Notification Detail

The Finnish Medicines Agency Fimea has drafted a new Decision on the list of medicinal products and its annexes. Fimea ratifies the list of medicinal products at least once every three years pursuant to Section 83 of the Finnish Medicines Act (395/1987). Finland's new draft decision: The Finnish Medicines Agency Fimea’s Decision (2022/xx) on the list of medicinal products.

Notification Number: 2021/839/FIN (Finland )
Date received: 08/12/2021
End of Standstill: 09/03/2022

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Message 002

Communication from the Commission - TRIS/(2021) 04489
Directive (EU) 2015/1535
Translation of the message 001
Notification: 2021/0839/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 - 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: 202104489.EN)

1. Structured Information Line
MSG 002 IND 2021 0839 FIN EN 08-12-2021 FIN NOTIF


2. Member State
FIN


3. Department Responsible
Työ- ja elinkeinoministeriö
Työllisyys ja toimivat markkinat -osasto
PL 32
FI-00023 VALTIONEUVOSTO
maaraykset.tekniset.tem@gov.fi
PUHELIN +358 29 5047015


3. Originating Department
Lääkealan turvallisuus- ja kehittämiskeskus (Fimea)
Mannerheimintie 166, PL 55
FI-00034 FIMEA

Puhelin +358 29 5223643


4. Notification Number
2021/0839/FIN - C00P


5. Title
The Finnish Medicines Agency Fimea has drafted a new Decision on the list of medicinal products and its annexes. Fimea ratifies the list of medicinal products at least once every three years pursuant to Section 83 of the Finnish Medicines Act (395/1987).

Finland's new draft decision:

The Finnish Medicines Agency Fimea’s Decision (2022/xx) on the list of medicinal products.


6. Products Concerned
Medicinal products and substances


7. Notification Under Another Act
-


8. Main Content
The Decision is intended for the supervisory authorities, particularly to facilitate the monitoring of imports and to provide clarification for the public as to what substances are deemed to be medicinal products. Fimea has updated the substances in the annexes and added substances relevant for control purposes to the previous list.

The list of medicinal products is drawn up taking into consideration the provisions of Sections 3 and 5 of the Finnish Medicines Act.

The most important changes to the annexes of the previous list of medicinal products are:
Annex 1. 2,778 medicinal substances, of which a total of 140 are new medicinal substances
Annex 1A. 92 medicinal substance analogues and prohormones, 46 of which are new
Annex 2. 399 herbal products with medicinal properties, no changes


9. Brief Statement of Grounds
The definition of a medicinal product under the Finnish Medicines Act is written in full in the Decision. The Decision states that the list is neither absolute nor exhaustive. The Decision states the difference between substances and preparations as regards their medicinal properties.

The substances and herbal products listed in Annexes 1 and 2 either have been or still are used for medicinal purposes, or may have a medicinal application.

The substances listed in Annex 1A are medicinal substance analogues and prohormones which will be brought under supervisory control.


10. Reference Documents - Basic Texts
Basic text references: Sections 3, 5, 6 and 83 of the Finnish Medicines Act (395/1987).


11. Invocation of the Emergency Procedure
No


12. Grounds for the Emergency
-


13. Confidentiality
No


14. Fiscal measures
No


15. Impact assessment
-


16. TBT and SPS aspects
TBT aspects

No - The draft has no significant impact on international trade.

SPS aspects

No - The draft is not a sanitary or 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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