Act No. 273 / 2013 Coll.
Act amending Act No. 167 / 1998 Coll., on addictive substances and amending some other laws, as amended, and some other laws
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Effective from 01.01.2014
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01.01.2014
10.09.2013
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273
THE LAW
of 22 August 2013
amending Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended, and certain other laws
Parliament has decided on this law of the Czech Republic:
Amendment to the REC
Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended by Act No. 354 / 1999 Coll., Act No. 117 / 2000 Coll., Act No. 132 / 2000 Coll., Act No. 57 / 2001 Coll., Act No. 185 / 2001 Coll., Act No. 407 / 2001 Coll., Act No. 320 / 2002 Coll., Act No. 223 / 2003 Coll., Act No. 141 / 2009 Coll., Act No. 167 / 2004 Coll., Act No. 50 / 2013 Coll., amended as follows:
1.
Subject matter
(1) This Act provides for:
(a) the treatment, export, import and transit operations of addictive substances;
(b) the treatment of products containing an addictive substance, of products containing an addictive substance and of a scheduled substance of category 1 in accordance with the directly applicable European Union drug precursor regulation (1) (hereinafter referred to as "category 1 substance") and medicinal products containing that substance of category 1, their export, import and transit operations; and
(c) the cultivation of poppy, hemp and coca and the export, import and disposal of macaquin.
(2) That law has been notified in accordance with Directive 98 / 34 / EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services, as amended. ';
2. footnote 1 shall read:
"(1) Regulation (EC) No 273 / 2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors, as amended."
3. in § 2 (a), § 3 (2), § 5 (1), (2), (4) and (8), § 10 (4), § 11 (1) and (2), § 20 (2) (b) to (d), § 21 (2) (b), (c) and (e), § 27 (1), § 27a (1) and § 43a (1) (b) (1), the words "this Act" shall be replaced by the words "Government Regulation on the list of addictive substances."
4. Paragraph 2 (b) reads as follows:
"(b) a solution or mixture in any physical state containing an addictive substance or an addictive substance and a scheduled category 1 substance or medicinal product under the drug law containing that category 1 substance,"
5. in Article 2, points (c) and (d), including footnotes 1a and 2, are deleted;
Points (e) to (j) shall be renumbered (c) to (h).
6. In Article 2 (c), the words "L. 'are inserted after the words" Papaver somniferum' and the words "except for whole poppy plants including capsules intended for ornamental purposes' are added at the end of the text of the letter.
7. in Article 2, points (f) and (g), including footnote 2b, are deleted;
Point (h) shall be renumbered as point (f).
8. in Article 2 (f), the words "and preparations containing 'are replaced by the words" preparations containing and macaquin';
9. In Part One of Title II: "PREPARATIONS AND PREPARATIONS '.
10. In the first sentence of Paragraph 3 (2), the words "limited researchers' shall be inserted after the words" used only to '.
Article 11 (3a), including the title, shall be deleted.
12. in Article 5 (1) of the Introductory Part of the provision, the words "or preparations containing ephedrine and pseudoephedrine" shall be replaced by "or medicinal products containing category 1 scheduled substance."
13. In Article 5, at the end of paragraph 1, the dot is replaced by a comma and the following point (c) is added:
"(c) prepare pharmacists or pharmaceutical assistants under the supervision of the pharmacist into pharmaceutical forms."
14. in Paragraph 5 (2) of the introductory part of the provision, the words "and preparations containing ephedrine and pseudoephedrine" shall be replaced by the words "and medicinal products containing category 1 scheduled substance."
15. in Article 5 (2) (a) and Article 32 (2), the words "constitutional social services" shall be replaced by the words "providing social services of residence."
16. in Articles 5 (2) (c) and 10 (4), the words "social welfare" shall be replaced by the words "providing social services."
17. in Article 5 (2) (d), the words "constitutional social welfare" shall be replaced by the words "providing social services or doctors with a contract for the preparation of medicinal products with a health insurance company."
18. in Article 5 (2) (g), the words "and to prepare for pharmaceutical forms" shall be deleted;
19. in Paragraph 5 (4), "and preparations containing ephedrine and pseudoephedrine" shall be replaced by "and medicinal products containing category 1 scheduled substance."
20. Paragraph 5 (5) reads:
"(5) No authorisation shall be required for the acquisition, storage and processing of hemp plants which may contain a maximum of 0,3% of the substances of the tetrahydrocannabinol group, only for industrial, technical and horticultural purposes, as well as for trade in hemp for those purposes. '
21. in the second sentence of Article 5 (7), the words "and the application for amendment of the entries in the list" shall be inserted after the words "that list."
22. in Article 5, the following paragraph 8 is inserted after paragraph 7:
"(8) Any changes to the information contained in the list referred to in paragraph 7 shall be notified in writing to the Ministry of Health without delay. ';
Paragraph 8 shall become paragraph 9.
23. in Article 5, the following paragraph 10 is added:
"(10) Narcotic substances listed in Annex 3 or 4 to the Government Ordinance on the list of addictive substances and preparations containing them may be disposed of, if not stored, by persons on the basis of consent granted by the Regional Authority.) The Ministry of Health shall inform the Regional Authority which granted the consent of the granting of the consent. This information shall be provided on a form issued by the Ministry of Health. ';
24. in Paragraph 8 (1), "7" is replaced by "6."
25. in the first sentence of Article 8 (2), "preparations or precursors" shall be replaced by "or preparations" and the second sentence shall be deleted;
26. in Paragraph 8 (3):
"(3) Authorisations for the treatment of addictive substances and preparations shall be issued for a maximum period of 5 years."
27. in Article 8, paragraph 5 is deleted;
Paragraphs 6 to 12 shall become paragraphs 5 to 11.
28. In Article 8 (6), the second and third sentences are replaced by the following: "The application shall be accompanied by:
(a) the original, a copy or an officially certified copy of the decision proving the authorisation for the treatment of medicinal products under the Medicines Act or the certificate of compliance with the conditions for carrying out veterinary medical and preventive activities under the Veterinary Chamber Act;
(b) proof of integrity where the procedure laid down in Article 8a (4) is not possible;
(c) proof of the business permit;
(d) a document containing the consent of the property owner to the activities specified in the application;
(e) a contract on professional veterinary activities, where that activity is carried out;
(f) proof of the provision of the person responsible in accordance with paragraph 5;
(g) the medical certificate referred to in Article 18;
(h) the proof of competence referred to in Article 19 (1);
(i) a statement by the applicant that, in the case of activities involving direct contact with addictive substances and preparations, the appropriate means of securing them shall be chosen in accordance with Sections 10 and 11;
(j) a description of the technology of the intended manufacture as regards the application for authorisation for the manufacture of addictive substances and preparations. "
29. in Articles 8 (7) and 8 (11), 9 (1), 10 (1) to (3), 14 (1) and 15 (c), the words "preparations and precursors" are replaced by the words "and preparations."
30. In Article 8, the following paragraph 9 is inserted after paragraph 8:
"(9) In the event of a change in the information contained in the application for a treatment permit concerning the change
(a) in already authorised activities or their extension;
(b) the name, registered office, legal form and identification number of the person, if it is a legal person; or
(c) residence and place of business, if different from residence, if it is a natural person;
the person intending to make these changes must submit a new application to the Ministry of Health for a treatment permit. ';
Paragraphs 9 to 11 shall be renumbered paragraphs 10 to 12.
31. in Article 8 (10), the words' and, for reasons laid down in an immediately binding regulation of the European Communities, 5c) 'shall be deleted;
footnote 5c is deleted.
32. in Paragraph 8, the following paragraph 13 is added:
"(13) A person who has been granted a new treatment permit shall be required to return an invalid treatment permit to the Ministry of Health within 14 days of the date on which the new treatment permit is acquired. This obligation shall also apply to persons who end up with a treatment permit pursuant to paragraph 7 and who no longer intend to handle addictive substances and preparations; the period for the repayment of the invalid treatment permit shall be 14 days from the date of expiry of the treatment permit. ';
33. The following Section 8a is inserted after Section 8:
integrity
(1) A right of treatment may be granted only to an upstanding natural person who is resident in the Czech Republic or to an upstanding legal person established in the Czech Republic. The condition of permanent residence or registered office in the Czech Republic shall not apply if it is a person who has a permanent residence or residence permit, place of business, registered office, central administration, principal place of business or organisational component in the territory of another Member State of the European Union, the Contracting State of the Agreement on the European Economic Area or the Swiss Confederation.
(2) For the purposes of this Act, the righteous are those who have not been convicted of an intentional or negligent offence committed in connection with the treatment of addictive substances or preparations.
(3) The integrity is demonstrated
(a) an extract from the Register of Penalties, not more than 3 months old
1. in the case of a natural person with a permanent residence or other residence in the Czech Republic,
2. in the case of a natural person who is, or was, a national of another Member State of the European Union or in another Member State of the European Union, has or has been resident;
3. in the case of a legal person established in the Czech Republic,
(b) evidence of a similar statement from the Register of Penalties
1. for a natural person with a place of permanent residence or other residence outside the Czech Republic and for a natural person who has remained continuously outside the Czech Republic for a period of more than 6 months in the last 5 years; a document similar to the extract from the Register of Penalties must be issued for that purpose by the competent authority of the State of permanent or other residence of that person, of the States in which that person has been continuously present for more than 6 months in the last 5 years and of a State which is not the same as the State of permanent residence or other residence of that person, and that person is a citizen of that person;
2. in the case of a legal person established outside the Czech Republic; a document similar to the extract from the Register of Penalties must be issued for that purpose by the competent authority of the State of residence;
(c) an honest declaration of integrity
1. in the case of a natural person, unless the State of residence or other residence of the natural person and the State where the natural person has been present continuously during the last 5 years, the document referred to in point (b); an affidavit of integrity shall be made before a notary or an authorised authority of the State of permanent or other residence of that person and of the States in which that person has remained continuously for more than 6 months in the last 5 years;
2. in the case of a legal person, unless the State of the legal person's registered office issues the document referred to in point (b); a declaration of integrity must be made before a notary or an authorised authority of the State of residence.
(4) In order to demonstrate the integrity of persons referred to in paragraph 3 (a) (1) and (3), the Ministry of Health shall obtain an extract from the Register of Penalties under the special legislation 5f. An application for an extract from the Register of Penalties and an extract from the Register of Penalties shall be sent in electronic form in a way that allows remote access. The Ministry of Health may also obtain other supporting documents if necessary to verify the information established in accordance with paragraph 3. ';
34. in the first sentence of Paragraph 9 (1), "§ 8 (6)" is replaced by "§ 8 (5)."
35. in Article 9 (4), the third sentence is deleted;
36. in Paragraph 9 (6):
"(6) The person who has been granted a treatment permit shall ensure that the activities for which a treatment permit is required are not carried out without the consent of the person responsible. ';
37. in the first sentence of Article 9 (9), "Section 8 (6)" is replaced by "Section 8 (5)."
38. In the second sentence of Article 9 (9), the words "the Ministry of Health 'are replaced by the words" a form issued by the Ministry of Health'.
39. in Article 11 (1) and (2), the words "preparations containing and precursors" are replaced by the words "and preparations containing."
40. in Paragraph 11 (2), "preparations or precursors" shall be replaced by "and preparations."
41. Paragraph 12, including the title, reads:
Trade
Narcotic substances and preparations may only be passed on or sold to persons authorised to handle them. The same applies to the transfer of other rights associated with addictive substances and preparations. '
42. Paragraph 13 (1) reads as follows:
"(1) A medicinal product under the Medicines Act (hereinafter referred to as the" medicinal product ') containing an addictive substance or a scheduled category 1 substance may be issued in a pharmacy to a person who has not been granted a treatment authorisation only for a prescription, a requisition or without a prescription with a restriction under the Medicines Act 6a). In the case of a medicinal product containing an addictive substance listed in Annex 1 or Annex 5 to the Government Ordinance on the list of addictive substances, it may be issued only for a recipe or a request marked with a blue stripe pointing from the lower left corner to the upper right corner, or exclusively for an electronic recipe, provided that this is provided for by the drug law (6). In the case of a medicinal product containing an addictive substance listed in Annex 1 or Annex 5 to the Government Ordinance on the list of addictive substances, which is also listed in Annex 8 to the Government Ordinance on the list of addictive substances, it may be issued in a prescription pharmacy or a requisition without a blue stripe.';
43.Paragraph 13 (10) reads as follows:
"(10) A medicinal product containing an addictive substance or a scheduled category 1 substance shall not be re-issued for a single recipe."
44. in the headings of Sections 14, 14 (2) and (3) and 35, the words "preparations and precursors" are replaced by "preparations."
45. In Paragraph 14, the sentence "The person responsible for the disposal of non-usable addictive substances and preparations and waste shall make a note thereof."
46. In Paragraph 14, the following paragraph 4 is added:
"(4) The treatment of useless addictive substances and preparations, as well as waste containing them, shall be treated in the same way as the management of hazardous waste, including the keeping of their records under the Waste Management Act. ';
47. in Article 15, point (b) is deleted;
Points (c) to (g) shall be renumbered as points (b) to (f).
48. in Paragraph 15 (d), the word "L." shall be inserted after the words "Papaver somniferum."
49. in Article 15 (f):
"(f) advertising of addictive substances and preparations not aimed at the professional public under the advertising regulation law.";
50. Article 16, including the title and footnotes 5e and 7c, shall be deleted.
51. In Part One of Title III, the following heading reads: "ELIGIBILITY FOR PREPARATION WITH COMPETENT SUBSTANCES AND PREPARATIONS '.
52. In the first sentence of Paragraph 17 (1), the words "(§ 8 (5)) 'shall be deleted and the second sentence shall be replaced by the words" Honesty shall be proved in accordance with Paragraph 8a'.
53. Paragraph 19 (1) reads as follows:
"(1) A natural person who has completed a Master's study programme in one of the following areas may be designated as responsible:
(a) pharmacy;
(b) general medical, dental or dental sciences;
(c) chemistry; or
(d) veterinary medicine. "
54. In Articles 20 (2) (a) and 21 (2) (a), the words "to this law" shall be replaced by the words "Government regulation on the list of addictive substances."
55. in Article 20 (2) (a), the words "or preparations containing ephedrine or pseudoephedrine" shall be replaced by "or medicinal products containing category 1 scheduled substance."
56. in Article 20 (2) (b), the words "or preparations containing ephedrine or pseudoephedrine" shall be replaced by "or medicinal products containing category 1 scheduled substance."
57. in Article 20 (2) (b), the words "or preparations containing ephedrine or pseudoephedrine" shall be replaced by "or medicinal products containing category 1 scheduled substance."
58. in Article 20 (2) (c), the words "or preparations containing ephedrine or pseudoephedrine" shall be replaced by "or medicinal products containing category 1 scheduled substance."
59. In Article 20 (2) (d), the words "or preparations containing ephedrine or pseudoephedrine" shall be replaced by "or medicinal products containing category 1 scheduled substance."
60.In Paragraph 20 (2) (e):
"(e) for the export of hemp plants which may contain a maximum of 0,3% of the substances of the tetrahydrocannabinol group for industrial, technical and horticultural purposes."
(61) Sections 20a and 20b are deleted, including the headings and footnotes No 8b.
62. In Article 21 (2) (a) and (c), the words "or preparations containing ephedrine or pseudoephedrine," shall be replaced by "or medicinal products containing category 1 scheduled substance,"
63.In Articles 21 (2) (b) and 26 (1) (c), the words "or preparations containing ephedrine or pseudoephedrine" shall be replaced by "or medicinal products containing category 1 scheduled substance."
64. in Article 21 (2) (b), the words "or preparations containing ephedrine or pseudoephedrine" shall be replaced by "or medicinal products containing category 1 scheduled substance."
65.In Paragraph 21 (2) (d):
"(d) for the import of hemp plants which may contain a maximum of 0,3% of the substances of the tetrahydrocannabinol group for industrial, technical and horticultural purposes,"
66. in Article 21 (2) (e), the words "or medicinal products containing ephedrine or pseudoephedrine," shall be replaced by "or medicinal products containing category 1 scheduled substance,"
67.In Articles 21 (4) and 43a (3) (e), the words "products, precursors or excipients of category 2 and 3 under the directly applicable regulation of the European Community2 'are replaced by the words" and preparations';
68. In the first sentence of Paragraph 22 (3), "6 'is replaced by" 3' and in the third sentence the words "available to it 'are deleted.
69. In Part One of Title V, the heading reads: "CONFERENCE, COKA, MEAT AND MAKOVINA '.
70. The heading of Section 24 reads: "Cannabis, coca and poppy seed."
71.In Article 24 (a):
"(a) to cultivate hemp plant species and varieties (Cannabis spp.) which may contain more than 0,3% of the substances of the tetrahydrokanabinol group, with the exception of cultivation under a licence granted under this law; the prohibition shall not apply to the cultivation of varieties of hemp plant (Cannabis genus) for research purposes, for the breeding of new varieties and for the maintenance of genetic diversity by scientific and research centres established by law or by the State as defined in the authorisation for treatment, ';
72.In Paragraph 24, at the end of point (b), the dot is replaced by a comma and the following point (c) is added:
'(c) to grow varieties of poppy seed (Papaver somniferum L.) which may contain in the dry matter more than 0,8% of morphine of the capsules; the prohibition shall not apply to the cultivation of poppy varieties (Papaver somniferum L.) for research and experimental purposes, for the breeding of new plant varieties and for the conservation of plant genetic diversity by scientific and research centres.';
73. In Paragraph 24, the present text becomes paragraph 1 and the following paragraphs 2 and 3 are added:
"(2) The person growing poppy seed (Papaver somniferum L.) or the person processing or storing the poppy seed shall also be required to immediately notify the local competent department of the Czech Police Department of any suspicious circumstances, in particular the entry of foreign persons into the crop, the cutting of macaques, the alienation of macaques or unusual orders that suggest that the poppy may be misused for the illegal manufacture of addictive substances.
(3) Macaquin produced in the Czech Republic must be exported or disposed of or processed in such a way that the substance contained cannot be used or obtained by any technological means. "
74. In Article 26 (1) (a), the words "disposal," shall be inserted after the words "preparations," and at the end of the text of the letter the words "if those persons have not treated these substances in the previous calendar year, they shall be sufficient to notify the Ministry of Health in writing."
75. in Article 26 (1) (b):
"(b) by the end of April, an estimate of the production, cultivation and import of addictive substances and preparations in the next calendar year; for products listed in Annex 8 to the Government Ordinance on the list of addictive substances, only the production estimate shall be provided; in the event that the initial production and import estimates are exceeded, those persons shall immediately increase the production and import estimates; These estimates may be adjusted 10b) by the International Narcotics Control Office 2a), ';
76. In Paragraph 26 (4), the last sentence shall be replaced by the sentence "If a natural person who has been granted a treatment permit dies, the obligation to make an extraordinary report referred to in paragraph 1 (a) shall pass on to the responsible person or his representative and, in the event that those persons are unable to fulfil that obligation, he shall pass on to the estate manager."
77. In Paragraph 27, at the end of paragraph 1, the sentence "If these persons have not treated these substances in the previous calendar year, it is sufficient to notify the State Institute for Drug Control in writing."
78. In the first sentence of Article 27a (1), the words "the competent Regional Veterinary Administration or the Municipal Veterinary Administration in Prague 'are replaced by the words" the Institute for State Control of Veterinary Bioprafts and Medicines (hereinafter referred to as the Veterinary Institute)' and the second sentence is replaced by the words "Reporting is to be submitted to the Veterinary Institute on a form issued by it '.
79.Paragraph 27a (2) shall be deleted;
Paragraph 3 shall become paragraph 2.
80.In § 27a (2), the words "Institute for State Control of Veterinary Bioprafts and Drugs' are replaced by the words" Veterinary Institute '.
Article 81 (28) shall be deleted, including the title.
82. In § 29 (a) (1):
"1. the area of parcels sown with poppy or hemp for harvesting in the relevant calendar year, including the name of the variety used 10g), the parcel number, the name and the cadastral zoning number 10h), or the soil block identification number and, where appropriate, the soil register part 10i), ';
83. Footnote 10g reads:
"10g) Act No. 219 / 2003 Coll., on the putting into circulation of seeds and propagating plants and amending certain laws (Act on the circulation of seed and seed), as amended."
84. in Paragraph 29 (b):
"(b) during the growing and harvesting or in the course of the destruction of the harvested maquis, data on the area of the parcels and the method of disposal of poppy seed, whether left on the parcel or harvested or hemp, including the name of the registered variety used (10g), the parcel numbers, the name and the cadastral zoning number (10h) or the soil block identification number or, where appropriate, the soil block part, the soil register (10i), no later than 5 days before their destruction; if the person planting poppy seed does not withdraw back the poppy seed from the purified seeds, the obligation to transmit the poppy seed disposal report to the person who cleaned the poppy seed shall pass; ';
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Regulation Information
| Citation | Act No. 273 / 2013 Coll., amending Act No. 167 / 1998 Coll., on addictive substances and amending some other laws, as amended, and certain other laws |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 10.09.2013 |
|---|---|
| Effective from | 01.01.2014 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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