117/2000 Sb.
LAW
of 6 May 1999. April 2000,
amending the Act No. 167/1998 Coll., on addictive substances and amending
certain other laws, as amended by Act No 354/1999 Coll. and Act No.
368/1992 Coll., on administrative fees, as amended
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 is amended as follows:
1. In article 1 (1). 2 letter a) including footnote # 2):
") in pharmaceuticals in dosage form, a ^ 2) with the exception of medicinal products
containing ephedrine and medicinal products containing greater amounts of
than 30 mg pseudoephedrine in unit dosage forms,
2) § 2 (2). 3 of Act No. 79/1997 Coll., on pharmaceuticals and on changes and additions to the
some related laws. ".
2. In article 1 (1). 2 (a). (b)), the words "used or obtained by using again
available resources "shall be replaced by the words" an easy way to apply or
recovered easily applicable ways. "
3. In paragraph 2 (a). (d)), the words "annex 10" the words "or in the
Annex # 11 ".
4. In article 3, paragraph 3. 2 the second sentence, the word "or" is replaced by a comma and at the end of
shall be added the words "or for other purposes on the basis of the authorisation
The Department of health ".
5. § 5 para. 1, after the words "containing" the words "or
preparations containing ephedrine and pseudoephedrine.
6. in § 5 para. 1 (b). a) after the word "Pharmacy" is a reference to the
footnote 2a) is added:
' 2a) § 16 para. 5 of Act No. 79/1997 Coll. ".
7. in § 5 para. 1 (b). (b)), after the words "disposing" the words ",
If they are not stored ".
8. in § 5 para. 2, after the words "this Act", the words "and
preparations containing ephedrine and pseudoephedrine.
9. in § 5 para. 2 (f)):
"(f)) according to the physician filled out and signed form (the recipe-based
"the recipe") or the order of natural and legal persons authorized to
provide health care or veterinary care (hereinafter referred to as "requisition")
to prepare and issue the pharmacists in pharmacies ".
10. in § 5 para. 2 at the end of subparagraph (j)) is replaced by a comma and dot
the letter k is added) including footnote 5a):
"to acquire, shriveled), store, transport or use of contracting authorities
or the investigator in the preparation or conduct of the trial
veterinary drugs under special legislation. ^ 5a)
5A) section 39 of Act No. 79/1997 Coll. ".
11. in § 5 para. 4, after the words "this Act", the words "and
preparations containing ephedrine and pseudoephedrine.
12. in section 6 (1). 1 (b). (c)), after the words "disposing" the words "
If they are not stored ".
13. in § 8 para. 3 the words "1 year" shall be replaced by "2 years".
14. in § 8 para. 5, the first sentence is replaced by the following sentences:
"The authorization to the treatment of good repute may be issued only to a natural person,
that has permanent residence in the territory of the Czech Republic, or to a legal person, the
based in the Czech Republic. The condition of permanent residence or headquarters in the Czech
the Republic does not apply in the case of a citizen of a Member State of the European Union,
a citizen of the United States, which does not have to stay in the Czech Republic,
or a legal person established in a Member State of the European Union.
A legal entity is obliged to prove the integrity of the natural persons who
they are entered in the commercial register as a person authorized to act for her;
the legal entity that will be entered in the commercial register, proof of
integrity of individuals, which are noted in the formation
documents as the person authorized to act for it. ".
15. In paragraph 8, the following paragraph 9 is added:
"(9) if the natural or legal person to carry on business,
that authorisation was granted to her treatment, it shall notify the
immediately to the Ministry of health that the authorization to the treatment of your
cancels the decision. ".
16. in section 9, paragraph 3 is added:
"(3) the responsible person can be appointed a natural person as permanent
the stay on the territory of the Czech Republic. The condition of permanent residence in the Czech
the Republic does not apply in the case of a citizen of a Member State of the European Union
or a citizen of the United States that does not have in the territory of the Czech Republic
the stay. This person must meet prerequisites General, medical and vocational
eligibility for the treatment of addictive substances. ".
17. in section 9, paragraph 3, the following paragraph 4 is added:
"(4) the medical fitness of the person responsible certifying medical
opinion. Opinion on the medical certificate issued by a doctor on examining the
based on the result of the medical examination, or other professional
examination. In cases where the responsible person is an employee in the
the ratio is posuzujícím doctor doctor facilities for racing
preventive care, in other cases, registering a general practitioner.
Opinion on the medical fitness of the responsible person is valid for 2 years from
the date of issue, unless there is a change in health status. For
medically qualified person responsible cannot be recognized by a person who
was reason to suspect that, in the exercise of this function would be jeopardised
her health or life, or that could arise in the performance of functions
the persons responsible in relation to the health of that person to the
threat to the health or life of other persons. ".
Paragraphs 4 to 9, shall be renumbered as paragraphs 5 to 10.
18. in § 9 para. 10, the number "30" is replaced by "10".
19. in section 10, paragraph 1. 1, after the word "ceilings" replaced by the word "and" with a comma, for
the word "flooring" with the words "Windows and doors" and at the end of the
the words "made of metal" are replaced by the words "steel or in a special for this purpose
the lockable device manufactured based on the wall, inseparably
the ceiling or floors made of hard materials (for example, brick
or concrete panels) ".
20. in section 10, paragraph 1. 4, the first sentence of the following sentence shall be inserted:
"Storage in these cases, however, it must be ensured, so that the
inventory of substances not access unauthorized persons. "and in the last sentence of the
the words "in annex No. 1 or 5" shall be replaced by ' in annex No. 1, 3, 4
or 5 ".
21. in paragraph 12 of the present text shall become paragraph 1 and the following
paragraph 2, which reads as follows:
"(2) the excipients listed in annex 10 of this law may be
sold only to persons who are entitled to dealing with and that
the seller shall submit the completed statement to the form issued by the
The Ministry of health. ".
22. section 13 including title and footnote No 6) and 6a):
"section 13
The forms for the recipes and requisitions with blue stripe
(1) the drug ^ 6) containing addictive substances and medicines containing ephedrine and
medicinal products containing more than 30 mg of pseudoephedrine in the drive
the pharmaceutical form may be issued to a person at the pharmacy, which has not been issued
the authorization to the treatment, only on the recipe or requisition. If this is about
medicines that contain addictive substances referred to in annexes 1 and 5
of this Act, must be a recipe or requisition marked with blue stripe
facing from bottom left to the top right corner. If this is about
medicinal preparations containing addictive substances referred to in annexes 1 and 5
of this Act and at the same time as referred to in annex 8 of this law, may
be issued in the pharmacy on prescription or requisition without marking blue
bar.
(2) the forms of recipes and requisitions with a blue stripe designating the ordinal
numbers of the form and the code of the County, which is issued, are subject to registration.
(3) the forms of recipes and requisitions with a blue stripe and can order
remove from the premises of the competent District Office, only the persons mentioned in §
5 (3). 2 (a). a) and b) of this Act, through its authorised
representatives. The next time you use the person's record.
(4) the production and distribution of recipes and requisitions with a blue stripe secure
the district authorities.
(5) the issue, return and undermining of the returned recipes and requisitions with
blue stripe lead the district offices.
(6) the Debased forms of the recipes or requisitions with a blue stripe are
the persons referred to in § 5 para. 2 (a). a) and b) of this Act are required to
commit the District Office which issued it.
(7) persons who no longer, fulfil the conditions set out in § 5 para. 2
(a). a) and b) of this Act, are required to surrender through
their appointed representatives of the unused or degraded forms of recipes
or requisitions with a blue stripe within 5 days the district authority that issued it.
About the takeover cast forms District Office will issue the certificate.
(8) when the death of a person, that were released with recipes or requisition forms
blue stripe authorised agent or directly by the District Office, is because
who lived with the deceased in the same household must have these forms
deliver within 10 days from the date of death of the authorized representative, if this is about
the person who was in employment or similar
the relationship, in other cases the District Office.
(9) the distribution, returns, liquidation and keeping records about the recipes and
requisitions with a blue stripe regulates special legislation. ^ 6a)
(10) the medicinal products containing addictive substances and medicines containing ephedrine and
pseudoephedrine cannot be issued repeatedly to one recipe.
6) § 2 (2). 1 of Act No. 79/1997 Coll.
6a) Decree No. 347/1997 Coll., laying down the method of prescribing
medicinal products, the particulars of prescriptions and their rules
use. ".
23. in article 14, paragraph 2, including footnote No. 6b):
"(2) the disposal of unusable substances, preparations and
precursors, as well as waste containing the drug, which are governed by the
special legislation. ^ 6b)
6B) § 50 of Act No. 79/1997 Coll. ".
24. In the title of § 16, after the word "third-party" the words ", exporters,
importers and retailers ".
25. In paragraph 16, the word "produce" the words "processing AIDS" and
shall be inserted after the words "or to export or import the excipients listed in
Annexes 10 and 11 of this Act, or to sell the excipients listed
in annex 10 of this Act, "and at the end of the first sentence shall be replaced by the word
"production", the word "activities".
26. in section 20 (2). 1, the first sentence is replaced by the following:
"To each individual export of addictive substances, preparations, precursors
and the excipients in the cases referred to in paragraph 3 shall be subject to authorization
The Ministry of health (hereinafter referred to as "export permit").
27. in section 20 (2). 2 (a). and) the words "in annex No. 2, 6 or 7 of this
the Act "shall be replaced by ' in annex No. 2, 6, 7 or 8 of this Act,
or preparations containing ephedrine or pseudoephedrine.
28. in section 20 (2). 2 (a). (b)) the words ' listed in annex No. 8
This law "the words" or of preparations containing ephedrine or
pseudoephedrine "and at the end of the words" or preparations
containing ephedrine or pseudoephedrine.
29. in section 20 (2). 2 (a). (c)), the words "Annex No. 2, 5, 6, or 7
This Act "shall be replaced by ' in annex No. 2, 5, 6, 7 or 8 of this
the law, or of preparations containing ephedrine or pseudoephedrine.
30. In article 20 (2). 2 (a). (d)), the words "Annex No 1, 2, 5, 6, or 7
This Act "shall be replaced by ' in annex No. 1, 2, 5, 6, 7 or 8
of this Act, or of preparations containing ephedrine or
pseudoephedrine. "
31. in § 20 paragraph 3 reads:
"(3) the Ministry of health Decree lays down the cases in which
requires an export permit to export of excipients, if the export
excipients without an export permit does not allow an international treaty,
the Czech Republic is bound, or if the requiring of export
enabling it is recommended that an international governmental organization
the fight against the illicit production of drugs and illicit trafficking
them. About the exportation of excipients, listed in annex No. 10
the Ministry of health shall inform the competent authority of the State to which
to be export takes place, if such an authority on information requests
through international governmental organizations engaged in the fight against
the illicit production of drugs and illicit trafficking ".
32. In section 21 para. 2 (a). and) the words "in annex No. 2, 6 or 7 of this
the Act "shall be replaced by ' in annex No. 2, 6, 7 or 8 of this Act,
or preparations containing ephedrine or pseudoephedrine.
33. In paragraph 21 of the paragraph. 2 (a). (b)) the words ' listed in annex No. 8
This law "the words" or of preparations containing ephedrine or
pseudoephedrine. "
34. In section 21 para. 2 (a). (c)), the words "Annex No. 2, 5, 6, or 7
This Act "shall be replaced by ' in annex No. 2, 5, 6, 7 or 8 of this
the law, or of preparations containing ephedrine or pseudoephedrine, ".
35. In section 21 para. 2 at the end of paragraph (d) is replaced by a comma and dot)
the following point (e)), which read as follows:
"e) to imports of proprietary medicinal products containing
addictive substances listed in Schedule 1, 2, 5, 6, 7 or 8 of this Act,
or medicinal products containing ephedrine or pseudoephedrine, if
imported units of the army of the United States upon termination or
restrictions on their activities abroad as the balance of stocks that have been
for their activities. ".
36. In § 26 para. 1 at the end of subparagraph (b)), the words "with the exception of
the products referred to in annex 8, ".
37. In section 26 para. 1 at the end of subparagraph (c)), the words ", with the exception of
products listed in annex No. 8 ".
38. In section 27, after the word "authority" the words "who has opened a pharmacy
or, "and at the end the words" with the exception of the products referred to in
Annex No. 8 of this Act ".
39. under section 27 shall be added to § 27a, which including the footnotes.
10A) is inserted:
"§ 27a
(1) a person operating a pharmacy and drug distributors ^ 10a) are required to
not later than 10. January of the calendar year to report the district
or urban veterinary preparations containing addictive subscription management
substances listed in the annexes 1 and 5 of this Act, with the exception of those
listed in annex 8 of this Act, for veterinarians
the previous calendar year.
(2) District and the city's veterinary service are required to pass the Constitution
for State control of veterinary Biologicals and medicaments to end of January
calendar year report for the previous calendar year of the consumption
preparations containing addictive substances referred to in annexes 1 and 5
This Act, with the exception of those listed in annex 8 of this
law, veterinary surgeons.
(3) the Institute for State control of veterinary Biologicals and medicaments is
obliged to transmit to the Ministry of health to the end of February calendar
year for the previous calendar year of the consumption of products
containing addictive substances referred to in annexes 1 and 5 of this Act,
with the exception of those listed in annex 8 of this Act,
veterinary surgeons.
10A) § 4 paragraph 2. 3 of Act No. 79/1997 Coll. ".
40. In the heading of section 28, the "producers", the words ", exporters and
importers ".
41. In article 28, the words "as manufacturers of excipients," after the words
"(§ 16)" with the words "with the exception of dealers of excipients"
After the word "manufacture" shall be inserted after the words "import and export" and at the end of the
the words "referred to in annexes 10 and 11 of this Act".
42. In article 32, paragraph 1, the following paragraph 2 is added:
"(2) of the export and import of excipients are required to keep a record of (i)
the person subject to the provisions of § 20 para. 3 this Act. ".
The former paragraph 2 becomes paragraph 3.
43. In § 33 para. 1, after the word "substances", the words "preparations,
"precursors" and other ingredients ".
44. in annex No 1 column "international non-proprietary name (INN)
the language of ", the words" Concentrate of poppy straw "are replaced by the words
"Concentrate from poppy concentrate" and in the "Note", the following text
"poloprodukt for the manufacture of alkaloids obtained treatment
poppy concentrate ".
45. in annex No. 1 of the column ' Note ", the narcotic" Levomethorfan "
the words "dextromethorphan Isomer [(+)-3-methoxy-N-methylmorfinan]
is excluded from the list of narcotic substances referred to in this annex ".
46. in annex No. 1 of the column ' Note ", the narcotic" Levorfanol "
the words "dextrorfanol Isomer [(+)-3-hydroxy-N-methylmorfinan]
excluded from the list of narcotic substances referred to in this annex ".
47. in annex No 1 column of the "Note" on narcotic substances "opium", the words
"D6 or CH5" shall be replaced by "D4 or CH2".
48. The Text of the notes at the end of the annex No 1 is added:
"Including isomers of narcotic drugs referred to in this list, esters and
ethers of narcotic substances referred to in this list and salts of narcotics
in this list, including the salts of isomers, esters and blended in all
cases where these salts can exist. ".
49. The Text of the notes at the end of Annex No. 2:
"Including isomers of narcotic drugs referred to in this list, salt
narcotic drugs referred to in this list, including the salts of isomers of substances
in this list, in all cases, when these salts can
exist. ".
50. in annex 5 column, "other international non-proprietary name or
the generic name "at" angel dust "psychotropic substances the following text
"PCP".
51. in annex No. 5 column "international non-proprietary name (INN)
the language of "into" Sekobarbital lines below the Word Word
"And in the column" Dronabinol "Note", the following text "matches in such a
stereochemickým varieties of delta-9-THC, such as.
[(-)-transdelta-9-THC] ".
52. in annex No 6 column, "other international non-proprietary name or
the generic name "are the" Kathin "following the word
"[(+)-norpseudoefedrin]".
53. the annex No. 8:
"Č. 8
PRODUCTS included in the list according to the single Convention on narcotic drugs
substances
(Decree No. 47/1965 Coll., as amended by communication No. 458/1991 Coll.)
+---------------------------------------+-------------------------------------------------------------------------+
| Preparations containing: | Conditions: |
+---------------------------------------+-------------------------------------------------------------------------+
| 1) one of the drugs: | Can contain one or more other substances (but not intoxicating) |
| Acetyldihydrokodein the amount of narcotic substances, | and |
| Dihydrocodeine | and) per tablet, capsule, ampoule, the cervix. in a different dosage form |
| Ethylmorfin | must not exceed 100 mg |
| Pholcodine | b) in solution must not be higher than the concentration of 2.5%. |
| Codeine | |
| Nikodikodin | |
| Nikokodin | |
| Norkodein | |
+---------------------------------------+-------------------------------------------------------------------------+
Difenoxin | 2) | a) the quantity shall not exceed difenoxinu per tablet, capsule, |
| | ampoule, the cervix. in another formulation of 0.5 mg. |
| | b) the amount of atropinia must be at least 5% of the amount |
| | difenoxinu per tablet, capsule, ampoule, the cervix, respectively. other |
| | formulation. |
+---------------------------------------+-------------------------------------------------------------------------+
| Difenoxylát | 3) and may not exceed the quantity difenoxylátu) per tablet, capsule |
| | ampoule, the cervix. in another formulation of 2.5 mg. |
| | b) the amount of atropinia must be at least 1% of the amount |
| | difenoxylátu per tablet, capsule, ampoule, the cervix, respectively. |
| | in a different formulation. |
+---------------------------------------+-------------------------------------------------------------------------+
| 4) Dextropropoxyphene | The amount of dextropropoxyphene |
| | &) must not exceed 135 mg per tablet, capsule, ampoule, cervix, |
| | eventually. in another formulation, |
| | b) in solution must not be higher than the concentration of 2.5%. |
| | The product must not contain any psychotropic substance. |
+---------------------------------------+-------------------------------------------------------------------------+
| 5) Cocaine | Quantities of cocaine, must not exceed 0.1% cocaine. |
+---------------------------------------+-------------------------------------------------------------------------+
| 6) Opium or morphine and morphine) quantity | may not exceed 0.2%. |
| (b)) can | can contain one or more other substances (but not |
| | narcotic drugs). |
| | Intoxicating substance contained in the product shall not be easily recovered |
| | in such quantity as to endanger the public health. |
+---------------------------------------+-------------------------------------------------------------------------+
| 7) opium powder Ipekakuanhový | a) quantity of opium in powder must not be higher than 10%. |
| | b) amount of ipekakuanhového root must not be higher than 10%. |
| | c) Quantity of one or more other substances (but not the narcotic) not |
| | be less than 80%. |
+---------------------------------------+-------------------------------------------------------------------------+
| 8)) and the amount of Propiram | not propiramu přesáhnout100 mg per tablet, capsule, |
| | ampoule, the cervix. in a different formulation. |
| | b) the amount of methyl cellulose in přípravkumusí be at least the same or more |
| | than propiramu. |
+---------------------------------------+-------------------------------------------------------------------------+
Including homeopathy manufactured products with a degree of dilution is
higher than D4 or CH2. ".
54. Annex # 10 reads as follows:
"Č. 10
AUXILIARY substances listed in table II of the UN Convention against
illicit traffic in narcotic drugs and psychotropic substances
(communication No. 461/1991 Coll.)
+---------------------------------------------------------------+------------------------+
| International non-proprietary name (INN) in the Czech language | Chemical name |
+---------------------------------------------------------------+------------------------+
| Anthranilic acid | 2-aminobenzoic acid |
+---------------------------------------------------------------+------------------------+
| Phenylacetic acid, phenylacetic acid, | |
+---------------------------------------------------------------+------------------------+
| Piperidine | hexahydropyridin |
+---------------------------------------------------------------+------------------------+
| Acetic anhydride | acetic anhydride |
+---------------------------------------------------------------+------------------------+
Including the salts of those substances in all cases where the existence of such
salt is possible. ".
55. After annex No 10 the following Annex No 11, which reads:
"Č. 11
AUXILIARY substances listed in table II of the UN Convention against
illicit traffic in narcotic drugs and psychotropic substances
(communication No. 461/1991 Coll.)
+---------------------------------------------------+-----------------------+
| International non-proprietary name (INN) in the Czech language | Chemical name |
+---------------------------------------------------+-----------------------+
| Acetone | 2-propanone |
+---------------------------------------------------+-----------------------+
| Ether | Diethyl ether |
+---------------------------------------------------+-----------------------+
| Hydrochloric acid | hydrochloric acid |
+---------------------------------------------------+-----------------------+
| Sulphuric acid | sulphuric acid |
+---------------------------------------------------+-----------------------+
| Potassium permanganate | Potassium permanganate |
+---------------------------------------------------+-----------------------+
| Methyl ethyl ketone | 2-butanone |
+---------------------------------------------------+-----------------------+
| Toluene | methylbenzene |
+---------------------------------------------------+-----------------------+
Including the salts of those substances in all cases where the existence of such
salt is possible, with the exception of the salts of hydrochloric acid and acid
sulfuric. ".
PART TWO
Amendment of the Act on administrative fees
Article II
Act No. 368/1992 Coll., on administrative fees, as amended by Act No.
10/1993 Coll., Act No. 72/1994 Coll., Act No. 85/1994 Coll., Act No.
273/1994 Coll., Act No. 36/1995 Coll., Act No. 118/1995 Coll., Act No.
160/1995 Coll., Act No. 301/1995 Coll., Act No. 151/1997 Coll., Act No.
305/1997 Coll., Act No. 148/1998 Coll., Act No. 157/1998 Coll., Act No.
167/1998 Coll., Act No. 63/1999 Coll., Act No. 167/1999 Coll., Act No.
167/1999 Coll., Act No. 222/1999 Coll., Act No. 326/1999 Coll., Act No.
353/1999 Coll., Act No. 359/1999 Coll., Act No. 360/1999 Coll., Act No.
363/1999 Coll., Act No. 46/2000 Coll. and Act No 62/2000, is amended
as follows:
In Tariff administrative fees in the following points (d) 131b)
(e)), and the note, which read as follows:
"(d)) registration producers, importers and exporters of auxiliary
$1000.0-substances
(e)) registration of dealers of excipients, Eur 1000.0-
Note:
The fee referred to in subparagraph (d)) this item is selected for registration of manufacturers,
importers and exporters of excipients that are listed in the annexes, No 10
and 11 of Act No. 167/1998 Coll., on addictive substances and amending certain
other laws, as amended by Act No. 118/2000 Sb.; fee referred to in point (a)
e) this item is selected for registration of sellers of excipients which
are listed in annex 10 of the same Act. ".
PART THREE
The EFFECTIVENESS of the
Article. (III)
This law shall enter into force on 30 April 2005. June 2000, with the exception of article. (I)
paragraph 22, regarding the provisions of § 13 para. 2, which shall take effect
on 30 April 2005. June 2001.
Klaus r.
Havel, v. r.
Zeman in r.
