66/2017 Sb.
LAW
of 31 March 2004. January 2017,
amending Act 378/2007 Coll., on pharmaceuticals and on changes of some
related laws (law on medicinal products), as amended,
and other related laws
Parliament has passed the following Act of the United States:
PART THE FIRST
Changing the law on pharmaceuticals
Article. (I)
Act 378/2007 Coll., on pharmaceuticals and on amendments to some related
laws (law on medicinal products), as amended by Act No. 124/2008 Coll., Act No.
296/2008 Coll., Act No. 141/2009 Coll., Act No. 281/2009 Coll., Act No.
291/2009 Coll., Act No. 75/2011 Coll., Act No. 375/2011 Coll., Act No.
50/2013 Coll., Act No. 70/2013 Coll., Act No. 250/2014 Coll., Act No.
80/2015 Coll. and Act No. 243/2016 Coll., is amended as follows:
1. at the end of footnote No. 2, the following sentence:
"Regulation of the European Parliament and of the Council (EU) No. 536/2014 of 16 December.
April 2014 on clinical trials of medicinal products and the
repeal of Directive 2001/20/EC.
The Commission delegated Regulation (EU) no 1252/2014 of 28 June.
may 2014 additional directive of the European Parliament and of the Council
2001/83/EC, as regards the principles and guidelines of good manufacturing practice for
active substances for human medicinal products. ".
2. in paragraph 5, the following paragraph 16, which including the footnotes.
101 reads:
"(16) the manufacture of the active substance for the purposes of this Act, with regard to its
use of investigational medicinal products or
veterinary medicinal products, shall mean any complete or partial
Act of acceptance of materials, production, packaging, repackaging, labelling,
relabelling, quality control or batch of the drug substance, as well as
related review. The definition of what is meant by the manufacture of the active substance,
with respect to its use in medicinal products, down right
Regulation of the European Union governing the applicable good manufacturing practice for
the active substance of ^ 101).
101) Commission delegated Regulation (EU) no 1252/2014. ".
3. in paragraph 11 of the letter g) is added:
"(g) the measures of a general nature) issues under section 77 d, which restricts or
prohibits distribution of the medicine abroad, ".
4. In paragraph 11 (h)):
"h) creates the conditions for the availability of medicinal products
relevant for the provision of health services, if required
ensure the availability of the release of the measures of a general nature and are
the conditions for his release, the procedure referred to in subparagraph (g)) or q), and
adopts measures to support research, development and availability of, medicinal
orphan medicinal products and medicinal products that may be
as such, it established, as well as medicinal products for use in the children's
medicine, ".
5. In paragraph 11, at the end of the letter p) dot is replaced by a comma and the following
the letter q) is added:
"q) measures of a general nature issued pursuant to section 77c, fixing the medicinal
medicine, whose lack of availability and effectiveness will be compromised
treatment of patients in the Czech Republic with a direct impact on the protection of the health
of the population and with significant impacts on the provision of health services, and
keep a list of such medicinal products. ".
6. In § 13 para. 2 (a). and point 1), after the words "the decision to allow
parallel imports, "the words" decision on confiscation of the medicinal
product ".
7. In § 13 para. 2 (a). and section 3 is the word) "operators" is deleted.
8. In § 13 para. 2 letter b) including footnote No. 104:
"(b)), decisions relating to the clinical trials referred to in § 51 and
stores the corrective measures within the meaning of article 87(1). 77 directly applicable legislation
The European Union governing clinical trials on medicinal products
^ 104 products) (hereinafter referred to as the "regulation about the clinical trial"), ".
104) European Parliament and Council Regulation (EU) No 536/2014. ".
9. In § 13 para. 2 at the end of the letter m), the dot is replaced by a comma and
the following point (n)), which read as follows:
"n) in the case of detection of the quality of the drug, which does not constitute a
threat to the life or health of persons, shall decide whether such drug
or its individual lot may distribute, publish, circulate
or use in the provision of health services. ".
10. In § 13 para. 3 at the end of the letter p) dot is replaced by a comma and
the following letters q) and r) are added:
"q) passes the Ministry of health of all the data required for the issue of
measures of a general nature referred to in section 77c,
r) based on the assessment of the situation on the market in medicinal products, inform the
The Ministry of health information pursuant to section 77c and transmits the complaint to
measures of a general nature referred to in section 77 d. ".
11. In article 16(1). 2 (a). and point 1), after the words "the decision to allow
parallel imports, "the words" decision on confiscation of the medicinal
product ".
12. in paragraph 19, the following new section 19a, which including the title reads as follows:
"§ 19a
The Directorate-General of customs
(1) the Directorate-General of customs duties provides upon request the Institute of
controlled by the person who places on the market or exported the drug, these
information:
and) identification of such persons, and in particular the name and
registered office,
(b)) description of pharmaceuticals, including trade name,
(c)), if necessary, information about the country of provenance and the country of origin of the drug and
(d)), the amount of drug, expressed in units of measure.
(2) the provision of the information referred to in paragraph 1 is not a violation of the obligations of the
confidentiality under the tax code. "
13. in article 21, paragraph 1 shall be deleted.
Paragraphs 2 and 3 shall become paragraphs 1 and 2.
14. in paragraph 2 of article 23. 2 (a). (b)) after the word "quality" the words ",
If the Department does not issue a decision pursuant to § 13 para. 2 (a). n) ".
15. In § 33 para. 2, in the first sentence the words "and types of containers" are replaced by
the words "types of containers and the code generated by the Institute or veterinary
the Institute ".
16. in § 33 para. 2, the last sentence is replaced by the phrases "the holder of the
decision on registration of the Institute provides complete and correct data on the volume of
supply of medicinal products placed on the market in the Czech Republic
electronically; data provided includes the identification of the holder of the
the marketing authorisation, the identification of the medicinal product and the information about the
whether the medicinal product has been delivered to the pharmacy or to the Distributor;
the structure, the way, the form and the time interval of the granting
by means of an electronic report lays down detailed legal
prescription. On the challenge of the Institute or of the Health Institute will give the holder of the
decision on registration of the Institute or the Veterinary Institute data on
the volume of prescriptions of the medicinal product and the data on the volume of supply
of medicinal products placed on the market in the Czech Republic, which has to
available. ".
17. in § 33 para. 3 (b). a), the words "to the distribution or to the pharmacy"
replaced by the words "put on the market in the Czech Republic".
18. In paragraph 34, the following shall be added at the end of paragraph 2, the phrase "a medicine
corresponding to the data and documentation before the extension of registration can be,
If it is not in the decision on renewal of the authorisation provides otherwise,
continue to be placed on the market for a maximum period of 180 days from the approval of the extension of the
registration. Distribute, issue, in the case of dedicated medicinal
products to sell, and use in the provision of health care services or
health care is such a medicinal product can be further for his
usability. ".
19. the heading of part 1 of title IV: "clinical studies".
20. section 51 to 53 shall be added:
"§ 51
Clinical evaluation of medicinal products
(1) the Institute shall examine the application for authorisation of a clinical trial of human
medicinal products referred to in article. 5, 13 and 14 of the regulation on the clinical trial
the application for authorisation and significant changes in the clinical evaluation in accordance with
article. 17 of the clinical trial. The Institute also carries out surveillance of
the progress of a clinical trial. All operations carried out in the context of the
the request for authorisation of a clinical trial and permit applications
significant changes to the clinical trial and ensuring the supervision shall be construed as
Professional acts.
(2) the Institute is in the Czech Republic the national contact point referred to in article. 83
the regulation for the clinical trial.
(3) the Institute within the framework of the assessment of the application for authorisation of a clinical trial
medicinal products or significant changes in clinical trial
and in the case of that) is the Czech Republic in relation to the clinical
reviews the rapporteur Member State referred to in article. 5 (3). 1, or article. 14
paragraph. 2 clinical trial regulation, carries out activities of a Member
State as laid down by the regulation on the clinical trial, relating to the
aspects, which are covered by part I of the assessment report
(b)) in the case of the Czech Republic is not in relation to the
clinical trial, carried out by the rapporteur Member State activities
the Member State concerned under article 2(1). 2 (2). 12 or article. 14 the regulation on
the clinical trial, relating to the aspects covered by part I of the
the assessment report, and
(c)) shall prepare part II of the assessment reports for the authorisation of a clinical
reviews relating to the United Kingdom, and the application for authorisation of the substantial
amendments relating to the Czech Republic, part of which is the opinion of the
prepared by the Ethics Committee.
(4) the Institute shall decide on the application for authorisation of a clinical trial and the
applications for authorisation of significant changes of the clinical trial in accordance with the regulation on
the clinical trial. This decision applies to the territory of the Czech Republic.
§ 52
Protection of certain groups of subjects
(1) the clinical trial can be performed on minors, provided
In addition to the informed consent of his legal representative agreed to
participation in a clinical trial by signing a written consent of the
a minor, if it is proportionate to its intellectual and volitional maturity.
(2) the clinical trial can be carried out under the conditions laid down in this
the law also in specific groups of subjects to which the person belongs
and) located in custody, security detention or in prison
deprivation of liberty,
b) residing in residential care facilities,
(c)) whose legal capacity has been restricted by the Court.
(3) the clinical trial can be performed by the persons referred to in paragraph 2 only
If these persons to it přivolí free and informed
consent and if there are scientifically based evidence to justify the
the expectation that participation in the clinical trial for these persons will have the direct
therapeutic or preventive health benefit that outweighs the
associated risks and burdens, or for inclusion in a clinical
the evaluation will be the only option, or improve the stabilization
adverse health condition.
§ 53
The Ethics Committee
(1) the Ethics Committee is a body of the Institute.
(2) the Ethics Committee carries out the ethics oversight of clinical trials and
performs an ethical review, including ethical, medical and scientific aspects
applications for authorisation of a clinical trial application for authorisation of a significant
changes to the clinical trial and deliver opinions to the extent and in the manner
under this Act and the regulations on the clinical trial.
(3) the Institute for the Ethics Committee, the conditions for its activities.
(4) the Institute with the prior consent of the Ministry of health will issue Status
the Ethics Commission. The rules of procedure of the Ethics Committee (hereinafter referred to as the "rules of procedure")
adopt the Ethics Committee itself. The status of the Ethics Committee and the rules of procedure of the Institute
be published on its website. ".
21. in paragraph 53, the following new section 53a to 53 c shall be inserted:
"§ 53a
The composition of the ethical Commission
(1) the Ethics Committee is composed of the groups. Groups are composed of
experts from the areas of health and medical education of the people.
The number of groups and the number of members of each group of the Ethics Committee shall determine
The status of the Ethics Committee. Members of the Ethics Committee shall be appointed to
each group of the Ethics Committee at least 5 persons, of whom at least 1
the person was without a medical education.
(2) the members of the Ethics Committee is appointed and recalled by the Minister of health,
to each group. The Group of the Ethics Committee shall consist of the President,
the Vice-President and the other members. The Chairman and Vice-Chairman are elected
members of the group in accordance with the rules of procedure of the Ethics Committee.
(3) the members of the Ethics Committee shall comply with the requirements of article. 9 of the regulation on
the clinical trial and must have the expertise and experience to assess and
evaluate the application for clinical evaluation in terms of ethical, medical and
scientific, with the exception of persons without medical training, assessment
application for a clinical trial in particular in terms of ethics.
(4) the members of the Ethics Committee shall refrain from comments on applications for authorisation
the clinical trial, the implementation of which they have a personal interest, as well as
representation of the possible applications for authorisation to carry out significant changes and
professional supervision over such a clinical trial and shall notify the
the emergence of personal interest to the clinical trial Ethics Committee considered and
Of the Institute.
(5) the members of the Ethics Committee shall have a duty to disclose
the information and the facts that are brought in connection with his
membership of the Ethics Committee.
(6) a member of the Ethics Commission cannot be the person who committed the offence
pursuant to § 108 paragraph. 8. Committed to the ethical Commission of such
the offense, his membership in the Ethics Committee ceases to exist.
§ 53b
The activities of the Ethics Commission
(1) the duties of the Ethics Committee is to contribute to the protection of the rights, safety, and
Health subjects.
(2) the Ethics Committee overseeing the clinical trial takes place on
basis of a report on the progress of a clinical trial in a medical
the device in which the clinical trial is in progress, (hereinafter referred to as "instead of
the clinical trial ") submitted pursuant to the principles of good clinical practice
the investigator or principal investigator. Requirements progress messages
the clinical trial and the time intervals for the submission sets out the
the implementing legislation.
(3) the Ethics Committee may invite the other to obtain the opinion of the experts. These
the experts shall comply with the requirements of article. 9 regulation of the clinical trial.
These experts have the obligation to maintain confidentiality of the information and
the facts that are brought in connection with his activities in ethics
to the Commission.
(4) the Ethics Committee carries out its activities in accordance with the rules of procedure,
which governs, in particular,
and planning meeting) way of communicating to the group members and conduct
the meeting,
(b)) the way the appeal favourable opinion of the Ethics Committee.
(5) the Ethics Committee also carries out its activities in accordance with working procedures
the Ethics Commission, which provides for the Institute and which regulate in particular the
and assessment of applications for) the way a clinical trial authorisation and requests
about enabling major changes in the scope of the clinical trial
Regulation on the clinical trial,
(b)) the procedures in the handling of reports of Examiners, or the major
examiners are where one exists, and the sponsors and with information obtained
the supervision of the clinical evaluation or obtained in any other way pursuant to article.
52 to 54 of the regulation about the clinical trial,
(c)) the way the Ethics Committee forwards its opinion on the Constitution
a clinical trial, including its justification.
§ 53 c
The opinion of the
(1) when preparing the opinion, concerning the aspects to which the
covered by part I of the assessment reports for the authorisation of a clinical
reviews, or significant changes in the application for authorisation of a clinical trial in
the range of aspects covered by part I of the assessment report, the ethical
the Commission will assess the extent of the clinical trial protocol
and the merits of a clinical trial) and its arrangement
(b) acceptance ratio) anticipated benefits and risks and the merits of the
his conclusions and
c) ethical aspects of clinical trials.
(2) If an Ethics Committee in accordance with the regulation on the clinical trial
a negative opinion, this opinion is binding and a request for authorization
clinical trial or to enable significant changes in clinical
reviews in the Czech Republic, the Institute shall reject the decision. Negative
an opinion concerning the aspects, which are covered by part I of the assessment
messages to the applications for the authorisation of a clinical trial or to request
significant changes in the clinical trial authorisation relating to Appendix
the Protocol may only be issued for the reasons given in the regulation on
the clinical trial. The opinion shall state the reasons on which it is
contains the list and description of the specific and relevant reasons for which
intrigued by its opinion, the Ethics Committee. For the proper processing of opinions and
its timely handover of the head of the Ethics Committee of the Institute.
(3) the Ethics Committee shall give its opinion before the start of the clinical trial
concerning the aspects, which are covered by part II of the assessment report to the
request with a detailed justification of his opinion. In the preparation of this
the opinion of the Ethics Committee shall act in accordance with the regulation on clinical
reviews.
(4) when processing the opinions of the Ethics Committee in accordance with paragraph 3, the Group
the Ethics Committee is intended to assess a particular clinical trial
assess the requirements laid down by regulation about the clinical trial
the documentation submitted by the applicant that will assess this documentation from the
point of view, whether the
and compensation or provide compensation) to the subject for the case
any injury as a result of his participation in the clinical trial are
provided by the insurance contract,
b) liability insurance for investigators and the principal investigator shall, if they are
one exists, and the contracting authority is provided by the insurance contract, or whether the
insurance of liability of the investigator and principal investigators, if they are
one exists, or the contracting authority is not part of their labor relations,
(c) the compensation does not exceed the estimated expenses) incurred by the entity
reviews in connection with his participation in the clinical trial,
(d) the amount of remuneration for the bodies) rating corresponds to the nature of the clinical
reviews, in particular in relation to the research performance of which does not
direct benefit to the subject,
(e)) is provided for the way to provide rewards for the investigator and the main
the investigator, if established,
f) investigators and principal investigator, if established, satisfy the requirements of
laid down in paragraph 54,
g) instead of a clinical trial is appropriate for the implementation of the
the clinical trial.
(5) the Ethics Committee shall be assessed in terms of the protection of the rights, safety, and
the subjects ' health, compensation and damages of subjects
and their remuneration and the remuneration of Examiners, or the principal investigators,
If one exists, referred to in the documentation for applications for authorisation of clinical
reviews.
(6) for the proper processing of the opinion referred to in paragraph 3, and its timely
pass the Institute conforms to the Chairman of the Ethics Committee. The opinion must
include justification for the comments.
(7) the Ethics Committee may revoke permanently or temporarily its affirmative
opinion on the implementation of the clinical trial, if there are any
new facts relevant to the safety of the subjects, or
the sponsor or the principal investigator or the investigator breaks the severe
way of implementation, or the arrangement of the clinical trial, which
the Ethics Committee released its concurring opinion. If the Ethics Committee finds,
that there were grounds for an appeal of its favourable opinion
referred to in the first sentence, asks the Department to request the opinion of the
the contracting authority, where applicable, the investigator, or a principal investigator to these
the reasons, except in cases where the safety of subjects
reviews. The appeal includes a favourable opinion of the Ethics Committee
and) the identification of the clinical trial, in particular its name,
the placing of the contracting authority or contracting authorities, of the European identification number and
the protocol number,
(b)), stating whether it is a temporary or permanent revocation of
favourable opinion, in the case of temporary withdrawal of consent must be
to define the conditions, after which approval shall lapse,
(c)) in the preamble, in which the reasons for the revocation of the corresponding
opinion, the basis for his extradition and considerations governing the Ethics Committee
She was driving,
(d)) the measures necessary for their clinical trial, in particular to the transfer of
subject to other treatments if they are not already listed in the Protocol,
(e) the date of the notice of appeal) favourable opinion and signature of the Chairman of the Group
the Ethics Commission, which issued the notice of appeal.
(8) the Ethics Committee is obliged to pass on the request of the Institute the Institute of their
an opinion on all the documents which are the subject of ethical assessment
by the Commission, not later than one working day before the last day of the period,
laid down by the Constitution for initial assessment and verification of the application, a communication on the
the completeness of the application dossier, coordinated review phase, stage
consolidation, the assessment of the additional information, the completion of the assessment
the request upon receipt of the additional information, which the final part I
evaluation reports or the submission of the final evaluation report, part II, in
the assessment referred to in article 14(2). 5, 6, 7, 13, 14, 17, 18, 20 and 22 of the regulation on the
the clinical trial.
(9) the Institute kept in connection with the activities of the Ethics Committee for 5 years
After the clinical trial the following documents:
and minutes of the meetings,)
(b)) Declaration of conflict of interest,
(c) curricula vitae of the members of the Ethics Committee),
d) records for the training and further education of the members of the Ethics Committee,
e) documents on the appointment and dismissal of the members of the Ethics Committee,
f) documents relating to the appointment, revocation of the members of the Ethics Committee,
as well as the resignation,
g) labour and similar agreements, including supporting documents, which served to
their copy, with experts cooperating with the Ethics Committee, and
h) correspondence of the Ethics Committee. ".
22. section 54 to 59, including footnotes # 102 and 103 shall be added:
"§ 54
The investigator and the clinical site reviews
(1) the investigators and the principal investigator may be only a doctor or dental
the doctor meeting the conditions laid down in ordinances ^ 29) for
the performance of the medical profession, which has the necessary scientific
knowledge and experience with the care of patients with diseases or conditions on
the treatment focuses the clinical trial, and has the knowledge
good clinical practice.
(2) the clinical trial can be performed only on providers of health
services in a healthcare facility.
(3) the provider of health services, which has carried out clinical
evaluation, in which the first filing an investigational medicinal
the medicine man, and the provider of health services, which is
carried out a clinical trial without treatment or preventive effect
for the subjects, especially the Bioequivalence and PK
clinical evaluation, must be the holder of the certificate of good clinical
practice issued by the Institute.
(4) for the providers of health services not referred to in paragraph 3, for
which are carried out clinical trials, does not obtain a certificate
good clinical practice required; However, they may ask for his extradition.
section 55
The language of the
(1) documentation of the clinical trial must be submitted in the Czech
c in respect of the following documents:
and a summary of the clinical trial protocol),
(b)) information for the patient, informed consent, the consent of the minor with
his participation in the clinical trial, and additions to these documents,
(c)) for information on how the recruitment of subjects in the Czech Republic,
(d)) recruitment materials related to the clinical trial,
e) all materials destined to the subjects,
(f) a list of investigators and main) investigators, if one exists,
g) list of the locations of the clinical trial,
h) proof of damages to the subjects,
I) information about how to ensure remuneration for the investigator and the main
the investigator, if one exists, and the remuneration or compensation for operators
reviews.
(2) other documentation of the clinical trial, unless the documents
referred to in paragraph 1, shall be presented in Czech, Slovak or English
language.
(3) the information on the labelling of medicinal products for clinical
assessment are provided in the English language, unless the decision of the Institute
otherwise noted.
§ 56
Rated and auxiliary medicinal products
(1) if the conditions laid down in article 4(1). paragraph 59. 2 of the regulation on
a clinical trial may be on the territory of the United States used in the
the clinical trial and the unregistered medicines.
(2) the contracting authority provides free investigational medicinal products, the auxiliary
medicinal products registered under this Act required
Protocol clinical trial and medical devices needed for
the implementation of the clinical trial that are intended for the administration of investigational
medicinal products. In the clinical trial for human use
If you cannot use the notified medical device can be
used after a previous approval by the Institute as well as a medical
a resource that otherwise does not comply with the requirements laid down by the law on
medical devices. If the sponsor is a non-commercial sponsor,
for the purposes of this Act, a provider of health
services set up by the State or territorial-based or local government total,
public University and public research institutions, and investigational
preparations are registered in the Czech Republic, there is no provision
investigational medicinal products free of charge required.
(3) in order to be in a clinical trial of medicinal products
used radiopharmaceutical non-registered under this Act, in accordance
with the requirements of the clinical trial, the sponsor shall submit, together with the
documentation for the authorisation of a clinical trial, the opinion of the
The State Office for nuclear safety issued under section 18.
(4) in order to be in a clinical trial of medicinal products
used products containing genetically modified organisms, shall submit to the
the contracting authority along with the documentation to the application for a clinical trial authorisation
the consent of the Ministry of the environment issued pursuant to other legal
prescription ^ 11).
(5) in order to be in a clinical trial of medicinal products
used products containing human embryonic stem cells, shall submit to the
the contracting authority along with the documentation to the application for a clinical trial authorisation
authorisation to dealing with human embryonic stem cells released
The Ministry of education, youth and sports, according to another legal
prescription ^ 102).
(6) for the cluster or low-intervention clinical trials
reviews pursuant to article. 2 (2). 3 regulation on clinical trials
non-commercial sponsor, which will be the basis for the registration or
a variation of the medicinal product, lays down the law
monitoring requirements, the contents of the basic documents and the additional
labelling of investigational medicinal products. To cluster the clinical
evaluation under the first sentence means a clinical trial carried out
only in the territory of the United States, whose goal is to evaluate the treatment groups
patients in which are all investigational medicinal products
registered under this Act in the Czech Republic and are used in
consistent with the summary of product characteristics, or out of the summary of
product, if such a method of using the same as the normal medical practice
or recommended treatments and sufficiently justified by the scientific
knowledge.
§ 57
The agreement with the sponsor
The Department may, under the conditions laid down in article 4(1). paragraph 42. 3 of the regulation on
a clinical trial to conclude an agreement with the contracting authority pursuant to which it will be
the sponsor of a suspected serious unexpected adverse reactions report
directly to the Institute; in this case, reports a suspected serious unexpected
adverse reactions to the Agency by the Institute.
§ 58
The system of compensation for the injury caused to the subject
(1) If a clinical trial subject as a result of the implementation of the
clinical evaluation of property or non-material damage, particularly on the
life or health, the sponsor is required to replace it in accordance with the
other legislation ^ 103). Compensation can be claimed for the contracting authority
through the providers of health services, which is the place
the clinical trial.
(2) the contracting authority is obliged to have throughout the period of implementation of the clinical
reviews of the agreed insurance, principal investigators,
If one exists, and investigators for the injuries suffered by the subject in the
as a result of the implementation of the clinical trial.
(3) paragraph 2 shall not apply where the clinical trial is carried out by a non-commercial
the sponsor, the insurance activities covers the use of medicinal products
in the clinical trial,
a) in medicinal products registered under this Act in the Czech
Republic and used in accordance with the summary of product characteristics,
or with medicinal products registered under this Act in the
The Czech Republic and used outside of the summary of product characteristics, if
such a method of using the same as the normal medical practice or recommended
treatments and sufficiently justified by the scientific evidence, and at the same time
(b)) additional diagnostic or monitoring procedures do not present in the
compared to normal medical practice is greater than the minimum additional risk
or burden for the safety of the subjects.
§ 59
The representation of the
If the contracting authority in the request submitted under regulation on clinical
reviews of his representative, or contact person, such shall be deemed to
designation for demonstrating the representation on the basis of power of Attorney, unless
the contracting authority or representative of the opposite.
102) Act 227/2006 Coll., on research on human embryonic
stem cells and related activities and amending certain
related laws, as amended.
103), for example, the civil code, the criminal code, law No. 101/2000
Coll., as amended.
Article. 75 European Parliament and Council Regulation (EU) No 536/2014. ".
23. in section 60 paragraph. 3 (b). (c)), the comma is replaced by a dot and the letter d)
including footnote # 64 repealed.
24. In § 62 para. 1 in the second sentence, the words "for the purpose of clinical
reviews and "are deleted.
25. In § 62 para. 3 (b). (b) "), the text of section 66 paragraph 1. 1 to 4 "is replaced by
the text "section 66 paragraph 1. 1 to 3 ".
26. in paragraph 64 (a). (b)), the words "§ 55 and approved in the framework of the
the application for authorisation or declaration of a clinical trial "shall be replaced by
"the clinical trial regulation and approved in the context of the application
clinical trial or to enable significant changes
a clinical trial '.
27. in paragraph 64 (a). w), the words "including investigational medicinal products for human use
products ' shall be deleted.
28. In article 66, paragraph 4 shall be deleted.
The present paragraph 5 shall become paragraph 4.
29. in section 67 para. 9, the text "section 66 paragraph 1. 5 "is replaced by the text" section 66 paragraph 1.
4. "
30. in the § 70 para. 1, in the first sentence after the word "regulation", the words
"and directly applicable European Union law ^ 101)" and after the word "substances"
the words "including active substances intended for export".
31. in paragraph 70, the following paragraph 7 is added:
"(7) the manufacturer of medicinal substances, which carries out the packing, repacking,
labelling, relabelling, quality control, or layoffs, as well as
related control of medicinal products coming from third countries
intended for the preparation of medicinal products must be available
the documents referred to in paragraph 2; This is without prejudice to the provisions of paragraphs 4 and
5. ".
32. In § 77 para. 1 (b). (f)), the words "the scope of the data and the way they
the provision in the form of reports, the Institute shall publish or veterinary Institute
your information resource "are replaced by" provided by the data
contain identification of the Distributor's identification of distributed
of the medicinal product and the identification of the persons referred to in subparagraph (c)), which was
medicine distributed; the structure of the data, the form, the method and time
the interval of their provision by means of an electronic report
down implementing legislation ".
33. In § 77 para. 1 letter h) is added:
"(h)) to ensure the supply of medicinal products for operators
authorized to supply medicinal products in quantity and time intervals
the corresponding need for patients in the Czech Republic. Distributor for
upon request, the operator authorized to supply medicinal products
ensure that the supply of the medicinal product within 2 working days from
the receipt of his request. Distributor for ensuring the availability of drugs on the
the market in the Czech Republic has the right to invite the holder of the marketing authorisation
on the supply of medicinal products in the range of market share
the Distributor and the marketing authorisation holder has an obligation to him is
supply, which fulfills his obligation provided for in § 33 para. 3 (b). (g))
point 3. The Distributor's market share is equal to the market share of the
the Czech market distribution of all medicinal products in a calendar
quarter preceding last completed calendar quarters.
Distributor or the marketing authorisation holder shall not be required
to supply medicinal products to the party that they have at least
a pecuniary debt for longer than 30 days after the due date or in
where is interrupted or terminated by the marketing of the medicinal product
product on the market in the Czech Republic. The Distributor is also required to
proceed in accordance with the measures issued by the Ministry of health for the
to ensure the availability of medicinal products pursuant to section 11 (b). (h))
or section 77 d. ".
34. In paragraph 77, the dot at the end of paragraph 1 is replaced by a comma and the following
the letter q) is added:
"q) in the case that it is his intention to distribute the medicine abroad
the product that is listed on the list of medicinal products pursuant to section 77c,
report this fact before the distribution of the Institute; notification
is provided electronically and contains the ID of the Distributor,
the identification of the medicinal product, the quantity of the medicinal product in the unit
units, state name, and the date of the planned distribution distribution
the medicinal product; the structure of the data to be given in the notification, method and
the form of their provision by means of an electronic report provides
the implementing legislation; the Distributor may make the intention to distribute
medicine only after a period of 15 working days from the date of this
the intention announced, if it was not issued within the said period the measures of a general nature
under section 77 d in respect of the medicinal product; in the event that, after the
the notification distributor was not to the date on which it shall expire 15 days of work
the date on which the distributor announced the intention to distribute the medicine
measures of a general nature issued under section 77 d in relation to the authorised
of the product, the distributor, execute the intended distribution as originally
the announced range. ".
35. under section 77b, the following new paragraph 77c and 77 d, which including the following title:
"§ 77c
(1) the Institute collects from marketing authorisation holders, distributors
and pharmacies information about the volume of medicines on the market in the Czech
Republic and about the volume of medicinal products issued and used in
provision of health services; This information is processed and
evaluates. When you handle the information in accordance with the first sentence of the Institute evaluates
If the quantity of the medicinal product, which is not replaceable by another medicine
with the corresponding therapeutic properties or medicinal products
substitutable due to their medicinal properties,
enough to cover the current needs of patients in the Czech Republic. If
The Institute based on the evaluation above, concludes that
the current supply of the medicinal product or medicinal products
already enough to cover the current needs of the patients in the Czech Republic and
the lack of this medicine or medicinal products which
means the lack of coverage of the current needs of patients in the Czech
Republic of the medicinal product or medicinal products, the
threatened by the availability and effectiveness of treatment of patients in the Czech Republic
direct impact on the protection of the health of the population and significant impacts on the
provision of health services, the Ministry of health shall communicate this
the information, including documents and information, on the basis of the Institute to
He reached this conclusion.
(2) If after evaluation of the information provided by the Institute referred to in paragraph
1 there is the Ministry of health to the conclusion referred to in paragraph 1 sentence
third, such a medicinal product or a medicinal product in the list
medicinal products whose distribution abroad have distributors
the obligation to report the Institute pursuant to § 77 para. 1 (b). q) (hereinafter referred to as
"The list"). The Ministry of Health maintains a list of which is published in the
the current text on their website. Medicinal products,
on the List are to be classified in the form of the measures of a general nature.
(3) when issuing the measures of a general nature referred to in paragraph 2 shall be treated
According to the code of administrative procedure, with the
and measures of a general nature) the application shall be served on and measures of a general nature,
announce the manner allowing remote access,
(b) the time limit for the application of the) comments on the draft of the measures of a general nature shall be
5 days from the date of its publication,
(c)) the measures of a general nature shall enter into force on the day following the date of
its publication.
(4) in the event that the Institute in accordance with paragraph 1, it concludes that the
the medicinal product in the list already in danger
the lack of coverage of the current needs of patients in the Czech Republic,
shall communicate this information including documents, on the basis of which this conclusion
reached, the Ministry of health. If the Ministry of health on
based on the evaluation of the information he provided in the first sentence the
an identical conclusion procedure laid down in paragraphs 2 and 3 of the medicinal product
The list excludes them.
section 77 d
Measures to ensure the availability of medicinal products
(1) if the Department finds that, taking into account the data collected
in particular, from the marketing authorisation holders, distributors and pharmacies that
an implementation of the distribution abroad in the following three months
period to the lack of a medicinal product which is not replaceable by any other
product corresponding to the therapeutic properties or medicinal
products that are substitutable due to their therapeutic
properties for the current needs of the patients in the Czech Republic and the
the lack of availability and effectiveness of treatment endangering patients in the Czech
Republic with a direct impact on the protection of the health of the population and a significant
affecting the provision of health services, the Ministry shall transmit to the
health care initiative to issue measures pursuant to paragraph 3.
(2) the initiative of the Institute must contain a justification based on the evaluation of the
the data collected in particular from marketing authorisation holders,
distributors and pharmacies that
and) it is clear that the current supply of the medicinal product, or
medicinal products already does not cover the current needs of the patients in the Czech
Republic, and
(b)) there are particular reasons for which the implementation of the distribution
of the medicinal product or medicinal products abroad
led to a further deterioration in the coverage of the current needs of patients in the Czech
Republic.
(3) the Ministry of health may issue to ensure the availability of
medicinal products for measures of a general nature, which restricts or
disables the distribution of medicinal of medicinal products
abroad. For the issuance of such measures of a general nature shall be
subject to the following conditions:
and) a medicine that is on the list,
b) distribution abroad could be the fact that the volume of the
a medicinal product that is not replaceable by another medicinal product
corresponding to the therapeutic properties or medicinal products that
are substitutable due to their medicinal properties, the
the market in the Czech Republic does not cover sufficiently the needs of patients in
The Czech Republic, and
(c)) the public interest in protecting the health of the population and to ensure the
availability of medicinal products for the current needs of the patients in the Czech
the appropriateness and adequacy of the Republic justifies the issuance of such measures
of a general nature in relation to the principle of free movement of goods in the internal market
Of the European Union.
(4) the Ministry of health shall immediately revoke the measures of a general nature,
no grounds for his release.
(5) when issuing the measures of a general nature referred to in paragraph 3 shall be applied to
pursuant to section 77c paragraph. 3 that measures of a general nature shall take effect
the date referred to therein.
(6) If the Department finds that there are no longer grounds for additional duration
measures of a general nature regarding the restriction of distribution abroad for
the specific medicinal product or medicinal products, report on the
Institute of information, without delay, the Ministry of health, together with the
the supporting documents that lead to this conclusion.
(7) the Ministry of health, if the official activities become aware of
the risk of lack of medicinal products, it shall request the Institute to provide data in
scope according to § 77c. ".
36. In paragraph 80 is at the end of paragraph 1, the following sentence "the prescriber's
obliged to inform the patient identification mark, which can be
apply electronic recipe at any pharmacy provider
care. ".
37. In section 82 para. 3 (b). (d)), after the words "as to the issue of medicinal
preparations ", the words" electronically ", and the words" range
the data and the way they are provided by the Institute shall publish a report on your
the information resource "are replaced by" provided by the data they contain
the operator's authorized to issue identification, identification
the prescriber, the identification of the entity to which the product has been
issued, and identification issued by the medicinal product; the structure of the data,
way, the form and the time interval to deliver them through the
an electronic report lays down implementing legislation ".
38. In paragraph 82, the dot at the end of paragraph 3 is replaced by a comma and the following
letter h) is added:
"h) if the operator of a pharmacy shall be obliged to use medicinal products
delivered by the distributor in accordance with § 77 para. 1 (b). h) exclusively for the
dispensing patients or providers of health services. ".
39. In § 82 para. 4 in the first sentence, the words "other pharmacies or", and
"for a pharmacy or" shall be deleted.
40. In § 82 para. 4 in the second sentence, the word "exceptionally" be deleted and for the
the words "by other pharmacies" are the words "only rarely".
41. In § 101 paragraph 1 reads:
"(1) when you check under this Act shall act authorities
the Administration referred to in paragraph 10, and inspectors under the inspection order.
To check the credentials in the form of licence Inspector. When Inspector
performance of inspection activities under this Act and other legal
legislation shows evidence of Inspector. ".
42. In § 101 paragraph. 5 letter e) is added:
"e) in justified cases, in particular in the case of a misleading designation
medicinal product or in case of reasonable suspicion that the medicinal
with a person who is treated to such activities is not in accordance with this
the law may be temporary; with this procedure
introduces Inspector controlled person and passes it the official record of the
temporary ensure together with the reason, description and quantity
secured by way of the medicinal products; This endorsement is attached to
of the Protocol on inspection; controlled person is liable to the secured medicinal
does the Inspector to issue; in the case that the person controlled release
the seized medicine refuses, an Inspector of his withdrawal;
on the issue of the withdrawal of the medicinal product, where appropriate, will draw up the official inspector
the record, which is annexed to the Protocol on the control; If the reason for dropping out
the temporary collateral or if it is proven that secured the medicines
meet the requirements of this Act, the animal health Institute or Institute of returns
a controlled person secured medicines in the intact condition;
However, does not return, if he proves that at the time of treatment with medicine
with such handling was not the person entitled to or
If it is proven that secured the medicines do not comply with this
the law; in that case, shall issue to the Institute or the Veterinary Department of the decision
about forfeiture or prevents the medicinal product; medicinal products,
which treats a person who is not entitled to such treatment by
This Act shall be regarded as medicinal products that do not meet the
the requirements of this Act; propadnuté or occupied by medicinal products is
Institute of Veterinary Institute is obliged to delete or under section 88; After a period of
duration of the measures and in the case of a decision on confiscation or prevents
the medicinal product does not belong to a person in a secured, controlled propadnuté
or occupied by medicinal products the refund; in the case of a decision on the
forfeiture or the prevents the medicinal product is a controlled person
required to pay the costs incurred by the Institute or the Veterinary Institute
associated with the storage of medicinal products and the removal of the secured
propadnutých or occupied by medicinal products for which a rate of decides to
Institute of Veterinary Institute or. ".
43. In § 101 paragraph. 5 the final part of the provision, the words "a) to (d))"
shall be replaced by ' a) to (e)) ".
44. In § 103 para. 6 (a). (d)), after the words "into circulation" is inserted after the word ",
issue ".
45. In § 103 para. 10 (a). (g)), the word "or" is deleted.
46. In paragraph 103, the dot at the end of paragraph 10 shall be replaced by "or", and
the following letter i), which read as follows:
"i) uses the product in violation of § 82 para. 3 (b). h).".
47. In § 105 para. 2 at the end of the letter p) the word "or" is deleted.
48. In paragraph 105 at the end of paragraph 2, the period is replaced by a comma and the following
the letters r) to t) are added:
"r) does not ensure the supply of the medicinal product in accordance with § 77 para. 1 (b). (h)),
to notify the intention to distribute with) medicine abroad as
provided for in § 77 para. 1 (b). q), or in violation of § 77 para. 1
(a). q) performs the distribution of the medicinal product, or
t) contrary to measures of a general nature, Department of health
issued under section 77 d distributes medicine abroad. ".
49. In § 105 para. 5, letter c) the following point (d)), which read as follows:
"(d)) does not provide data on the volume of supply of a medicinal product referred to in
the market in the Czech Republic according to § 33 para. the last 2 sentences. "
Subparagraph (d)) to x) shall become letters (e)) to y).
50. in paragraph 105 paragraph 6 is added:
"(6) the contracting authority is guilty of an administrative offense by that, contrary to
Regulation on clinical trials
and clinical trial) without a permit or in violation of the terms
referred to in it,
(b)) makes a material change of the clinical trial without a permit or in
contrary to the conditions laid down in the authorization,
(c)) performs a clinical evaluation in an emergency in accordance with the conditions
established for the conduct of clinical trials in emergency situations,
d) notifies the
1. the information about the start, suspend, restart, early
termination or completion of the clinical trial,
2. the first visit of the first subject in the Czech Republic, or
3. end the recruitment of subjects in the Czech Republic,
(e) a summary of the results does not send) clinical trial
(f)) does not properly and completely pharmacovigilance records
g) does not ensure the reporting of suspected serious unexpected adverse reactions
or does not inform the investigator or fails to make emergency
the security measures adopted to protect the subjects, does not ensure
a qualified physician as the contact person of the data subject
or does not ensure the implementation of the clinical trial in accordance with the Protocol and
with the principles of good clinical practice,
(h)) does not ensure that the examiner and other persons involved in the implementation of the
the clinical trial must meet the conditions laid down by the regulation on clinical
reviews or the conditions laid down in § 54,
I) announces serious breach of regulations on clinical trial policy
clinical practice or protocol or does not inform about new
the facts, or does not report urgent safety measures adopted
to protect subjects,
j) does not provide a zkoušejícímu investigator's brochure or this
does not update the file,
k) does not record, does not retain or does not process information on clinical
reviews, or does not result, or does not archive the basic document of the clinical
reviews in accordance with the conditions laid down by the regulation on clinical
reviews, or
l) as a non-commercial sponsor of a clinical trial of the agreed
insurance activities. ".
51. In paragraph 105 paragraph 6 the following paragraph 7 is added:
"(7) the contracting authority is also guilty of an administrative offense, by
and) in violation of § 58 para. 2 not at all times conducting clinical
reviews of the agreed insurance, a principal investigator and
the investigator's brochure for the injuries suffered during the conduct of the trial, or
failed to pay premiums,
(b) the clinical trial) will launch the veterinary medicinal product in violation of
with § 60 para. 3,
(c)) does not ensure the implementation of the clinical trial in accordance with § 61 para. 2 (a).
and)
(d)) fails to comply with information requirements under § 61 para. 2 (a). (b)), or
(e)) does not provide the zkoušejícímu medicines or not retained their sample
According to § 61 para. 2 (a). c).".
Paragraphs 7 and 8 shall be renumbered as paragraphs 8 and 9.
52. In section 106 paragraph. 1 and § 108 paragraph. 3 at the end of subparagraph (a)), the word ",
or "is replaced by a dot, the letter b) shall be deleted and shall be deleted at the same time
marking (a)).
53. In article 106, paragraph 3 reads:
"(3) the individual entrepreneur is guilty of an administrative offense to the fact that
contrary to regulation about the clinical trial
and as the investigator is) if only one clinical trial site
the investigator or as a principal investigator, if at the point of clinical
reviews more examiners,
1. does not ensure the implementation of the clinical trial at a clinical site
reviews,
2. unless other members of the team of investigators in writing instructions
3. initiate the clinical trial without consent
the subject or his legal representative, except for those
where such consent is not required, or written permission to
the participation of minors, if required for the clinical trial,
4. initiate the clinical trial without communication from the contact details of the body
reviews or his legal representative,
(b)) as the investigator does not record, nezdokumentuje or does not report adverse
incident or laboratory deviation,
(c)) does not ensure the retention of the source data and the clinical documentation
reviews,
(d)) in the implementation of the clinical trial fails to take immediate measures to
protection of trial subjects,
(e)) performs a clinical trial as the investigator, without meeting the conditions
laid down by the regulation on clinical trials or the conditions laid down in §
54, or
(f) does not comply with the principle of) good clinical practice in the conduct of clinical
evaluation. ".
54. In paragraph 107 para. 1, letter a) is added:
"and 100 000 CZK) in the case of an administrative offence under § 105 para. 6 (a). (d))
paragraph 2 or 3, § 105 para. 6 (a). (j)), § 106 paragraph. 3 (b). and) or (c))
or § 106 paragraph. 5 (b). b),".
55. In section 107 para. 1 (b). (b)), the words "§ 106 paragraph. 3 (b). a) or b) "
replaced by the words "§ 106 paragraph. 3 (b). (b)) ".
56. In paragraph 107 para. 1 (b). (c)), the words "§ 103 para. 10 (a). a), b), (d))
or (f)) "shall be replaced by the words" § 103 para. 10 (a). a), b), (d)), f) or even) ".
57. In article 107 paragraph 1. 1 (b). (c)), the words "g), (j)),), w) or x)"
replaced by the words "h), k), p), x) or y)".
58. In article 107 paragraph 1. 1 (b). (c)), the words "§ 105 para. 6 (a). (c)), d), (f)),
(h)) to l) "are replaced by the words" § 105 para. 6 (a). c) or (d)), item 1, section 105
paragraph. 6 (a). (e)), f), (g)), h), (i))) ".
59. In article 107 paragraph 1. 1 (b). (c) "), the text of § 105 para. 7 or 8 "shall be replaced
the text "§ 105 para. 7, 8 or 9 ".
60. In paragraph 107 para. 1 at the end of the text of subparagraph (c)), the words "or section
paragraph 106. 3 (b). d), (e) or (f))) ".
61. In paragraph 107 para. 1 (b). (d)), the words "h), k), (l)), m), q), r), s), t)
u), v) "shall be replaced by ' i), l), m), (n)), r), s) t))))".
62. In section 107 para. 1 (b). (d)), the words "(b)), e), (g)), or m)" are replaced by
the words "), and (b)) or-l)".
63. In section 107 para. 1 (b). (e)), after the words "§ 104 paragraph. 7 (b). (b)) or
(c)), "the words" § 105 para. 2 (a). r) to t) ".
64. In article 107 paragraph 1. 1 (b). e), the words "d), (e)), f), (i)), n) or p)"
replaced by the words "d), (e)), f), (g)), j), o) or q)".
65. In paragraph 107 para. 2, after the words "in accordance with" the words "§ 105 para. 2
(a). t) and ".
66. In § 108 paragraph 5 is added:
"(5) means a natural person has committed the offense by that, contrary to the regulation on
the clinical trial
and) as the investigator or principal investigator
1. does not ensure the implementation of the clinical trial at a clinical site
reviews,
2. unless other members of the team of investigators in writing instructions
3. initiate the clinical trial without consent
the subject or his legal representative, except for those
where such consent is not required, or written permission to
the participation of minors, if required for the clinical trial,
4. initiate the clinical trial without communication from the contact details of the body
reviews or his legal representative,
(b)) as the investigator does not record, nezdokumentuje or does not report adverse
incident or laboratory deviation,
(c)) does not ensure the retention of the source data and the clinical documentation
reviews,
(d)) in the conduct of the trial has not taken immediate measures to
protection of trial subjects,
(e)) performs a clinical trial as the investigator, without meeting the conditions
laid down by the regulation on clinical trials or the conditions laid down in §
54, or
(f)) in the implementation of the clinical trial does not comply with the principles of good
clinical practice ".
67. In section 108, paragraph 7, the following paragraph 8 is added:
"(8) a natural person as a member of the Ethics Committee of the State Institute for
drug control committed the offense by that, contrary to § 53a para. 5
breach of an obligation of professional secrecy. ".
Paragraphs 8 and 9 shall be renumbered 9 and 10.
68. In § 108 paragraph. 9 (a). and the word ") (c))" shall be replaced by ")".
69. In § 108 paragraph. 9 (a). (b)), the words "and) or (b))" is replaced by "b)
or (c)) ".
70. in § 108 paragraph. 9 at the end of the text of subparagraph (c)), the words "or
paragraph 5 (b). d), (e) or (f))) ".
71. In § 108 paragraph. 9 (a). (d)), the words "or of paragraph 5 (b). (d)) "
shall be deleted.
72. In paragraph 108, the following paragraph 11, which read:
"(11) for the offence referred to in paragraph 8 is saved ban.".
73. in paragraph 108, the following new section 108a and 108b, which including headings
shall be added:
"section 108a
Forfeiture of the medicinal product
(1) the forfeiture of a medicinal product can be saved, if the medicinal product
belongs to the perpetrator of the administrative offense, and
and) was for committing an administrative offense taken or intended, or
(b)) was in connection with committing an administrative offense obtained.
(2) the owner of a forfeited medicine becomes a State.
§ 108b
Prevents the medicinal product
(1) if it has not been saved the forfeiture of the medicinal product, as referred to in section 108a
paragraph. 1 (b). and) or (b)), you can decide to prevent, if
and belongs to the perpetrator of the administrative offense), which cannot be considered an administrative offence
to prosecute,
(b)) do not belong to the offender of the administrative offense or do not belong to him completely, or
(c)) the owner is not known.
(2) the owner of the seized medicine becomes the State. ".
74. In paragraph 112, after paragraph 5, insert a new paragraph 6 is added:
"(6) if the Government, with funds from the Institute converts the account maintained
in accordance with paragraph 5 to the revenue account of the State budget of the Czech Republic
set up for the Ministry of health of the amount provided for
Government. ".
Paragraphs 6 and 7 are renumbered as paragraphs 7 and 8.
75. In section 114 para. 1, after the words "§ 24 para. 2, 3, 4, 8, and 9.0 "
the words "§ 33 para. 2, § 53b para. 2, § 56 para. 6 ", for the words" section 67 para.
10 and 11.0 "with the words" § 77 para. 1 (b). (f)), and (q)), "and at the end of
the text of paragraph 1, the words "and shall be added to § 82 para. 3 (b). (d)) ".
76. In section 114 para. 2 the words "§ 51 para. 2 (a). (h)), § 52 para. 6, § 53
paragraph. 1, 8, 12 and 13, § 54 para. 1, § 55 para. 7 to 9, § 56 para. 1
(a). and, § 56 paragraph 1). 3 and 7, § 57 para. 2, § 58 para. 8, § 59 paragraph 1. 1 "
shall be deleted.
77. In section 114 para. 2 the words "§ 60 para. 2, 4, 5 and 9, § 61 para. 2
(a). a) and b) points 1 and 6, § 61 para. 2 (a). (c)), § 61 para. 4 (b).
(e)), "be deleted.
78. In section 114 para. 2 the text "section 66 paragraph 1. 4 "is deleted.
79. In section 114 para. 2, after the words "§ 77 para. 1 (b). (e)), "shall be replaced
"f),".
80. in section 114 para. 4, after the words "§ 48 para. 2, 3 and 6 of "the words"
§ 60 para. 2, 4, 5 and 9, § 61 para. 2 (a). a) and b) points 1 and 6, § 61
paragraph. 2 (a). (c)), § 61 para. 4 (b). (e)) ".
Article II
Transitional provisions
1. If the request for authorisation of a clinical trial presented
The State Institute for drug control before the date on which it shall expire 6 months
from the date of publication of the notice in the official journal of the European Union
According to the article. paragraph 82. 3 European Parliament and Council Regulation (EU) No.
536/2014 of 16 May. April 2014 about clinical trials on
medicinal products and repealing Directive 2001/20/EC, referred to a clinical
reviews will continue to be governed by existing laws, and by the day,
which have passed 42 months from the date of publication of this notice.
2. If the request for authorisation of a clinical trial presented
The State Institute for drug control, after the date on which six months have elapsed from the date
date of publication of the Commission's notification referred to in article. paragraph 82. 3 regulation of the European
Parliament and of the Council (EU) No. 536/2014 of 16 December. April 2014 on clinical
trials of medicinal products and repealing Directive
2001/20/EC but not later than the date on which passed 18 months from the date of
publication of this notice, can be referred to clinical trial management
reviews start according to the existing legislation and referred
the clinical trial will continue to be governed by existing laws, and it
until the date on which the 42 months have elapsed from the date of publication of this notice.
PART TWO
Amendment of the Act on regulation of advertising
Article. (III)
Act 40/1995 Coll., on regulation of advertising and amending and supplementing Act No.
468/1991 Coll. on the operation of radio and television broadcasting, in
as amended, as amended by Act No. 258/2000 Coll., Act No.
231/2001 Coll., Act No. 256/2001 Coll., Act No. 138/2002 Coll., Act No.
320/2002 Coll., Act No. 132/2003 Coll., Act No. 217/2004 Coll., Act No.
326/2004 Coll., Act No. 480/2004 Coll., Act No. 384/2005 Coll., Act No.
444/2005 Coll., Act No. 25/2006 Coll., Act No. 109/2007 Coll., Act No.
160/2007 Coll., Act No. 36/2008 Coll., Act No. 296/2008 Coll., Act No.
281/2009 Coll., Act No. 132/2010 Coll., Act No. 28/2011 Coll., Act No.
245/2011 Coll., Act No. 375/2011 Coll., Act No. 275/2012 Coll., Act No.
279/2013 Coll., Act No. 303/2013 Coll., Act No. 202/2015 Coll., Act No.
180/2016 Coll. and Act No. 188/2016 Coll., is amended as follows:
1. in paragraph 6b of the paragraph. 1, the second sentence is added to the sentence "in the case of advertising on
medicinal products, dietary supplements, foods for special
nutrition, initial and follow-on formulae shall be responsible for
compliance with the law the contracting authority and disseminator of the jointly and severally. ".
2. In paragraph 8, the dot at the end of paragraph 1 is replaced by a comma and the following
the letter o) is added:
"the spread of the drug ad), medicinal products, food supplements,
food for particular nutritional uses, initial and follow-on formula
nutrition, whose content is in violation of § 5, 5a, 5b, 5 d, 5e, 5f, or in
contrary to the directly applicable EU regulation governing data
about food in terms of their nutritional value and impact on
Health ^ 21a). ".
3. In § 8 para. 5 (b)):
"(b)) to 500 000 CZK in the case of an offense referred to in paragraph 1 (b). a), m)
or o), paragraph 2 (a). (d)) or under paragraph 3 (b). f),".
4. In section 8a, the dot at the end of paragraph 1 is replaced by a comma and the following
the letter r) shall be added:
"r) spread advertising on pharmaceuticals, medicinal products, food supplements,
food for particular nutritional uses, initial and follow-on formula
nutrition, whose content is in violation of § 5, 5a, 5b, 5 d, 5e, 5f, or in
contrary to the directly applicable EU regulation governing data
about food in terms of their nutritional value and impact on
Health ^ 21a). ".
5. In section 8a of the paragraph. 5 letter a) is added:
"and the 500 000 CZK), in the case of an administrative offence referred to in paragraph 1 (b). and)
p) or r) ".
PART THREE
Amendment of the Act on public health insurance
Article IV
Act 48/1997 Coll., on public health insurance and amending and
certain related laws, as amended by Act No. 242/1997
Coll., Act No. 2/1998 Coll., Act No. 127/1998 Coll., Act No. 225/1999
Coll., Act No. 363/1999 Coll., Act No. 18/2000 Coll., Act No. 132/2000
Coll., Act No. 155/2000 Coll., Constitutional Court, declared under no.
167/2000 Coll., Act No. 220/2000 Coll., Act No. 258/2000 Coll., Act No.
459/2000 Coll., Act No. 176/2002 Coll., Act No. 198/2002 Coll., Act No.
285/2002 Coll., Act No. 309/2002 Coll., Act No. 320/2002 Coll., Act No.
222/2003 Coll., Act No. 274/2003 Coll., Act No. 362/2003 Coll., Act No.
424/2003 Coll., Act No. 425/2003 Coll., Act No. 455/2003 Coll., Act No.
85/2004 Coll., Act No. 359/2004 Coll., Act No. 422/2004 Coll., Act No.
436/2004 Coll., Act No. 438/2004 Coll., Act No. 123/2005 Coll., Act No.
168/2005 Coll., Act No. 253/2005 Coll., Act No. 350/2005 Coll., Act No.
361/2005 Coll., Act No. 47/2006 Coll., Act No. 109/2006 Coll., Act No.
112/2006 Coll., Act No. 117/2006 Coll., Act No. 165/2006 Coll., Act No.
189/2006 Coll., Act No. 214/2006 Coll., Act No. 245/2006 Coll., Act No.
264/2006 Coll., Act No. 340/2006 Coll., Constitutional Court,
declared under the No. 57/2007 Coll., Act No. 181/2007 Coll., Act No.
261/2007 Coll., Act No. 296/2007 Coll., Act No. 129/2008 Coll., Act No.
137/2008 Coll., Act No. 270/2008 Coll., Act No. 274/2008 Coll., Act No.
306/2008 Coll., Act No. 59/2009 Coll., Act No. 158/2009 Coll., Act No.
227/2009 Coll., Act No. 281/2009 Coll., Act No. 362/2009 Coll., Act No.
298/2011 Coll., Act No. 365/2011 Coll., Act No. 369/2011 Coll., Act No.
458/2011 Coll., Act No. 1/2012 Coll., Act No. 275/2012 Coll., Act No.
401/2012 Coll., Act No. 403/2012 Coll., Act No. 44/2013 Coll., the award
The Constitutional Court declared under no. 238/2013 Coll., Act No. 60/2014
Coll., Act No. 109/2014 Coll., Act No. 250/2014 Coll., Act No. 256/2014
Coll., Act No. 267/2014 Coll., Act No. 1/2015 Coll., Act No. 200/2015
Coll., Act No. 314/2015 Coll. and Act No. 47/2016 Coll., is amended as follows:
1. In § 39a para. 5 (b). and the number ") 15" is replaced by "30".
2. In § 39a para. 5 (b). (b)), the number "32" is replaced by "40".
3. In paragraph 39a is inserted after paragraph 6 a new paragraph 7, which reads as follows:
"(7) the Institute shall calculate the maximum price of other similar products in the
the reference group referred to in paragraph 4 and that price will reduce the procedure
in accordance with paragraph 5. ".
Paragraphs 7 and 8 shall be renumbered as paragraphs 8 and 9.
Article. In
Transitional provision
The proceedings initiated pursuant to § 39a Act No. 48/1997 Coll., in the version in force in
the effective date of this Act shall be completed pursuant to Act No. 48/1997
Coll., in the version in force until the date of entry into force of this Act.
PART FOUR
Amendment of the Act on civil service
Čl.VI
In section 2 of the Act No. 234/2014 Coll. on State service, as amended by Act No.
131/2015 Coll., Act No. 137/2016 Coll., Act No. 190/2016 Coll., Act No.
195/2016 Coll., Act No. 302/2016 Coll. and Act No. 319/2016 Coll., on
the end of paragraph 1, the period is replaced by a comma and the following letter o)
added:
"a member of the Ethics Committee of the State) Institute for drug control.".
PART FIVE
FINAL PROVISIONS
Article. (VII)
Technical regulation
This Act has been notified in accordance with the directive of the European Parliament and of the
The Council (EU) 2015/1535 of 9 June. September 2015, the procedure for the provision
information in the field of technical regulations and of rules on services,
the information society, as amended.
Article. (VIII)
The effectiveness of the
This Act shall take effect on the first day of the calendar month
following the date of its publication, with the exception of the provisions
and) article. I, section 8, art. I, point 13, art. I, point 8, in terms of section 51, 52 and section
53 para. 2, article. I, point 21, in terms of § 53b para. 1, 2, 3 and § 53 c
paragraph. 1 to 8, and article. I, points 22, 24, 26, 27, 28, 48, 49, 50, 51, 52, 55,
57, 60, 64, 66, 67, 68 and 69, which shall take effect at 6
months from the date of publication of the notice in the official journal of the European
the Union referred to in article. paragraph 82. 3 European Parliament and Council Regulation (EU) No.
536/2014 of 16 May. April 2014 about clinical trials on
medicinal products and repealing Directive 2001/20/EC; the date when this
notice shall notify the Ministry of health in the form of a communication
in the collection of laws;
(b)) article. I, point 20 in terms of § 53 para. 1, 3 and 4, and article. I, point 9,
in terms of section 53a, § 53b para. 4, 5 and § 53 c para. 9 and article. I, points 65 and
70, which shall take effect on the first day of the calendar month
following the date of publication of the notice in the official journal of the
The European Union pursuant to article. paragraph 82. 3 regulation of the European Parliament and of the
Council Regulation (EU) No. 536/2014 of 16 December. April 2014 on clinical trials
medicinal products and repealing Directive 2001/20/EC; the day when
This notice shall notify the Ministry of health in the form of
communication in the collection of laws;
(c)) article. I, points 3, 4, 5, 7, 10, 16, 31, 32, 33, 43, 44, 47, 54, 58, 61,
62 and 63, which shall take effect on the first day of the ninth calendar
the month following its publication.
Hamáček in r.
Zeman in r.
Sobotka in r.
