Notification Detail

Draft Order amending the Order of the 1st of June 2021 prescribing the general measures necessary to manage the exit from the health crisis

Notification Number: 2022/46/F (France )
Date received: 26/01/2022
End of Standstill: 24/02/2022
Invocation of the Emergency Procedure: Yes

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Message 002

Communication from the Commission - TRIS/(2022) 00259
Directive (EU) 2015/1535
Translation of the message 001
Notification: 2022/0046/F

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: 202200259.EN)

1. Structured Information Line
MSG 002 IND 2022 0046 F EN 26-01-2022 F NOTIF


2. Member State
F


3. Department Responsible
Direction générale des entreprises
SQUALPI
Bât. Sieyès -Teledoc 151
61, Bd Vincent Auriol
75703 PARIS Cedex 13
d9834.france@finances.gouv.fr


3. Originating Department
Direction des affaires juridiques
Ministère des solidarités et de la santé
14, avenue Duquesne
75 007 PARIS
Tél : 01 40 56 65 57
E-mail :
daj-sec@sg.social.gouv.fr


4. Notification Number
2022/0046/F - S00S


5. Title
Draft Order amending the Order of the 1st of June 2021 prescribing the general measures necessary to manage the exit from the health crisis


6. Products Concerned
- Medicines
- Medical devices


7. Notification Under Another Act
-


8. Main Content
The proposed scheme would implement a series of measures:
Firstly, with regard to the paediatric vaccination campaign, the decree provides for the expansion of the swabbers. Midwives, nurses and dispensing pharmacists, on the condition that they have completed the common law training in vaccination, may prescribe and administer vaccines for children between 5 and 11 years of age. Dental surgeons will be able to administer the same vaccines once they have been prescribed in advance by a healthcare professional authorised to do so and provided that they have undergone specific training in vaccination against COVID-19. Within the vaccination centres, the categories of professionals and students authorised to carry out such vaccination are expanded. Postgraduate students in medicine and pharmacy will therefore be able to inject these vaccines for children, as well as graduate students in medicine, pharmacy and midwifery and nursing students who have validated their first year of training if they have completed the theoretical and practical teachings related to vaccination as part of their curriculum and only in the presence of a doctor, nurse or pharmacist. Firefighters and holders of second-level first aid training (PES2) are also authorised to do so under the responsibility of a doctor and provided that they have undergone specific training in carrying out this action.

The project then provides for the remuneration of healthcare professionals involved in prescribing, dispensing and monitoring of new oral antiviral treatments for COVID-19 with authorisation for early access, for which dispensing in pharmacies is made possible by way of derogation, in addition to dispensing in hospitals. : Lastly, provision is made for the State to take charge of paying compensation for any damage connected with the administration of these medicinal products.


9. Brief Statement of Grounds
In the context of the COVID-19 pandemic, protection by the widest possible vaccination of the population is essential; for this purpose, where necessary, in order to facilitate the deployment of the vaccination campaign for children aged 5 to 11 against COVID-19, the list of healthcare professionals, health students and other professionals who may intervene to prescribe, administer or inject paediatric vaccines should be extended and the procedures by which they may carry out such actions should be specified;

New COVID-19 treatments can be of significant benefit to patients with COVID-19, especially those with contraindications to vaccination. Their dispensation is permitted in a derogatory framework in pharmacies. It is therefore appropriate to align the compensation scheme for possible losses with the scheme applicable to vaccines against COVID-19 and to establish the conditions of remuneration of the personnel involved in the prescribing, dispensing and monitoring of oral antiviral treatments in cities subject to authorisation for early access.


10. Reference Documents - Basic Texts
References to basic texts: Article L. 3131-1 of the Public Health Code


11. Invocation of the Emergency Procedure
Yes


12. Grounds for the Emergency
Emergency measure designed to protect the population from the serious health threat posed by the novel coronavirus (COVID-19)


13. Confidentiality
No


14. Fiscal measures
No


15. Impact assessment
-


16. TBT and SPS aspects
TBT aspect

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

SPS aspect

NO - The draft does not have a significant 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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