Notification Detail

Amendment of Decree No 55/2014 of the Ministry of Human Capacities of 30 December 2014 on substances or groups of compounds classified as new psychoactive substances (hereinafter: ‘Decree’)

Notification Number: 2022/49/HU (Hungary )
Date received: 27/01/2022
End of Standstill: 14/02/2022
Invocation of the Emergency Procedure: Yes

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Message 002

Communication from the Commission - TRIS/(2022) 00268
Directive (EU) 2015/1535
Translation of the message 001
Notification: 2022/0049/HU

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 - Não 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: 202200268.EN)

1. Structured Information Line
MSG 002 IND 2022 0049 HU EN 27-01-2022 HU NOTIF


2. Member State
HU


3. Department Responsible
Igazságügyi Minisztérium
EU Jogi Megfelelésvizsgálati Főosztály - Műszaki Notifikációs Központ
H-1055 Budapest, Nádor u. 22.
E-mail: technicalnotification@im.gov.hu


3. Originating Department
Emberi Erőforrások Minisztériuma
Gyógyszerészeti és Orvostechnikai Főosztály
H-1054 Budapest V. Akadémia utca 3.
E-mail cím: gyogyszerv@emmi.gov.hu


4. Notification Number
2022/0049/HU - C00P


5. Title
Amendment of Decree No 55/2014 of the Ministry of Human Capacities of 30 December 2014 on substances or groups of compounds classified as new psychoactive substances (hereinafter: ‘Decree’)


6. Products Concerned
The list of new psychoactive substances in Annex 1 to the Decree (hereinafter referred to as ‘List’) is extended with 3 new unique psychoactive substances that are susceptible to abuse.


7. Notification Under Another Act
-


8. Main Content
The 3 individual new psychoactive substances (desmethylmoramide, 5F-BZO-POXIZID, ADB-FUBIATA) that are to be included in the List of Annex 1 to the Decree shall not be freely marketed in Hungary and all activities carried out in their use shall only be carried out after registration by the authorities. In view of this, health risks will be reduced, as it will be made more difficult for substance users to gain access to these substances.


9. Brief Statement of Grounds
Section 15/B(1) of Act XCV of 2005 on medicinal products for human use and on the amendment of other regulations related to medicinal products (hereinafter referred to as ‘Medicines Act’) stipulates that a substance or group of compounds may be classified as a new psychoactive substance after prior professional evaluation.

Pursuant to Section 15/B (3) of the Medicines Act such preliminary professional evaluation should verify that, concerning the given substance or group of compounds, the Hungarian authorities and expert institutions
(a) have no knowledge of any information that would indicate the pharmaceutical use of the substance or the group of compounds, and
(b) nor do they have any information which rules out the possibility that the given substance or group of compounds poses a threat to public health to a similar extent as the drugs specified in Section 1 (4) of the Medicines Act or the substances listed in Schedules I and II of Legislative Decree No 25 of 1979 on the promulgation of the Convention on Psychotropic Substances, signed in Vienna on 21 February 1971, or the substances included in the lists of Annex 2 to the Medicines Act.

Pursuant to Section 27(4a) of Government Decree No 66/2012 of 2 April 2012 on activities related to narcotic drugs, psychotropic substances and new psychoactive substances, on the listing of these substances and on the modification of the lists (hereinafter: ‘Government Decree’), the new task of the Hungarian National Drug Focal Point is to monitor within the framework of information exchange, on a monthly basis, the list of suspected new psychoactive substances that are released abroad. As part of this, 2 new substances were found that are included in the European Early Warning System (EMCDDA Early Warning System) but are not subject to control in Hungary. 1 additional substance has been identified in the domestic market.

In accordance with Section 27 (4)(c) and (4a) of the Government Decree, the National Drug Focal Point contacted the National Institute of Pharmacy and Nutrition (hereinafter: NIPN) and the National Food Chain Safety Office (hereinafter: NFCSO) in connection with the above-mentioned 3 substances to verify whether the conditions specified in Section 15/B (3) of the Medicines Act are met. Based on NIPN's and NFCSO’s response and its own further investigation, the National Drug Focal Point concluded that the abusive use of these substances and their presence on the black market can be presumed, which justifies their classification as new psychoactive substances.

In line with the above, 3 new unique psychoactive substances will be added to the List in Annex 1 to the Decree.


10. Reference Documents - Basic Texts
Restrictions on the marketing or use of chemical substances, preparations or products
Reference(s) to basic text(s): Decree No 55/2014 of the Ministry of Human Capacities of 30 December 2014 on substances or groups of compounds classified as new psychoactive substances (Notification No. 2015/62/HU, 2017/417/HU, 2018/514/HU, 2019/530/HU, 2020/463/HU, 2021/0017/HU, 2021/225/HU, 2021/365/HU, 2021/554/HU, 2021/718/HU, 2021/840/HU, 2021/910/HU)
The basic texts were forwarded with an earlier notification: 2012/137/HU: 2014/589/HU


11. Invocation of the Emergency Procedure
Yes


12. Grounds for the Emergency
Notification of the amendments to the List in Annex 1 of the Decree, as a matter of urgency, is justified on grounds of both public health and public security. However, as long as the 3 compounds concerned are not included in the List, the Hungarian authorities are not authorised, under national law, to intervene and are unable to prevent such substances with unpredictable effects from claiming new victims. Inclusion in the List means several months of procedure. This enables distributors to sell these substances to consumers with impunity during this period.

The rapid entry into force of the amendment could ensure that there is a real chance for real-time response on behalf of the authorities once a new psychoactive substance already present in another Member State appears in Hungary. This could be an alternative to following up the changing market supply of illegal substances, which could force the country to allow the marketing of such substances without prosecution in the absence of the necessary legal prohibition. Recent experience has shown that it does not take long for any new psychoactive substance appearing in a Member State to also reach Hungary.

Any delay in this matter risks more young people falling victim to these new psychoactive substances.

Based on our experience, it is noted that these substances may be even more dangerous for consumers than traditional drugs or the new psychoactive substances that have appeared in the past as their mechanism of action and its effects are unpredictable.


13. Confidentiality
No


14. Fiscal measures
No


15. Impact assessment
Yes


16. TBT and SPS aspects
TBT aspect

No – the draft is neither a technical regulation nor a conformity assessment procedure.

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

SPS aspect

No – the draft is neither a sanitary nor a phytosanitary measure.

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

Contact point Directive (EU) 2015/1535
Fax: +32 229 98043
email: grow-dir2015-1535-central@ec.europa.eu

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