What is Act No. 241 / 2024 Coll.?

Act No. 241 / 2024 Coll., amending Act No. 375 / 2022 Coll., on in vitro medical devices and diagnostic medical devices, and Act No. 378 / 2007 Coll., on medicinal products and on amendments to certain related laws (Law on medicinal products), as amended — Act amending Act No. 375 / 2022 Coll., on in vitro medical devices and diagnostic medical devices, and Act No. 378 / 2007 Coll., on medicinal products and on amendments to certain related laws (Law on medicinal products), as amended.

When it became Act No. 241 / 2024 Coll. effectiveness?

Act No. 241 / 2024 Coll. became effective 23.08.2024.

Is Act No. 241 / 2024 Coll. still valid?

Yes, Act No. 241 / 2024 Coll. is still valid and effective.

How many times was it Act No. 241 / 2024 Coll. amended?

Act No. 241 / 2024 Coll. has 3 time versions of the text.

Act No. 241 / 2024 Coll. - Act amending Act No. 375 / 2022 Coll., o...

241

THE LAW

of 10 July 2024

amending Act No. 375 / 2022 Coll., on in vitro medical devices and diagnostic medical devices, and Act No. 378 / 2007 Coll., on medicinal products and on amendments to certain related laws (Law on medicinal products), as amended

Parliament has decided on this law of the Czech Republic:

ČÁST PRVNÍ

Amendment of the Law on in vitro medical devices and diagnostic medical devices

Čl. I

Act No. 375 / 2022 Coll., on in vitro medical devices and diagnostic medical devices, is amended as follows:

1. In Article 4 (c), "Paragraph 65 (1) 'is replaced by" Paragraph 64 (1)'.

2. In Article 4, at the end of point (e), the dot is replaced by a comma and the following points (f) to (i) are added:

"(f) proposes, in accordance with Regulation (EU) 2022 / 12324 of the European Parliament and of the Council (" the Regulation on enhanced role "), a representative of the Czech Republic to the Executive Management Group for the lack of medical devices established under Article 21 of the Regulation on enhanced role (" the Steering Group "),

(g) proposes representatives to a working group established under Article 25 (1) of the Regulation on enhanced role and is a single point of contact in relation to the lack of resources within the meaning of the second subparagraph of Article 21 (5) of the Regulation on enhanced role;

(h) submit a request to the Steering Group for the provision of aggregated data and demand forecasts in accordance with Article 24 (2) of the enhanced role Regulation; and

(i) take into account the recommendations of the Steering Group adopted pursuant to Article 24 (3) or (4) of the Regulation on enhanced role or guidelines and recommendations adopted by the European Commission pursuant to Article 28 (b) of the Regulation on enhanced role and coordinate its activities in this field with the competent authorities of other Member States.

24) Regulation (EU) 2022 / 123 of the European Parliament and of the Council of 25 January 2022 on the enhanced role of the European Medicines Agency in crisis preparedness and crisis management in the field of medicinal products and medical devices. '.

3. in Article 5 (2) (g), the text "Article 65 (2)" is replaced by "Article 64 (2)."

4. In Article 5, at the end of paragraph 2, the dot is replaced by a comma and the following points (t) to (w) are added:

"(t) cooperate with the European Medicines Agency in carrying out its task under Article 25 (1) (b) of the Regulation on enhanced role in the development of information systems and ensure fulfilment of the obligations of the Czech Republic under Article 27 of the Regulation on enhanced role;

(u) take into account the recommendations of the Steering Group adopted pursuant to Article 24 (3) or (4) of the Regulation on enhanced role or the guidelines and recommendations adopted by the European Commission pursuant to Article 28 (b) of the Regulation on enhanced role and coordinate its activities in this area with the competent authorities of other Member States;

(v) inform the Steering Group in accordance with the second subparagraph of Article 22 (1) and Article 27 (4) (c) of the Regulation on the enhanced role; and

(w) pursuant to Article 27 (2) of the Regulation on enhanced role from manufacturers, authorised representatives, notified bodies, importers, distributors and health service providers, require further information on the production and supply problems faced by those persons in the area of resources. ';

5. Paragraph 7 (5) reads as follows:

"(5) Other persons may be authorised to conduct operations in the Information System of Medical Devices under this or other law. The power of attorney may only be granted and accepted by the agent by means of an electronic form available through the Information System of Medical Devices. '

6. In the first sentence of Article 16 (2), the text "Article 19 (1) 'is replaced by" Article 15 (1) and (2)'.

7. In Paragraph 20 (5), the last sentence is replaced by the following: "If the clinical trial is not initiated within one year of the date on which the decision on its authorisation becomes final, the clinical trial cannot be initiated."

8. In the last sentence of Paragraph 20 (8), "71 'is replaced by" 70'.

9. In Paragraph 22 (3), at the end of the second sentence, the words "and the opinion of the Ethics Commission 'shall be added, in the third sentence, the word" Clinical' shall be replaced by the words "Other clinical 'and after the words" Since notification,' the words "but not later than one year 'shall be inserted, and in the fourth sentence, the word" Other' shall be inserted after the words "Data Identifying '.

10. in Paragraph 22 (2), (3), (4), (6) and (7), "clinical trials" is replaced by "other clinical trials";

11. in § 22 (4), (6) and (7), the words "clinical trial" are replaced by the words "other clinical trial";

12. Paragraph 22 (5) reads as follows:

"(5) The contracting authority shall notify the Institute of Termination and the conclusions of another clinical trial pursuant to Article 82 of the Regulation on medical devices. Another clinical trial is completed by the last visit of the last subject of another clinical trial, unless otherwise specified in the plan for another clinical trial. The notification of the termination of another clinical trial and the conclusions of another clinical trial shall be notified by the contracting authority through the Information System of Medical Devices. The contracting authority shall notify the completion of another clinical test within 15 days and the conclusions of another clinical test in the form of a report on another clinical test within 12 months of the date of completion of another clinical test. The notification of the termination of another clinical test shall contain data identifying another clinical test, the contracting entity of another clinical test, the place where the other clinical test was conducted and the date of completion of another clinical test. The report on another clinical test shall contain data identifying another clinical test, the contracting entity of another clinical test, the signature of the examiner, the summary of another clinical test and the evaluation of all data collected during another clinical test. The details of the notification of the completion of another clinical test and the report of another clinical test shall be laid down in the implementing legislation. ';

13. In the first sentence of Paragraph 22 (6), "point 'is replaced by" paragraph'.

14. In Article 22 (7), the word "point 'is replaced by" paragraph', the words "at least 30 days before their implementation 'are deleted and the words" after 30 days after notification' are replaced by the words "after the expiry of the period laid down in Article 75 (3) of the Health Devices Regulation from the date of notification '.

15. in Article 22, the following paragraph 8 is added:

"(8) If the contracting authority has temporarily suspended another clinical trial under Article 82 of the Health Devices Regulation or has terminated another clinical trial prematurely, it shall notify the Institute of this fact through the Information System of Medical Devices within 15 days of the date of interruption or termination of another clinical trial; Part of the notification is the justification for the temporary interruption or early termination of another clinical trial. In the event that the sponsor temporarily interrupted or terminated another clinical trial early for safety reasons, he shall report this fact within 24 hours of its establishment through the Information System of Medical Devices. Notwithstanding the results of another clinical trial, the contracting authority shall submit to the Institute, through the Information System of Medical Devices, conclusions in the form of a report on another clinical test within 3 months of its early termination or temporary interruption; paragraph 5 shall apply mutatis mutandis for the details of the report on another clinical test. The details of the notification of temporary interruption and early termination of another clinical test shall be laid down in the implementing legislation. ';

16. in Paragraph 34 (a):

"(a) ensure the publication of information on the consignment, namely:

1. offer of the device; publication of the offer is not considered as advertising under the Advertising Regulation Act (14),

2. the period within which the device may be sent to the client;

3. its remuneration from public health insurance (9) and the amount of the supplement; and

4. the payment for the delivery of the device to the client at the address chosen by him, only if the maximum trade premium is exceeded when the transport costs are included; the payment for service must be determined on the basis of the transport costs actually incurred and must not give rise to the benefit of the exporter; ';

17. The heading of Section 39 reads: "Obligations of the health service provider and other persons when using the device."

18. In Paragraph 39, the following paragraph 7 is added:

"(7) Persons providing services other than medical services by means of a device shall be subject to the obligations laid down for the provision of health services by means of the means referred to in Parts Seven, Eighth and Ninth of this Act mutatis mutandis. ';

19. in Paragraph 50 (1) (b), "all documentation" is replaced by "and all documentation."

20. in Paragraph 56 (1), the word "or" shall be deleted at the end of point (l).

21. In Article 56, at the end of paragraph 1, the dot is replaced by a comma and the following points (n) to (r) are added:

"(n) in accordance with Article 20 (2), does not inform the Institute or the Ethics Committee concerned of the initiation of a clinical trial or performance study;

o) does not provide in accordance with § 20 (2) The Institute or the relevant Ethics Committee shall report on the course and safety assessment of the clinical trial or performance study,

(p) in accordance with Paragraph 20 (3), it shall not immediately inform the Institute, the Ethics Committee or the subjects of the clinical trials of any significant new information which could affect the assessment of the benefit and risk of the test product;

(q) in accordance with Article 20 (3), for performance studies which do not require informed consent, it shall not immediately inform the Institute or the Ethics Commission of any significant new information that could affect the assessment of the benefit and risk of the tested device; or

(r) in contravention of Paragraph 19 (1), he shall not take out insurance for the entire duration of the clinical trial or performance study. ";

22. In Paragraph 56, the following paragraph 3 is inserted after paragraph 2:

"(3) The contracting authority of another clinical trial pursuant to Article 82 of the Health Devices Regulation shall commit an offence by:

(a) does not carry out another clinical trial in accordance with Article 82 (1) of the Regulation on medical devices;

(b) not report any intention to conduct another clinical trial in accordance with § 22 (3) of the Institute;

(c) in contravention of § 22 (3), initiate another clinical trial before the expiry of 60 days or initiate the clinical trial even if the Institute has decided otherwise;

d) does not inform contrary to § 20 (2) The Institute or the Ethics Committee responsible for initiating another clinical trial,

e) does not provide in accordance with § 20 (2) An annual report on the course and safety assessment of other clinical trials,

(f) in contravention of Article 22 (7), make a substantial change before the period laid down in Article 75 (3) of the Regulation on medical devices expires from the date of notification of the Constitution;

(g) not to report to the Institute the interruption or early termination of another clinical trial in accordance with § 22 (8);

(h) not submit the conclusions of another clinical trial to the Institute in accordance with § 22 (8); or

(i) in contravention of Article 19 (1), he shall not take out insurance for the entire duration of another clinical trial. "

Paragraph 3 shall become paragraph 4.

23. in Article 56 (4), the words "or (n) or (3) (d) or (h)" shall be added at the end of the text in point (a).

24. in Article 56 (4) (b), the words "or (k)" shall be replaced by the words "(k), (o), (p) or (q)," or "or under" shall be replaced by "or" and at the end of (b) the words "or (e) or (f) of paragraph 3" shall be added. "

25. in Article 56 (4) (c), the words "or (j)" shall be replaced by "(j) or (r)," or "shall be replaced by" or "and at the end of the text of (c) the words" or paragraph 3 (g) shall be added. "

26. in Article 56 (4) (e), the words "or paragraph 3 (b), (c) or (i)" shall be inserted after the words "or (m)."

27. in Article 56 (4), the words "or paragraph 3 (a)" shall be added at the end of the text of point (f);

28.

„§ 59

Transfers in the field of the activities of the health service provider and of persons providing services other than health services by means of a device

(1) A health service provider commits an offence by:

(a) not to report to the Institute the establishment or demise of the Ethics Commission in accordance with Paragraph 13 (1);

(b) in contravention of Paragraph 13 (3), it shall not keep records of the activities of the Ethics Commission it has set up for a specified period;

(c) does not ensure that the manufacturer's declaration on a custom-made medical device is transmitted to the patient in accordance with Article 39 (1) (f);

(d) make no entry in the medical file in accordance with § 39 (3);

(e) does not provide the patient with information on the implantable device in place in accordance with § 40 (2);

(f) as a manufacturer of devices referred to in Article 5 (5) (d) of the Regulation on medical devices or in Article 5 (5) (d) of the Regulation on in vitro diagnostic medical devices, shall not submit, at the request of the Institute, information in accordance with Article 5 (5) (d) of the Regulation on medical devices or Article 5 (5) (d) of the Regulation on in vitro diagnostic medical devices;

(g) as a manufacturer of devices referred to in Article 5 (5) of the Regulation on medical devices or in Article 5 (5) of the Regulation on in vitro diagnostic medical devices, shall not produce or publish on request a declaration in accordance with Article 5 (5) (e) of the Regulation on medical devices or Article 5 (5) (e) of the Regulation on in vitro diagnostic medical devices; or

(h) in contravention of § 50 (2), it does not keep in the patient's medical file information on suspected serious adverse events.

(2) A health service provider or a legal or commercial natural person providing services other than medical services by means of a means other than a medical service commits an offence by:

(a) in contravention of Paragraph 38 (2), use a device which does not comply with the requirements of the Regulation on medical devices or the Regulation on in vitro diagnostic medical devices;

(b) in breach of Article 39 (1) (a), shall not ensure that the device is used in accordance with the manufacturer's instructions;

(c) shall not ensure that a measuring instrument is operated in accordance with Paragraph 39 (1) (b);

(d) does not provide guidance to a person providing health services or persons using a device in the framework of the provision of a service other than a medical service in accordance with Article 39 (1) (c);

(e) does not ensure compliance with good storage practice in accordance with Paragraph 39 (1) (d);

(f) ensure that the service of the device is not carried out in accordance with Paragraph 39 (1) (e);

(g) use a means of providing health services or other services than medical services in breach of Article 39 (2);

(h) it does not retain a unique identification of the means supplied to it or submit information to the Institute in accordance with Paragraph 39 (4);

(i) does not keep documentation of the means used in accordance with Article 39 (5) or with the implementing regulation issued pursuant to Article 39 (6);

(j) does not ensure that the person providing the health services or the person using the device in the framework of the provision of a service other than medical information is in accordance with Paragraph 40 (1);

(k) shall not ensure that the device is operated or used only by a person who fulfils the conditions laid down in Paragraph 41 (1);

(l) it does not keep information on any instructions made in accordance with Paragraph 41 (3);

(m) it does not maintain a safety technical inspection record in accordance with § 45 (5) or it does not maintain a repair record in accordance with § 46 (3);

(n) contrary to Article 50 (1) (a), it does not take the necessary measures to minimise the negative effects of the event;

(o) in breach of Article 50 (1) (b), the device and all documentation shall not be made available to the manufacturer or the Institute; or

(p) contrary to Article 50 (1) (c), it shall not provide all the necessary synergies and information to determine the causes of the event.

(3) A fine may be imposed up to the amount of:

(a) 200 000 CZK if the offence referred to in paragraph 1 (a), (b) or (c) or paragraph 2 (p) is committed;

(b) 500 000 CZK if the offence referred to in paragraph 1 (d) or (h) or paragraph 2 (c), (d), (j), (l) or (m) is committed;

(c) 2 000 000 CZK if it is an offence referred to in paragraph 1 (e), (f) or (g) or paragraph 2 (f), (i) or (k); or

(d) 5 000 000 CZK if the offence referred to in paragraph 2 (a), (b), (e), (g), (h), (n) or (o) is committed. "

29. After Paragraph 62, the following Section 62a is inserted:

„§ 62a

Transfers in the area of critical means

(1) The manufacturer, authorised representative, health service provider, importer or distributor shall commit an offence by failing to provide information on the resources included in the list of critical means, contrary to Article 64a (1).

(2) The manufacturer, authorised representative, importer, distributor or notified body shall commit an infringement by not establishing a single point of contact in accordance with Section 64b.

(3) The manufacturer, authorised representative, importer, distributor or notified body shall commit an infringement by failing to provide the single point of contact established under Paragraph 64b, upon request, with information on the means included in the list of critical means referred to in Article 25 (2) (c) of the enhanced role Regulation.

(4) The manufacturer, authorised representative, importer or distributor commits an infringement by:

(a) does not provide or update the information required by Article 26 (1) of the enhanced role Regulation within the time limit set;

(b) fail to take into account the recommendations referred to in Article 24 (3) and (4) of the enhanced role regulation;

(c) fail to take into account the guidelines and recommendations referred to in Article 28 (b) of the enhanced role Regulation;

(d) fail to comply with measures taken at European Union or Member State level pursuant to Article 27 and Article 28 of the enhanced role Regulation; or

(e) shall not inform the Steering Group of any action taken pursuant to Articles 27 and 28 of the Regulation on enhanced role or report on the results of such action or provide information on a solution to the actual or potential shortage of funds in the area of critical funds.

(5) The manufacturer, authorised representative, notified body, importer or distributor shall commit an infringement by not duly justifying the failure to provide information or non-compliance with the time limit referred to in Article 26 (1) of the enhanced role Regulation.

(6) The single point of contact established under Paragraph 64b shall be committed by not transmitting to the European Medicines Agency the information required under Article 25 (2) (c) of the enhanced role Regulation.

(7) A fine may be imposed for an offence up to the amount of:

(a) 1 000 000 CZK if the offence referred to in paragraph 4 (e) or paragraph 5 is committed;

(b) 1 500 000 CZK if the offence referred to in paragraph 4 (a), (b) or (c) is committed;

(c) 2 000 000 CZK if the offence referred to in paragraph 1, 2, 3 or 6 is committed; or

(d) 3 000 000 CZK if the offence referred to in paragraph 4 (d) is committed. "

30. in Article 64 (1) (a):

"(a) is a device the use of which is necessary in view of the medical condition of a particular patient or patient group;"

31. in Article 64 (1) (c), the words "or group of patients" shall be inserted after the words "patient health."

32. After Paragraph 64, the following Sections 64a and 64b are inserted:

„§ 64a

Critically important means

(1) Manufacturers, their authorised representatives, health service providers, importers and distributors of funds and notified bodies are required, in accordance with Article 27 (2) of the enhanced role Regulation, to provide, upon request by the Institute, information on the means included in the list of critical means to the extent referred to in Article 22 (2) of the enhanced role Regulation.

(2) Information on critical means included in the list of critical means is obtained by the Institute through the Eudamed database, the Information System of Medical Devices and in accordance with the procedure laid down in paragraph 1.

(3) The persons referred to in paragraph 1 shall be required to duly justify the failure to provide any information requested and any delay in providing it within the time limit set by the Institute.

(4) The persons referred to in paragraph 1 shall identify the information which is of a trade secret nature, mark such information and indicate why such information is commercially confidential.

§ 64b

Single point of contact

The manufacturer, the authorised representative, the importer, the distributor and the notified body shall establish a single point of contact for the purpose of fulfilling the obligations laid down in Article 25 (2) (a) and (c) of the enhanced role Regulation. ';

33.In Article 68, "5 and 7" is replaced by "5, 7 and 8."

34. In the last sentence of Article 69 (2), the words "trade name and name of generic group22) 'are replaced by the words" the name and, where appropriate, the name, surname and address of the manufacturer's registered office, if the manufacturer is a natural person, or the business name and address of the manufacturer's registered office, if the manufacturer is a legal person, and the commercial name and risk class of the device'.

footnote 22 is deleted.

35. in Article 73 (5), the words "and full functionality of the Eudamed database" and the words "Section 10 (6)" shall be replaced by the words "Section 10 (3) and (6)."

Čl. II

Transitional provision

Until the full functionality of the Eudamed Institute database beyond the procedure under Section 64a (1) of Act No. 375 / 2022 Coll., on medical devices and diagnostic medical devices in vitro, as effective from the date of entry into force of this Act, the information under Section 64a (2) of the Act No. 375 / 2022 Coll., as effective from the date of entry into force of the Act, via the Information System of Medical Devices and the Register of Medical Devices established by Act No. 268 / 2014 Coll., on diagnostic medical devices in vitro, as effective before the date of entry into force of the Act No. 375 / 2022 Coll.

ČÁST DRUHÁ

Amendment to the Drug Act

Čl. III

Act No. 378 / 2007 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. 251 / 2017 Coll., Act No. 36 / 2018 Coll., Act No. 44 / 2019 Coll., Act No. 65 / 2017 Coll., Act No. 66 / 2017 Coll., Act No. 183 / 2017 Coll.

1. In footnote 2, the sentence "Regulation (EU) 2022 / 123 of the European Parliament and of the Council of 25 January 2022 on the enhanced role of the European Medicines Agency in crisis preparedness and crisis management in the field of medicinal products and medical devices' is added to the new line.

2. In Article 13, the following paragraph 4 is added:

"(4) The Institute for Medicinal Products for Human Use

(a) proposes representatives of the Czech Republic to the Executive Management Group on the deficiency and safety of medicinal products established pursuant to Article 3 of Regulation (EU) 2022 / 123 of the European Parliament and of the Council of 25 January 2022 on the enhanced role of the European Medicines Agency in crisis preparedness and crisis management in the field of medicinal products and medical devices ("the Regulation on enhanced role") ("the Steering Group") and proposes a member of the Working Group set up pursuant to:

1. Article 9 (1) (d) of the enhanced role Regulation; and

2. Article 15 (1) of the Regulation on enhanced role,

(b) make requests to the Steering Board for recommendations on measures that the Commission, the Member States, marketing authorisation holders, representatives of healthcare professionals and other persons could adopt to prevent or mitigate the actual or potential shortage of medicinal products or to ensure preparedness to address the actual or potential shortage of medicinal products caused by emergency situations in the field of public health or serious occurrences referred to in Article 8 (3) and (4) of the enhanced role Regulation;

(c) submit, through the single point of contact referred to in Article 3 (6) of the Regulation on the enhanced role of the Steering Group, a request for the provision of aggregated data and demand forecasts in accordance with Article 8 (2) of the Enhanced role Regulation;

(d) cooperate with the Agency in carrying out its task under Article 9 (1) (c) of the Regulation on enhanced role in the development of information systems;

(e) may, pursuant to Article 9 (4) of the Regulation on enhanced role from distributors and other relevant persons, request further information on any logistical problems faced by the supply chain;

(f) ensure fulfilment of the obligations of the Czech Republic under Article 11 of the Regulation on enhanced role;

(g) take account of recommendations in the exercise of its powers Management groups adopted pursuant to Article 8 (3) or (4) of the enhanced role Regulation or guidelines and recommendations adopted by the European Commission pursuant to Article 12 (c) of the enhanced role Regulation and shall coordinate their activities with the competent authorities of the other Member States; and

(h) inform the Steering Group referred to in Article 11 (4) (b) of the Regulation on the enhanced role and, where appropriate, inform it of the reasons for the different procedure within the meaning of the second subparagraph of Article 11 (4) of the Regulation on the enhanced role. ";

3. In Article 33, at the end of paragraph 3, the dot is replaced by a comma and the following point (j) is added:

"(j) in the case of emergency situations in the field of public health and major events referred to in Article 2 of the Regulation on enhanced role at the request of the Constitution and within the time limit laid down by it to provide information on medicinal products included in the list of critical medicinal products referred to in Article 6 of the Regulation on enhanced role requested by the Institute; the marketing authorisation holder shall apply mutatis mutandis to the provision of this information in accordance with Article 11 (2) of the enhanced role Regulation. ';

4. In Article 53a (5), the sentence "Obligation to remain silent under the first sentence shall continue after the expiry of membership of the Ethics Commission."

5. Paragraph 67 (6) reads:

"(6) The professional requirement for the performance of the function of a qualified person of a transfusion service facility is duly completed

(a) higher education which provides higher education covering at least 4 years of theoretical and practical teaching in pharmacy, general medicine, biochemistry or biology; or

(b) higher education, other than those referred to in (a), and successful completion of the training programme of specialising education in clinical haematology and transfusion services or in haematology and transfusion medicine

and at least 3 years of professional experience, of which 2 years in a blood service facility or bank. ';

6. Paragraph 68 (2) reads as follows:

"(2) The professional condition for the performance of the function of a qualified person of a blood bank shall be duly completed four years

(a) higher education which provides higher education covering at least 4 years of theoretical and practical teaching in farmacie31), general medication31), biochemistry or biology; or

(b) higher education, other than those referred to in (a), and successful completion of the training programme of specialising education in clinical haematology and transfusion services or in haematology and transfusion medicine

and at least 1 year of professional experience in a blood bank or blood service facility. ';

7. In Paragraph 77, at the end of paragraph 1, the dot is replaced by a comma and the following point (t) is added:

"(t) in the case of emergency situations in the field of public health and major events referred to in Article 2 of the Regulation on enhanced role at the request of the Constitution and within the time limit set by it, to provide the information referred to in Article 11 (2) of the Regulation on enhanced role on medicinal products included in the list of critical medicinal products referred to in Article 6 of the Regulation on enhanced role.";

8. in Paragraph 82 (3), the following point (k) is inserted after point (j):

"(k) in the event of emergency situations in the field of public health and major events referred to in Article 2 of the Enhanced Role Regulation, they shall be required to provide the information referred to in Article 11 (2) of the Enhanced Role Regulation on medicinal products included in the list of critically important medicinal products referred to in Article 6 of the Enhanced Role Regulation,"

Citation	Act No. 241 / 2024 Coll., amending Act No. 375 / 2022 Coll., on in vitro medical devices and diagnostic medical devices, and Act No. 378 / 2007 Coll., on medicinal products and on amendments to certain related laws (Law on medicinal products), as amended
Regulation Type	Law
Author	-
Collection	Code of Laws

Date of Promulgation	08.08.2024
Effective from	23.08.2024
Effective until	-
Status	Valid

Act No. 241 / 2024 Coll.

Act amending Act No. 375 / 2022 Coll., on in vitro medical devices and diagnostic medical devices, and Act No. 378 / 2007 Coll., on medicinal products and on amendments to certain related laws (Law on medicinal products), as amended

Contents

ČÁST PRVNÍ

Čl. I

„§ 59

„§ 62a

„§ 64a

§ 64b

Čl. II

ČÁST DRUHÁ

Čl. III

Contents

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Regulation Information

Public Contracts 5

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