Act No. 70 / 2013 Coll.
Act amending Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Law on Medicines), as amended
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Law
Effective from 02.04.2013
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70
THE LAW
of 19 February 2013
amending Act No. 378 / 2007 Coll., on Medicines and Changes to Certain Related Acts (Law on Medicines), as amended
Parliament has decided on this law of the Czech Republic:
Amendment to the Drug Act
Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (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. and Act No. 50 / 2013 Coll., is amended as follows:
1. In footnote 1, the first sentence is replaced by the sentence "Directive 2001 / 83 / EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Directive 2002 / 98 / EC of the European Parliament and of the Council, Commission Directive 2003 / 63 / EC, Directive 2004 / 24 / EC of the European Parliament and of the Council, Directive 2004 / 27 / EC of the European Parliament and of the Council, Regulation (EC) No 1901 / 2006, Regulation (EC) No 2006 / 2004 of the European Parliament and of the Council of 27 / EC, Directive 2008 / 29 / EC of the European Parliament and of the Council, Directive 2009 / 120 / EC, Directive 2010 / 84 / EU of the European Parliament and of the Council and Directive 2011 / 62 / EU of the European Parliament and of the Council. ';
2. At the end of footnote 2, the sentence "Commission Regulation (EC) No 1234 / 2008 of 24 November 2008 on the assessment of variations to marketing authorisations for medicinal products for human and veterinary use shall be added to the separate line. '
3. in Article 2 (2) (n), the word "transfusion" shall be deleted;
4. Paragraph 2 (4) reads as follows:
"(4) In particular, the substance referred to in paragraph 3 shall be:
(a) an active substance which means any substance or mixture of substances intended for use in the manufacture or preparation of a medicinal product which, after being used in that manufacture or preparation, becomes an active ingredient of a medicinal product intended to develop a pharmacological, immunological or metabolic effect for the purpose of restoring, modifying or influencing physiological functions or establishing a medical diagnosis;
(b) an additive which means any constituent of a medicinal product which is not an active substance or packaging material. ';
5. In Article 3 (2), the words "European Union Regulation (5) 'are replaced by the words" European Union Regulation laying down procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin (5)'.
footnote 5:
"(5) Regulation (EC) No 470 / 2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377 / 90 and amending Directive 2001 / 82 / EC of the European Parliament and of the Council and Regulation (EC) No 726 / 2004 of the European Parliament and of the Council (Text with EEA relevance)."
6. In Paragraph 3 (4) of the Introductory Part of the provision, the first sentence is replaced by the sentence "For the purposes of this Act, the non-desirable effect of a medicinal product is the response to a medicinal product which is unfavourable and unintended. For the purposes of this Act, the undesired effect of a veterinary medicinal product shall be the adverse and unintended response to its administration, which occurs after a dose commonly used for prophylaxis, treatment or diagnosis of disease, or for the renewal, modification or other influence of physiological functions; in the case of a clinical trial of a veterinary medicinal product, this is an adverse and unintended response to any dose. ';
7. In Article 3 (7), the words "for a veterinary medicinal product" shall be inserted after the word "safety."
8. In Article 3, paragraphs 11 and 12 are deleted.
9. The following Section 3a is inserted after Section 3:
(1) For the purposes of this Act, a safety pooling study for a medicinal product for human use means any study concerning a authorised medicinal product for human use carried out to identify, describe or quantify the safety risk, confirm the safety profile of the medicinal product or establish the effectiveness of the risk management measures.
(2) A non-interventional post-authorisation study for a medicinal product for human use for the purposes of this Act means any study in which the authorised medicinal product is used in a normal manner and in accordance with the terms of its marketing authorisation and where the use of the medicinal product is not determined by the inclusion of the patient in such a study but by the decision of the treating physician, and no additional diagnostic or monitoring procedures are used in patients and epidemiological methods are used to analyse the data collected; non-interventional post-registration studies shall include in particular epidemiological, pharmacological and research studies.
(3) Pharmacovigilance system means, for the purposes of this Act, a system of monitoring and reporting used by the marketing authorisation holder and by the authorities in the field of pharmaceuticals to perform the tasks and to ensure the duties referred to in Title Five of this Act in the pharmacovigilance section and to monitor the safety of authorised medicinal products and to identify any changes in their risk-benefit ratio.
(4) For the purposes of this Act, the basic pharmacovigilance system document shall mean a detailed description of the pharmacovigilance system used by the marketing authorisation holder for one or more authorised medicinal products.
(5) For the purposes of this Act, a risk management system shall mean a set of pharmacovigilance activities and interventions intended to identify, describe, prevent or reduce the risks associated with the medicinal product, including an assessment of the effectiveness of those activities and interventions.
(6) For the purposes of this Act, a risk management plan means a detailed description of the risk management system.
(7) For the purposes of this Act, a serious adverse reaction is an unintended response of a donor or a patient related to blood collection or its component or transfusion of a transfusion product resulting in death, life-threatening, permanent or significant harm to health or limitation of the patient's ability, or requires hospitalisation or extension of ongoing hospitalisation.
(8) For the purposes of this Act, a serious undesirable event shall mean an adverse event related to blood collection or its components, testing, processing, storage and distribution of a released transfusion product or raw material for further production or disposal of a transfusion product which could result in death, life-threatening, permanent or significant harm to the health or limitation of the patient's ability.
(9) For the purposes of this Act, reference substances shall mean substances with a defined purity which have a valid certificate indicating the quality and shelf life.
(10) The placing on the market of a medicinal product in the Czech Republic for the purposes of this Act shall mean the transmission of a medicinal product after the completion of production, delivery from another Member State or of imports which are made for the purpose of distributing the medicinal product, except for its use in a clinical trial. '
10. in the first sentence of Article 5 (5) and in Article 6 (1) (b), the words "medicinal products" shall be replaced by the words "medicines."
11. in Article 5, paragraphs 13 to 15 are added:
"(13) For the purposes of this Act, through the provision of medicinal products for human use, all activities linked to the purchase or sale of medicinal products for human use which do not involve the physical treatment or distribution of products and which are the subject of independent negotiations on the purchase or sale of medicinal products on behalf of another person.
(14) For the purposes of this Act, falsified medicinal product means any medicinal product for human use,
(a) which contains false particulars of its identity, including packaging and labelling, name or composition in respect of any of its constituents, including the ingredients and the strength of those constituents;
(b) which contains false indications of its origin, including the manufacturer, the country of manufacture, the country of origin or the marketing authorisation holder; or
(c) which is accompanied by documentation containing false historical data, including records and documents relating to the distribution channels used.
(15) A medicinal product with unintended quality defects shall not be considered as a falsified medicinal product in accordance with paragraph 14. ';
12. in Article 6 (1) (a), the words "the manufacturer of active substances and the manufacturer of excipients" shall be replaced by the words "and the manufacturer of active substances."
13. in Article 6 (2), the words "or, where appropriate, the production of excipients pursuant to Article 70," shall be deleted;
14. in Paragraph 8 (3) of the introductory part of the provision, 'if' is replaced by 'only in a situation where at the same time';
15. in Article 8 (3) (b):
"(b) is a medicinal product which is:
1. already registered in another State; or
2. a modern therapy product, the manufacturer of which holds an authorisation to manufacture a given pharmaceutical form to the extent appropriate to the authorisation to manufacture investigational medicinal products issued by the State Institute for Drug Control, '.
16. In the sixth sentence of paragraph 8 (5), the words "or use 'shall be inserted after the word" prescribing' and at the end of paragraph 5, the sentence "Medicinal product as referred to in paragraph 3 (b) (2) must be labelled in at least the manner laid down in paragraph 57 (2). ';
17. in Article 8, the following paragraph 8 is added:
"(8) Treatment of medicinal products other than in accordance with this Act shall be prohibited. '
18. in Paragraph 9 (2) (a), the words "State Veterinary Administration" are replaced by the words "Central Veterinary Administration of the State Veterinary Administration (" Central Veterinary Administration ")."
19. In Paragraph 9 (14), the words "Regional Veterinary Administration or Municipal Veterinary Administration in Prague" are replaced by the words "Regional Veterinary Administration of the State Veterinary Administration or Municipal Veterinary Administration in Prague State Veterinary Administration."
20. in Article 10 (1), point (e) is deleted;
Points (f) to (j) shall be renumbered (e) to (i).
21. In § 10 (2) (b), § 15, § 15 of the introductory part of the provision, § 16 (1) of the first sentence, § 46 (1) of the introductory part of the provision, § 46 (1) (a) (2), § 46 (2), (3) and (6), § 47 (1) and in § 79 (8), the word "State" is replaced by "Central."
22. in Article 11 (e), "plasma for the production of blood derivatives" is replaced by "raw materials for further production."
23. in Article 11 (p), the words "or raw material for further production" shall be inserted after the words "transfusion preparations."
24. In Article 11, at the end of point (p), the comma is replaced by a dot and point (q) is deleted.
25. In the headings of Sections 12, 12 and 109 (4) (e), the comma shall be replaced by "a" and the words "and the Ministry of Finance" shall be deleted.
26. in Paragraph 13 (2) (g) read:
"(g) checks compliance with this law with operators, other persons handling medicinal products, marketing authorisation holders, brokers of medicinal products for human use (the intermediary), manufacturers and importers of excipients."
27. In Paragraph 13, at the end of paragraph 2, the dot is replaced by a comma and the following points (j) to (m) are added:
"(j) is the authority responsible for carrying out the tasks of the Czech Republic in the field of pharmacovigilance and provides pharmacovigilance information to the Commission and the Agency,
(k) assess the degree of danger to public health in the event of an adverse effect or defect in the quality of the medicinal product, active substance or excipients; publish this evaluation in a way that allows remote access;
(l) allows for an exemption allowing the use of an unregistered advanced therapy medicinal product in a hospital providing hospital care facility (hereinafter referred to as the "hospital exemption") and decides to terminate the authorisation of the hospital exemption,
(m) administer a restricted register of medicinal products. "
28. In Article 13, at the end of paragraph 3, the dot is replaced by a comma and the following points (o) and (p) are added:
"(o) keeps a register of intermediaries which is a public administration information system;
(p) carry out or promote information campaigns to the public aimed, inter alia, at the hazards of falsified medicinal products and the risks associated with medicinal products supplied by illegal mail delivery using electronic means ("mail delivery using electronic means"), in particular in cooperation with the Commission, the Agency and the competent authorities of the Member States. "
29. in Articles 18, 31 (7) and 55 (2), the words "the source of ionising radiation13)" shall be deleted;
30. In Article 23, at the end of paragraph 1, the dot is replaced by a comma and the following point (e) is added:
"(e) to take all measures necessary to withdraw the medicinal product from the market, where the marketing authorisation holder takes measures to the extent and in a manner communicated by the marketing authorisation holder to the operator in the event of an adverse effect or defect in the quality of the medicinal product, active substance or excipients; when adopting and implementing such measures, the provisions of the Product Safety Act shall be without prejudice to the provisions of the Product Safety Act, but the operator, when going on a medicinal product for human use, shall act in accordance with the hazard assessment provided for in Section 13 (2) (k), if such an assessment has been carried out and published by the Institute. ';
31. in Article 23 (2) of the introductory part of the provision, the words "on the market and" shall be inserted after the words "may not be indicated."
32. in Article 23 (4), the words "for medicinal products for human use or veterinary medicinal products" shall be added at the end of the text in point (a); In the case of medicinal products for human use, the certificate of professional competence of the seller of reserved medicinal products for pharmaceuticals and pharmaceutical assistants29), if applicable for veterinary medicinal products, may replace the certificate of professional competence of the seller of reserved medicinal products with a proof of termination of the study in an accredited medical master's programme of veterinary hygiene and ecology '.
33. In Article 23 (4) (f), the words "and documents relating to the purchase, storage and sale of reserved medicinal products for at least 5 years" shall be deleted.
34. In Paragraph 23, at the end of paragraph 4, the dot is replaced by a comma and the following point (g) is added:
"(g) keep a complete and conclusive record of the storage, purchase and sale of reserved medicinal products by item, allowing the identification of the pharmaceutical form, the quantity of the active substance contained in the unit of mass, volume or pharmaceutical form, the type of packaging and the package size of the medicinal product, including the code of the medicinal product, and keep it together with evidence of the purchase, storage and sale of the reserved medicinal products for 5 years."
35. in the first sentence of Article 24 (4), "plasma for the production of blood derivatives" is replaced by "raw material for further production."
36. in Article 24 (5) (a), "plasma for the production of blood derivatives" is replaced by "raw materials for further production."
37. in § 24 (5) (d), the words "haemotherapy," or "haemotherapy," shall be replaced by "haemotherapy."
38. in § 24 (5) (e), including footnote 37a:
"(e) such imports from a third country or exports to a third country or such distribution of transfusion products or raw materials for further production should be made from withdrawals other than voluntary free blood donors, with the exception of the authorisation to export plasma containing anti-D antibodies; a donor who has been paid in accordance with the provisions on blood treatment or its components of the Law on Specific Health Services (37a) is considered to be a free blood donor; or
37a) § 32 (2) of Act No. 373 / 2011 Coll., on Specific Health Services. '
39. In Article 24, the following point (f) is added at the end of paragraph 5:
"(f) its release could endanger the life or health of persons in the Czech Republic."
40. In Paragraph 24, the following paragraph 7 is inserted after paragraph 6:
"(7) The Ministry of Health may withdraw the consent referred to in paragraph 4 if the operator to whom the consent was granted did not comply with the consent granted to it for the previous period. ';
Paragraphs 7 to 9 shall be renumbered paragraphs 8 to 10.
41. In Article 24 (8), the first sentence is replaced by the following: "The operator to whom consent has been granted pursuant to paragraph 4 shall inform the Ministry of Health of imports from third countries or exports to third countries or distribution within the European Union within 10 days of the expiry of the consent granted."
42. Paragraph 24a, including the title and footnote 88, reads as follows:
Driving in case of doubt whether it is a medicinal product or another product
(1) The application for a decision pursuant to Article 13 (2) (h) or Article 16 (2) (f) in addition to the general terms of the application contains:
(a) indication of the product name, form and package size;
(b) the qualitative and quantitative composition of the product; in the case of plants, the names shall be given preferably in Latin, indicating both the native and species names, the part of the plant used and the form in which the plant is contained in the product; in the case of an extract, the ratio of the extract to the crude drug shall be given; for chemicals, a common name shall be given;
(c) the purpose of using the product;
(d) the mechanism of action of the product;
(e) indication of the homeopathic production process, if the product is homeopathic,
(f) the text on the packaging and other written information distributed with the product;
(g) data on product classification in other countries;
(h) where the product is marketed in the Czech Republic, the documentation on the basis of which the product in question was marketed.
(2) In order to examine any initiatives which might justify the initiation of a decision procedure pursuant to Article 13 (2) (h) or Article 16 (2) (f), the persons who have the information referred to in paragraph 1 shall, upon request, provide such information to the Institute or the Veterinary Institute within the time limit set by them.
(3) The operative part of the decision referred to in Article 13 (2) (h) or Article 16 (2) (f) also includes the information referred to in paragraph 1 (a), (b), (c) and (f).
(4) If, after assessing all the characteristics of the product, it is not possible to clearly determine whether it is a medicinal product or another product88), the medicinal product is a medicinal product.
88) For example, § 25 of Act No. 258 / 2000 Coll., on the Protection of Public Health and on the Amendment of Certain Related Acts, as amended, § 2 of Act No. 110 / 1997 Coll., on Food and Tobacco Products and on the Amendment and Addition of Certain Related Acts, as amended, § 2 of Act No. 123 / 2000 Coll., as amended. "
43. In Paragraph 25, at the end of paragraph 2, the dot is replaced by a comma and the following point (i) is added:
"(i) advanced therapy medicinal products authorised under the hospital exemption."
44.Paragraph 25 (3) reads as follows:
"(3) The registration referred to in paragraph 1 is also required for radionuclide generators, radionuclides, radionuclide precursors of radiopharmaceuticals and industrially manufactured radiopharmaceuticals."
45. in Article 26 (5), the following point (i) is inserted after point (h):
"(i) a written confirmation that the manufacturer of the medicinal product has verified through audits that the manufacturer of the active substance complies with good manufacturing practice and the instructions referred to in Article 64 (l), if applicable, in relation to the medicinal product for human use; the written confirmation shall include the date of audit and the statement that the audit result confirms that production is carried out in accordance with good manufacturing practice and these instructions; ';
Points (i) to (s) shall be renumbered (j) to (t).
46. in Article 26 (5) (k):
"(k) a summary of the pharmacovigilance system of the registrant
1. proof that the registrant has at his disposal a qualified person responsible for pharmacovigilance,
2. an indication of the Member State in which the qualified person resides and carries out his duties;
3. an indication of the contact details of the qualified person;
4. a declaration signed by the registrant that he has the necessary means to carry out the tasks and ensure pharmacovigilance accountability,
5. an indication of the place where the pharmacovigilance system master file for the medicinal product concerned is kept, '.
47. in Article 26 (5), the following point (l) is inserted after point (k):
"(l) a risk management plan describing the risk management system implemented by the registrant for the medicinal product concerned, together with a summary of that plan; Where a veterinary medicinal product is used, a risk management plan shall be submitted only where the risks associated with the veterinary medicinal product cannot be managed by other measures or conditions established in the field of registration or pharmacovigilance of the veterinary medicinal product. ';
Points (l) to (t) shall be renumbered as points (m) to (u).
48. in § 26 (5) (p):
"(p) a copy:
1. any marketing authorisations for the medicinal product concerned obtained in another Member State or in a third country, a summary of the safety data, including those contained in the periodic safety update reports, if available, and reports of suspected adverse reactions, together with the list of Member States in which the application for marketing authorisation is submitted and assessed,
2. the summary of product characteristics proposed by the registrant or approved by the competent authority of the Member State concerned and the package leaflet proposed by the registrant or approved by the competent authority of the Member State concerned,
3. any decision refusing registration in the European Union or in a third country, stating the reasons for such a decision; ';
49. in Article 26 (5), the comma at the end of point (t) is replaced by a dot and point (u) is deleted;
50. In § 26 (6), first and second sentences, § 27 (1), (7), (8) and (10), § 28 (3), § 30 (3) (a) and § 31 (5) (h), "(i)" is replaced by "(j)."
51. in the third sentence of Article 26 (7), "(n)" shall be replaced by "(p)";
52. The heading above Section 28 "Simplified registration procedure" is deleted and the heading under Section 28 reads: "Simplified registration procedure for homeopathic medicinal products for human use."
53.In the second sentence of Article 28 (3), "(j), (k) and (l)" is replaced by "(k) to (n)."
54. After Paragraph 28, the following Section 28a is inserted:
Procedure for specific human homeopathic products
(1) Specific human homeopathic products are homeopathic products for oral or external use to relieve or treat minor symptoms or minor diseases that do not require the supervision or intervention of a physician.
(2) The application for authorisation of a specific human homeopathic product is accompanied by:
(a) the data and documentation referred to in Articles 26 (5) (a), (c) to (h), (k), (o), (p) and (t) and the results of the pharmaceutical tests referred to in Articles 26 (5) (j) (1) and 26 (6); and
(b) the qualitative and quantitative composition of the preparation, indicating the scientific name of the basic substance or of the basic substances followed by the degree of dilution expressed by the pharmaceutical symbol.
(3) For specific human homeopathic products, the registrant is not required to submit the results of preclinical pharmacological and toxicological tests provided that he is able to demonstrate the safety of essential homeopathic substances with scientific data demonstrating safety based on published scientific literature.
(4) For specific human homeopathic products, the registrant may demonstrate homeopathic use and therapeutic indications of the product or of the essential homeopathic substances from which the product is composed by reference to publications recognised in the Member States with traditional homeopathic practice or research results, which are referred to as homeopathic methods of demonstration and are based on the administration of the substance to humans for the purpose of detecting the symptoms caused by the substance. ';
55. in Paragraph 30 (3) (a), "l), (m), (q) and (s)" shall be replaced by "n), (o) and (s)";
56. in Paragraph 30 (7), the last sentence is deleted;
57. In Article 30, the following paragraphs 9 and 10 are added:
"(9) Where a medicinal product already authorised under § 27 complies with the conditions set out in paragraphs 1 and 2, the marketing authorisation holder shall, within 180 days of the date on which these conditions have been met, apply for an amendment to the marketing authorisation in order to comply with the requirements for the marketing authorisation of a traditional medicinal product. If the marketing authorisation holder fails to comply with this obligation, the marketing authorisation of this medicinal product shall expire on the first day of the month following the futile expiry of the period laid down for the application to amend the marketing authorisation.
(10) Where a traditional medicinal product no longer fulfils the conditions set out in paragraphs 1 and 2, the marketing authorisation holder shall, within 180 days of the date on which it ceased to comply, apply for a change to the marketing authorisation in order to comply with the marketing authorisation provided for in paragraphs 26 and 27. If the marketing authorisation holder fails to comply with this obligation, the marketing authorisation of that medicinal product shall expire on the first day of the month following the futile expiry of the period prescribed for the submission of an application for amendment of the marketing authorisation. ';
58. in Paragraph 31 (4), "(n)" is replaced by "(p)";
59. In Article 31 (5) (a), the words "and whether it does not give rise to a misleading or misleading impression when assessing the name of the medicinal product in relation to the target group and the Summary of Product Characteristics" shall be added at the end of the text in point 4.
60.In Paragraph 31 (5) (c):
"(c) may, in the assessment referred to in paragraph 1 or 2, invite the registrant to complete the submitted data and documentation, if any, to submit samples for laboratory control in accordance with (b)."
61.Paragraph 31 (8) reads as follows:
"(8) The Institute or Veterinary Institute shall draw up a report on the evaluation of the medicinal product containing the evaluation of the registration dossier taking into account the results of pharmaceutical, preclinical and clinical trials; Where a medicinal product for human use is concerned, the Institute shall draw up an assessment report, including in the light of the risk management system and the pharmacovigilance system of the medicinal product concerned, and the veterinary medicinal product concerned, as well as the results of the safety and residue tests. The report on the evaluation of a medicinal product shall be updated by the Institute or the Veterinary Institute whenever they are aware of new information relevant to the evaluation of the quality, safety or efficacy of the medicinal product. ';
62. The following Section 31a is inserted after Section 31:
In the Marketing Authorisation, the Institute may require that the registrant within the prescribed period:
(a) take measures to ensure the safe use of the medicinal product as contained in the risk management system;
(b) carry out post-authorisation safety studies;
(c) record and report suspected adverse reactions which are more severe than those referred to in Title Five of this Act;
(d) modify the pharmacovigilance system operated under Paragraph 91 (1);
(e) carry out post-authorisation efficacy studies where doubts regarding certain aspects of the efficacy of the medicinal product cannot be removed before it is placed on the market; or
(f) fulfil other obligations or restrictions if they are necessary to ensure the safe and effective use of the medicinal product. ";
63.In Paragraph 32 (1), the final part of the provision reads:
"When issuing a marketing authorisation, the Institute or the Veterinary Institute shall inform the marketing authorisation holder of the approved summary of product characteristics. If homeopathic products are authorised under § 28 or 29, the Annex to the Marketing Authorisation is not the Summary of Product Characteristics. '
64. in Article 32 (2), "Article 34 (3)" is replaced by "Article 34a."
65.Paragraph 32 (3) reads as follows:
"(3) In exceptional circumstances, the marketing authorisation may impose obligations concerning the safety of the medicinal product, the notification of any incident related to its use by the Institute or the Veterinary Institute and the measures to be taken. A marketing authorisation may be granted only if the registrant demonstrates that, for objective reasons that can be verified, he is unable to provide complete data on the efficacy and safety of the medicinal product under normal conditions of use. Implementation of the obligations imposed shall be assessed annually. The Institute or Veterinary Institute may amend or revoke the marketing authorisation on the basis of the results of such assessment. ';
66. in Article 32 (4) (b), the words "Article 92 (7) or" shall be deleted;
67. The following Sections 32a and 32b are inserted after Section 32, including footnote 91:
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Regulation Information
| Citation | Act No. 70 / 2013 Coll., amending Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Law on Medicines), as amended |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 19.03.2013 |
|---|---|
| Effective from | 02.04.2013 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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