Notification Detail | TRIS - European Commission

Preliminary draft law setting out various provisions on health

Notification Number:

2022/0162/B (Belgium)

Date received:

17/03/2022

End of Standstill:

20/06/2022

Draft Text:

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

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Message

Message 002

Communication from the Commission - TRIS/(2022) 00913
Directive (EU) 2015/1535
Translation of the message 001
Notification: 2022/0162/B

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: 202200913.EN)
1. MSG 002 IND 2022 0162 B EN 17-03-2022 B NOTIF

2. B

3A. FOD Economie, KMO, Middenstand en Energie
Algemene Directie Kwaliteit en Veiligheid - Dienst Normalisatie en Competitiviteit - BELNotif
NG III – 2de verdieping
Koning Albert II-laan, 16
B - 1000 Brussel
Tel: 02/277.53.36
be.belnotif@economie.fgov.be

3B. Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten
Afdeling Wetgeving en Geschillen
Galileelaan 5/03
1210 Brussel
IUS@fagg-afmps.be; + 32 2 528 40 00

4. 2022/0162/B - C10P

5. Preliminary draft law setting out various provisions on health

6. This draft pertains to the naming of medicinal products for human use authorised in Belgium.

7. -

8. The provision in question is an express normative provision stipulating that the invented name of a medicinal product shall not create confusion with other medicinal products, medical devices or food supplements. Nor shall the invented name of a medicinal product create confusion regarding its quality or other properties.

This rule will apply to ‘new’ medicinal products, i.e. those that have not yet received a ‘national’ marketing authorisation, and medicinal products already ‘nationally’ authorised, whose marketing authorisation holder applies for a name change.

9. In practice, the invented names proposed for medicinal products are often highly similar to the invented names of medicinal or other products that are already authorised. In addition, the authorities often find that a proposed invented name contains information that is confusing, incorrect, etc., regarding the quality or properties of the medicinal product in question. These kinds of invented names increase the risk of improper use (e.g. for the target population, indications or composition) of the medicinal products. An express normative provision setting the principle that the invented name of a medicinal product shall not create confusion with the invented name of other products, nor regarding the quality and/or other properties of the medicinal product, is necessary in the interest of public health.

10. No basic text(s) available

11. No

12. -

13. No

14. No

15. -

16. TBT aspect

NO - The draft does not have a major impact on international trade.

SPS aspect

NO - The draft does not have a major impact on international trade.

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

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

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