Download 1. ------IND- 2016 0145 HU- EN- ------ 20160405 --- --

1. ------IND- 2016 0145 HU- EN- ------ 20160405 --- --- IMPACT
Impact assessment of the amendment of Act XXV of 1998 on medicinal products for
human use
The following rows 74–77 are added to ‘A) Schedule’ in the Annex to Act XXV of 1998 on
medicinal products for human use:
[A
B
Official name(or other name or
abbreviation, or way of writing
Chemical name]
often used abroad)
74. MTP, methcathinone thiophen 2-(methylamino)-1-(thiophen-2-yl)propan-1-one
analog
2-(2-chlorophenyl)-2-(ethylamino)cyclohexanone
75. N-ethylnorketamine
76. AM-1248 azepane isomer
77. ADB-FUBINACA
74. MTP, methcathinone thiophen
analog
adamant-1-yl[1-(1-methylazepan-3-yl)-1H-indol-3yl]methanone
N-[1-(aminocarbonyl)-2,2-dimethylpropyl]-1-[(4fluorophenyl)methyl]-1H-indazole-3-carboxamide
2-(methylamino)-1-(thiophen-2-yl)propan-1-one
This is a derivative of the stimulant phenylalkylamine, which belongs to the cathinone group.
The substances in this group cause addiction in around 20 % of cases. As a methamphetamine
analog, it is a stimulant of the central nervous system which causes behavioural changes,
euphoria and sleeping problems. Its use can also lead to rebound depression.
75. N-ethylnorketamine
2-(2-chlorophenyl)-2-(ethylamino)cyclohexanone
This is a substance which is similar in structure to ketamine. It has the same effects as
ketamine, but is approximately 1.5 times more potent. Side effects include sensory and
orientation problems, hallucinations, feelings of depersonalisation, bluntness, drowsiness,
memory and learning difficulties, severe anxiety, panic, paranoia, aggression, high blood
pressure and an increased heart rate. Given the similar structure, this substance can result in
addiction. It may lead to abuse and adverse side effects similar to the listed PCP. While under
its influence, users' behaviour may be reckless and they may take excessive risks.
76. AM-1248 azepane isomer
adamant-1-yl[1-(1-methylazepan-3-yl)-1H-indol-3yl]methanone
This is a synthetic cannabinoid and analog of the original AM-1048 synthetic cannabinoid.
The effect of the drug is presumably similar to the parent compound, although no literature
data is available with regard to its strength. Its use can lead to comprehension difficulties and
mood swings. Like other cannabis derivatives, it can cause visual and auditory hallucinations.
The precise receptor effect is unknown. Cannabis derivatives cause addiction in 6–10 % of
cases.
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Although modest clinical data is available, due to its mind-altering effects, it may cause
public health problems. It is now referred to as a ‘designer drug’ on the Internet. It is likely, as
in the case of other cannabinoids in the Schedule, that abuse may lead to public health and
social problems.
77. ADB-FUBINACA
N-[1-(aminocarbonyl)-2,2-dimethylpropyl]-1-[(4fluorophenyl)methyl]-1H-indazole-3-carboxamide
Known as the ‘Facebook tablet’, this is a potent CB1 cannabinoid receptor agonist. Regular
stimulation of these receptors causes addiction in 6–10 % of cases. It is effective, even in very
small doses. The following side effects were noted in the 15 poisoning cases in May 2015:
drowsiness, breathing difficulties, CO2 retention, hypotonia, hypothermia, vomiting, sinus
tachycardia, dilated pupils, extrapyramidal movements, hyperkinesia, auditory and visual
hallucinations and restlessness.
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