally these persons should be included in clinical trials only when
p.(None):
p.(None): (1) OJ C 306, 8.10.1997, p. 9 and
...
...
p.(None): written authorisation should, however, be required.
p.(None):
p.(None): (12) The principles of good manufacturing practice should be applied to investigational medicinal
p.(None): products.
p.(None):
p.(None): (13) Special provisions should be laid down for the labelling of these products.
p.(None):
p.(None): (14) Non-commercial clinical trials conducted by researchers without the participation of the
p.(None): pharmaceuticals industry may be of great benefit to the patients concerned. The Directive should therefore
p.(None): take account of the special position of trials whose planning does not require particular manufacturing or
p.(None): packaging processes, if these trials are carried out with medicinal products with a marketing
p.(None): authorisation within the meaning of Directive 65/65/EEC, manufactured or imported in accordance
p.(None): with the provisions of Directives 75/319/EEC and 91/356/EEC, and on patients with the same characteristics
p.(None): as those covered by the indication specified in this marketing authorisation. Labelling of the
p.(None): investigational medicinal products intended for trials of this nature should be subject to simplified provisions
...
...
p.(None): concerned. In the case of xenogenic cell therapy there shall be no time limit to the authorisation
p.(None): period.
p.(None): 5. Without prejudice to paragraph 6, written authorisation may be required before the commencement of
p.(None): clinical trials for such trials on medicinal products which do not have a marketing authorisation within the
p.(None): meaning of Directive 65/65/EEC and are referred to in Part A of the Annex to Regulation (EEC) No 2309/93, and
p.(None): other medicinal products with special characteristics, such as medicinal products the active
p.(None): ingredient or active ingredients of which is or are a biological product or biological products
p.(None): of human or animal origin, or contains biological components of human or animal origin, or the manufacturing of
p.(None): which requires such components.
p.(None): 6. Written authorisation shall be required before commencing clinical trials involving medicinal products
p.(None): for gene therapy, somatic cell therapy including xenogenic cell therapy and all medicinal products
...
Searching for tag substance:
(return to top)
...
p.(None): in accordance with the terms of the marketing authorisation. The assignment of the patient to a
p.(None): particular therapeutic strategy is not decided in advance by a trial protocol but falls within current
p.(None): practice and the prescription of the medicine is clearly separated from the decision to include the patient
p.(None): in the study. No additional diagnostic or monitoring procedures shall be applied to the patients
p.(None): and epidemiological methods shall be used for the analysis of collected data;
p.(None): (d) ‘investigational medicinal product’: a pharmaceutical form of an active substance or placebo being
p.(None): tested or used as a reference in a clinical trial, including products already with a marketing author- isation
p.(None): but used or assembled (formulated or packaged) in a way different from the authorised form, or
p.(None): when used for an unauthorised indication, or when used to gain further information about the authorised
p.(None): form;
p.(None): (e) ‘sponsor’: an individual, company, institution or organisation which takes responsibility for the initiation,
...
Searching for tag vulnerable:
(return to top)
...
p.(None): 2001L0020 — EN — 07.08.2009 — 002.001 — 3
p.(None):
p.(None): ▼B
p.(None): there are grounds for expecting that the administering of the medicinal product would be of direct
p.(None): benefit to the patient, thereby outweighing the risks. However, there is a need for clinical trials
p.(None): involving children to improve the treatment available to them. Children represent a vulnerable
p.(None): population with developmental, physiological and psychological differences from adults, which make age- and
p.(None): development- related research important for their benefit. Medicinal products, including vaccines,
p.(None): for children need to be tested scientifically before wide- spread use. This can only be achieved by ensuring that
p.(None): medicinal products which are likely to be of significant clinical value for children are fully studied.
p.(None): The clinical trials required for this purpose should be carried out under conditions affording the best
...