Act No. 66 / 2017 Coll.
Act amending Act No. 378 / 2007 Coll., on Medicines and on Changes to Certain Related Acts (Law on Medicines), as amended, and other Related Laws
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Effective from 01.04.2017
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66
THE LAW
of 31 January 2017
amending Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Law on Medicines), as amended, and other Related Acts
Parliament has decided on this law of the Czech Republic:
Amendment to the Drug Act
Act No. 378 / 2007 Coll., on medicinal products and on amendments to certain related laws (Act on Medicines), 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. The following is added at the end of footnote 2:
"Regulation (EU) No 536 / 2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use and repealing Directive 2001 / 20 / EC.
Commission Delegated Regulation (EU) No 1252 / 2014 of 28 May 2014 supplementing Directive 2001 / 83 / EC of the European Parliament and of the Council with regard to the principles and guidelines of good manufacturing practice for active substances for medicinal products for human use. ';
2. In Article 5, the following paragraph 16 is added:
"(16) For the purposes of this Act, when used in investigational medicinal products for human use or veterinary medicinal products, the manufacturing, packaging, repackaging, labelling, marking, quality control or release of the active substance shall mean any complete or partial act of taking over the material, of manufacturing, packaging, repackaging, marking, remarking, quality control or release of the active substance, as well as any related control. The definition of what is meant by the production of the active substance, when applicable in medicinal products for human use, is laid down in a directly applicable European Union regulation governing good manufacturing practice for the active substance (101).
(101) Commission Delegated Regulation (EU) No 1252 / 2014. '
3. in Article 11 (g):
"(g) issue measures of a general nature pursuant to Article 77d which restrict or prohibit the distribution of a medicinal product abroad;"
4. Paragraph 11 (h) reads as follows:
"(h) creates the conditions for ensuring the availability of medicinal products relevant to the provision of health services, requiring their availability to be made available by issuing measures of a general nature and complying with the conditions for its issue, acting in accordance with point (g) or (q), and taking measures to promote the research, development and availability of orphan and medicinal products which may be established as such, as well as medicinal products for use in paediatric medicine;"
5. In Article 11, at the end of point (p), the dot is replaced by a comma and the following point (q) is added:
"(q) issues general measures pursuant to § 77c establishing a medicinal product in which the availability and effectiveness of treatment of patients in the Czech Republic with a direct impact on the health of the population and with a significant influence on the provision of health services are compromised and a list of such medicinal products is maintained."
6. in Paragraph 13 (2) (a) (1), the words "the decision to forfeit the medicinal product" shall be inserted after the words "the decision to authorise parallel imports."
7. in Article 13 (2) (a) (3), the word "operators" shall be deleted;
8. in Paragraph 13 (2) (b), including footnote 104,
"(b) issue decisions relating to clinical trials pursuant to Paragraph 51 and impose corrective measures within the meaning of Article 77 of the directly applicable European Union law governing the clinical evaluation of medicinal products for human use (104) (hereinafter referred to as the" Clinical Evaluation Regulation "),"
(104) Regulation (EU) No 536 / 2014 of the European Parliament and of the Council. '
9. In Article 13 (2), the dot at the end of point (m) is replaced by a comma and the following point (n) is added:
"(n) in the event of a defect in the quality of a medicinal product which does not pose a threat to the life or health of persons, it shall decide whether such medicinal product or its individual batches may be distributed, released, put into circulation or used in the provision of health services.";
10. In Article 13 (3), at the end of point (p), the dot is replaced by a comma and the following points (q) and (r) are added:
"(q) transmit to the Ministry of Health all information necessary for the issue of general measures pursuant to § 77c;
(r) on the basis of an assessment of the situation on the market in medicinal products, the Ministry of Health shall communicate the information referred to in Article 77c and provide it with an incentive to take general measures pursuant to Article 77d. ';
11. in Article 16 (2) (a) (1), the words "the decision to forfeit the medicinal product" shall be inserted after the words "the decision to authorise parallel imports,"
12. After Paragraph 19, the following Section 19a is inserted:
Directorate-General for Customs
(1) The Directorate-General for Customs shall provide the following information on a request from the Institute for the controlled person who places the medicinal product on the market or exports it:
(a) identification details of such person, in particular name or name and registered office;
(b) a description of the medicinal product, including the trade name;
(c) where necessary, information on the country of dispatch and the country of origin of the medicinal product; and
(d) the quantity of medicinal product expressed in units of measurement.
(2) The provision of the information referred to in paragraph 1 shall not constitute a breach of confidentiality under the tax rules. ';
13. Paragraph 21 (1) is deleted.
Paragraphs 2 and 3 shall be renumbered paragraphs 1 and 2.
14. in Article 23 (2) (b), the words "unless the Institute has taken a decision pursuant to Article 13 (2) (n)" shall be inserted after the word "quality."
15. in the sentence of Paragraph 33 (2), the first words "and types of packaging" shall be replaced by "the types of packaging and the code assigned by the Institute or the Veterinary Institute."
16. In Paragraph 33 (2), the last sentence is replaced by the following: "The Marketing Authorisation Holder provides the Institute with complete and correct information on the volume of supplies of medicinal products placed on the market in the Czech Republic electronically; the data provided shall include the identification of the marketing authorisation holder, the identification of the medicinal product and the information on whether the medicinal product has been delivered to a pharmacy or distributor; the structure, manner, form and time interval of their provision by electronic reporting shall be laid down in the implementing legislation. At the request of the Institute or the Veterinary Institute, the marketing authorisation holder of the Institute or Veterinary Institute shall provide the information relating to the volume of prescription of the medicinal product and the volume of supply of medicinal products placed on the market in the Czech Republic at his disposal. '
17. in Paragraph 33 (3) (a), the words "to distribution or pharmacy" are replaced by the words "to be marketed in the Czech Republic."
18. Paragraph 34 shall be added at the end of paragraph 2 to the sentence "The medicinal product corresponding to the data and the documentation before the renewal of the marketing authorisation may, unless otherwise provided for in the decision to extend the marketing authorisation, continue to be placed on the market for a maximum period of 180 days from the approval of the renewal of the marketing authorisation. In the case of reserved medicinal products to be sold and used in the provision of health services or veterinary care, such medicinal product may continue to be used for the duration of its application. ';
19. The heading of Episode 1 of Title IV reads "Clinical Studies."
20.
Clinical evaluation of medicinal products for human use
(1) The Institute shall examine applications for authorisation of a clinical trial of medicinal products for human use pursuant to Articles 5, 13 and 14 of the clinical trial Regulation and applications for authorisation of a significant change to the clinical trial in accordance with Article 17 of the clinical trial Regulation. The Institute shall also supervise the course of the clinical trial. All actions carried out in connection with the handling of the application for authorisation of a clinical trial and the application for authorisation of a significant change of clinical trial and supervision shall be considered as professional activities.
(2) The Institute is the National Contact Point in the Czech Republic under Article 83 of the Clinical Evaluation Regulation.
(3) Institute in the context of the examination of an application for authorisation of a clinical trial of medicinal products for human use or significant changes to a clinical trial
(a) where the Czech Republic is the rapporteur Member State in relation to the relevant clinical trial pursuant to Article 5 (1) or Article 14 (2) of the clinical trial Regulation, it shall carry out the activities of the rapporteur Member State established by the clinical trial Regulation concerning the aspects covered by Part I of the assessment report;
(b) where the Czech Republic is not the rapporteur Member State in relation to the relevant clinical trial, it shall carry out the activities of the Member State concerned in accordance with Article 2 (12) or Article 14 of the clinical trial Regulation concerning the aspects covered by Part I of the assessment report; and
(c) draws up Part II of the evaluation reports on the application for authorisation of a clinical trial in respect of the Czech Republic and on the application for authorisation of a significant change in respect of the Czech Republic, including an opinion drawn up by the Ethics Commission.
(4) The Institute decides on the application for authorisation of a clinical trial and on the application for authorisation of a significant change to a clinical trial under the clinical trial Regulation. These decisions apply to the territory of the Czech Republic.
Protection of certain groups of evaluation bodies
(1) A clinical trial may be conducted with a minor, provided that, in addition to the informed consent of his / her legal representative, he / she has authorised a minor to participate in the clinical trial by signing a written consent, provided that this is appropriate for his / her rational and free maturity.
(2) Clinical trials may also be carried out under the conditions laid down by this law in specific groups of subjects to which persons belong
(a) in custody, security detention or the execution of a prison sentence,
(b) residing in an institution of constitutional care,
(c) whose jurisdiction has been restricted by the court.
(3) A clinical trial may be conducted for the persons referred to in paragraph 2 only if they have been granted free and informed consent and if there is scientific evidence to justify the expectation that participation in a clinical trial will have a direct therapeutic or health benefit for those persons that outweighs the risks and burdens involved, or that their inclusion in the clinical trial will be the only option for stabilising or, where appropriate, improving the adverse health status.
Ethics Committee
(1) The Ethics Commission is the institution of the Constitution.
(2) The Ethics Committee shall exercise ethical oversight of clinical trials and conduct an ethical review, including ethical, medical and scientific aspects, requests for authorisation of clinical trials, requests for authorisation of significant changes to the clinical trial, and shall issue opinions to the extent and in a manner covered by this Law and the Regulation on clinical trials.
(3) The Institute provides the Ethics Committee with the conditions for its activities.
(4) The Institute, after prior approval by the Ministry of Health, will issue the Statute of the Ethics Commission. The Rules of Procedure of the Ethics Commission (hereinafter referred to as the Rules of Procedure) shall be adopted by the Ethics Commission itself. The Statute of the Ethics Commission and the Rules of Procedure of the Institute shall be published on its website. '
21. The following Sections 53a to 53c are inserted after Section 53:
Composition of the Ethics Commission
(1) The Ethics Committee is composed of groups. The groups are composed of health professionals and non-healthcare professionals. The number of groups and the number of members of each group of the Ethics Commission shall be determined by the Statute of the Ethics Commission. Members of the Ethics Commission shall be appointed in such a way that there are at least 5 persons in each group of Ethics Committee, of which at least 1 person was without medical education.
(2) The members of the Ethics Commission are appointed and dismissed by the Minister for Health, in individual groups. The groups of the Ethics Commission shall consist of the President, Vice-President and other members. The President and Vice-President shall be elected by the members of the Group in accordance with the Rules of Procedure of the Ethics Commission.
(3) The members of the Ethics Committee must comply with the requirements of Article 9 of the clinical trial Regulation and must have the qualifications and experience to assess and evaluate the application for a clinical trial from an ethical, medical and scientific point of view, except for a person without a medical education who assesses the application for a clinical trial in particular from an ethical point of view.
(4) The members of the Ethics Committee shall refrain from making comments on requests for authorisation of a clinical trial for which they have a personal interest, as well as any requests for authorisation of a significant change and professional supervision of such a clinical trial, and shall immediately notify the establishment of a personal interest in the clinical trial under consideration to the Ethics Commission and the Institute.
(5) The members of the Ethics Commission are obliged to remain silent about the information and facts they learn in connection with their membership of the Ethics Commission.
(6) A person who has committed an offence pursuant to Paragraph 108 (8) may not be a member of the Ethics Commission. If a member of the Ethics Commission has committed such an offence, his membership of the Ethics Committee shall cease.
Activities of the Ethics Commission
(1) It is the responsibility of the Ethics Commission to contribute to the protection of the rights, safety and health of the subjects of the evaluation.
(2) The Ethics Committee shall supervise the clinical trial on the basis of a report on the conduct of the clinical trial in the medical establishment in which the clinical trial is conducted (hereinafter referred to as "the clinical trial site") submitted in accordance with the principles of good clinical practice by the investigator or principal investigator. The details of the clinical trial progress report and the time intervals for its submission shall be laid down in the implementing legislation.
(3) The Ethics Committee may invite other experts to give its opinion. Such experts shall comply with the requirements of Article 9 of the clinical trial Regulation. These experts have an obligation to keep quiet about the information and facts they learn in connection with their activities on the Ethics Commission.
(4) The Ethics Committee shall act in accordance with the Rules of Procedure, which shall in particular:
(a) the way in which meetings are planned, the communication of members of the group and the way in which they are conducted;
(b) the manner in which the opinion of the Ethics Commission is withdrawn.
(5) Furthermore, the Ethics Committee shall carry out its activities in accordance with the working procedures of the Ethics Committee established by the Institute, which shall in particular:
(a) the way in which applications for authorisation of a clinical trial and applications for authorisation of a significant change to a clinical trial are assessed, to the extent provided for in the clinical trial Regulation;
(b) the procedures for handling the reporting of examiners or principal examiners, if any, and the contracting entities and the information obtained from the supervision of clinical trials or otherwise obtained pursuant to Article 52 to 54 of the clinical trial Regulation;
(c) the manner in which the Ethics Committee transmits its opinion to the Institute on the clinical trial, including its justification.
Opinion
(1) In preparing an opinion on the aspects covered by Part I assessment reports for an application for authorisation of a clinical trial or for an application for authorisation of a significant change to a clinical trial to the extent covered by Part I of the assessment report, the Ethics Panel shall assess the clinical trial protocol to the extent that:
(a) the merits of the clinical trial and its organisation;
(b) the acceptability of the expected benefit / risk ratio and the justification for its conclusions; and
(c) the ethical aspects of the clinical trial.
(2) If the Ethics Committee has delivered a negative opinion in accordance with the Regulation on clinical trials, this opinion shall be binding and the request for authorisation of a clinical trial or for the authorisation of a significant change to a clinical trial in the Czech Republic shall be rejected by the Institute by decision. Negative opinion on aspects covered in part I assessment reports for an application for authorisation of a clinical trial or for an application for authorisation of a significant change to a clinical trial concerning the addendum to the protocol may be issued only for the reasons set out in the clinical trial Regulation. The opinion shall state the reasons for listing and describing the specific and relevant reasons for which the Ethics Committee has delivered its opinion. The President of the Ethics Commission shall be responsible for the proper processing of the opinion and its timely transmission to the Institute.
(3) The Ethics Committee shall give an opinion before commencing a clinical trial on the aspects covered by Part II of the evaluation report on the application with detailed justification for its opinion. In preparing this opinion, the Ethics Committee shall act in accordance with the Regulation on clinical trials.
(4) When preparing the opinion of the Ethics Committee referred to in paragraph 3, the group of Ethics Committee designated for the assessment of a specific clinical trial shall assess the dossier submitted by the applicant in accordance with the requirements laid down in the clinical trial Regulation, with a view to assessing this dossier, whether:
(a) compensation or compensation to the subject in the event of any damage caused by his participation in the clinical trial shall be covered by an insurance contract;
(b) liability insurance for examiners and principal examiners, if they are established, and the contracting entity is provided with an insurance contract, or if the insurance of the responsibility of examiners and principal examiners, if they are established, or the contracting entity is not part of their employment relationships;
(c) the compensation does not exceed the expected costs incurred by the entity in connection with its participation in the clinical trial;
(d) the level of remuneration for the subjects is consistent with the nature of the clinical trial, in particular in relation to those research performances from which the subject does not benefit directly;
(e) the method of securing remuneration for the examiner and principal examiner, if established;
(f) the examiners and principal examiners, if established, comply with the requirements set out in Section 54;
(g) instead of a clinical trial, it is appropriate to carry out the clinical trial in question.
(5) The Ethics Panel assesses, in terms of the protection of the rights, safety and health of subjects, the assessment of compensation and compensation of the subjects of the evaluation and their remuneration and remuneration of the examiners or principal examiners, if established, listed in the application dossier for the authorisation of the clinical trial.
(6) The President of the Ethics Commission shall be responsible for the proper processing of the opinion referred to in paragraph 3 and its timely transmission to the Institute. The opinion shall state the reasons for the comments.
(7) The Ethics Panel may withdraw its consent to carry out a clinical trial on a permanent or temporary basis if new facts of relevance to the safety of the subjects of the evaluation or the sponsor or principal examiner or examiner seriously infringe the conditions for the conduct or organisation of the clinical trial on which the Ethics Panel has given its consent. If the Ethics Committee finds that there are grounds for withdrawing its consent as set out in the first sentence, it shall request the Institute to seek the opinion of the contracting authority or, where appropriate, the examiner or principal examiner on these grounds, except where the safety of the evaluation bodies is compromised. Withdrawal of the opinion of the Ethics Committee shall include:
(a) identification details of the clinical trial, in particular its name, designation of the contracting authority or contracting entities, European identification number and protocol number;
(b) express indication of whether this is a temporary or permanent withdrawal of the consent, in the case of a temporary withdrawal of the consent, the conditions for the withdrawal of the consent must be laid down after the withdrawal of the consent has been completed;
(c) a statement of reasons stating the reasons for the withdrawal of the consent opinion, the documents for its publication and the considerations followed by the Ethics Committee;
(d) the measures necessary to end the clinical trial, in particular the transfer of the subject to another treatment, unless it is already mentioned in the protocol;
(e) the date of revocation of the consent opinion and the signature of the Chairman of the Ethics Commission Group which issued the appeal.
(8) The Ethics Committee shall, upon request of the Institute, forward its opinion to the Institute on all documents subject to the Ethics Committee assessment, no later than one working day before the last day of the deadline, established by the Institute for the initial assessment and verification of the application, the communication on the completeness of the application dossier, the stage of coordinated review, the phase of consolidation, the assessment of supplementary information, the completion of the examination of the application after receipt of the additional information, the submission of the final part I of the evaluation report or the submission of the final part II of the assessment report, as part of the assessment referred to in Article 5, 6, 7, 13, 14, 17, 18, 20 and 22 of the clinical evaluation Regulation.
(9) The Institute shall keep the following documents in connection with the activities of the Ethics Commission for a period of 5 years after the end of the clinical trial:
(a) minutes of the hearing;
(b) a statement of conflict of interest;
(c) biographies of members of the Ethics Commission;
(d) records of training and further training of members of the Ethics Commission;
(e) documents appointing and withdrawing members of the Ethics Commission;
(f) documents relating to the appointment, removal of members of the Ethics Commission, and resignation;
(g) contracts of employment and similar nature, including documents used to produce them, with experts working with the Ethics Commission; and
(h) correspondence of the Ethics Commission. ';
22. ';
Examiner and site of clinical trial
(1) Only a physician meeting the conditions laid down by other legislation29) may be a examiner and lead examiner with the necessary scientific knowledge and experience in the management of patients with a disease or condition targeted by the clinical trial and a knowledge of good clinical practice.
(2) The clinical evaluation may only be carried out by a health service provider in a healthcare establishment.
(3) A health service provider carrying out a clinical trial for the first time administering an investigational medicinal product to a human being and a health service provider carrying out a clinical trial without a therapeutic or preventive effect for the subjects of the evaluation, in particular bioequivalence and pharmacokinetic clinical trials, must hold a certificate of good clinical practice issued by the Institute.
(4) health service providers other than those referred to in paragraph 3 for which clinical trials are carried out shall not be required to obtain a certificate of good clinical practice; they may, however, request its issue.
Language
(1) The clinical trial documentation shall be submitted in the Czech language as regards the following documents:
(a) a summary of the clinical trial protocol,
(b) information for the patient, informed consent, authorisation of the minor to participate in the clinical trial and additions thereto;
(c) information on how to recruit subjects of evaluation in the Czech Republic,
(d) recruitment materials related to the clinical trial concerned,
(e) any material intended for the evaluation bodies;
(f) a list of examiners and main examiners, if they are established;
(g) the list of clinical trial sites,
(h) proof of compensation for the assessment bodies;
(i) information on how to ensure remuneration for examiners and principal examiners, if established, and remuneration or compensation for evaluation subjects.
(2) Other documentation of the clinical trial, not including the documents referred to in paragraph 1, shall be submitted in the Czech, Slovak or English language.
(3) The information on the labelling of medicinal products for clinical trial shall be given in the Czech language, unless otherwise specified in the decision of the Institute.
Medicinal products evaluated and auxiliary
(1) If the conditions laid down in Article 59 (2) of the clinical trial Regulation are met, non-authorised medicinal products may also be used in clinical trials in the Czech Republic.
(2) The contracting authority shall provide free of charge investigational medicinal products, ancillary medicinal products not authorised under this Act required by the protocol of the clinical trial and the medical devices required for carrying out the clinical trial which are intended for the administration of investigational medicinal products. In the context of a clinical trial of medicinal products for human use, where a notified medical device cannot be used, a medical device which otherwise does not comply with the requirements laid down in the Health Devices Act may be used after prior approval by the Institute. If the contracting authority is a non-commercial contracting authority which, for the purposes of this Act, means a health service provider established or established by a State or a local authority, a public university and a public research institution, and the investigational medicinal products are registered in the Czech Republic, the provision of investigational medicinal products is not free of charge.
(3) If radiopharmaceuticals not registered under this Act are to be used in the clinical trial of medicinal products for human use, the contracting authority shall, in accordance with the requirements of the clinical trial regulation, submit, together with the documentation on the application for authorisation of a clinical trial, the opinion of the State Nuclear Safety Authority issued pursuant to Paragraph 18.
(4) Where products containing genetically modified organisms are to be used in the clinical trial of medicinal products for human use, the contracting authority shall, together with the documentation for the application for authorisation of a clinical trial, submit the consent of the Ministry of the Environment, issued under another legislation11).
(5) If products containing human embryonic stem cells are to be used in the clinical trial of medicinal products for human use, the sponsor shall, together with the documentation for the application for authorisation of a clinical trial, submit a permit for the management of human embryonic stem cells issued by the Ministry of Education, Youth and Sports under another legislation102).
(6) For cluster clinical trials or low-intervention clinical trials as referred to in Article 2 (3) of the clinical trial Regulation carried out by non-commercial contracting entities which are not the basis for the marketing authorisation or amendment of the marketing authorisation of a medicinal product, the implementing legislation shall lay down the monitoring requirements, the content of basic documents and the additional labelling of investigational medicinal products. A positive clinical trial according to the first sentence means a clinical trial conducted only on the territory of the Czech Republic, the purpose of which is to evaluate the treatment of patient groups in which all investigational medicinal products are registered under this law in the Czech Republic and are used in accordance with the Summary of Product Characteristics or outside the Summary of Product Characteristics, if such a method of use is consistent with normal medical practice or recommended medical procedures and is sufficiently justified by scientific knowledge.
Agreement with the contracting authority
The Institute may, under the conditions laid down in Article 42 (3) of the clinical trial Regulation, conclude an agreement with the contracting authority under which the contracting authority will report the suspected serious unexpected adverse reactions directly to the Institute; in which case they shall report suspected serious unexpected adverse reactions to the Institute.
Injury compensation scheme of the subject
(1) Where a clinical trial subject is created as a result of carrying out a clinical trial of property or non-property damage, in particular to life or health, the contracting authority is obliged to replace him in accordance with other legislation103). The compensation may be applied to the contracting authority through the health service provider, which is the place of the clinical trial.
(2) The contracting authority shall, throughout the course of the clinical trial, have agreed insurance of the liability of its principal examiners, if they are established, and of the examiners for the damage suffered by the subject as a result of the clinical trial.
(3) Paragraph 2 shall not apply where a clinical trial is carried out by a non-commercial contracting entity whose activity insurance covers the use of medicinal products in a clinical trial,
(a) with medicinal products registered under this Act in the Czech Republic and used in accordance with the Summary of Product Characteristics or, where applicable, with medicinal products registered under this Act in the Czech Republic and used outside the Summary of Product Characteristics, if such use is consistent with normal medical practice or recommended treatment procedures and is sufficiently justified by scientific knowledge,
(b) additional diagnostic or monitoring procedures do not present a greater than minimum additional risk or burden on the safety of the subjects than normal medical practice.
Representation
Where the contracting authority designates a representative or a contact person in an application submitted under the clinical trial Regulation, such designation shall be considered as proof of a proxy, unless the contracting authority or the representative proves otherwise.
102) Act No. 227 / 2006 Coll., on research on human embryonic stem cells and related activities and amending certain related laws, as amended.
103) For example civil code, penal code, Act No. 101 / 2000 Coll., as amended. Article 75 of Regulation (EU) No 536 / 2014. ';
23. in Paragraph 60 (3) (c), the comma shall be replaced by a dot and point (d) shall be deleted, including footnote 64.
24. In Paragraph 62 (1), in the sentence, the second words "for clinical trial and 'are deleted.
25. in Article 62 (3) (b), the text "Article 66 (1) to (4)" is replaced by "Article 66 (1) to (3)."
26. in § 64 (b), the words "§ 55 and approved in the context of the procedure for the application for authorisation or for the notification of a clinical trial" shall be replaced by the words "Regulation on clinical trial and approved in the context of the procedure for the application for the authorisation of a clinical trial or for the authorisation of a significant change in the clinical trial."
27. in Article 64 (w), the words "including investigational medicinal products for human use," shall be deleted;
28. Paragraph 66 (4) is deleted.
Paragraph 5 shall become paragraph 4.
29. in Paragraph 67 (9), "Paragraph 66 (5)" is replaced by "Paragraph 66 (4)."
30. In Article 70 (1), the words "and directly applicable European Union101 'shall be inserted after the words" including active substances intended for export' in the sentence of the first paragraph.
31. in Paragraph 70, the following paragraph 7 is added:
"(7) The manufacturer of active substances carrying out the packaging, repackaging, labelling, marking, quality control or release as well as the related controls of active substances originating in third countries for the preparation of medicinal products shall have the documents referred to in paragraph 2; this shall be without prejudice to the provisions of paragraphs 4 and 5. ';
32. in Article 77 (1) (f), the words "the scope of the data and the manner in which they are provided by means of notification shall be published in its information medium" shall be replaced by the words "the data provided shall include the identification of the distributor, the identification of the distributed medicinal product and the identification of the person to whom the medicinal product has been distributed, the structure of the data, the form, manner and time interval of their provision by electronic notification, shall be laid down in implementing legislation."
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Regulation Information
| Citation | Act No. 66 / 2017 Coll., amending Act No. 378 / 2007 Coll., on Medicines and on Changes to Certain Related Acts (Law on Medicines), as amended, and other Related Acts |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 06.03.2017 |
|---|---|
| Effective from | 01.04.2017 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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