Act No. 141 / 2009 Coll.
Act amending Act No. 167 / 1998 Coll., on addictive substances and amending some other laws, as amended, and some other laws
Valid
Law
Effective from 01.06.2009
Text versions:
01.06.2009
25.05.2009
141
THE LAW
of 28 April 2009
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. 362 / 2004 Coll., Act No. 228 / 2005 Coll., Act No. 74 / 2006 Coll., Act No. 124 / 2008 Coll., Act No. 41 / 2009 Coll., is amended as follows:
1. Paragraph 1 (1), including footnote 1, reads as follows:
"(1) This law provides for the treatment of precursors and auxiliary substances following the directly applicable rules of the European Communities (1) and provides for the powers and powers of the administrative authorities to comply with the obligations laid down by that law and the directly applicable rules of the European Communities (1), which are exercised by the Member State under those directly applicable rules of the European Communities.
1) Regulation (EC) No 273 / 2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors. Council Regulation (EC) No 111 / 2005 of 22 December 2004 laying down rules for the monitoring of trade in drug precursors between the Community and third countries. Commission Regulation (EC) No 1277 / 2005 of 27 July 2005 laying down detailed rules for the application of Regulation (EC) No 273 / 2004 of the European Parliament and of the Council on drug precursors and Council Regulation (EC) No 111 / 2005 laying down rules for the monitoring of trade in drug precursors between the Community and third countries. '
2. In Article 1 (2) (c), "more than 30 mg of pseudoephedrine in the unit of the pharmaceutical form 'is replaced by" pseudoephedrine'.
3. In Article 3a (1), the words "Category 2 and 3 'are deleted.
4. In Article 3a, the following paragraph 2 is inserted after paragraph 1:
"(2) The treatment of precursors requires authorisation or special authorisation under the directly applicable provisions of the European Communities (1)."
Paragraph 2 shall become paragraph 3.
5. Paragraph 3a (3) reads as follows:
"(3) For the treatment of Category 2 and Category 3 auxiliary substances, registration or specific registration is required according to the directly applicable provisions of the European Communities (1)."
6. in Sections 4, 7, 17 (1), 18 (1), 19 (2), 26 (1) to (3) and 36 (1) (b), "preparations and precursors" shall be replaced by "and preparations."
7. In Article 5 (2) (g), "laboratory 'is replaced by" assistants'.
8. in Article 5 (3), the words "preparations and precursors' are replaced by the words" and preparations, 'and the words "preparations and precursors' are replaced by the words" and preparations';
9. Article 6 shall be deleted, including the title.
10. In Paragraph 8 (1), the second sentence is replaced by the following: "No authorisation shall be granted if a person fails to comply with the requirements laid down in paragraph 7 on request."
11. in Article 8 (3) (b), the words "laid down directly by the provisions of the European Communities (1)" shall be replaced by the words "3 years and the special authorisation for the treatment of precursors shall be issued for an unlimited period."
12. In Paragraph 8 (7), the following sentence shall be inserted after the first sentence: "The application shall be accompanied by a statement from the applicant that, in the case of activities involving direct contact with addictive substances and preparations, the appropriate method of security shall be chosen in accordance with paragraphs 10 and 11."
13. in Article 9 (3), the words "to treat addictive substances" shall be deleted;
14. In Paragraph 13 (1), the first sentence is replaced by the sentence "Medication6) containing addictive substances and medicinal products containing ephedrine and pseudoephedrine may be issued in a pharmacy to a person who has not been authorised for treatment only for a recipe, requisition or without a prescription with a restriction of 6a)."
footnotes 6 and 6a read:
"6) Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Law on Medicines), as amended.
6a) § 39 (3) of Act No. 378 / 2007 Coll. '.
Footnotes 6a and 6b are renumbered as footnotes 6b and 6c, including the footnotes.
15. in the second sentence of Paragraph 13 (1), the words "recipe or request marked" shall be replaced by "issued only on the recipe or request marked."
16. in Paragraph 13 (5):
"(5) Receipts, stocks, sales, return and depreciation of returned recipes and blue-striped applications shall be kept by the municipal authorities of the municipalities with an extended register. This register shall carry out an annual inventory on the last day of the calendar year. ';
17. in Article 16, the heading reads: "Registration of entities engaged in auxiliary activities."
18. in Paragraph 16 (1):
"(1) Persons intending to deal with the activities listed in the directly applicable European Community rules on drug precursors, with Category 2 and 3 auxiliary substances listed in those regulations, are required to register with the Ministry of Health before starting this activity. The application for registration shall be submitted in 2 copies on forms issued by the Ministry of Health. ';
19. in Article 17 (1) and Article 18 (1), the words "and in Article 6 (1) (a) and (2)" shall be deleted;
20. in Article 19 (2), the words "and in Article 6 (1) (a)" shall be deleted;
21.
Export and import of precursors
The export and import of precursors shall be carried out in accordance with the provisions directly applicable to trade in drug precursors (8b).
8b) Council Regulation (EC) No 111 / 2005 of 22 December 2004 laying down rules for the monitoring of trade in drug precursors between the Community and third countries. Commission Regulation (EC) No 1277 / 2005 of 27 July 2005 laying down detailed rules for the application of Regulation (EC) No 273 / 2004 of the European Parliament and of the Council on drug precursors and Council Regulation (EC) No 111 / 2005 laying down rules for the monitoring of trade in drug precursors between the Community and third countries. '
Footnotes 8c to 8i are deleted, including references to footnotes.
22.
Exports of excipients
The export of the excipients referred to in categories 2 and 3 of the European Communities' directly applicable rules on drug precursors (1) shall be carried out in accordance with the directly applicable provisions of the European Communities on trade in drug precursors (8b) '.
footnote 8k is deleted, including the footnote reference.
23. In Paragraph 22 (3), at the end of the third sentence, the words "including the reason why no import or export took place 'shall be added.
24. in Articles 26 (1) (a) to (c) and 26 (3) (a), the words "preparations and precursors" shall be replaced by the words "and preparations."
25. in Article 26 (2) to (4), the words "and in Article 6 (3)" shall be deleted;
26. In the first sentence of Article 27 (1), the words "the Regional Office 'are replaced by the words" the State Institute for Drug Control'; in the second sentence, the words "the Ministry of Health 'are replaced by the words" the State Institute for Drug Control'.
27. in Article 27 (2), the words "the Regional Office" shall be replaced by the words "the State Institute for Drug Control."
28.
Reporting obligation for activities with auxiliary substances
(1) Persons who have been or have been involved in the activities referred to in directly applicable European CommunityRegulations (1) with Category 2 and (3) auxiliary substances referred to in those Regulations during the previous calendar year are required to transmit to the Ministry of Health:
(a) by 15 February for the previous calendar year, a summary report on the activities with Category 2 and 3 auxiliary substances, in accordance with the provisions directly applicable to the European Communities (1);
(b) all information on unusual circumstances under the directly applicable rules of the European Community1).
(2) Persons registered with the Ministry of Health pursuant to § 16 are required to inform the Ministry of Health by 15 February of the following calendar year of activities involving Category 2 and 3 auxiliary substances referred to in the directly applicable regulations of the European Community1), even if they have not been involved in these activities during the previous calendar year.
(3) The reports referred to in paragraph 1 (a) shall be made on forms issued by the Ministry of Health in writing or in electronic form, accompanied by a guaranteed electronic signature (10a). "
footnotes 8j and 10f are deleted.
29. in Article 29 (a) and (c), the words "or soil block identification number, or part of soil block, shall be added at the end of point 1;"
30. In Paragraph 29 (c), at the end of point 2, the dot is replaced by a comma and the following point 3 is added:
"3. the weight, the year of harvest of the mackerel or hemp sold or otherwise transferred and the identification of the new acquirer. ';
31. in Article 31 (1), the words "except for the reports referred to in Article 27, which are submitted on forms issued by the State Institute for Drug Control," shall be inserted after the words "Ministry of Health."
32. In Article 34 (1), the words "and from the directly applicable provisions of the European Communities (1) 'shall be inserted after the words" the law' and the words "its' shall be replaced by the words" theirs'.
33. In Paragraph 34 (1), the words "in the absence of checks on pharmacies or checks on compliance with obligations arising from the provisions directly applicable to the European Communities (1) and decisions given thereunder" shall be added at the end of the text in point (c).
34. in Paragraph 34 (1), the following point (d) is inserted after point (c):
"(d) the State Institute for Drug Control in matters relating to pharmacies,"
Points (d) and (e) shall be renumbered as points (e) and (f).
35. in Article 34 (1), the words "and the control obligations arising for customs authorities from the directly applicable provisions of the European Communities (1) and decisions given thereunder" shall be added at the end of the text in point (e).
36. In Paragraph 34, the following paragraph 2 is inserted after paragraph 1:
"(2) Inspectors are entitled to carry out non-pre-notified checks."
Paragraphs 2 to 7 shall be renumbered paragraphs 3 to 8.
37. in Article 36 (1) (a), "(Article 3a (2))" shall be replaced by "(Article 3a (3))";
38. in Paragraph 36 (1) (p):
"(p) exports addictive substances or preparations containing them without an export authorisation in accordance with Paragraph 20;"
39. in Paragraph 36 (1), point (q) is deleted;
40. In Paragraph 36, the following paragraph 2 is inserted after paragraph 1:
"(2) In addition, a natural person, legal or business, commits an administrative offence by:
(a) carry out an activity which is required under the directly applicable regulation of the European Communities on drug precursors (1), a permit for treatment or a special authorisation for treatment, without such authorisation;
(b) the export or import of precursors in breach of § 20a;
(c) the export or import of the excipients is in breach of Article 20b. ';
Paragraphs 2 to 5 shall be renumbered paragraphs 3 to 6.
41. in Article 36 (3) (a) and (c), the words "Regional Office" shall be replaced by the words "State Institute for Drug Control."
42.Paragraph 36 (5) reads as follows:
"(5) A legal person, or an undertaking natural person, who has been engaged or has been involved in activities with Category 2 and 3 auxiliary substances referred to in directly applicable European Community1 during the previous calendar year, shall commit an administrative offence by:
(a) does not transmit a summary report on Category 2 and 3 auxiliary activities in contravention of Sections 28 (1) (a) and (3) or include incorrect or incomplete information in the report; or
(b) it shall not transmit all information on unusual circumstances pursuant to Paragraph 28 (1) (b). ';
43. in Paragraph 36, the following paragraph 6 is inserted after paragraph 5:
"(6) Legal or business natural person shall, as a person registered with the Ministry of Health pursuant to Article 16, commit an administrative offence by not informing of activities involving Category 2 and 3 auxiliary substances contrary to Section 28 (2). ';
Paragraph 6 shall become paragraph 7.
44. in Paragraph 37 (1) (b), "(q)" shall be deleted;
45. In Paragraph 37, the following paragraph 2 is inserted after paragraph 1:
"(2) A fine shall be imposed on the administrative offence referred to in Article 36 (2):
(a) 10 000 000 CZK if the administrative offence referred to in (a), (b) or (c) is an export or import of Category 21 excipients;
(b) CZK 1 000 000 000 where the administrative offence referred to in (c) applies in respect of the export or import of Category 31 ingredients. "
Paragraphs 2 to 5 shall be renumbered paragraphs 3 to 6.
46. In Paragraph 37 (3), "2 'is replaced by" 3'.
47. in Paragraph 37 (4), "3" is replaced by "4."
48. in Paragraph 37 (5):
"(5) For an administrative offence pursuant to § 36 (5), a fine of up to CZK 1 000 000 shall be imposed."
49. In Paragraph 37, the following paragraph 6 is inserted after paragraph 5:
"(6) A fine of up to 500 000 CZK shall be imposed for the administrative offence referred to in Section 36 (6)."
Paragraph 6 shall become paragraph 7.
50. In Paragraph 37 (7), "5 'is replaced by" 7'.
51. in Paragraph 40 (4), "4" is replaced by "5."
52. Paragraph 40 (5) reads as follows:
"(5) The administrative offences referred to in Article 36 (1) (g), (k), (y) and (z), committed in a medical facility outside the pharmacy, shall be dealt with at first instance by the Regional Office."
53. In Paragraph 40, the following paragraph 6 is inserted after paragraph 5:
"(6) Administrative offences under Article 36 (1) (g), (k), (y) and (z) and under Article 36 (3) (a), (b) and (c), committed in pharmacies, are at first instance discussed by the State Institute for Drug Control."
Paragraphs 6 to 11 shall be renumbered paragraphs 7 to 12.
54. In Paragraph 40 (7), "5 'is replaced by" 7'.
55. in Paragraph 40 (8), "3" is replaced by "4."
56. in Article 44b, the words "including the annexes which form an integral part thereof" shall be inserted after the words "Paragraph 43 (6)."
57. In Annex 1, in the column "International non-proprietary name (INN) in the Czech language ', the following entry" Oripavin' is inserted after the entry "Opium 'and in the column" Chemical name' the words "4,5α-epoxy-6-methoxy-17-methyl-6,7,8,14-tetradehydromorfinan-3-ol '.
58. In Annex No 7, in the column "Other international non-proprietary name or common name ', the following entry" Benzylpiperazine' is inserted after the entry "Benzylpiperazine 'and in the column" Chemical name' is inserted after "Benzylpiperazine '.
Amendment of the Administrative Charges Act
In the Annex to Act No. 634 / 2004 Coll., on administrative fees, as amended by Act No. 217 / 2005 Coll., Act No. 228 / 2005 Coll., Act No. 361 / 2005 Coll., Act No. 444 / 2005 Coll., Act No. 553 / 2005 Coll., Act No. 545 / 2005 Coll., Act No. 130 / 2006 Coll., Act No. 136 / 2006 Coll., Act No. 138 / 2006 Coll., Act No. 138 / 2006 Coll., Act No. 161 / 2006 Coll., Act No. 179 / 2006 Coll.
| „Položka 100 | ||
| a) | Vydání povolení k zacházení s omamnými látkami, psychotropními látkami nebo přípravky je obsahujícími | Kč 5 000 |
| b) | Vydání povolení k zacházení s prekursory – povolení podle přímo použitelných předpisů Evropských společenství o prekursorech drog59) | Kč 3 000 |
| c) | Vydání povolení k zacházení s prekursory – povolení podle přímo použitelných předpisů Evropských společenství o prekursorech drog59) pro soudně toxikologické laboratoře, laboratoře zdravotních ústavů, specializovaná diagnostická, vědecko-výzkumná a výuková pracoviště vysokých škol a specializovaná diagnostická a vědecko-výzkumná pracoviště Akademie věd České republiky | Kč 1 000 |
| d) | Vydání povolení k zacházení s prekursory – zvláštní povolení podle přímo použitelných předpisů Evropských společenství o prekursorech drog59) pro Policii České republiky, Armádu České republiky, Vězeňskou službu České republiky a Celní správu České republiky | Kč 500 |
| e) | Vydání povolení k zacházení s prekursory – zvláštní povolení podle přímo použitelných předpisů Evropských společenství o prekursorech drog59) | Kč 5 000 |
| f) | Vydání povolení k vývozu nebo dovozu omamných látek, psychotropních látek nebo přípravků je obsahujících | Kč 1 000 |
| g) | Vydání povolení k vývozu nebo dovozu prekursorů a k vývozu pomocných látek podle přímo použitelných předpisů Evropských společenství o prekursorech drog59) | Kč 1 000 |
| h) | Vydání povolení k vývozu nebo dovozu makoviny | Kč 500 |
| i) | Registrace jednotlivých činností s pomocnými látkami podle přímo použitelných předpisů Evropských společenství o prekursorech drog59) | Kč 3 000 |
| j) | Zvláštní registrace jednotlivých činností s pomocnými látkami podle přímo použitelných předpisů Evropských společenství o prekursorech drog59) | Kč 3 000 |
Exemption
Persons operating a pharmacy shall be exempt from the fees referred to in points (b), (e), (i) and (j) only when treating precursors and auxiliary substances when operating a pharmacy.
Amendment to the Drug Act
In Section 89 (2) of Act No 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (the Law on Medicines), the words "the relevant Region of Transferring 'are replaced by the words" State through the Regional Authority'.
EFFECTIVE
That law shall take effect on the first day of the calendar month following its publication.
Wolf
Klaus v. r.
Fischer v. r.
59) Regulation (EC) No 273 / 2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors. Council Regulation (EC) No 111 / 2005 of 22 December 2004 laying down rules for the monitoring of trade in drug precursors between the Community and third countries. '
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Regulation Information
| Citation | Act No. 141 / 2009 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 | 25.05.2009 |
|---|---|
| Effective from | 01.06.2009 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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