Changes To The Laws On Addictive Substances, On The Administrative Fee. And On Pharmaceuticals

Original Language Title: změny zákonů o návykových látkách, o správních popl. a o léčivech

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Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=68632&nr=141~2F2009~20Sb.&ft=txt

141/2009 Sb.



LAW



of 28 June. April 2009,



amending the Act No. 167/1998 Coll., on addictive substances and amending

certain other acts, as amended, and certain other

the laws of the



Parliament has passed the following Act of the United States:



PART THE FIRST



Amendment of the Act on addictive substances



Article. (I)



Act No. 167/1998 Coll., on substance abuse and on the amendment of certain other

laws, as amended by Act No 354/1999 Coll., Act No. 121/2000 Coll., Act

No 132/2000 Coll., from ákona No 57/2001 Coll., Act No. 185/2001 Coll., Act

No. 407/2001 Coll., Act No. 320/2002 Coll., Act No. 222/2003 Coll., Act

No 362/2004 Coll., Act No. 228/2005 Coll., Act No. 74/2006 Coll., Act

No 124/2008 Coll. and Act No. 41/2009 Coll., is amended as follows:



1. in article 1, paragraph 1, including footnote No 1 is added:



"(1) this Act regulates the following on directly applicable provisions of

Of the European Communities ' ^ 1 ') treatment of precursors and other substances and

provides the power and scope of the administrative bodies of compliance with the

the obligations laid down by law and the directly applicable provisions

Of the European Communities ' ^ 1 '), which, according to these directly applicable

regulations of the European Communities shall be exercised by the Member State.



1) European Parliament and Council Regulation (EC) No 273/2004 of 11 March.

February 2004 on drug precursors.



Council Regulation (EC) No 111/2005 of 22 December 2004. 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 June. July 2005

detailed rules for the regulation of the European Parliament and of the Council (EC)

No 273/2004 on drug precursors and for 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 (1). 2 (a). (c)), the words "a greater amount than the 30 mg

pseudoephedrine in the drive of the formulation "shall be replaced by

"pseudoephedrine".



3. In § 3a paragraph 2. 1, the words "category 2 and 3 ' shall be deleted.



4. In section 3a is inserted after paragraph 1, paragraph 2, which reads as follows:



"(2) the handling of precursors is subject to authorization or special

authorisation in accordance with applicable regulations of the European right

Community ^ 1). ".



The former paragraph 2 becomes paragraph 3.



5. In section 3a, paragraph 3 reads:



"(3) to the treatment of the other category 2 and 3 shall be

registration or special registration under directly applicable regulations

Of the European Communities ^ 1). ".



6. In section 4, 7, § 17 para. 1, § 18 para. 1, § 19 para. 2, § 26 para. 1 to

3 and § 36 odst. 1 (b). (b)), the words "products and precursors"

replaced by the words "and preparations".



7. in § 5 para. 2 (a). (g)), the word "laboratory" is replaced by

"assistants".



8. in § 5 para. 3 the words "products and precursors" shall be replaced by

"and preparations," and the words "products and precursors" shall be replaced by

"and preparations".



9. section 6, including the title.



10. In § 8 para. 1, the second sentence is replaced by the phrase "the authorization to the treatment

is not issued if the person fails to comply with the requirements for a request under

paragraph 7. ".



11. In § 8 para. 3 (b). (b) set out) the words "directly applicable

regulations of the European Communities ^ 1) "is replaced by" 3 years and special

the authorization to the treatment of precursors is issued for an unlimited period of time. "



12. In section 8 paragraph 1. 7, the first sentence of the following sentence "the application shall

provide proof of the applicant's statements that, in the case of activities which are

comes into direct contact with addictive substances and preparations will be elected

the appropriate way to their security pursuant to section 10 and 11 ".



13. in § 9 para. 3 the words "to the treatment of addictive substances" are deleted.



14. in § 13 para. 1, the first sentence is replaced by the phrase "Drug ^ 6) containing the

addictive substances and medicines containing ephedrine and pseudoephedrine may be

issued in a pharmacy to a person that has not been issued a permit to the treatment,

only on prescription, requisition, or no prescription limited ^ 6a). ".



Footnote No. 6 and 6a shall be inserted:



"6) Law No 378/2007 Coll., on pharmaceuticals and on changes of some

related laws (law on medicinal products), as amended.



6a) § 39 para. 3 of the law No 378/2007 Sb. ".



Former footnote No. 6a and 6b are referred to as comments below

line no. 6b and 6 c, including references to footnotes.



15. In § 13 para. 1 the second sentence, the words "a recipe or requisition marked"

replaced by the words "released only on a prescription or requisition marked".



16. in article 13, paragraph 5 is added:



"(5) on receipt, inventory, supply, return and the depreciation of the returned

the forms of recipes and requisitions with a blue stripe lead the municipal authorities of municipalities with

extended powers. As part of this registration is done by the annual

counting on the last day of the calendar year. ".



17. in section 16 of title is "Registration bodies engaged in the activities with the

the other ingredients ".



18. in article 16, paragraph 1 reads:



"(1) persons who intend to deal with the activities referred to in

applicable regulations of the European communities on drug precursors, and

it with the other ingredients in category 2 and 3 referred to in these regulations,

are required to register before beginning this activity for

The Ministry of health. An application for registration shall be submitted within 2

copies on forms issued by the Ministry of health. ".



19. in section 17(2). 1 and in section 18 para. 1 the words "and in section 6 (1). 1 (b). and)

(a). 2 ' shall be deleted.



20. in section 19 para. 2, the words "and in section 6 (1). 1 (b). and) "are deleted.



21. section 20a including title and footnote No. 8b:



"section 20a



The export and import of precursors



When you export and import of precursors of the process according to the directly applicable

the laws of the European Community on trade in drug precursors ^ 8b).



8B) Council Regulation (EC) No 111/2005 of 22 December 2004. 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 June. July 2005

detailed rules for the regulation of the European Parliament and of the Council (EC)

No 273/2004 on drug precursors and for Council Regulation (EC) No 111/2005,

laying down rules for the monitoring of trade in drug precursors between the

Community and third countries. '.



Footnote No. 8 c-8i are deleted, including links to

the footnote.



22. section 20b including title:



"section 20b



The export of excipients



When you export the excipients listed in category 2 and 3 directly

applicable regulations of the European communities on drug precursors ^ 1)

follow the directly applicable provisions of the European communities on

trade in drug precursors ^ 8b) ".



Footnote # 8 k is deleted, including a link to the note under

line.



23. in section 22 para. 3 at the end of the text of the third sentence, the words ",

including the reason why import or export has not taken place ".



24. in section 26 para. 1 (b). a) to (c)) and in section 26 para. 3 (b). a), the words "

, products and precursors "shall be replaced by the words" and preparations ".



25. in section 26 para. 2 to 4, the words "and in section 6 (1). 3 "shall be deleted.



26. in section 27 para. 1 the first sentence, the words "regional authority" be replaced by

the words "State Institute for drug control", and in the second sentence, the words

"Ministry of health" shall be replaced by the words "State Institute for

drug control ".



27. in section 27 para. 2, the words "regional authority" be replaced by "State

Institute for drug control ".



28. section 28 including the title reads as follows:



"section 28



The obligation for activities with other ingredients



(1) persons who are engaged in, or in the last calendar year

deal with the activities set out in the applicable regulations of the European

Community ^ 1) with the other category 2 and 3 set out in these

regulations, are required to transmit to the Ministry of health



and). February for the previous calendar year summary reports on the

activities with the other category 2 and 3 according to the directly applicable

regulations of the European Communities ' ^ 1 '),



(b)), all information about unusual circumstances by the directly applicable

regulations of the European Communities ^ 1).



(2) persons registered with the Ministry of health in accordance with § 16 are

obliged to under 15. February of the following calendar year inform the

The Ministry of health on the activities with the other category 2

and 3 referred to in legislation directly applicable European

Community ^ 1), even in the case that for the previous calendar year

These activities were over.



(3) the information referred to in paragraph 1 (b). a) submitted on forms

issued by the Ministry of health in writing or in electronic form

equipped with advanced electronic signature ^ 10a). ".



Footnote # 8j and 10f are deleted.



29. in section 29 (b). and) and c) at the end of paragraph 1, the words "or

the identification number of the soil block, or a part of the soil block

registration of land ".



30. In paragraph 29 (b). (c)) at the end of paragraph 2 is replaced by a comma and dot

the following paragraph 3 is added:



"3. the weight, the year of harvesting poppy concentrate or hemp sold or otherwise

the converted and details of the new acquirer. ".




31. in § 31 para. 1, after the words "the Ministry of health,"

the words "except for the information referred to in section 27, which shall be submitted on forms

published by the State Institute for drug control, ".



32. In section 34 para. 1, after the words "this Act", the words "and of the

directly applicable regulations of the European Communities ' ^ 1 ') "and the word" its "

shall be replaced by the word "their".



33. In § 34 paragraph 1. 1 at the end of the text of subparagraph (c)), the words ",

If it's not about inspections of pharmacies or control of compliance with the obligations

arising from the applicable regulations of the European communities directly ^ 1)

and from the decision issued on the basis thereof ".



34. In section 34 para. 1, letter c) the following point (d)), which read as follows:



"(d)) of the State Institute for drug control in matters relating to

pharmacies ".



Subparagraph (d)) and e) shall become letters (e)), and (f)).



35. In section 34 para. 1 at the end of the text of the letter e), the words "and

the control of the Customs authorities of the obligations arising from the right

applicable regulations of the European Communities ' ^ 1 ') and of the decision of the

issued on the basis thereof ".



36. In article 34, paragraph 1, the following paragraph 2 is added:



"(2) inspectors are authorized to make unannounced inspections in advance.".



Paragraphs 2 to 7 shall become paragraphs 3 to 8.



37. In § 36 odst. 1 (b). and) the words "(§ 3a paragraph 2. 2) "is replaced by

"(§ 3a paragraph 2. 3) ".



38. In § 36 odst. 1 p) is added:



"p) takes the addictive substances or preparations with their content without an export

the authorization pursuant to section 20, ".



39. In § 36 odst. 1 the letter q) repealed.



40. In article 36, paragraph 1, the following paragraph 2 is added:



"(2) a legal entity or individual entrepreneur is also committed by the administrative

tort by



and activity,) which is required by directly applicable

Regulation of the European communities on drug precursors ^ 1)

treatment or special treatment permit, without this authorisation,



(b)) when you export or import of precursors in contravention of section 20a,



(c)) shall proceed when you export or import of excipients, contrary to section

20b. ".



Paragraphs 2 to 5 shall become paragraphs 3 to 6.



41. In § 36 odst. 3 (b). a) and (c)), the words "regional authority" be replaced by

the words "State Institute for drug control".



42. In article 36, paragraph 5 is added:



"(5) a legal entity or individual entrepreneur, which deals with the

or in the past calendar year, dealt with the activities with the other

substances of category 2 and 3 set out in the applicable regulations

Of the European communities "^ 1"), is guilty of an administrative offense, by



and the summary report does not pass) activities with the other ingredients category

2 and 3 in violation of § 28 para. 1 (b). (a)) 3 or in the report shall be

incorrect or incomplete information, or



(b)) does not pass all the information about the unusual circumstances in accordance with § 28 para.

1 (b). b).“.



43. In section 36 shall be inserted after paragraph 5 a new paragraph 6 is added:



"(6) a legal entity or individual entrepreneur as a person

registered with the Ministry of health under section 16 commits

the administrative offense that does not inform about the activities with other ingredients

category 2 and 3 in violation of § 28 para. 2. ".



The present paragraph 6 is renumbered as paragraph 7.



44. In § 37 para. 1 (b). (b)) the letter ', q) "is deleted.



45. In article 37, paragraph 1, the following paragraph 2 is added:



"(2) an administrative offence under § 36 odst. 2, fined the



and $10 000 000), in the case of an administrative offence under (a)), (b)) or

subparagraph (c)), if it is for export or import of auxiliary substances of category

2 ^ 1)



(b)) 1 000 000 CZK in the case of an administrative offence referred to in subparagraph (c)), if the

It is for export or import of auxiliary substances of category 3 ^ 1). ".



Paragraphs 2 to 5 shall become paragraphs 3 to 6.



46. In § 37 para. 3, the number "2" is replaced by "3".



47. In § 37 para. 4, the number "3" by "4".



48. In article 37, paragraph 5 is added:



"(5) for the administrative offence under § 36 odst. 5 are imposed to 1 000 000

CZK. ".



49. In article 37, paragraph 5 the following paragraph 6 is added:



"(6) for the administrative offence under § 36 odst. 6 500 000 imposed in

CZK. ".



The present paragraph 6 shall become paragraph 7.



50. in § 37 para. 7, the number "5" shall be replaced by "7".



51. In section 40 para. 4, the number "4" is replaced by "5".



52. In § 40 paragraph 5 is added:



"(5) administrative offenses under § 36 odst. 1 (b). (g))), y), and z), committed

in a medical facility outside the pharmacy, in the first instance hearing

regional authority. ".



53. In § 40 paragraph 5 the following paragraph 6 is added:



"(6) administrative offenses under § 36 odst. 1 (b). (g))), y), and z) and under section

paragraph 36. 3 (b). a), b) and (c)), committed in pharmacies, in the first instance

discusses the State Institute for drug control. ".



Paragraphs 6 to 11 shall become paragraph 7 to 12.



54. In paragraph 2 of section 40. 7, the number "5" shall be replaced by "7".



55. In section 40 para. 8, the number "3" by "4".



56. In section 44b is added after the words "§ 43 para. 6 "the words", including the annexes,

of which they are an integral part of, ".



57. in annex No. 1, in the column "international non-proprietary name (INN)

Czech language "after the entry" Opium "the following item" Oripavin "and

in the column headed "chemical formula" words

"4?-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

the generic name "after the entry" Benzfetamin "inserts a new item

"And in the column" Benzylpiperazine "chemical name" Word

"1-benzylpiperazine".



PART TWO



Amendment of the Act on administrative fees



Article. (II)



In the annex to the 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. 48/2006 Coll., Act No. 56/2006 Coll., Act No. 57/2006 Coll.

Act No. 81/2006 Coll., Act No. 109/2006 Coll., Act No. 112/2006 Coll.

Act No. 130/2006 Coll., Act No. 137/2006 Coll., Act No. 137/2006 Coll.,

Act No. 159/2006 Coll., Act No. 179/2006 Coll., Act No. 186/2006 Coll.

Act No 215/2006 Coll., Act No. 227/2006 Coll., Act No. 227/2006 Coll.

Act No. 235/2006 Coll., Act No. 309/2006 Coll., Act No. 575/2006 Coll.

Act No. 106/2007 Coll., Act No. 261/2007 Coll., Act No. 261/2007 Coll.

Act No. 374/2007 Coll., Act No. 379/2007 Coll., Act No. 38/2008 Coll.,

Act No. 130/2008 Coll., Act No. 140/2008 Coll., Act No. 182/2008 Coll.,

Act No. 189/2008 Coll., Act No. 230/2008 Coll., Act No. 239/2008 Coll.,

Act No. 254/2008 Coll., Act No. 297/2008 Coll., Act No. 297/2008 Coll.,

Act No 301/2008 Coll., Act No. 309/2008 Coll., Act No 312/2008 Coll.,

Act No. 382/2008 Coll., Act No. 9/2009 Coll. and Act No. 41/2009, Coll.,

item 100, including footnote # 59:

"Item 100

and the issue of permits to treatment) drugs

substances, psychotropic substances, or

preparations containing $5,000 is



b) authorisation to dealing with precursors-

authorisation in accordance with the applicable legislation directly

Of the European communities on precursors

drugs ^ 59) $3,000

c) authorisation to dealing with precursors-

authorisation in accordance with the applicable legislation directly

Of the European communities on precursors

^ 59) for drug court-toxicology

the laboratory, the laboratory of health

institutes, specialized diagnostic,

research and teaching departments

universities and specialized

diagnostic and scientific research departments

Academy of Sciences of the Czech Republic, Eur 1 000

d) authorisation to dealing with precursors-

a special permit by directly applicable

the laws of the European communities on

drug precursors ^ 59) for the police

The Czech Republic, the army of the Czech Republic,

The prison service of the Czech Republic and customs

the administration of the United States-$ 500

e) authorisation to dealing with precursors-

a special permit by directly applicable

the laws of the European communities on

drug precursors ^ 59) $5,000

f) licence to export or import

narcotic substances, psychotropic substances

or preparations containing £ 1,000

g) licence to export or import

the export of precursors and auxiliary substances

by directly applicable regulations

Of the European communities on precursors

drugs ^ 59) $1,000

h) release the authorization to export or import

poppy concentrate-$ 500

I) registration of individual activities

with the other ingredients by directly

applicable regulations of the European

the community on drug precursors ^ 59) $3,000

j) special registration of individual

activities with the other ingredients according to

the directly applicable provisions of the European

the community on drug precursors ^ 59) $3,000



Exemption



From the fees referred to in subparagraphs (b)), (e)), i) and (j)) of this item shall be exempt

a person operating a pharmacy, and that's only when dealing with precursors and

the other ingredients during the operation of the pharmacy.



59) European Parliament and Council Regulation (EC) No 273/2004 of 11 March.

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. '.



PART THREE



Changing the law on pharmaceuticals



Article. (III)



In § 89 paragraph 1. 2 of law No 378/2007 Coll., on pharmaceuticals and on changes of some

related laws (law on medicinal products), the words "the competent State

by "are replaced by the words" the State, through the regional

the Office ".



PART FOUR



The EFFECTIVENESS of the



Article. (IV)



This Act shall take effect on the first day of the calendar month

following the date of its publication.



Vaidya in the r.



Klaus r.



Fischer v. r.