Act No. 362 / 2004 Coll.
Act amending Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended, and Act No. 2 / 1969 Coll., on the Establishment of Ministries and other Central Authorities of the Czech Republic, as amended
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Effective from 01.07.2004
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362
THE LAW
of 20 May 2004
amending Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended, and Act No. 2 / 1969 Coll., on the establishment of ministries and other central bodies of the Czech Government, as amended
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. and Act No. 223 / 2003 Coll., is amended as follows:
1. In Article 1 (2), the words "and auxiliary substances' shall be inserted after the words" precursors'.
Footnote (1a):
"(1a) Article 1 (2) (a) of Council Regulation (EEC) No 3677 / 90 of 13 December 1990 laying down measures to be taken to prevent the diversion of certain substances to the illicit manufacture of narcotic drugs and psychotropic substances, as amended by Council Regulation (EC) No 1116 / 2001."
2. in Paragraph 1 (2) (b):
"(b) in other products, where the composition of such products is such that precursors and excipients contained therein cannot be easily used or re-obtained in an easy-to-use manner, as provided for in the immediately binding regulation of the European Communities. 1a) '.
3. in Article 2 (c), the words "solution or mixture 'are replaced by the words" solution, mixture or natural product';
4. In Article 2, at the end of the text of point (d), the words "as well as a mixture or natural product in any physical state containing at least one such substance, except those referred to in Article 1 (2) (b) of this Law, 1a) 'are added.
5. At the end of § 2, the dot is replaced by a comma and the following points (g) to (j) are added:
"(g) coca shrub all types of Erythroxylon shrub and coca leaf leaves of coca shrub, except for leaves from which all ecgonin, cocaine and other ecgonin alkaloids have been extracted, 2a)
(h) the final consignee of the substances listed in Annexes 9 to 11 to this Act, any natural person or legal person under an immediately binding regulation of the European Communities, 2b)
(i) placing on the market the supply of substances listed in Annexes 9 to 11 to this Law produced in the countries of the European Community to a third party or for free circulation in the countries of the European Community, whether for consideration or free of charge;
(j) the export or import of addictive substances and preparations involves their physical transfer from one State to another. 2a), 2c)
2a) Decree No 47 / 1965 Coll., on the Single Convention on Narcotic Drugs, as amended by Communication No 458 / 1991 Coll., Protocol on Amendments to the Single Convention on Narcotic Drugs, 1961.
(2b) Article 1 (2) (f) of Council Regulation (EEC) No 3677 / 90, as amended by Council Regulation (EEC) No 900 / 92.
2c) Convention on Psychotropic Substances published under No 62 / 1989 Coll. '
footnote (2a) shall be renumbered footnote (2d), including the footnote reference.
6. The heading of Section 3 reads: "Treatment of addictive substances and preparations."
7. in Article 3 (1), the words "substances, preparations and precursors' are replaced by the words" substances and preparations' and the words "substances, preparations and precursors' are replaced by the words" substances and preparations';
8. the following Section 3a is inserted after Section 3, including the title and footnote 2d:
Treatment of precursors and excipients
(1) Treatment of precursors means:
(a) production and marketing of precursors, including activities related thereto;
(b) the export, import and transit of precursors referred to in the immediately binding regulation of the European Community2d) from or into the customs territory of the European Community.
(2) Treatment of excipients means:
(a) the manufacture and placing on the market of the excipients listed in Annex 10 to this Law or mixtures thereof, except potassium permanganate;
(b) the export from the customs territory of the European Communities of the excipients referred to in the immediately binding regulation of the European Communities (2d), the importation of those substances into or transit through that customs territory of those substances.
(3) For the treatment of auxiliary substances, registration under Section 16 of this Act is required, unless otherwise provided for in this Act.
(2d) Article 1 (2) of Council Regulation (EEC) No 3677 / 90. "
footnote 2d shall be renumbered footnote 2e, including the footnote reference.
9. In Section 5 (7), the words "health laboratories' are replaced by the words" laboratories of health institutes'.
10. in Article 5, the following paragraph 8 is added:
"(8) The authorisation for treatment shall not be required for persons operating a pharmacy who acquire, withdraw and store addictive substances listed in Annexes 3 and 4 to this Act for the purpose of supplying them to the persons referred to in paragraph 7. ';
11. in Article 6 (2), the words "persons representing customs, 5b, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5b, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5b, 5b, 5b, 5b, 5b, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5b, 5c, 5c, 5b, 5c, 5c, 5c, 5b, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5b, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c, 5c,
footnotes 5b and 5c are as follows:
"5b) § 107 (2) of Act No. 13 / 1993 Coll., as amended.
5c) Article 2a (1) of Council Regulation (EEC) No 3677 / 90, as amended by Council Regulation (EEC) No 900 / 92. '
Footnotes 5b and 5c to date are referred to as footnotes 5d and 5e, including the footnotes.
12. in Article 8 (3), "2" is replaced by "5" and at the end of the paragraph the sentence "If the applicant so requests, the authorisation for treatment may be issued for a shorter period."
13. in Paragraph 8 (10), the words "and, for reasons laid down in an immediately binding regulation of the European Communities, 5c)" shall be inserted after the words "in the application for authorisation for treatment."
14. In Article 8, the sentence "Application for revocation of a treatment permit shall be added at the end of paragraph 11, using a form issued by the Ministry of Health."
15. in Article 9 (4), the fourth sentence is deleted;
16. in Paragraph 12 (2), including footnote (5f):
"(2) Excipients listed in Annex No 10 to this Act, with the exception of potassium permanganate, may be transmitted or sold only to persons who submit to the transmitting or selling a completed customer declaration in accordance with the immediately binding regulation of the European Communities. 5f)
5f) Commission Regulation (EC) No 1485 / 96 of 26 July 1996 laying down detailed rules for the application of Council Directive 92 / 109 / EEC as regards customer declarations concerning the specific use of certain substances used in the illicit manufacture of narcotic drugs and psychotropic substances, as amended by Commission Regulation (EC) No 1533 / 2000. '
footnote 5e is deleted, including the footnote reference.
17. in Article 12, paragraphs 3 and 4 are added, including footnote 5g:
"(3) The obligation referred to in paragraph 2 shall not apply to persons who intend to transmit or sell any of the excipients listed in Annex 10 to this Act whose total quantity does not exceed the quantity laid down by the Ministry of Health in the calendar year of the decree.
(4) Persons intending to manufacture, import, export, transfer or sell precursors and excipients listed in Annex 10 to this Act are required to ensure that they are labelled before they are placed on the market. The label shall bear the name of the substance which must correspond to the annexes to this Act, 5g) and may bear its normal trade description; A similar designation is required in transit of precursors and excipients (Section 23).
5g) Article 2 (2) of Council Regulation (EEC) No 3677 / 90. '
18. in Paragraph 15 (a), "substances, preparations and precursors" is replaced by "substances and preparations."
19. in Article 15, the following point (b) is inserted after point (a), including footnote 7a:
"(b) import and export precursors and excipients for the reasons set out in the immediately binding Regulation of the European Communities, 7a)
7a) Article 6 (2) of Council Regulation (EEC) No 3677 / 90, as amended by Council Regulation (EC) No 988 / 2002. '
Points (b) to (f) shall be renumbered as points (c) to (g).
20. The heading of Section 16 reads: "Registration of producers, exporters, importers and persons placing the excipients on the market."
21. Paragraph 16 (1), including footnote 7b, reads:
"(1) Persons intending to produce, export, import, place on the market or deal with the transit of the excipients listed in Annex 10 to this Act, with the exception of the manufacture and placing on the market of potassium permanganate, and persons intending to export the excipients listed in Annex 11 to this Act are required to register with the Ministry of Health prior to the commencement of activity. The application for registration shall be made in duplicate on forms issued by the Ministry of Health.
7b) Article 2a (2) of Council Regulation (EEC) No 3677 / 90, as amended by Council Regulation (EEC) No 900 / 92. '
22. In Article 16, the following paragraph 2 is inserted after paragraph 1, including footnote 7c:
"(2) The obligation referred to in paragraph 1 shall not apply to persons intending to export any of the excipients listed in Annex 11 to this Law whose total quantity does not exceed the quantity in a calendar year in accordance with the immediately binding regulation of the European Communities. (c)
7c) Article 1 (1) of Commission Regulation (EEC) No 3769 / 92 of 21 December 1992 implementing and amending Council Regulation (EEC) No 3677 / 90 as amended by Commission Regulation (EC) No 1232 / 2002. "
Paragraphs 2 to 4 shall become paragraphs 3 to 5.
23. in Article 16 (3), the words "and the conditions laid down by special legislation" shall be deleted;
24. In Article 16, the following paragraph 6 is added:
"(6) The Ministry of Health shall decide, for the persons referred to in paragraph 1, to reject the application for registration or to suspend, withdraw or revoke the marketing authorisation already issued.
(a) where false or incomplete information is found in the application for a marketing authorisation;
(b) in the event of a breach of obligations under this law or of a decision given under it; or
(c) where the holder of the registration has been convicted of a criminal offence the facts of which relate to that activity, unless he is regarded as not being convicted. ";
25. Paragraph 19 (1) reads:
"(1) A natural person who has achieved a university Master's degree in pharmacy, medicine, veterinary medicine or chemical technology may be designated as the responsible person. ';
26. The heading of Section 20 reads: "Exports of addictive substances and preparations containing them."
27. in Article 20 (1), "substances, preparations, precursors and excipients in the cases referred to in paragraph 3" is replaced by "substances and preparations."
28. Paragraph 20 (3) is deleted.
Paragraphs 4 to 6 shall become paragraphs 3 to 5.
29. In Article 20, the words "the limit set by the International Narcotics Control Office for Importcountry (8a) shall not be exceeded at the end of the text of paragraph 3 'shall be added.
Footnote 8a) reads as follows:
"8a) Decree No. 47 / 1965 Coll., as amended by Communication No. 458 / 1991 Coll. Convention on Psychotropic Substances, published under No. 62 / 1989 Coll. '.
30. in Paragraph 20 (5), the third sentence is deleted;
31. after Article 20, the following paragraphs 20a and 20b are inserted:
Exports of precursors
(1) The export of precursors shall be carried out in accordance with the immediately binding provisions of the European Communities. 8b)
(2) The Ministry of Health shall issue an export notification under special legislation 8c), 8d) and send it to the State to which the export is to take place. On the basis of the opinion of the competent authority of the State to which the export is to be made, the Ministry of Health shall decide on the issue of an export authorisation. (e)
(3) The decision on an application for export outside the Member States of the European Community must be taken by the Ministry of Health within 15 working days of receiving the reply from the competent authority of the State to which the export is to be made. 8f, 8g)
(4) The Ministry of Health shall decide on the refusal of an application for an export authorisation or the withdrawal of an export authorisation already issued in respect of illicit trade under international agreements by which the Czech Republic is bound, or in respect of a case provided for in a direct binding regulation of the European Communities. 8h)
(5) The Ministry of Health shall suspend or revoke the export authorisation if there are grounds under an immediately binding regulation of the European Communities. 8i)
Exports of excipients
(1) The exports of the excipients listed in Annexes 10 and 11 to this Act shall be treated mutatis mutandis in accordance with the immediately binding provisions of the European Community8j), 8k) and § 20a thereof.
(2) In the case of exports of potassium permanganate or acetic acid anhydride in excess of the limit laid down by the Ministry of Health Order, the following procedure shall be followed:
(a) the natural or legal person is required to disclose this fact to the Ministry of Health;
(b) the Ministry of Health shall, on the basis of this communication, issue a notice of intended exports in accordance with the immediately binding provisions of the European Community8c), 8d) and send it to the State to which the export is to be effected;
(c) the statement of the competent authority of the State to which the export is to be made or the International Bureau of Narcotic Control shall be communicated by the Ministry of Health to the natural or legal person intending to export potassium permanganate or acetic acid anhydride and to the Ministry of Industry and Trade.
8b) Council Regulation (EEC) No 3677 / 90, as amended by Council Regulation (EC) No 988 / 2002.
8c) Article 12 (10) of the United Nations Convention against Illicit Trade in Narcotic Drugs and Psychotropic Substances, published under No 462 / 1991 Coll. Resolution No 20 / 4 of 1998 of the United Nations General Assembly Special Meeting on Drugs.
8d) Article 4 of Council Regulation (EEC) No 3677 / 90, as amended by Council Regulation (EC) No 988 / 2002.
8e) Article 4a of Council Regulation (EEC) No 3677 / 90, as amended by Council Regulation (EC) No 988 / 2002.
8f) Article 4a (3) of Council Regulation (EEC) No 3677 / 90, as amended by Council Regulation (EC) No 988 / 2002.
8g) Article 4a (9) of Council Regulation (EEC) No 3677 / 90, as amended by Council Regulation (EC) No 988 / 2002.
8h) Article 4a (4) of Council Regulation (EEC) No 3677 / 90, as amended by Council Regulation (EC) No 988 / 2002.
8i) Article 4a (8) of Council Regulation (EEC) No 3677 / 90, as amended by Council Regulation (EC) No 988 / 2002.
8j) Articles 2 and 3 of Commission Regulation (EEC) No 3769 / 92, as amended by Commission Regulation (EC) No 1232 / 2002.
8k) Articles 5 and 5a of Council Regulation (EEC) No 3677 / 90, as amended by Council Regulation (EEC) No 900 / 92 and Council Regulation (EC) No 988 / 2002. '
32. in Section 21, the heading reads: "Imports of addictive substances and preparations containing them."
33. in Paragraph 21 (1), the words "substances, preparations and precursors" are replaced by the words "substances and preparations."
34. in Article 21 (3), the first and second sentences are deleted;
35. In Paragraph 22, at the end of paragraph 2, the sentence "Changes to the information contained in the application for an export authorisation or import authorisation shall be added to the statement of the natural or legal person in writing to the Ministry of Health no later than 5 days after the date on which the changes took place."
36. In Paragraph 22 (3), the words "or at the request of the importer may be issued for a shorter period 'shall be added at the end of the sentence of the first sentence, and the second sentence shall be replaced by the words" The period of validity of the export authorisation shall be determined by the Ministry of Health according to the period of validity of the import authorisation of the State in whose territory the export is to be effected unless the exporter requests a shorter period'.
37. In Paragraph 22, the following paragraphs 5 and 6 are inserted after paragraph 4:
"(5) Where addictive substances and preparations are exported, the customs declaration for placing goods under the export procedure shall be lodged with the customs office of residence or place of business of the natural person or registered office of the legal person. In addition, an export permit pursuant to § 20, 20a and 20b of this Act shall be submitted if it has to be issued under this Act.
(6) On importation of addictive substances and preparations, the customs declaration for release for free circulation or economic effects shall be lodged with the customs office of residence or place of business of the natural person or registered office of the legal person. In addition, an import authorisation shall be submitted pursuant to Article 21 of this Act if it has to be issued under this Act. ';
Paragraph 5 shall become paragraph 7.
38. in Paragraph 22 (7):
"(7) The Ministry of Health shall decide to refuse an application for an export permit or import authorisation, to suspend, withdraw or revoke an export permit or import authorisation in respect of:
(a) illicit trade under international treaties by which the Czech Republic is bound;
(b) the indication of false data or the failure to complete incomplete information in the application for an export authorisation or import authorisation within the time limit set;
(c) infringement of obligations under this law or of a decision given on the basis thereof; or
(d) the holder of an authorisation for the treatment of a convicted person for an offence the nature of which relates to that activity, unless he is regarded as not being convicted. "
39. In Paragraph 25, at the end of paragraph 1, the sentence "An application for an export permit or import authorisation shall be made using a form issued by the Ministry of Health."
40. In Article 26 (1), the words "on forms issued by the Ministry of Health in writing or in electronic form signed by a guaranteed electronic signature in accordance with a specific legislation 'shall be inserted after the words" to pass on to the Ministry of Health'. 10a) '.
Footnote 10a) reads as follows:
"10a) Act No. 227 / 2000 Coll., on electronic signature and amending certain other laws (Act on electronic signature), as amended. Government Decree No. 304 / 2001 Coll., implementing Act No. 227 / 2000 Coll., on Electronic Signature and on the Amendment of Certain Other Acts (Electronic Signature Act). '
Footnotes 10 (a) to 10 (c) shall be renumbered as footnotes 10 (b) to 10 (d), including the footnotes.
41. in Paragraph 26 (1), the words "; the estimates referred to above may be adjusted 10b) by the International Narcotic Control Office (IPCO), 2a)" shall be added at the end of the text in point (b).
Footnote 10b) reads as follows:
"10b) Articles 19 (2) and 21 (3) of Decree No 47 / 1965 Coll. '.
Footnotes 10b to 10d shall be renumbered as footnotes 10c to 10e, including the footnotes.
42. In Paragraph 26, the following paragraph 3 is inserted after paragraph 2:
"(3) Persons who are authorised to handle addictive substances, preparations and precursors on the basis of a treatment permit and persons who are not required for their activity to issue authorisation for the treatment of addictive substances, preparations and precursors pursuant to Articles 5 (7) and 6 (3) shall be required to inform the Ministry of Health without delay.
(a) the alienation of addicts, preparations and precursors;
(b) special circumstances, such as unusual orders and transactions in these substances;
(c) on the basis of his request for further details relating to the activities covered by the authorisation for treatment. "
Paragraph 3 shall become paragraph 4.
43.In Article 26 (4), "1 month" is replaced by "30 days."
44. Paragraph 27, including the title and footnote 10c, reads:
Reporting obligation for persons operating a pharmacy
(1) Persons operating a pharmacy shall be required to transmit to the Regional Office by the end of February the annual report for the previous calendar year on the state and movement of stocks of addictive substances listed in Annex 1 or 5 to this Law, as well as the preparations containing them, with the exception of the products listed in Annex 8 to this Law. The annual report shall be made on a form issued by the Ministry of Health in writing or in electronic form signed by a guaranteed electronic signature under a specific legislation. 10a)
(2) At the end of the pharmacation10c) the person who has been operating this activity shall be required to submit an emergency report to the Regional Office within 30 days of the end of the activity to the extent specified in paragraph 1.
10c) Act No. 160 / 1992 Coll., on health care in non-state health institutions, as amended. '
Footnotes 10 (c) to 10 (e) are renumbered as footnotes 10 (d) to 10 (f), including the footnotes.
45. in Article 27a (1), the words "district or urban veterinary administration" shall be replaced by the words "regional veterinary administration or municipal veterinary administration in Prague," and at the end of paragraph 1, the sentence "the report shall be submitted on a form issued by the competent veterinary administration in writing or in electronic form signed by a guaranteed electronic signature under a specific legislation. 10a) '.
46. in Article 27a (2), the words "Regional and municipal veterinary administrations" are replaced by the words "Regional veterinary administrations and the Municipal Veterinary Administration in Prague."
47. Paragraph 28, including the title and footnote 10f, reads:
Reporting obligation for producers, exporters, importers and persons placing the excipients on the market
(1) Persons registered with the Ministry of Health (Section 16), with the exception of those placing on the market of auxiliary substances, are required to transmit to the Ministry of Health:
(a) by the end of February for the previous calendar year, the annual reports on the production, export and import of the excipients listed in Annex 10 to this Act and the export reports of the excipients listed in Annex 11 to this Act;
(b) by the 15th day of the following month, monthly export reports of the excipients listed in Annexes 10 and 11 to this Law in cases for which an export authorisation is required, 10e)
(c) at his request, further detailed information on the production, export and import of the excipients;
(d) any information concerning the stolen ingredients and other circumstances under specific legislation. 10f)
(2) Upon termination of the activity for which registration is required, the person who carried out the activity shall be required to submit an emergency report to the Ministry of Health within 30 days of the end of the activity to the extent specified in paragraph 1 (a).
(3) The reports referred to in paragraph 1 (a) and (b) shall be made on forms issued by the Ministry of Health in writing or in electronic form signed by a guaranteed electronic signature under a specific legislation. 10a)
10f) Article 3 of Council Regulation (EEC) No 3677 / 90, as amended by Council Regulation (EEC) No 900 / 92. '
footnote 10 (f) shall be renumbered as footnote 10 (g), including the footnote reference.
48. Article 29, including the title and footnotes 10g) and 10h) shall read as follows:
Reporting obligation on persons growing poppy seed or hemp
Persons growing poppy seed or hemp on a total area of more than 100 m2 shall be required to submit a report to the local competent customs authority according to the place of cultivation, in writing or in electronic form, signed by a guaranteed electronic signature in accordance with the special legislature10a)
(a) by the end of May
1. the area of land sown with poppy seed or hemp in the relevant calendar year, including the name of the registered variety used, 10g) the parcel number, the name and the cadastral territory number, 10h)
2. an estimate of the area of land on which poppy seed or hemp will be grown in the next calendar year,
(b) during vegetation and harvesting, data on the area of land and the method of disposal of poppy seed, macaws or hemp, including the name of the registered variety used, 10g) the parcel number, the name and the cadastral area number, 10h), no later than 5 days before their destruction;
(c) by the end of December of the calendar year concerned,
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Regulation Information
| Citation | Act No. 362 / 2004 Coll., amending Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended, and Act No. 2 / 1969 Coll., on the Establishment of Ministries and other Central Authorities of the Government of the Czech Republic, as amended |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 15.06.2004 |
|---|---|
| Effective from | 01.07.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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