Notification Detail

Government Decree amending Annex IV to the Government Decree on substances, preparations and plants to be classified as narcotics Two new substances – acetylfentanyl and ocfentanil – will be classified as narcotics.

Notification Number: 2015/361/FIN (Finland)
Date received: 09/07/2015
End of Standstill: 23/07/2015
Invocation of the Emergency Procedure: Yes

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Message 002

Communication from the Commission - TRIS/(2015) 02108
Directive 98/34/EC
Translation of the message 001
Notification: 2015/0361/FIN

No abre el plazo - Nezahajuje odklady - Fristerne indledes ikke - Kein Fristbeginn - Viivituste perioodi ei avata - Καμμία έναρξη προθεσμίας - Does not open the delays - N'ouvre pas de délais - Non fa decorrere la mora - Neietekmē atlikšanu - Atidėjimai nepradedami - Nem nyitja meg a késéseket - Ma’ jiftaħx il-perijodi ta’ dawmien - Geen termijnbegin - Nie otwiera opóźnień - Nao inicia o prazo - Neotvorí oneskorenia - Ne uvaja zamud - Määräaika ei ala tästä - Inleder ingen frist - Не се предвижда период на прекъсване - Nu deschide perioadele de stagnare - Nu deschide perioadele de stagnare.

(MSG: 201502108.EN)

1. Structured Information Line
MSG 002 IND 2015 0361 FIN EN 09-07-2015 FIN NOTIF



2. Member State
FIN


3. Department Responsible
Työ- ja elinkeinoministeriö
Työelämä- ja markkinaosasto
PL 32
FI-00023 VALTIONEUVOSTO

Puhelin +358 9 10 606 4686
Faksi +358 9 10 604 8998
maaraykset.tekniset@tem.fi


3. Originating Department
Sosiaali- ja terveysministeriö


4. Notification Number
2015/0361/FIN - C00C


5. Title
Government Decree amending Annex IV to the Government Decree on substances, preparations and plants to be classified as narcotics

Two new substances – acetylfentanyl and ocfentanil – will be classified as narcotics.


6. Products Concerned
Acetylfentanyl
IUPAC: N-(1-Phenethylpiperidin-4-yl)-N-phenylacetamide
CAS: 3258-84-2

Ocfentanil
IUPAC: N-(2-fluorphenyl)-2-methoxy-N-[1-(2-phenylethyl)piperidin-4-yl]acetamide
CAS: 101343-69-5


7. Notification Under Another Act
-


8. Main Content
Finland intends to define the substances as narcotics within the meaning of the Narcotics Act (373/2008), with the result that among other things, these substances may not be manufactured, imported, distributed or held in one’s possession without a separate permit from the Finnish Medicines Agency.


9. Brief Statement of Grounds
Acetylfentanyl is a potent synthetic opioid that, based on its structure, belongs in the phenylpiperidine class. It is a derivative of the potent fentanyl, which is classified as a narcotic and used as an analgesic. Based on its structure and pharmacological properties, ocfentanil is a synthetic opioid related to fentanyl, which has been classified as a narcotic.

In addition to its analgesic effect, substances similar to fentanyl cause the same pharmacological effects as other opioid analgesics: mood changes, euphoria, drowsiness, hypoventilation, suppression of cough reflex, constriction of pupils and slowdown of digestive tract movements. An overdose of opioids may be fatal due to hypoventilation.

Based on their health effects and pharmacological properties, these substances should be equated to narcotics, which, when abused, will cause damage similar to that caused by substances classified as narcotics. The substances are not controlled substances in the UN or the EU. These substances have been reported to the Early Warning System of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) and now their abuse has spread to Finland.


10. Reference Documents - Basic Texts
Reference(s) to basic text(s): Annex: Government Decree amending Annex IV to the Government Decree on substances, preparations and plants to be classified as narcotics


11. Invocation of the Emergency Procedure
Yes


12. Grounds for the Emergency
Protection of public health. The substances should be urgently classified as narcotics, as there is a potential user population. The national health risks of fentanyl derivatives are comparable to those of fentanyl and other opioids. The use of fentanyl derivatives may be primarily of interest to prior users of opioids. Abuse of these substances has already spread to Finland.


13. Confidentiality
No


14. Fiscal measures
No


15. Impact assessment
Yes


16. TBT and SPS aspects
TBT aspect

No – the draft has no significant impact on international trade.

SPS aspect

No – the draft has no significant impact on international trade.




**********
European Commission

Contact point Directive 98/34
Fax: +32 229 98043
email: dir83-189-central@ec.europa.eu

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