Notification Detail | TRIS - European Commission

Regulations amending the Swedish Medical Products Agency's Regulations (LVFS 2011:9) on the Control of Narcotic Drugs

Notification Number:

2024/0533/SE (Sweden)

Date received:

20/09/2024

End of Standstill:

23/12/2024 (closed)

Draft Text:

SV BG HR CS DA NL EN ET FI FR GA DE EL HU IT LV LT MT PL PT RO SK SL ES

Impact assessment:

SV EN FR DE

Final Text:

SV BG CS DA DE EL EN ES ET FI FR GA HR HU IT LT LV MT NL PL PT RO SK SL

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Message

Message 001

Communication from the Commission - TRIS/(2024) 2549

Directive (EU) 2015/1535

Notification: 2024/0533/SE

Notification of a draft text from a Member State

Notification – Notification – Notifzierung – Нотификация – Oznámení – Notifikation – Γνωστοποίηση – Notificación – Teavitamine – Ilmoitus – Obavijest – Bejelentés – Notifica – Pranešimas – Paziņojums – Notifika – Kennisgeving – Zawiadomienie – Notificação – Notificare – Oznámenie – Obvestilo – Anmälan – Fógra a thabhairt

Does not open the delays - N'ouvre pas de délai - Kein Fristbeginn - Не се предвижда период на прекъсване - Nezahajuje prodlení - Fristerne indledes ikke - Καμμία έναρξη προθεσμίας - No abre el plazo - Viivituste perioodi ei avata - Määräaika ei ala tästä - Ne otvara razdoblje kašnjenja - Nem nyitja meg a késéseket - Non fa decorrere la mora - Atidėjimai nepradedami - Atlikšanas laikposms nesākas - Ma jiftaħx il-perijodi ta’ dewmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Nu deschide perioadele de stagnare - Nezačína oneskorenia - Ne uvaja zamud - Inleder ingen frist - Ní osclaíonn sé na moilleanna

MSG: 20242549.EN

1. MSG 001 IND 2024 0533 SE EN 20-09-2024 SE NOTIF

2. Sweden

3A. Kommerskollegium
Box 6803, 113 86 Stockholm
Sverige
Tel: 08-690 48 00
epost: 1535@kommerskollegium.se

3B. Läkemedelsverket
Dag Hammarskjölds väg 42
752 37 Uppsala
Sverige

4. 2024/0533/SE - C10P - Pharmaceuticals

5. Regulations amending the Swedish Medical Products Agency's Regulations (LVFS 2011:9) on the Control of Narcotic Drugs

6. - Tramadol preparations
- Cocaine preparations

7.

8. Section 2 and the Appendix to the Swedish Medical Products Agency's regulations (LVFS 2011:9) on the Control of Narcotic Drugs regulate which narcotic substances are exempted from certain provisions in the regulations on the control of narcotic drugs. The exemptions concern, inter alia, authorisation requirements in certain situations and rules concerning the handling of narcotic drugs. Certain Tramadol preparations are currently exempted from these provisions. The draft regulation means that these preparations will no longer be exempt, which results in tighter regulation for these Tramadol preparations. Furthermore, the draft means that certain cocaine preparations will be included in the exemptions.

The draft concerns the following goods:
- Tramadol preparations containing not more than 400 mg Tramadol per divided dose in a mixture with one or more other ingredients or containing not more than 10 percent Tramadol, if the preparations are not divided into doses
- Cocaine preparations containing in a mixture not more than 0.1 percent cocaine, calculated as cocaine base, mixed with one or more non-narcotic substances in such a way that the constituent narcotic drug cannot be extracted by simple methods.

9. The purpose of the proposal, in so far as it concerns tightening the requirements for certain Tramadol preparations, is to increase the control of the substance in order to protect public health. The stricter requirements lead to increased control of Tramadol drugs in Sweden and reduce the risk that these end up on the illegal market because increased control will make it difficult to divert such drugs from the legal supply chain.

The purpose of the proposal, in so far as it concerns cocaine preparations, is to achieve better use of resources and to reduce the administrative burden for businesses and authorities by exempting certain such preparations exclusively intended for medical use from requirements not deemed necessary for such preparations and uses.

The proposals are deemed to comply with EU law as they are non-discriminatory, proportionate and their implementation is necessary in order to ensure public health. For this reason, it is considered to be a permitted restriction on the free movement of goods.

The drug regulations are nationally regulated by the member states. One of the substances in question (Tramadol) is not classified as a narcotic drug in all Member States. The authorisations provided for in the regulations cannot be issued by an authority in another Member State. Mutual recognition of another country's authorisation or other decisions relating to the substance is therefore not possible.

10. Reference(s) to basic text(s): No basic texts available

11. No

12.

13. No

14. No

15. Yes

16.
TBT aspects: No

SPS aspects: No

**********
European Commission
Contact point Directive (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu

Disclosed messages

message-id	Year	Number	Country	Type	Title	Date received
109504	2024	2550	COMEuropean Commission	003	Receipt of the draft text	20-09-2024
109505	2024	2551	COMEuropean Commission	037	Competitiveness analysis	20-09-2024
111971	2025	1444	COMEuropean Commission	049	Acknowledgement of receipt of the adopted text	05-06-2025

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