Act No. 44 / 2019 Coll.
Act amending Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Law on Medicines), as amended, and Act No. 372 / 2011 Coll., on Health Services and Conditions for Their Provision (Law on Health Services), as amended
Valid
Law
Effective from 02.03.2019
44
THE LAW
of 30 January 2019
amending Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Law on Medicines), as amended, and Act No. 372 / 2011 Coll., on Health Services and the Conditions for Their Provision (Law on Health Services), as amended
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. 251 / 2017 Coll., Act No. 36 / 2016 Coll., Act No. 65 / 2017 Coll., Act No. 66 / 2017 Coll., Act No. 183 / 2017 Coll.
1. At the end of footnote 2, the sentence "Commission Delegated Regulation (EU) 2016 / 161 of 2 October 2015 supplementing Directive 2001 / 83 / EC of the European Parliament and of the Council by laying down detailed rules for the protection features on the packaging of medicinal products for human use 'is added to the separate line.
2. Paragraph 5 (7) reads as follows:
"(7) The sale of reserved medicinal products for human use means the purchase, storage or sale of such medicinal products. The sale of reserved veterinary medicinal products means the purchase, storage or sale to the final consumer. ';
3. In Article 6, at the end of paragraph 2, the sentence "In the case of medicinal products for human and veterinary use, the rules of good manufacturing practice shall apply mutatis mutandis to imports from third countries."
4. In Section 8, the following paragraph 9 is added:
"(9) In a situation where it is not possible to verify the safety features of the medicinal product to the extent that, in accordance with Article 10 of the directly applicable European Union Regulation, it is not possible to carry out a verification of the safety features on the packaging of medicinal products for human use (hereinafter referred to as" the Regulation on protective elements'), as this medicinal product does not comply with the requirements of this Regulation, the Ministry of Health may exceptionally authorise, at the request of the marketing authorisation holder, the distribution and supply of that medicinal product. In such a case, marketing authorisation holders, manufacturers of medicinal products, distributors and persons authorised to supply them shall comply with the obligations arising from the Regulation on protective elements mutatis mutandis. Liability for defects in medicinal products under special legislation12) is not affected. The Ministry of Health shall inform the State Institute for Drug Control of the measure. The Ministry of Health will post the measure on its official record and publish it in a way that allows remote access.
(106) Commission Delegated Regulation (EU) 2016 / 161 of 2 October 2015 supplementing Directive 2001 / 83 / EC of the European Parliament and of the Council by laying down detailed rules for the protection features on the packaging of medicinal products for human use. ';
5. In Article 11, at the end of point (q), the dot is replaced by a comma and the following point (r) is added:
"(r) in order to ensure the availability of medicinal products, it shall issue a temporary measure pursuant to Article 8 (9) authorising the distribution and supply of medicinal products which, on completion of manufacture, do not comply with the requirements of the Regulation on protective elements.";
6. In Article 13 (2), the words "and directly applicable European Union provisions governing the field of medicinal products for human use 'shall be added at the end of the text in point (g).
7. In Article 13, at the end of paragraph 2, the dot is replaced by a comma and the following point (o) is added:
"(o) is the competent authority of the Czech Republic for the performance of its tasks in the field of compliance with the rules on the protection elements on the packaging of medicinal products, carries out checks on compliance with the obligations laid down in the Regulation on protective elements, has access to the system of storage sites and the information contained therein in accordance with Article 39 of the Regulation on protective elements, and exercises control over the functioning of the system, monitor and evaluate the risks of falsification of medicinal products and the risks arising from their falsification and provide information to the Commission in this area."
8. In Article 13, at the end of paragraph 2, the dot is replaced by a comma and the following points (p) and (q) are added:
"(p) is the competent authority of the Czech Republic for the performance of the tasks established by the directly applicable European Union Regulation laying down the principles and guidelines for good manufacturing practice for investigational medicinal products107) (hereinafter referred to as the" Regulation on good manufacturing practice for investigational medicinal products ") and the directly applicable European Union Regulation laying down rules for the implementation of inspection procedures of good clinical practice (hereinafter referred to as the" Regulation on the implementation of good clinical practice inspection procedures "),
(q) is the competent authority of the Czech Republic for issuing authorisations for the manufacture and import of investigational medicinal products under the clinical trial regulation.
(107) Commission Delegated Regulation (EU) 2017 / 1569 of 23 May 2017 supplementing Regulation (EU) No 536 / 2014 of the European Parliament and of the Council by laying down principles and guidelines for good manufacturing practice for investigational medicinal products for human use and rules for conducting inspections.
108) Commission Implementing Regulation (EU) 2017 / 556 of 24 March 2017 on detailed rules for the implementation of good clinical practice inspection procedures under Regulation (EU) No 536 / 2014 of the European Parliament and of the Council. ';
9. in Article 13 (3) (l):
"(l) establish and maintain a quality system which ensures:
1. keeping records of qualifications and training of a staff member of the Institute who carries out an evaluation and inspection and takes decisions under this law or directly applicable European Union regulations, including a description of his duties, responsibilities and training requirements;
2. compliance with the conditions of good clinical practice inspection procedures in accordance with the Regulation on the implementation of good clinical practice inspection procedures;
3. the proper conduct of checks on compliance with this law and the relevant European Union rules on manufacturers of medicinal products for human use, including investigational medicinal products, ';
10. In Article 13 (3), the words "carrying out training activities in the fields relating to pharmaceuticals in particular by means of expert lectures and 'shall be inserted at the beginning of the text of point (p).
11. in Article 16 (3) (j), "quality" is replaced by "quality."
12. in Article 22 (2), the words "veterinary medicinal products" shall be inserted after the words "evaluation."
13. In Article 23, at the end of paragraph 1, the dot is replaced by a comma and the following points (f) to (h) are added:
"(f) without delay notify the Institute, if it is a medicinal product for human use, of the suspected falsified medicinal product, unless that obligation of the Constitution does not result from the regulation on protective features,
(g) provide the Institute with synergies in the verification of facts related to suspected falsification of the medicinal product;
(h) immediately notify the Veterinary Institute of suspected falsified veterinary medicinal product. ";
14. In Article 24 (10), the words "as declarant 'are deleted.
15. In Article 34, the following paragraph 9 is added:
"(9) The Institute or the Veterinary Institute shall immediately initiate an ex officio procedure to amend the marketing authorisation of a medicinal product included in the reserved medicinal product in the event of new developments concerning the safety of the reserved medicinal product. ';
16. In Article 37 (1), the words "not for a unique identifier 'shall be inserted after the words" not for a unique identifier'; the words "European code of goods (EAN) 'shall be replaced by the words" internationally recognised standard of identification'; the words "and meeting the requirements of the standard coding system 'shall be inserted after the words" the code assigned to the packaging of medicinal products for human use in accordance with Article 32 (5)';
17. In the first sentence of Article 37 (7), the words "under the Regulation on protective elements' shall be inserted after the words" under the Regulation on protective elements'; at the end of the text of the sentence the words "(hereinafter referred to as" the safeguard elements') shall be added and the last sentence shall be replaced by "The form and technical processing of the protective elements shall be as laid down in the Regulation on protective elements'.
18. in Paragraph 37 (8):
"(8) The protective features referred to in paragraph 7 shall be accompanied by medicinal products for human use, issued only on medical prescription or restricted prescription, which are not included in the list of medicinal products which may not be accompanied by protective features set out in Annex I to the Regulation on protective elements. The protective features referred to in paragraph 7 shall not include medicinal products for human use which may be issued without a prescription and which are not included in the list of medicinal products which must be accompanied by the protective features set out in Annex II to the Regulation on protective elements. A technical solution ensuring the integrity of the medicinal product by which the holder of the marketing authorisation shall affix an outer packaging of a medicinal product which is not subject to a prescription and is not listed in Annex II to the Regulation on protective elements shall not be considered as a protective element under the Regulation on protective elements. ';
19. In Paragraph 45, at the end of paragraph 7, the dot is replaced by a comma and the following point (f) is added:
"(f) when repackaging a medicinal product for human use, discard the existing unique identifier and include the new unique identifier in accordance with the procedure laid down in the Regulation on protective elements.";
20. in Paragraph 64 (d):
"(d) establish and maintain a quality control system and ensure the conditions for the operation of the quality control unit in such a way that that department, which is under the authority of the person referred to in point (e), is independent from other organisational services of the manufacturer of medicinal products, ';
21. In Article 64 (f), the words "at any time and" and the Agency "shall be inserted after the word" recall "and the words" and the Agency "shall be replaced by the words" the Agency and the marketing authorisation holder, and, where possible, the State for which the medicinal product was intended; in the case of the manufacture of investigational medicinal products for human use, the rules laid down in the Regulation on good manufacturing practice for investigational medicinal products';
22. In Article 64 (j), the words "carry out an activity in accordance with a production permit, comply with the rules of good manufacturing practice 'are replaced by the words" carry out production activities in accordance with the rules of good manufacturing practice, with a production permit'.
23. in Paragraph 77 (1) (b) (4), "13" is replaced by "12."
24. in Paragraph 77 (1) (c), point 5 is deleted;
Points 6 to 14 shall become points 5 to 13.
25. in Paragraph 77 (1) (c) (11):
"11. blood banks, if they are transfusions, transfusions, transfusions, blood derivatives, provided that such distribution of transfusions is provided by the transfusions provided for in Article 67 (3), ';
26. In Paragraph 77, at the end of paragraph 1, the dot is replaced by a comma and the following point (r) is added:
"(r) verify the safety features and carry out the disposal of the unique identifier in accordance with the procedure laid down in the Regulation on protective elements before the medicinal product delivers:
1. to veterinary surgeons,
2. The Army of the Czech Republic to secure the armed forces of the Czech Republic of medicines and to maintain the stockpiles of medicinal products for the purpose of securing the armed forces of the Czech Republic of medicines when they are broadcast abroad pursuant to § 111a, or
3. health service providers to whom immunological medicinal products for vaccination are supplied pursuant to Paragraph 77 (1) (c) (12). ';
27. in Paragraph 80 (4), "Veterinary medicinal products" is replaced by "Medicinal products for animal treatment."
28. in Paragraph 82 (2), point (c) is deleted;
Points (d) to (g) shall be renumbered (c) to (f).
29. In Paragraph 82, at the end of paragraph 3, the dot is replaced by a comma and the following point (i) is added:
"(i) verify the safety features and dispose of the unique identifier in respect of all medicinal products issued with the safety features in accordance with the procedure laid down in the Regulation on protective features.";
30. In Paragraph 89, the following paragraph 4 is added:
"(4) The person carrying out the verification of the protective elements or the disposal of the unique identifier under the Regulation on protective elements may return the medicinal product to the supplier who supplied it if, even after 14 calendar days after the first unsuccessful verification of the protective elements or the disposal of the unique identifier, it is not possible to successfully perform this action. The medicinal product returned to the supplier shall be accompanied by documentation demonstrating the reason for the return of the medicinal product in order to prevent the verification of the safety features or the disposal of the unique identifier. The supplier of such medicinal product shall take it back. ';
31. in Paragraph 99, paragraphs 7 and 8 are added:
"(7) The Institute shall, on request, provide the repository operator set up under Article 31 of the Safeguards Regulation (" the repository ') with information that results from the exercise of its competence and is necessary for the functioning of the repository.
(8) The Institute provides information from the repository it obtains or has access to pursuant to Paragraph 13 (2) (o) only to other persons, provided that other legislation so provides, with the exception of the Freedom of Information Act. "
32. In Section 100 (8) of the Introductory Part of the Provisions, the words "or Veterinary Institute as appropriate 'shall be inserted after the word" Institute'.
33. In Paragraph 100a, the word "counterfeit 'is replaced by" falsified medicinal product'.
34. in Paragraph 103 (6), the word "or" shall be deleted at the end of point (f).
35. In Article 103, at the end of paragraph 6, the dot is replaced by a comma and the following points (h) to (k) are added:
"(h) infringes the obligation to comply with the instructions of the Commission or the Agency in accordance with Article 23 (1) (a);
(i) without delay notify the Institute of suspected falsified medicinal product pursuant to Article 23 (1) (f) or (h);
(j) in contravention of or in breach of the Regulation on protective elements
1. they shall not verify the authenticity of the unique identifier or the integrity of the device to verify the handling of the packaging, if not of the health service provider authorised to supply medicinal products,
2. Distributes or issues a medicinal product with a unique identifier which has been discarded, without the cases provided for in Article 12 of the Safeguard Regulation, where it is entitled to do so,
3. changes the status of the discarded unique identifier to an active identifier without fulfilling the conditions laid down in Article 13 (1) of the Safeguard Regulation; or
4. return to storage a medicinal product with a unique identifier for which no active status can be returned for non-compliance with the conditions laid down in Article 13 (2) of the Regulation on protective elements;
(k) does not provide the Institute with synergies in the verification of facts related to suspected falsification of a medicinal product pursuant to Article 23 (1) (g); or
(l) in contravention of Paragraph 89 (4), it shall not take over a returned medicinal product which has failed to verify the safety features or to discard a unique identifier. ';
36. In Paragraph 103, paragraphs 15 to 21 are added:
"(15) A manufacturer of medicinal products commits an offence by acting in violation of a regulation on protective features or by this law
(a) they do not place a unique identifier on the packaging of the medicinal product or place it on the packaging of the medicinal product without complying with the specified technical specifications;
b) does not encode a unique identifier into a two-dimensional barcode;
(c) determine the printing quality which does not guarantee the accuracy of the data matrix throughout the supply chain for at least 1 year from the expiry date of the package, or for 5 years from the time when the package was released for sale or distribution;
(d) does not print on the packaging of the medicinal product in a format legible to the naked eye the specified data elements of the unique identifier;
(e) they shall not verify, before the release of the medicinal product, that the two-dimensional barcode bearing the unique identifier is legible to the naked eye in accordance with the requirements laid down and contains the correct information,
(f) does not record, if the manufacturer places the protective features, any action which he makes with a unique identifier on the packaging of the medicinal product or on that identifier;
(g) they shall not verify the integrity of the packaging or the authenticity of the unique identifier before the partial or complete removal or overlay of the protective features, or if it is replaced, or remove or overlap, in whole or in part, the protective features contrary to § 64a;
(h) do not verify the safety features or assign a unique identifier on the packaging of the medicinal product before it is repackaged or relabelled in order to be able to use it as a registered investigational medicinal product or as a registered auxiliary medicinal product, if it is a manufacturer authorised to produce pursuant to Article 62 (1) or an authorisation to manufacture and import investigational medicinal products into the European Union as provided for in Article 61 of the clinical trial Regulation;
(i) when placing an equivalent unique identifier for the purpose of complying with the requirements set out in Section 64a, they shall not verify that, in respect of the product code and the national reimbursement number or other national number identifying the medicinal product, the structure and composition of the unique identifier placed on the packaging complies with the requirements of the Member State in which the medicinal product is to be placed on the market in order to enable the unique identifier to be authenticated and discarded;
(j) it shall place the medicinal product on the market or shall not immediately notify the Institute if it has reason to believe that the packaging of the medicinal product has been tampered with or if verification of the safety features indicates that the product may not be genuine; or
(k) shall indicate on the packaging of the medicinal product, which shall bear a two-dimensional barcode bearing a unique identifier, an additional visible two-dimensional barcode.
(16) The distributor commits an offence by:
(a) in contravention of the Regulation on protective elements or of that Act
1. does not verify the authenticity of the unique identifier for medicinal products in its physical possession and not received from persons designated in Article 20 of the Regulation on protective elements;
2. does not verify the authenticity or non-elimination of the unique identifier for medicinal products provided for in Article 22 of the Regulation on protective elements; or
3. deliver or export the medicinal product or immediately notify the Institute if it has reason to believe that the packaging of the medicinal product has been tampered with, or if verification of the safety features of the medicinal product indicates that the product may not be genuine,
(b) infringes the obligation to verify the security features or to discard the unique identifier referred to in Article 77 (1) (r); or
(c) after verifying the protective elements referred to in Article 37 (7) and carrying out the disposal of the unique identifier, the medicinal product shall be supplied to a person other than those referred to in Article 77 (1) (r).
(17) A health service provider authorised to supply medicinal products shall commit an offence by:
(a) in contravention of the Regulation on protective elements or of that Act
1. does not verify the safety features or carry out the disposal of a unique identifier of a medicinal product bearing the safety features it issues, at the time of issue, or at the time of first opening of the package at the time of issue, or does not do so retrospectively in the case of situations referred to in Article 29 of the Regulation on protective elements;
2. they shall not verify the safety features or carry out the disposal of a unique identifier of medicinal products bearing the safety features provided for in Article 25 (4) of the Regulation on protective features;
3. issue the medicinal product or immediately notify the Institute if it has reason to believe that the packaging of the medicinal product has been tampered with, or if verification of the safety features of the medicinal product indicates that the product may not be genuine, or
4. Issue a medicinal product with a unique identifier which has been discarded, without prejudice to the cases provided for in Article 12 of the Protection Elements Regulation, where it is entitled to do so; or
(b) infringes the obligation under Article 82 (3) (i) to verify the safety features or to discard a unique identifier when the medicinal product is fitted with protective features.
(18) The marketing authorisation holder or, in the case of medicinal products imported or distributed simultaneously with an equivalent unique identifier for the purpose of meeting the requirements laid down in § 64a, the person responsible for placing such medicinal products on the market shall commit an offence by contravening the Regulation on protective features or by this law.
(a) shall not ensure that the information provided for in the Regulation on protective elements is uploaded to the storage system before the medicinal product is released for sale or distribution by the manufacturer, or that such information is subsequently updated;
(b) without delay take the measures provided for in Article 40 of the Safeguard Regulation; or
(c) upload unique identifiers to the storage system before removing, if present, older unique identifiers containing the same product code and serial number as the unique identifiers to be uploaded.
(19) A person setting up or managing a repository which is part of a repository system shall commit an offence in breach of or in violation of a regulation on protective features or this law.
(a) it does not keep the specified information in the repository it manages and to which it was originally loaded for a period of 1 year from the expiry date of the medicinal product concerned or for a period of 5 years from the time the product was released for sale or distribution;
(b) shall not carry out the operations provided for in Article 37 of the Regulation on protective elements;
(c) as a person setting up and managing a repository used to verify the authenticity or disposal of unique identifiers of medicinal products placed on the market in the Czech Republic, the Institute shall not provide access to the repository and the information contained therein for the purpose of carrying out tasks under the Safeguard Regulation;
(d) fails to meet the conditions for the functioning of the storage system laid down in accordance with Article 35 (1) and (2) of the Safeguard Regulation;
(e) ensure that the conditions laid down in Article 32 (3) or (4) of the Regulation on protective elements are not fulfilled;
(f) does not ensure the connection of its established and managed repository to the central repository; or
(g) allow the recording or retention of a unique identifier containing the same code of the medicinal product and a serial number as any other unique identifier already stored in the repository.
(20) The person responsible for placing the medicinal product on the market shall commit an offence by not informing the central repository of the batch or package number of each batch of repackaged or remarked packages of medicinal products on which equivalent unique identifiers have been placed in contravention of the Regulation on protective features or by this law.
(21) The marketing authorisation holder who supplies a medicinal product that is equipped with protective features as a free sample in accordance with the law regulating advertisement51) shall commit an offence by not designating it as a free sample in the storage system in contravention of or by the regulation on protective features or by not ensuring the disposal of its unique identifier before it is granted to persons authorised to prescribe medicinal products for human use. ';
37. in Paragraph 104, the following paragraph 14 is added:
"(14) A manufacturer of investigational medicinal products for human use commits an offence by:
(a) in contravention of the clinical trial Regulation, fails to comply with the principles and guidelines of good manufacturing practice set out in the Regulation on good manufacturing practice for investigational medicinal products; or
(b) in the course of an inspection carried out under the Regulation on good manufacturing practice for investigational medicinal products, it shall not allow the authorisation referred to in Article 20 (2) of the Regulation on good manufacturing practice for investigational medicinal products to be exercised. ";
38. in Paragraph 105 (2) (t), the word 'according' is replaced by 'based';
39. in Paragraph 105 (4) (f):
"(f) infringes the obligation laid down in Article 45 (7) (c) or (f),"
40. In Paragraph 105, the following paragraph 10 is added:
"(10) An operator referred to in Article 6 (1) (e) shall commit an infringement as a controlled entity by not allowing the authorisation referred to in Article 10 (2) to (5) of the Regulation to be exercised in the course of an inspection carried out under the Regulation on the conduct of good clinical practice inspection procedures. ';
41. In Article 106 (1) (a), as effective before the date of entry into force of this Act, the words "contrary to Article 66 (1)" shall not be inserted after the words "contrary to Article 66 (1)" in order to ensure that the packaging of the medicinal product is provided with the protective features referred to in Article 37 (7), or "
42.In Paragraph 106 (1):
"(1) The natural person acting as a qualified person of a medicinal product manufacturer shall commit an offence by not ensuring, in breach of Article 66 (1), that the packaging of a medicinal product is provided with the protective features referred to in Article 37 (7), or that each batch of a medicinal product is manufactured and controlled in accordance with this Act, the registration documents and the marketing authorisation decision, or in breach of Article 66 (3), does not certify this fact in the register or equivalent document set out for that purpose or in contravention of Article 62 of the Clinical Evaluation Regulation, and shall not ensure that each batch of investigational medicinal products manufactured in the European Union or imported into the European Union comply with the requirements set out in Article 63 of the Clinical Evaluation Regulation and shall not certify that those requirements. ';
43.In Article 107 (1) (b), the words "or (l)" shall be inserted after the words "Paragraph 103 (6) (c)."
44. in § 107 (1) (b), the words "§ 103 (12) (d)" are inserted after the words "§ 103 (17) (a) (1) or (2) or (b)," and the words "§ 104 (7) (a)";
45. in Article 107 (1) (c), the words "Article 103 (6) (e)," shall be inserted after the words "Article 103 (6) (j) (3) or (k)," and after the words "Article 103 (14)," shall be inserted the words "Article 103 (15) (c), (e), (f), (h), (i) or (k), Article 103 (16) (c), Article 103 (17) (a) (3), (4), (18) (c), Article 103 (20) or (21,";
46. in § 107 (1) (c), "§ 105 (7), (8) or (9)" is replaced by "§ 105 (7), (8), (9) or (10)."
47. in Article 107 (1) (d), the words "Article 103 (6) (b), (d) or (f)" shall be inserted after the words "Article 103 (6) (j) (1), (2) or (4)," and after the words "Article 103 (10) (h)"; "
48. in § 107 (1) (d), "§ 105 (6) (a), (b) or (l)" is replaced by "§ 105 (6) (b) or (l)."
49. in Article 107 (1) (e), "§ 103 (6) (a) or (g)" is replaced by "§ 103 (6) (a), (g), (h) or (i)" and after "§ 103 (13)" the words "§ 103 (15) (g) or (j), § 103 (16) (a) (3)" are inserted.
50. in Article 107 (1) (e), the words "Article 104 (7) (b) or (c)" are inserted after the words "Article 104 (7) (b) or (c)," and the words "or Article 105 (6) (a)" are deleted;
51. In Article 108 (3), in the version effective before the date of entry into force of this Act, the words "in contravention of Paragraph 66 (1)," shall not ensure that the packaging of the medicinal product is provided with the protective features referred to in Article 37 (7), or ';
52. In Article 108 (3), the words "or contrary to Article 62 of the clinical trial Regulation shall not be inserted after the words" for this purpose "and shall not ensure that each batch of investigational medicinal products manufactured in the European Union or imported into the European Union complies with the requirements laid down in Article 63 of the clinical trial Regulation and shall not certify that those requirements are met '.
53. In Paragraph 114 (1), the text "§ 82 (2) (d) and (e)" is replaced by "§ 82 (2) (c) and (d)."
Amendment to the Health Services Act
In Section 65 of Act No. 372 / 2011 Coll., on health services and the conditions for their provision (Health Services Act), as amended by Act No. 205 / 2015 Coll., the dot is replaced by a comma at the end of paragraph 2 and the following point (o) is added, including footnote 55:
"(o) Inspectors authorised to carry out inspections related to the clinical evaluation of medicinal products for human use in accordance with the directly applicable European Union Regulation laying down detailed rules for the implementation of the inspection procedures of the correct clinical prax55).
55) Commission Implementing Regulation (EU) 2017 / 556 of 24 March 2017 on detailed rules for the implementation of good clinical practice inspection procedures under Regulation (EU) 536 / 2014 of the European Parliament and of the Council. ';
Communication in the Collection of Laws
The Ministry of Health shall notify by means of a communication in the Collection of Laws the date on which the Commission notice was published in the Official Journal of the European Union pursuant to Article 82 (3) of 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.
Efficacy
This Law shall enter into force on 9 February 2019, with the exception of Article I (35) as regards points (1) and (36) of point (a) (1) and (2) and points (b) and (17), (18), (21) and (21) of Article I (3), (8), (9), (11), (12), (20), (21), (22), (37), (40), (42), (44), (46), (48), (50), (52) and (III), which take effect 6 months after the date of publication of the Commission notice in the Official Journal of the European Union pursuant to Article 82 (3) of Regulation (EU) of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human medicinal products and repealing Directive 2001 / 20 / EC.
Vondracek v. r.
Zeman v. r.
v z. Brabec v. r.
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Regulation Information
| Citation | Act No. 44 / 2019 Coll., amending Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Law on Medicines), as amended, and Act No. 372 / 2011 Coll., on Health Services and Conditions for Their Provision (Law on Health Services), as amended |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 15.02.2019 |
|---|---|
| Effective from | 02.03.2019 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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