Message 001
Communication from the Commission - TRIS/(2024) 0555
Directive (EU) 2015/1535
Notification: 2024/0114/DK
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: 20240555.EN
1. MSG 001 IND 2024 0114 DK EN 28-02-2024 DK NOTIF
2. Denmark
3A. Erhvervsstyrelsen
Langelinie Allé 17
2100 København Ø
Danmark
+45 35 29 10 00
nofitikationer@erst.dk
3B. Indenrigs- og Sundhedsministeriet
Slotsholmsgade 10-12
1216 København K
Danmark
+45 72 26 90 00
sum@sum.dk
4. 2024/0114/DK - S00S - HEALTH, MEDICAL EQUIPMENT
5. - Order on medicinal products covered by mandatory stocks and reporting obligations for critical medicinal products
6. The following products are affected by the draft Act:
Critical medicinal products, cf. Annex 1 to the draft Order on medicinal products covered by mandatory stocks and reporting obligations for critical medicinal products
7.
8. The following products are affected by the draft Act:
Critical medicinal products, cf. Annex 1 to the draft Order on medicinal products covered by mandatory stocks and reporting obligations for critical medicinal products
The following groups are affected by the draft Act:
Marketing authorisation holders in Denmark, holders of parallel import authorisations and companies distributing medicinal products in parallel to Denmark after notification to the European Medicines Agency.
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, OJ 2001 L 311, p. 67, as amended, inter alia, by Directive 2010/84/EU of 15 December 2010, OJ 2010 L 348, p. 74, Directive 2011/62/EU of 8 June 2011, OJ 2011 L 174, p. 74, and Directive 2012/26/EU of 25 October 2012, OJ 2012 L 299, p. 1.
Implementation of parts of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, OJ 2001 L 311, p. 67, as amended, inter alia, by Directive 2010/84/EU of 15 December 2010, OJ 2010 L 348, p. 74, Directive 2011/62/EU of 8 June 2011, OJ 2011 L 174, p. 74, and Directive 2012/26/EU of 25 October 2012, OJ 2012 L 299, p. 1.
The draft Order, which is to be seen in the context of the Order on mandatory stocks and reporting obligations for critical medicinal products, will implement the enabling provisions in Section 75(4) and Section 75 b(2) of the draft Act amending the Act on medicinal products (Mandatory stocks of critical medicinal products etc.).
The Order on medicinal products covered by mandatory stocks and reporting obligations for critical medicinal products lays down in Annex 1 of the Order which medicinal products are considered critical and covered by the stock obligation. The Danish Medicines Agency is expected to assess every 3 months whether Annex 1 should be updated/revised.
9. The draft Act amending the Act on medicinal products (Mandatory stocks of critical medicines etc.) and the Orders will create an obligation for companies placing critical medicinal products for use in the primary sector on the market to maintain security stocks of the medicinal products concerned.
Stocks shall cover the need for critical medicinal products in the event of short-term supply difficulties, so that patients and communities are not affected. They shall also give the Danish Medicines Agency and other operators time to take the necessary measures to mitigate the consequences of long-term supply difficulties that cannot be covered by the stocks.
At the same time, the scheme must be designed in such a way that it does not impose obligations on companies beyond what is deemed necessary to achieve the necessary security in the supply of critical medicinal products. The scheme must be organised as flexibly as possible, without impairing its effect.
10. References in the basic text: Basic texts have been forwarded as part of an earlier notification:
2024/0111/DK
2024/0113/DK
11. No
12.
13. No
14. No
15. No
16.
TBT aspects: No
SPS aspects: No
**********
European Commission
Contact point Directive (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu
