86/2008 Sb.
The DECREE
of 26 March. February 2008
on the determination of the principles of good laboratory practice in the area of pharmaceuticals
The Ministry of health and Ministry of agriculture determined in accordance with section
paragraph 114. 2 and § 23 paragraph. 6 Act No 378/2007 Coll.
pharmaceuticals and on changes of some related laws (law on medicinal products):
§ 1
Introductory provisions
This Decree incorporates the relevant provisions of European Community ^ 1)
and regulates the procedures for non-clinical safety testing of pharmaceuticals in the
performing laboratory tests in accordance with the principles of good laboratory practice
(hereinafter "the policy"), which are listed in the annex to this Decree.
§ 2
Decree of the Ministry of health is hereby repealed and the Ministry of
Agriculture no 504/2000 Coll., laying down good laboratory
practice in the area of pharmaceuticals.
§ 3
This Decree shall take effect on the date of its publication.
Minister of health:
Mudr. Julínek, MBA in r.
Minister of agriculture:
Mgr. Gandalovič in r.
Annex
AND THE PRINCIPLES OF GOOD LABORATORY PRACTICE.
PART I
INTRODUCTORY PROVISIONS
1. the interpretation of the terms
For the purposes of this policy means the
and) test facility-the persons, premises and equipment, which are
necessary to the carrying out of studies; in the case of the studies carried out on the more
the test facility shall mean the place where the head of the
studies and all the individual test sites, individually or
as a whole can be considered as test equipment,
(b)) a test place-a place where the individual phases of the study are carried out,
(c)) the head of a test facility-natural person or the natural
the person responsible for the organisation and operation of the test equipment in the
accordance with the provisions of this Decree and have the necessary powers to ensure the
the activities referred to in section II, point 1, subparagraph 1.1 of the annex to this
the Decree,
(d) the test points-leader) of the natural person who ensures that the phase of the
the study, for which he is responsible, shall be carried out in accordance with this Decree;
the head of a test place is appointed in the case that a study is underway on
more places
(e)) the contracting authority – natural or legal person who commissions,
financially and submitted for assessment, provides a study
f) study-the natural person who is responsible for the overall
the implementation of studies and has the necessary powers to ensure that the activities referred to
in part II, section 1, subsection 1.2 of the annex to this Decree,
g) principal investigator-a natural person, which, if you study
runs in multiple places, acting on behalf of the study Director and is responsible for
the defined phase of the study,
(h) quality assurance program) – a system for protection of the quality of the results
studies in conformity with these principles carried out by employees of the independent
These studies; This system is designed and documented procedures
schvalovanými head of the test facility,
I) standard operating procedures-procedures that describe how to perform
tests or activities that are not listed in detail in the study plan
or test guidelines; These procedures are intended and approved
the head of the test facility,
(j))-list of studies list of ongoing and completed studies with
information about the kind of studies, the start and end dates, test
system, method, the use of the test substance and the name of the head of the study; These
the information is used to plan activities and to monitor the studies in
test equipment,
to study or test) file tests, which under laboratory
conditions or in the environment, where the study is being performed, the test
entry in order to obtain data on its properties and safety for
the purpose of the presentation to the competent authority and other safety evaluation
the properties of the drug, ^ 2)
l) short-term study-a study carried out in a short time range
the specified number of days, and not exceeding a period of one month for the use of
routine and widely used methods,
m) study plan-a document which defines the objectives of the study and proposal of its
the experimental design, including accessories,
n) complement the study plan-proposed change to the study plan documented
After the date of the initiation of the study,
about) derogation from the study plan-unintended change from the study plan after the
the date of the initiation of the study,
p) test system-any biological, chemical or physical
a system or combination thereof used in a study,
q) raw data-all original records and documentation, or their
certified copies of which were obtained in the test facility as a result of
observations and activities during the study; raw data can be particularly
photographs, microfilms, or copies of, the records on mikroštítků
electronic media, which is dictated by the observation records of the automatic
apparatus or records on any other media that store
the information, which is commonly considered to be safe for the storage of information on
the period referred to in section II, point 10 of the annex to this Decree,
r) sample test system-any material, which is obtained from the
test system for testing, evaluation or retention,
with) the study initiation date-the date the study Director has signed a plan
the study,
t) date of commencement of the experimental studies-the day when the first have been obtained
information related to the study,
at the date of termination of the experimental studies)-the last day, when the
obtained information related to the study,
in the study end date)-the date the study Director has signed a final
the message,
w) test entry-material that is the subject of the study,
x) reference item-a material that is used for the purpose of comparison
with test item
s) batch-specific quantity or part of the test or reference
items prepared in the defined production cycle in such a way that the
It can be assumed uniform properties, and is properly labeled,
from) carrier-means any substance with which the test or reference item
mixed, or in which it is released and dispersed in order to facilitate
its application to the test system.
2. The scope of the
According to the policy, while the non-testing of test items
contained in the human and veterinary pharmaceuticals. These test
the items are of natural origin, biological origin or synthetic
chemicals; may also be living organisms. The purpose of testing these
the test items is to obtain information about their properties and safety
with regard to the health of humans, animals and the environment.
Non-clinical safety studies with an impact on health and the environment
(hereinafter referred to as "the study") included in this privacy policy pertain to the work of the
carried out in the laboratories of the testing equipment, greenhouses and on
fields.
These principles apply to all the studies required for the purpose of
authorisation of medicinal products.
PART II
EACH PART of the POLICY ^ 3)
1. the test facility organisation and personnel
1.1 test facility Manager
1.1.1 the head of test equipment ensures the appropriate test
equipment compliance with these principles.
1.1.2. The head of the testing facility within its scope provides a
and) that is available to a document that specifies it as the person who bears the
responsibility for the management of the test equipment, in accordance with the following
the principles,
(b)) that are available to qualified employees, as well as the premises,
equipment and materials to enable the timely and proper conduct of the study,
(c) documentation of qualifications), training and practice of all expertise and
technical staff, including descriptions of their work,
(d)) that the staff understands the activities to perform, and if it is
the employee must be trained,
(e)) that are developed and complied with technically valid standard
operating procedures, and these procedures, whether original or revised,
approved
(f)) that is applied to the quality assurance program, including the determination of persons
responsible for this program, and also ensures that the assurance
quality is carried out in accordance with these principles,
(g)) before the start of each study the provisions of the head of the study, which has
the relevant qualifications, training and experience; replacement of the head of the study
in accordance with established procedures and is documented,
h) in the case studies on multiple sites, the provisions of the head of
investigator, which has the relevant qualifications, training and experience to
could control the phase of the study entrusted to him; substitute head of the Sub-
testing is performed according to established procedures and is documented,
I) documented approval of the study plan by the study Director,
(j)) that the head of the study made available by an approved plan of study staff
quality assurance,
to all applicable and retention) of invalid versions of standard operating
practices in at least one copy,
l) provisions of the employee responsible for keeping a filing cabinet,
m) a register of studies and the retention of the list,
n) that supply the testing equipment comply with the requirements for their
in the study,
about that ongoing studies) on multiple sites, there are unique ways
the exchange of information between the study Director, principal investigator,
the head of the quality assurance programme and other staff
involved in the study,
p) characterisation of the test and reference items.
1.1.3. the Leading test equipment within their scope of sets
the procedures, which ensure that computerised systems are suitable for
intended purpose and are validated, used and maintained in accordance with
These principles.
1.1.4. the head of the test takes place in a given test point
the responsibility for ensuring the operations manager of the test facility,
the exception of the activities referred to in subparagraph 1.1.2. (b). (g)), i), (j)), and o).
1.2 study Director
1.2.1 the study Director is the only management person study and is responsible for
the overall design and for the final report of the study.
1.2.2 Head studies in the framework of their responsibilities and approve the study plan
all of the study plan and these affixes your signature and the date.
1.2.3 the study Director within its scope, ensures that the
and quality assurance staff have) available in good time a copy of the plan
studies and all its accessories,
(b)) to the employee who is involved in the study, have a plan
before the start of the study, the experimental, all accessories and
standard operating procedures,
(c)) in the study plan in progress in more places, and its final report, the
are identified and defined the role of all principal investigators,
any test facilities and test sites, where to study
be carried out,
(d)) shall comply with the procedures specified in the study plan, assesses and documents the
the effect of any deviations from the study plan on the quality and integrity of the study, and
If it is necessary, performs the corrective measures; in the course of the study assesses the
and confirms the deviations from standard operating procedures,
(e)), any primary data are completely documented and
recorded,
f) computer systems used in the study are validated,
(g)) after their studies are stored: the study plan, final report,
raw data and supporting material.
1.2.4 the study Director can effectively cooperate with employees
quality in the course of the study.
1.2.5. Head of studies confirms its signature together with the data
the final report and the responsibility for the validity of the data and shall
the extent of compliance of the study complies with these principles.
1.3 principal investigator
Senior investigator ensures that he conferred on the phase of the study
be carried out in accordance with these principles. Study Director's responsibility for the
the overall conduct of the study cannot be delegated to the head of the Sub-
testing; in particular, it cannot be transferred the responsibility for the approval of the plan
the study and its appendices, the approval of the final report and the statement that the
the following principles are complied with.
1.4 the staff conducting the study
1.4.1 all the staff who carried out the study, must be familiar
with those parts of the policy that are relevant to their role in the study.
1.4.2 Employees conducting the study have access to the study plan and the
the relevant standard operating procedures used in
the implementation of the study. Responsible for it that will follow these
documents. Any deviation from these documents it is necessary to record and
notify the head of the study, where appropriate, the head investigator.
1.4.3 Employees are responsible for conducting a study of the immediate and
accurate recording of raw data, for the quality of these data and for
compliance with these principles.
1.4.4 Employees carrying out the study shall comply with the measures for minimizing the
threat to their health and to ensure the integrity of the study. The staff of the
the principal investigator shall notify changes in your health. Head of studies
excludes employees of those activities which may affect the study.
2. Quality assurance programme
2.1 in General
2.1.1. The test device has a documented quality assurance programme
ensuring that studies are carried out in accordance with these principles.
2.1.2 the Program quality assurance is carried out by the employee or
employees who are directly subordinate to the head of the test equipment
and are familiar with the test procedures.
2.1.3 employees who ensure the quality of the studies, they cannot
participate in its implementation.
2.2 quality assurance Staff
2.2.1 Employees ensuring quality within its scope:
and maintain copies of all approved) plans and studies, standard
operating procedures, which are used in the test device, and have
access to a valid copy of the studies,
b) verify that the study plan contains the information required to achieve the
compliance with these principles; This validation documents
(c) the inspection shall be carried out for the purpose) to determine whether all the studies underway
in accordance with these principles; inspections also are finding that employees
conducting the study are available, and is governed by the plans of studies and
standard operating procedures; the inspections are divided into three
the categories, which are described in standard operating procedures
the quality assurance programme, namely:
1. inspection of the studies,
2. inspection of premises and equipment,
3. the inspection processes;
the minutes of the inspections referred to in points 1 and 3 shall be kept,
d) inspect the final reports and affirm that the methods, procedures and
observations are faithfully and accurately described and that the reported results accurately
and completely reflect the raw data of the studies,
(e)) shall immediately report any inspection results to the head of the test
the device and to the study Director, or also to the head investigator
and the head of the test locations
(f)) and the signature of the Declaration to affirm the expose to accompany the final
the report, which lists the categories of inspections and their dates of implementation,
including the phase inspektované studies, the date of notification of the results of inspections
the head of the test facility and to the study Director, or also
the head investigator; This statement also confirms that
the final report reflects the raw data.
3. the premises
3.1 General
3.1.1. the Test device has premises of such size, design and
the location to meet the requirements of the study and to minimize
the disruptive factors that may adversely affect the validity of the study.
3.1.2 premises are arranged so that the degree of separation of the different
activities to ensure the proper conduct of each study.
3.2 Spaces for test systems
3.2.1 Spaces for test systems have a number of rooms or
sections, to ensure the separation of test systems and individual
projects that use materials or organisms, which are known or
they are suspected of being biohazardous.
3.2.2 there are rooms or areas for the diagnosis, treatment and
control of the disease, in order to ensure that there is no undue
the deterioration of test systems.
3.2.3 available are storage facilities for supplies and equipment.
Storage areas are separate from rooms or areas in which the
are test systems, and must ensure adequate protection against
infestation, contamination and spoilage.
3.3 facilities for the treatment of tested and reference items
3.3.1 Are set aside separate areas for receiving and storing
test and reference items, and mixing of the test items with
carrier, in order to prevent contamination or mix-ups.
3.3.2 the storage facilities for the tested items are separate from the
space for test systems, in order to preserve the identity,
concentration, purity and stability of the test item and ensure
safe storage of dangerous substances.
3.4 premises for filing
Spaces for filing are equipped to provide safe
storage and search plans studies, raw data, final
messages, items and samples to test samples of the test systems.
The design of the filing cabinets and storage conditions shall be designed to
protect the stored material from untimely deterioration.
3.5 waste disposal ^ 4)
The handling of wastes and their disposal is done so as not to
compromised the integrity of the studies and includes ensuring space for the collection,
storage and disposal of waste, and the procedures for the decontamination and transport.
4. Apparatus, materials and reagents
4.1 apparatus, including validated computerised systems, used for the
obtaining, saving and creating the data and for monitoring the environment
studies related to the construction and capacity commensurate with the needs of the
the study.
4.2. Apparatus used in the study are checked regularly,
cleaned, maintained, and calibrated according to standard operating procedures.
Records of these activities are maintained. Calibration, if it is
possible, continuity of measurement standards has in the Czech Republic, or
international standards of measurement.
4.3. Apparatus and materials used in the study will not affect the unwanted
way test systems.
2.7 Chemicals, reagents and solutions are known by the name, or
concentration on the indication of the time of application, and instructions on the
specific storage conditions. The data are available also
regarding the origin, date of preparation and stability. Shelf life can be
extended on the basis of a documented testing or analysis.
5. Test systems
5.1 physical and chemical test systems placement and properties
equipment used to obtain the chemical and physical data
correspond to the needs of the study; their construction and capacity is proportional to the
the purpose of the use.
Ensure the integrity of the physical and chemical test systems.
5.2 biological test systems
5.2.1 creates and maintains the proper conditions for the location of housing,
care and handling of biological test systems, in order to
guarantee the quality of the data.
5.2.2 newly received animal and plant test systems should be isolated,
until their health status has been evaluated. If different
death or illness, the delivery does not apply to study and, where appropriate,
the test systems are killed in accordance with other legal regulation ^ 5). When
experimental study of the initiation of the test systems are free from
any disease or conditions that could adversely affect the
purpose or progress of the study. Test systems that become ill during the study
or get injured, should be isolated or treated, if it is necessary to maintain the
the integrity of the study. All of the diagnosis and treatment of any disease before
or in the course of the study shall be recorded.
5.2.3. Records of source, date of arrival and the conditions of the supply of test systems
shall be kept.
5.2.4 biological test systems, making the test conditions
reasonable period of time before the first submission (applications) of the test or
the reference item.
5.2.5 all information needed to properly identify the
the test systems should appear on their housing or containers.
Individual test systems, which are in the course of the study excluded from
cages or containers, according to the possibilities.
5.2.6 the use of bedding and cleaning cages and containers for test
systems shall be in accordance with any other law ^ 6).
5.2.7 test systems, which are used in field studies, the
are placed so as to avoid interference in the study from spray drift and
the previous use of plant protection products ^ 7).
6. Test and reference items
6.1 receipt, handling, sampling and storage
6.1.1 shall be recorded and shall keep the data characterizing the tested and
the reference item, the date of their receipt, the period of application of the adopted
the quantity and the quantity used in the studies.
6.1.2 handling, sampling and storage shall be carried out so as to
eliminate any confusion and contamination and ensure the acceptable
the degree of homogeneity and stability.
6.1.3 storage container to indicate identification information, time
usability and specific instructions about storage.
6.2 Characterization
6.2.1. Each test and reference item is appropriately identified
and characterized by, for example. the code number of the CAS (Chemical Abstracts Service
Registry Number), name, or biological, physical and chemical
parameters.
6.2.2. For each study, the identity is known or tested reference
the items, including lot numbers, purity, concentration or other
the parameters that define each batch appropriately.
in cases where the test item is supplied, the contracting authority is established
the procedure drawn up together by the sponsor and the test facility, which
verifying the identity of the item to be tested, which is the subject of the study.
6.2.4 For any study is known, the stability of test and reference
items under the conditions of storage and testing.
6.2.5. If the tested item served or applied in the medium shall be determined by
the homogeneity, concentration and stability of the test item in this
medium; for test items used in field studies, for example. the mixture
in the tanks of these parameters can be set by using the separate
laboratory tests.
6.2.6 for all studies except short-term studies shall be kept
samples from each batch of test items for analytical purposes.
7. Standard operating procedures
7.1 test equipment has established written standard operating
procedures approved by the head of the test facility, designed to ensure the
the quality and completeness of the data generated in the test device. The revision of the
standard operating procedures approved lead test facility.
7.2 Each part of the test facility has immediate use valid
the version of the standard operating procedures that apply to the activities in the
This component functions. The annexes to these standard operating
procedures can be published textbooks, methods of analysis, publication and
of the manual.
7.3. Deviations from standard operating procedures that relate to the
the study should be documented and confirmed by the study Director, or head
investigator.
7.4 standard operating procedures are available, in particular for
the following activities in the test device:
7.4.1. Test and reference items
Receipt, identification, labelling, handling, sampling and
storage.
7.4.2. Apparatus, materials and reagents
and servicing), maintenance, cleaning and calibration,
(b)) computer systems validation, operation, maintenance, reliability,
change control and backup
c) materials, reagents and solutions preparation and marking.
7.4.3. Record keeping, recording, storage and retrieval
Coding of studies, data collection, preparation of reports, indexes, handling systems
with the data, including the use of computer systems.
7.4.4 test systems (if applicable)
and preparation of the rooms and the conditions) environment for the test system,
b) procedures for the receipt, transfer, proper placement, characterisation,
identification and care of test system
(c) preparation of the test system), observations and examinations at the beginning,
during and at the end of the study,
(d)) treatment of individuals test system, who are found in the
during the study of the dying or the dead,
e) subscription, identification and handling of samples of the test system
including necropsy and histopathology,
(f)) the location of the test systems test facility in the space plan.
7.4.5 quality assurance Procedures
Staff quality assurance procedures in planning, layout,
implementing, documenting and recording method of inspections.
8. the conduct of the study
8.1 study plan
8.1.1 for each study exists before a written plan
the study. The study plan by signature of the study Director is approved, indicating the
data signature is authenticated and its compliance with these principles of staff
quality assurance, as defined in subsection 2.2.1 (b). (b)).
8.1.2.
and the study plan) are justified, approved and signed by the head of the
study with an indication of the date of signature and shall be kept, together with the plan
the study.
(b) deviations from the study plan) are leading the study, where appropriate, the head of the
investigator immediately described, explained, acknowledged and provided with
date and shall be kept, together with the study raw data.
8.1.3. In the case of short-term studies, a general study plan can be used,
who is accompanied by a supplement in which their every study.
8.2. Content of the study plan
The study plan includes in particular the following information:
8.2.1. Identification of the study, the test item and reference item:
and descriptive name)
(b)) Declaration that characterizes the nature and purpose of the study,
(c) identification of the test item by code), name (IUPAC), CAS number
or biological parameters,
(d)) used the reference item.
8.2.2 for information about the sponsor and the test facility:
and the name and address of the contracting authority),
(b) the names and addresses of all) test facilities and test sites
relating to the study,
(c) name and surname of the head) of the study and the address of the relevant test
the device,
(d) the name and address of each) of the lead investigator and study phase,
which defined the study Director and principal investigator for the corresponding to the
testing.
8.2.3 Data
and) date of approval of the study plan by signature of the study Director,
(b)), the proposed start and end dates of the experimental study.
8.2.4. Test method
Reference to OECD Test guideline chemicals ^ 8). or to another
documented procedure or method of carrying out the tests ^ 9)
8.2.5 for more information (if applicable):
and the rationale for the selection of the test system),
(b) characterisation of the test system) such as. species, strain, substrain, source
the source of supply, number, body weight range, sex, age and other
relevant information,
(c) the method of administration and the reason) of this selection,
(d) the size of the dose or concentration), frequency and duration of application,
(e) detailed information about) the experimental design, including a description of
prediction of the chronological course of study by listing all of the
the used methods, materials and conditions, type and frequency of analysis, measurements,
observations and examinations to be performed, and statistical methods
If they will be used.
8.2.6 Records
The list of records that shall be kept.
5.2 Implementation study
8.3.1 Each study is clearly marked. All items relating to the
This study bear this marking. Samples of the test systems must be
in order to be able to prove their origin. Such designation
must allow traceability of the respective sample and test system
the study.
8.3.2. The study shall be carried out in accordance with the study plan.
8.3.3. Any information obtained in the course of the study shall be recorded directly,
promptly, accurately and legibly by the employee who performs the input data.
These minutes shall be signed or initialled and dated.
8.3.4. Any change in the raw data is carried out, so that was not covered by the
originally the registered information, and state the reason for the change, including the date and signature
parafy or the employee who made the change.
8.3.5. The data obtained as a direct computer input are identified in the
the time of data entry staff, which is responsible for the direct introduction of
of the data. Computer systems are designed to allow the monitoring of the
all of the changes without obscuring the original data. It is recorded that
employee data change made, for example, by using the electronic
signatures that indicate the time and date of signature. Enter the reason for the changes.
9. Report on the results of the study
9.1 General
9.1.1 for each study to draw up a final report. In the case of
short-term studies can be used to prepare a standardised final report
accompanied by a specific tag.
9.1.2. Reports of principal investigators or scientists
who participate in the study, shall be their signatures and data signatures.
9.1.3 final report provides the signature of the study Director,
This accepts responsibility for the validity of the data, with an indication of the date of signature.
Indicate the extent of compliance with these principles.
9.1.4 the repair and extension of the final report shall be in the form of supplements.
In food shall indicate the reason for the corrections or extensions and affix the signature
the head of the study with an indication of the date of signature.
9.1.5 Edit the final report in the form required by the relevant authorities
does not make the repair, expansion or addition to the final report.
9.2 the contents of the final report
The final report contains the following information:
9.2.1 identification of the study, the test item and reference item:
and descriptive name)
(b) identification of the test item by code), name (IUPAC), CAS number
or biological parameters,
(c) identification of the reference item is used),
d) characterisation of the test item including purity, stability and
homogeneity.
9.2.2 the information about the sponsor and the test facility:
and the name and address of the contracting authority),
(b) the names and addresses of all) test facilities and test sites, which
regarding the study,
(c) name and surname of the head) of the study and the address of the relevant test
the device,
(d) the name and address of each) of the lead investigator and study phase,
which defined the study Director and principal investigator for the corresponding to the
testing,
(e)) the names and addresses of researchers who contributed their messages
to the final report.
9.2.3 Data
The experimental data, the start and end of the study.
9.2.4 Declaration
A quality assurance programme statement that lists the categories
the inspection and the date of their implementation, including the phase inspektované studies
the date of notification of the results of inspections and testing equipment manager
the head of the study, where appropriate, the head investigator. This
the statement also confirmed that the final report reflects the raw data.
9.2.5 description of materials and test methods
and) description of methods and materials,
(b)) reference to OECD guideline for testing of chemicals, 9) or to another
documented procedure or method of carrying out the tests ^ 10).
9.2.6 Results
Summary of the results, and)
(b)) all the information required in the study plan,
(c)) the presentation of results, including calculations and determine the statistical
significance,
(d) the evaluation and discussion of the results) and, where appropriate, conclusions.
9.2.7 Retention
The place where they are kept for the study plan, samples of test and
reference items, specimens, raw data of the test systems and
the final report.
10. Storage and retention of records and materials
10.1 in the registraturách shall be kept for at least 10 years following
records and materials:
10.1.1 the study plan, raw data, samples of test and reference
items, samples of test systems and the final report for each
the study,
10.1.2 records of all inspections carried out by the quality assurance staff
and the basic quality of the timesheets
10.1.3 the records of the qualifications, training and experience of staff and descriptions
their work,
10.1.4 records and reports of the maintenance and calibration of equipment,
10.1.5 the validation documentation for computerised systems,
10.1.6. all prior and valid version of the standard operating
procedures,
10.1.7 the environmental monitoring records.
If the samples of test and reference items and specimens of test
systems are destroyed before the expiry of the period of storage,
such a procedure will be documented and justified. Samples of the test and
reference items and samples of test systems should be maintained only
as long as their quality allows the guest.
6.3 Stored materials are known to be their proper
storage and easy to search.
6.4 Into the filing cabinets have access only to the employees of destination Manager
the test facility. The entry of material into a filing cabinet and the output from it, the
records.
10.4 If the termination of the activities of the test facility or
device providing storage and there is no contract legal successor,
the cached material moves to the filing cabinets of contracting authorities.
(B) MONITORING COMPLIANCE WITH THE CONDITIONS OF GOOD LABORATORY PRACTICE
Principles of the procedure for the monitoring of compliance with the requirements of good laboratory
practice, valid for the OECD countries ^ 10), shall be published in the journal of the National
Institute for drug control.
1) European Parliament and Council Directive 2004/9/EC of 11 July 2001. February
2004 on the inspection and verification of good laboratory practice (GLP).
Directive of the European Parliament and of the Council 2004/10/EC of 11 July 2001. February 2004
on the harmonisation of laws, regulations and administrative provisions relating to the principles of good
laboratory practice and the verification of the application of these principles for tests
carried out with chemical substances.
for example, § 2), 13 and 16 of Act No. 378/2007 Coll., on pharmaceuticals and on changes
some related laws (law on medicinal products), regulation of the European
Parliament and of the Council (EC) No 726/2004 of 31 March 2004. March 2004
lays down Community procedures for the authorisation and supervision of medicinal products for human and
veterinary medicinal products and establishing a European medicines
the Agency, in its up-to-date version.
3) Appendix II (principles of good laboratory practice), to Council decision
The OECD on mutual recognition of data for the evaluation of chemical substances of
May 12, 1981, as amended by the OECD Council decision [C (97) 186 of 26 March.
November 1997.
Directive of the European Parliament and of the Council 2004/10/EC on the harmonisation of the laws
and administrative provisions relating to the application of the principles of good laboratory
practice and the verification of their application for tests on chemical substances.
4) Law No 185/2001 Coll., on waste and amending certain other
laws, as amended
5) Act No 246/1992 Coll., on the protection of animals against cruelty, as amended by
amended
6) Decree No 207/2004 Coll., on the protection, breeding and use of experimental
animals.
7) Law No 326/2004 Coll., on phytosanitary care and amendments to certain
related laws, as amended by Act No. 626/2004 Coll., as amended by
amended.
8) of the OECD Series on Principles of GLP and Compliance Monitoring.
9) Decree No. 443/2004 Coll., laying down the methods for the
toxicity testing of chemical substances and chemical preparations, as amended by
Decree No. 449/2005 Sb.
10) Annex I and II of the OECD Council decision-recommendation C/89/87 on the conformity with the
the principles of good laboratory practice from day 2. October 1989, as amended by
OECD Council decision C/95/8 amending the annex to
decision-recommendation of the Council on compliance with the principles of good laboratory
the practice of 9 March. March 1995
European Parliament and Council Directive 2004/9/EC on the inspection and verification
good laboratory practice.
